[sheet: Cover]

Field	Value
Document Title	Substantial Equivalence Comparison Table
Subject Device	Solstice Lumina™ CGM System (Lumina C14 Sensor & Lumina R7 Reader/Transmitter)
Applicant	Solstice Biomedical Inc.
Applicant Address	220 Westbrook Drive, Suite 400, Cambridge, MA 02142
Delaware File No.	7834291
Parent Entity	Solstice Biomedical Devices Ltd., Unit 14, Liffey Innovation Park, Chapelizod, Dublin D20 FX72, Ireland (CRO No. 648231)
Submission Type	Traditional 510(k)
Product Code (Anticipated)	QKQ — Electrode, Glucose, Subcutaneous
Regulation Number (Anticipated)	21 C.F.R. § 862.1355
Device Classification	Class II
Primary Predicate Device	NovaSense GlucoTrack NX-500 CGM System, 510(k) No. K211034, Cleared June 18, 2022
Secondary Predicate (Reference Device)	NovaSense GlucoTrack NX-700 CGM System, 510(k) No. K230489, Cleared March 7, 2024
Additional Reference Device	Solstice GlucoStrip RX-200 Test Strip Reader, 510(k) No. K192847, Cleared November 14, 2019 (corporate pedigree / prior FDA interaction only; not cited as predicate for substantial equivalence)
Primary Predicate Manufacturer	NovaSense Medical Technologies Inc., 4800 Innovation Parkway, San Diego, CA 92121
Target 510(k) Submission Date	April 30, 2026
Prepared By	Calderwood & Harkness LLP, 1401 K Street NW, Suite 900, Washington, D.C. 20005
Engagement Reference No.	1037-00002
Draft Date	April 2025
Status	DRAFT — For Internal Review Only
Regulatory Consultant	Pinnacle Regulatory Consulting Group LLC, 9500 Medical Center Drive, Suite 210, Rockville, MD 20850

[sheet: Intended Use & Indications]

Comparison Parameter	Subject Device — Solstice Lumina™ CGM System	Primary Predicate — NovaSense GlucoTrack NX-500 (K211034)	Secondary Predicate — NovaSense GlucoTrack NX-700 (K230489)	Substantial Equivalence Assessment
Intended Use	Continuous measurement of glucose levels in the interstitial fluid of persons aged 18 and older with Type 1 or Type 2 diabetes mellitus	Continuous measurement of glucose levels in the interstitial fluid of adults with Type 1 or Type 2 diabetes mellitus	Continuous measurement of glucose levels in the interstitial fluid of adults with Type 1 or Type 2 diabetes mellitus	Same intended use — no new questions of safety or effectiveness
Indications for Use	Prescription use; real-time continuous glucose monitoring for diabetes management in persons aged 18+ with Type 1 or Type 2 diabetes mellitus; intended to replace fingerstick blood glucose testing for diabetes treatment decisions	Prescription use; real-time CGM for adults with Type 1 or Type 2 diabetes mellitus	Prescription use; real-time CGM for adults with Type 1 or Type 2 diabetes mellitus; intended to replace fingerstick SMBG	Substantially equivalent indications for use
Target Patient Population	Adults aged ≥ 18 years with Type 1 or Type 2 diabetes mellitus	Adults with Type 1 or Type 2 diabetes mellitus	Adults with Type 1 or Type 2 diabetes mellitus	Same patient population
Prescription / OTC Status	Prescription (Rx) only	Prescription (Rx) only	Prescription (Rx) only	Same
Use Environment	Home use / ambulatory / outpatient	Home use / ambulatory / outpatient	Home use / ambulatory / outpatient	Same
Adjunctive vs. Non-Adjunctive	Non-adjunctive (intended to replace fingerstick SMBG)	Non-adjunctive	Non-adjunctive	Same
Contraindications	MRI incompatibility during sensor wear; patients < 18 years of age	MRI incompatibility during sensor wear	MRI incompatibility during sensor wear	Substantially equivalent; age-specific contraindication consistent with labeled indication
Duration of Use per Sensor Application	Up to 14 days continuous wear	Up to 10 days continuous wear	Up to 14 days continuous wear	Consistent with secondary predicate; supported by clinical and biocompatibility data
User / Operator	Patient self-use (lay user) under prescription of a healthcare professional	Patient self-use under prescription	Patient self-use under prescription	Same
Intended Use Statement Summary	The Solstice Lumina™ CGM System is a prescription, non-adjunctive, real-time continuous glucose monitoring system for adults (≥ 18 years) with diabetes mellitus	Prescription, non-adjunctive, real-time CGM for adults with diabetes mellitus	Prescription, non-adjunctive, real-time CGM for adults with diabetes mellitus	Same intended use — substantially equivalent

[sheet: Device Description & Design]

Comparison Parameter	Subject Device — Solstice Lumina™ CGM System	Primary Predicate — NovaSense GlucoTrack NX-500 (K211034)	Secondary Predicate — NovaSense GlucoTrack NX-700 (K230489)	Substantial Equivalence Assessment
System Components	Lumina C14 implantable sensor + Lumina R7 wearable reader/transmitter + Lumina™ Mobile App (iOS and Android)	Subcutaneous sensor + Handheld receiver	Subcutaneous sensor + Handheld receiver + Mobile App	Similar system architecture; differences in reader form factor addressed below
Sensor Type	Subcutaneously implantable continuous glucose monitoring sensor	Subcutaneously implantable CGM sensor	Subcutaneously implantable CGM sensor	Same sensor type
Sensor Technology	Fourth-generation enzymatic electrochemical biosensor	Enzymatic electrochemical biosensor	Enzymatic electrochemical biosensor (enhanced)	Same fundamental sensing technology
Sensor Insertion Site	Upper arm / abdomen (subcutaneous)	Abdomen (subcutaneous)	Upper arm / abdomen (subcutaneous)	Similar; subject device consistent with secondary predicate
Sensor Dimensions	C14 sensor: 35 mm diameter × 5 mm height; filament length 6.5 mm	34 mm diameter × 5 mm height; filament length 6.0 mm	35 mm diameter × 5 mm height; filament length 6.5 mm	Similar dimensions; consistent with secondary predicate
Sensor Weight	Approximately 4.2 g (with adhesive patch)	Approximately 3.8 g	Approximately 4.0 g	Similar weight
Reader / Transmitter Form Factor	Arm-worn integrated wearable reader/transmitter (Lumina R7)	Handheld receiver	Handheld receiver	Different form factor — arm-worn vs. handheld; does not alter intended use or raise new safety/effectiveness questions; functionally equivalent data display and alert capabilities
Reader Dimensions	R7 reader: 48 mm × 32 mm × 12 mm	Handheld: 96 mm × 52 mm × 14 mm	Handheld: 94 mm × 50 mm × 13 mm	Different form factor; smaller wearable design
Reader Display Features	Real-time glucose value, trend arrows, 8-hour trend graphs, configurable hypo/hyperglycemia alerts	Real-time glucose value, trend arrows, trend graphs, alerts	Real-time glucose value, trend arrows, trend graphs, configurable alerts	Functionally equivalent display capabilities
Mobile Application	Solstice Lumina™ Mobile App v1.0.3 (iOS and Android); receives BLE data from R7 reader	N/A (handheld receiver only)	Mobile app (iOS and Android)	Subject device includes mobile app consistent with secondary predicate
Sensor Applicator	Single-use automated inserter	Single-use automated inserter	Single-use automated inserter	Same
Product Code	QKQ (anticipated)	QKQ	QKQ	Same product code
Device Classification	Class II	Class II	Class II	Same classification
Regulation Number	21 C.F.R. § 862.1355	21 C.F.R. § 862.1355	21 C.F.R. § 862.1355	Same regulation number
Water Resistance Rating	IP28 (submersion up to 2.5 m for 30 minutes)	IP27 (submersion up to 1.0 m for 30 minutes)	IP28 (submersion up to 2.5 m for 30 minutes)	Consistent with secondary predicate; improved water resistance does not raise new safety questions

[sheet: Technological Characteristics]

Comparison Parameter	Subject Device — Solstice Lumina™ CGM System	Primary Predicate — NovaSense GlucoTrack NX-500 (K211034)	Secondary Predicate — NovaSense GlucoTrack NX-700 (K230489)	Difference from Primary Predicate?	Substantial Equivalence Assessment
Sensor Wear Duration	14 days (336 hours)	10 days (240 hours)	14 days (336 hours)	Yes — 14 days vs. 10 days	Difference aligned with secondary predicate K230489 (14-day wear). Extended wear duration supported by biocompatibility and performance data. Does not raise new questions of safety or effectiveness.
Electrode Material	Platinum-iridium (proprietary PtIr-4G electrode coating)	Platinum	Platinum (enhanced coating)	Yes — Platinum-iridium vs. Platinum	Different electrode alloy composition; PtIr-4G provides enhanced signal stability and corrosion resistance. Biocompatibility of PtIr-4G assessed per ISO 10993 series. Performance data demonstrates equivalent or superior sensor accuracy. Does not raise new questions of safety or effectiveness.
Wireless Communication Protocol	Bluetooth Low Energy (BLE) 5.2	Bluetooth Low Energy (BLE) 5.0	Bluetooth Low Energy (BLE) 5.0	Yes — BLE 5.2 vs. BLE 5.0	Incremental update to industry-standard wireless protocol; backward-compatible; improved data throughput and range. EMC testing per applicable standards demonstrates compliance. Does not raise new questions of safety or effectiveness.
Reader/Transmitter Form Factor	Arm-worn integrated wearable reader/transmitter	Handheld receiver	Handheld receiver	Yes — arm-worn vs. handheld	Different physical form factor for data display component; does not alter sensing technology, measurement methodology, or data processing. Biocompatibility of skin-contact materials assessed per ISO 10993. Does not raise new questions of safety or effectiveness.
Glucose Prediction Algorithm	Solstice proprietary algorithm — LuminaPredict v2.1	NovaSense proprietary algorithm	NovaSense proprietary algorithm (updated)	Yes — different algorithm	Different proprietary algorithm; LuminaPredict v2.1 has been validated through analytical and clinical performance studies demonstrating MARD ≤ 9.0%. Software verification and validation documentation provided. Does not raise new questions of safety or effectiveness.
Sensing Mechanism	Enzymatic electrochemical (glucose oxidase)	Enzymatic electrochemical (glucose oxidase)	Enzymatic electrochemical (glucose oxidase)	No	Same fundamental sensing mechanism
Calibration Method	Factory-calibrated (no user calibration required)	Factory-calibrated	Factory-calibrated	No	Same calibration approach
Data Transmission Frequency	Every 1 minute	Every 1 minute	Every 1 minute	No	Same
Alert Capability	Configurable hypo/hyperglycemia alerts; alert latency ≤ 5 minutes from sensor reading to user notification	Hypo/hyperglycemia alerts	Configurable hypo/hyperglycemia alerts	No (enhanced configurability consistent with secondary predicate)	Substantially equivalent alert functionality
Power Source (Sensor)	Integrated non-rechargeable battery (14-day life)	Integrated non-rechargeable battery (10-day life)	Integrated non-rechargeable battery (14-day life)	No (battery life matches sensor wear duration)	Battery life proportional to sensor wear; consistent with secondary predicate
Power Source (Reader)	Rechargeable lithium-polymer battery	Rechargeable battery	Rechargeable battery	No	Same
Operational Temperature Range	10°C to 45°C (50°F to 113°F)	10°C to 45°C	10°C to 45°C	No	Same operational temperature range
Storage Temperature Range	2°C to 30°C (36°F to 86°F)	2°C to 30°C	2°C to 30°C	No	Same storage temperature range
Operating Humidity Range	10% to 95% RH (non-condensing)	10% to 95% RH (non-condensing)	10% to 95% RH (non-condensing)	No	Same
Data Storage Capacity	90 days of glucose data on reader; unlimited via mobile app cloud sync	60 days on receiver	90 days on receiver; cloud sync via app	No (consistent with secondary predicate)	Enhanced data storage consistent with secondary predicate
Sensor Insertion Depth	Approximately 6.5 mm subcutaneous	Approximately 6.0 mm subcutaneous	Approximately 6.5 mm subcutaneous	No (consistent with secondary predicate)	Consistent with secondary predicate
Number of Electrodes	Three-electrode system (working, counter, reference)	Three-electrode system	Three-electrode system	No	Same electrode configuration
Wireless Communication Range	Up to 10 meters (line of sight)	Up to 6 meters	Up to 6 meters	No (improved range is a benefit of BLE 5.2)	Enhanced range consistent with BLE 5.2; does not raise new safety or effectiveness questions

[sheet: Performance Specifications]

Performance Parameter	Subject Device — Solstice Lumina™ CGM System	Primary Predicate — NovaSense GlucoTrack NX-500 (K211034)	Secondary Predicate — NovaSense GlucoTrack NX-700 (K230489)	Substantial Equivalence Assessment
MARD (Mean Absolute Relative Difference) — Overall	Target: ≤ 9.0%	≤ 9.5% (per 510(k) clearance data)	≤ 8.8% (per 510(k) clearance data)	Subject device MARD target consistent with or superior to both predicates; consistent with FDA iCGM expectations per September 2023 guidance
Consensus Error Grid (Clarke Error Grid Analysis)	Target: ≥ 99% of paired data points in Zones A+B	≥ 98.5% in Zones A+B	≥ 99% in Zones A+B	Subject device target meets or exceeds both predicates
Measurement Range	40–400 mg/dL	40–400 mg/dL	40–400 mg/dL	Same measurement range
Sensor Functional Life	336 hours (14 days)	240 hours (10 days)	336 hours (14 days)	Consistent with secondary predicate; performance data supports extended 14-day wear
Warm-Up Time	≤ 60 minutes	≤ 60 minutes	≤ 60 minutes	Same
Alert Latency	≤ 5 minutes from sensor reading to user notification	≤ 5 minutes	≤ 5 minutes	Same
Sensor Accuracy in Hypoglycemic Range (< 70 mg/dL)	Data to be provided from LUMINA-US clinical study (Protocol SBD-LUM-CL-001)	Per clearance data	Per clearance data	To be demonstrated via pivotal clinical study
Sensor Accuracy in Euglycemic Range (70–180 mg/dL)	Data to be provided from LUMINA-US clinical study (Protocol SBD-LUM-CL-001)	Per clearance data	Per clearance data	To be demonstrated via pivotal clinical study
Sensor Accuracy in Hyperglycemic Range (> 180 mg/dL)	Data to be provided from LUMINA-US clinical study	Per clearance data	Per clearance data	To be demonstrated via pivotal clinical study
Interference Testing	Per FDA guidance; acetaminophen, ascorbic acid, salicylic acid, and other common interferents tested	Per FDA guidance	Per FDA guidance	Same testing approach
Linearity	40–400 mg/dL (tested per CLSI EP6-A)	40–400 mg/dL	40–400 mg/dL	Same
Precision (Within-Sensor CV)	Target: ≤ 5% CV	Per clearance data	Per clearance data	Comparable precision targets
Drift Assessment	Target: ≤ 10% signal drift over 14-day wear period	Per clearance data (10-day)	Per clearance data (14-day)	Drift target assessed over full 14-day wear; consistent with secondary predicate
Response Time (T90)	≤ 10 minutes (90% of steady-state response)	≤ 10 minutes	≤ 10 minutes	Same

[sheet: Materials & Biocompatibility]

Comparison Parameter	Subject Device — Solstice Lumina™ CGM System	Primary Predicate — NovaSense GlucoTrack NX-500 (K211034)	Secondary Predicate — NovaSense GlucoTrack NX-700 (K230489)	Substantial Equivalence Assessment
Sensor Electrode Material	Platinum-iridium alloy (proprietary PtIr-4G coating)	Platinum	Platinum (enhanced coating)	Different electrode material; biocompatibility evaluated per ISO 10993 series at Whitmore Laboratories Inc. (A2LA Certificate No. 3847.01)
Sensor Substrate / Housing Material	Medical-grade polymer (biocompatible polyurethane)	Medical-grade polymer	Medical-grade polymer	Same material class
Sensor Enzyme Layer	Glucose oxidase immobilized on electrode surface	Glucose oxidase	Glucose oxidase	Same enzyme system
Sensor Membrane	Biocompatible polymer membrane (diffusion-limiting layer)	Biocompatible polymer membrane	Biocompatible polymer membrane	Same membrane technology class
Adhesive (Sensor Patch)	Medical-grade skin adhesive (hypoallergenic, 14-day wear rated)	Medical-grade skin adhesive (10-day)	Medical-grade skin adhesive (14-day)	Similar adhesive; extended wear duration consistent with secondary predicate; sensitization and irritation testing per ISO 10993-10 and ISO 10993-23
Reader Housing Material (R7)	Medical-grade polycarbonate / silicone (skin-contact)	ABS plastic housing (handheld, limited skin contact)	ABS plastic housing (handheld)	Different form factor requires skin-contact biocompatibility assessment for R7
Reader Strap / Band Material	Medical-grade silicone (prolonged skin contact)	N/A (handheld)	N/A (handheld)	New component requiring prolonged skin-contact biocompatibility testing per ISO 10993
Biocompatibility Testing — C14 Sensor	Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-23), Acute Systemic Toxicity (ISO 10993-11), Subchronic Toxicity (ISO 10993-11), Implantation (ISO 10993-6), Hemocompatibility (ISO 10993-4), Genotoxicity (ISO 10993-3)	Per ISO 10993 (scope per clearance)	Per ISO 10993 (scope per clearance)	Comprehensive biocompatibility testing per ISO 10993-1:2018 risk-based approach; testing performed at Whitmore Laboratories Inc.; target completion August 31, 2025
Biocompatibility Testing — R7 Reader	Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-23)	Limited skin contact — per ISO 10993	Limited skin contact — per ISO 10993	Appropriate scope for prolonged skin-contact wearable device
Sterilization Method (Sensor)	Ethylene oxide (EO) sterilization	Ethylene oxide (EO)	Ethylene oxide (EO)	Same sterilization method
Sterilization Validation	Per ISO 11135:2014 (EO sterilization validation)	Per ISO 11135	Per ISO 11135	Same sterilization validation standard
Biocompatibility Testing Budget	$485,000 (Whitmore Laboratories quote dated March 3, 2025)	N/A	N/A	Reference for submission planning
Biocompatibility Testing Laboratory	Whitmore Laboratories Inc., 1625 Shady Grove Road, Suite 300, Gaithersburg, MD 20878; A2LA Certificate No. 3847.01	N/A	N/A	FDA-recognized, ISO 17025-accredited laboratory
Biocompatibility Testing Completion Target	August 31, 2025	N/A	N/A	On track per current project timeline

[sheet: Cover]
Field | Value
Document Title | Substantial Equivalence Comparison Table
Subject Device | Solstice Lumina™ CGM System (Lumina C14 Sensor & Lumina R7 Reader/Transmitter)
Applicant | Solstice Biomedical Inc.
Applicant Address | 220 Westbrook Drive, Suite 400, Cambridge, MA 02142
Delaware File No. | 7834291
Parent Entity | Solstice Biomedical Devices Ltd., Unit 14, Liffey Innovation Park, Chapelizod, Dublin D20 FX72, Ireland (CRO No. 648231)
Submission Type | Traditional 510(k)
Product Code (Anticipated) | QKQ — Electrode, Glucose, Subcutaneous
Regulation Number (Anticipated) | 21 C.F.R. § 862.1355
Device Classification | Class II
Primary Predicate Device | NovaSense GlucoTrack NX-500 CGM System, 510(k) No. K211034, Cleared June 18, 2022
Secondary Predicate (Reference Device) | NovaSense GlucoTrack NX-700 CGM System, 510(k) No. K230489, Cleared March 7, 2024
Additional Reference Device | Solstice GlucoStrip RX-200 Test Strip Reader, 510(k) No. K192847, Cleared November 14, 2019 (corporate pedigree / prior FDA interaction only; not cited as predicate for substantial equivalence)
Primary Predicate Manufacturer | NovaSense Medical Technologies Inc., 4800 Innovation Parkway, San Diego, CA 92121
Target 510(k) Submission Date | April 30, 2026
Prepared By | Calderwood & Harkness LLP, 1401 K Street NW, Suite 900, Washington, D.C. 20005
Engagement Reference No. | 1037-00002
Draft Date | April 2025
Status | DRAFT — For Internal Review Only
Regulatory Consultant | Pinnacle Regulatory Consulting Group LLC, 9500 Medical Center Drive, Suite 210, Rockville, MD 20850
[sheet: Intended Use & Indications]
Comparison Parameter | Subject Device — Solstice Lumina™ CGM System | Primary Predicate — NovaSense GlucoTrack NX-500 (K211034) | Secondary Predicate — NovaSense GlucoTrack NX-700 (K230489) | Substantial Equivalence Assessment
Intended Use | Continuous measurement of glucose levels in the interstitial fluid of persons aged 18 and older with Type 1 or Type 2 diabetes mellitus | Continuous measurement of glucose levels in the interstitial fluid of adults with Type 1 or Type 2 diabetes mellitus | Continuous measurement of glucose levels in the interstitial fluid of adults with Type 1 or Type 2 diabetes mellitus | Same intended use — no new questions of safety or effectiveness
Indications for Use | Prescription use; real-time continuous glucose monitoring for diabetes management in persons aged 18+ with Type 1 or Type 2 diabetes mellitus; intended to replace fingerstick blood glucose testing for diabetes treatment decisions | Prescription use; real-time CGM for adults with Type 1 or Type 2 diabetes mellitus | Prescription use; real-time CGM for adults with Type 1 or Type 2 diabetes mellitus; intended to replace fingerstick SMBG | Substantially equivalent indications for use
Target Patient Population | Adults aged ≥ 18 years with Type 1 or Type 2 diabetes mellitus | Adults with Type 1 or Type 2 diabetes mellitus | Adults with Type 1 or Type 2 diabetes mellitus | Same patient population
Prescription / OTC Status | Prescription (Rx) only | Prescription (Rx) only | Prescription (Rx) only | Same
Use Environment | Home use / ambulatory / outpatient | Home use / ambulatory / outpatient | Home use / ambulatory / outpatient | Same
Adjunctive vs. Non-Adjunctive | Non-adjunctive (intended to replace fingerstick SMBG) | Non-adjunctive | Non-adjunctive | Same
Contraindications | MRI incompatibility during sensor wear; patients < 18 years of age | MRI incompatibility during sensor wear | MRI incompatibility during sensor wear | Substantially equivalent; age-specific contraindication consistent with labeled indication
Duration of Use per Sensor Application | Up to 14 days continuous wear | Up to 10 days continuous wear | Up to 14 days continuous wear | Consistent with secondary predicate; supported by clinical and biocompatibility data
User / Operator | Patient self-use (lay user) under prescription of a healthcare professional | Patient self-use under prescription | Patient self-use under prescription | Same
Intended Use Statement Summary | The Solstice Lumina™ CGM System is a prescription, non-adjunctive, real-time continuous glucose monitoring system for adults (≥ 18 years) with diabetes mellitus | Prescription, non-adjunctive, real-time CGM for adults with diabetes mellitus | Prescription, non-adjunctive, real-time CGM for adults with diabetes mellitus | Same intended use — substantially equivalent
[sheet: Device Description & Design]
Comparison Parameter | Subject Device — Solstice Lumina™ CGM System | Primary Predicate — NovaSense GlucoTrack NX-500 (K211034) | Secondary Predicate — NovaSense GlucoTrack NX-700 (K230489) | Substantial Equivalence Assessment
System Components | Lumina C14 implantable sensor + Lumina R7 wearable reader/transmitter + Lumina™ Mobile App (iOS and Android) | Subcutaneous sensor + Handheld receiver | Subcutaneous sensor + Handheld receiver + Mobile App | Similar system architecture; differences in reader form factor addressed below
Sensor Type | Subcutaneously implantable continuous glucose monitoring sensor | Subcutaneously implantable CGM sensor | Subcutaneously implantable CGM sensor | Same sensor type
Sensor Technology | Fourth-generation enzymatic electrochemical biosensor | Enzymatic electrochemical biosensor | Enzymatic electrochemical biosensor (enhanced) | Same fundamental sensing technology
Sensor Insertion Site | Upper arm / abdomen (subcutaneous) | Abdomen (subcutaneous) | Upper arm / abdomen (subcutaneous) | Similar; subject device consistent with secondary predicate
Sensor Dimensions | C14 sensor: 35 mm diameter × 5 mm height; filament length 6.5 mm | 34 mm diameter × 5 mm height; filament length 6.0 mm | 35 mm diameter × 5 mm height; filament length 6.5 mm | Similar dimensions; consistent with secondary predicate
Sensor Weight | Approximately 4.2 g (with adhesive patch) | Approximately 3.8 g | Approximately 4.0 g | Similar weight
Reader / Transmitter Form Factor | Arm-worn integrated wearable reader/transmitter (Lumina R7) | Handheld receiver | Handheld receiver | Different form factor — arm-worn vs. handheld; does not alter intended use or raise new safety/effectiveness questions; functionally equivalent data display and alert capabilities
Reader Dimensions | R7 reader: 48 mm × 32 mm × 12 mm | Handheld: 96 mm × 52 mm × 14 mm | Handheld: 94 mm × 50 mm × 13 mm | Different form factor; smaller wearable design
Reader Display Features | Real-time glucose value, trend arrows, 8-hour trend graphs, configurable hypo/hyperglycemia alerts | Real-time glucose value, trend arrows, trend graphs, alerts | Real-time glucose value, trend arrows, trend graphs, configurable alerts | Functionally equivalent display capabilities
Mobile Application | Solstice Lumina™ Mobile App v1.0.3 (iOS and Android); receives BLE data from R7 reader | N/A (handheld receiver only) | Mobile app (iOS and Android) | Subject device includes mobile app consistent with secondary predicate
Sensor Applicator | Single-use automated inserter | Single-use automated inserter | Single-use automated inserter | Same
Product Code | QKQ (anticipated) | QKQ | QKQ | Same product code
Device Classification | Class II | Class II | Class II | Same classification
Regulation Number | 21 C.F.R. § 862.1355 | 21 C.F.R. § 862.1355 | 21 C.F.R. § 862.1355 | Same regulation number
Water Resistance Rating | IP28 (submersion up to 2.5 m for 30 minutes) | IP27 (submersion up to 1.0 m for 30 minutes) | IP28 (submersion up to 2.5 m for 30 minutes) | Consistent with secondary predicate; improved water resistance does not raise new safety questions
[sheet: Technological Characteristics]
Comparison Parameter | Subject Device — Solstice Lumina™ CGM System | Primary Predicate — NovaSense GlucoTrack NX-500 (K211034) | Secondary Predicate — NovaSense GlucoTrack NX-700 (K230489) | Difference from Primary Predicate? | Substantial Equivalence Assessment
Sensor Wear Duration | 14 days (336 hours) | 10 days (240 hours) | 14 days (336 hours) | Yes — 14 days vs. 10 days | Difference aligned with secondary predicate K230489 (14-day wear). Extended wear duration supported by biocompatibility and performance data. Does not raise new questions of safety or effectiveness.
Electrode Material | Platinum-iridium (proprietary PtIr-4G electrode coating) | Platinum | Platinum (enhanced coating) | Yes — Platinum-iridium vs. Platinum | Different electrode alloy composition; PtIr-4G provides enhanced signal stability and corrosion resistance. Biocompatibility of PtIr-4G assessed per ISO 10993 series. Performance data demonstrates equivalent or superior sensor accuracy. Does not raise new questions of safety or effectiveness.
Wireless Communication Protocol | Bluetooth Low Energy (BLE) 5.2 | Bluetooth Low Energy (BLE) 5.0 | Bluetooth Low Energy (BLE) 5.0 | Yes — BLE 5.2 vs. BLE 5.0 | Incremental update to industry-standard wireless protocol; backward-compatible; improved data throughput and range. EMC testing per applicable standards demonstrates compliance. Does not raise new questions of safety or effectiveness.
Reader/Transmitter Form Factor | Arm-worn integrated wearable reader/transmitter | Handheld receiver | Handheld receiver | Yes — arm-worn vs. handheld | Different physical form factor for data display component; does not alter sensing technology, measurement methodology, or data processing. Biocompatibility of skin-contact materials assessed per ISO 10993. Does not raise new questions of safety or effectiveness.
Glucose Prediction Algorithm | Solstice proprietary algorithm — LuminaPredict v2.1 | NovaSense proprietary algorithm | NovaSense proprietary algorithm (updated) | Yes — different algorithm | Different proprietary algorithm; LuminaPredict v2.1 has been validated through analytical and clinical performance studies demonstrating MARD ≤ 9.0%. Software verification and validation documentation provided. Does not raise new questions of safety or effectiveness.
Sensing Mechanism | Enzymatic electrochemical (glucose oxidase) | Enzymatic electrochemical (glucose oxidase) | Enzymatic electrochemical (glucose oxidase) | No | Same fundamental sensing mechanism
Calibration Method | Factory-calibrated (no user calibration required) | Factory-calibrated | Factory-calibrated | No | Same calibration approach
Data Transmission Frequency | Every 1 minute | Every 1 minute | Every 1 minute | No | Same
Alert Capability | Configurable hypo/hyperglycemia alerts; alert latency ≤ 5 minutes from sensor reading to user notification | Hypo/hyperglycemia alerts | Configurable hypo/hyperglycemia alerts | No (enhanced configurability consistent with secondary predicate) | Substantially equivalent alert functionality
Power Source (Sensor) | Integrated non-rechargeable battery (14-day life) | Integrated non-rechargeable battery (10-day life) | Integrated non-rechargeable battery (14-day life) | No (battery life matches sensor wear duration) | Battery life proportional to sensor wear; consistent with secondary predicate
Power Source (Reader) | Rechargeable lithium-polymer battery | Rechargeable battery | Rechargeable battery | No | Same
Operational Temperature Range | 10°C to 45°C (50°F to 113°F) | 10°C to 45°C | 10°C to 45°C | No | Same operational temperature range
Storage Temperature Range | 2°C to 30°C (36°F to 86°F) | 2°C to 30°C | 2°C to 30°C | No | Same storage temperature range
Operating Humidity Range | 10% to 95% RH (non-condensing) | 10% to 95% RH (non-condensing) | 10% to 95% RH (non-condensing) | No | Same
Data Storage Capacity | 90 days of glucose data on reader; unlimited via mobile app cloud sync | 60 days on receiver | 90 days on receiver; cloud sync via app | No (consistent with secondary predicate) | Enhanced data storage consistent with secondary predicate
Sensor Insertion Depth | Approximately 6.5 mm subcutaneous | Approximately 6.0 mm subcutaneous | Approximately 6.5 mm subcutaneous | No (consistent with secondary predicate) | Consistent with secondary predicate
Number of Electrodes | Three-electrode system (working, counter, reference) | Three-electrode system | Three-electrode system | No | Same electrode configuration
Wireless Communication Range | Up to 10 meters (line of sight) | Up to 6 meters | Up to 6 meters | No (improved range is a benefit of BLE 5.2) | Enhanced range consistent with BLE 5.2; does not raise new safety or effectiveness questions
[sheet: Performance Specifications]
Performance Parameter | Subject Device — Solstice Lumina™ CGM System | Primary Predicate — NovaSense GlucoTrack NX-500 (K211034) | Secondary Predicate — NovaSense GlucoTrack NX-700 (K230489) | Substantial Equivalence Assessment
MARD (Mean Absolute Relative Difference) — Overall | Target: ≤ 9.0% | ≤ 9.5% (per 510(k) clearance data) | ≤ 8.8% (per 510(k) clearance data) | Subject device MARD target consistent with or superior to both predicates; consistent with FDA iCGM expectations per September 2023 guidance
Consensus Error Grid (Clarke Error Grid Analysis) | Target: ≥ 99% of paired data points in Zones A+B | ≥ 98.5% in Zones A+B | ≥ 99% in Zones A+B | Subject device target meets or exceeds both predicates
Measurement Range | 40–400 mg/dL | 40–400 mg/dL | 40–400 mg/dL | Same measurement range
Sensor Functional Life | 336 hours (14 days) | 240 hours (10 days) | 336 hours (14 days) | Consistent with secondary predicate; performance data supports extended 14-day wear
Warm-Up Time | ≤ 60 minutes | ≤ 60 minutes | ≤ 60 minutes | Same
Alert Latency | ≤ 5 minutes from sensor reading to user notification | ≤ 5 minutes | ≤ 5 minutes | Same
Sensor Accuracy in Hypoglycemic Range (< 70 mg/dL) | Data to be provided from LUMINA-US clinical study (Protocol SBD-LUM-CL-001) | Per clearance data | Per clearance data | To be demonstrated via pivotal clinical study
Sensor Accuracy in Euglycemic Range (70–180 mg/dL) | Data to be provided from LUMINA-US clinical study (Protocol SBD-LUM-CL-001) | Per clearance data | Per clearance data | To be demonstrated via pivotal clinical study
Sensor Accuracy in Hyperglycemic Range (> 180 mg/dL) | Data to be provided from LUMINA-US clinical study | Per clearance data | Per clearance data | To be demonstrated via pivotal clinical study
Interference Testing | Per FDA guidance; acetaminophen, ascorbic acid, salicylic acid, and other common interferents tested | Per FDA guidance | Per FDA guidance | Same testing approach
Linearity | 40–400 mg/dL (tested per CLSI EP6-A) | 40–400 mg/dL | 40–400 mg/dL | Same
Precision (Within-Sensor CV) | Target: ≤ 5% CV | Per clearance data | Per clearance data | Comparable precision targets
Drift Assessment | Target: ≤ 10% signal drift over 14-day wear period | Per clearance data (10-day) | Per clearance data (14-day) | Drift target assessed over full 14-day wear; consistent with secondary predicate
Response Time (T90) | ≤ 10 minutes (90% of steady-state response) | ≤ 10 minutes | ≤ 10 minutes | Same
[sheet: Materials & Biocompatibility]
Comparison Parameter | Subject Device — Solstice Lumina™ CGM System | Primary Predicate — NovaSense GlucoTrack NX-500 (K211034) | Secondary Predicate — NovaSense GlucoTrack NX-700 (K230489) | Substantial Equivalence Assessment
Sensor Electrode Material | Platinum-iridium alloy (proprietary PtIr-4G coating) | Platinum | Platinum (enhanced coating) | Different electrode material; biocompatibility evaluated per ISO 10993 series at Whitmore Laboratories Inc. (A2LA Certificate No. 3847.01)
Sensor Substrate / Housing Material | Medical-grade polymer (biocompatible polyurethane) | Medical-grade polymer | Medical-grade polymer | Same material class
Sensor Enzyme Layer | Glucose oxidase immobilized on electrode surface | Glucose oxidase | Glucose oxidase | Same enzyme system
Sensor Membrane | Biocompatible polymer membrane (diffusion-limiting layer) | Biocompatible polymer membrane | Biocompatible polymer membrane | Same membrane technology class
Adhesive (Sensor Patch) | Medical-grade skin adhesive (hypoallergenic, 14-day wear rated) | Medical-grade skin adhesive (10-day) | Medical-grade skin adhesive (14-day) | Similar adhesive; extended wear duration consistent with secondary predicate; sensitization and irritation testing per ISO 10993-10 and ISO 10993-23
Reader Housing Material (R7) | Medical-grade polycarbonate / silicone (skin-contact) | ABS plastic housing (handheld, limited skin contact) | ABS plastic housing (handheld) | Different form factor requires skin-contact biocompatibility assessment for R7
Reader Strap / Band Material | Medical-grade silicone (prolonged skin contact) | N/A (handheld) | N/A (handheld) | New component requiring prolonged skin-contact biocompatibility testing per ISO 10993
Biocompatibility Testing — C14 Sensor | Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-23), Acute Systemic Toxicity (ISO 10993-11), Subchronic Toxicity (ISO 10993-11), Implantation (ISO 10993-6), Hemocompatibility (ISO 10993-4), Genotoxicity (ISO 10993-3) | Per ISO 10993 (scope per clearance) | Per ISO 10993 (scope per clearance) | Comprehensive biocompatibility testing per ISO 10993-1:2018 risk-based approach; testing performed at Whitmore Laboratories Inc.; target completion August 31, 2025
Biocompatibility Testing — R7 Reader | Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-23) | Limited skin contact — per ISO 10993 | Limited skin contact — per ISO 10993 | Appropriate scope for prolonged skin-contact wearable device
Sterilization Method (Sensor) | Ethylene oxide (EO) sterilization | Ethylene oxide (EO) | Ethylene oxide (EO) | Same sterilization method
Sterilization Validation | Per ISO 11135:2014 (EO sterilization validation) | Per ISO 11135 | Per ISO 11135 | Same sterilization validation standard
Biocompatibility Testing Budget | $485,000 (Whitmore Laboratories quote dated March 3, 2025) | N/A | N/A | Reference for submission planning
Biocompatibility Testing Laboratory | Whitmore Laboratories Inc., 1625 Shady Grove Road, Suite 300, Gaithersburg, MD 20878; A2LA Certificate No. 3847.01 | N/A | N/A | FDA-recognized, ISO 17025-accredited laboratory
Biocompatibility Testing Completion Target | August 31, 2025 | N/A | N/A | On track per current project timeline

[sheet: Cover]

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