[sheet: Device Comparison]

Parameter

--- DEVICE IDENTIFICATION ---

Device Trade Name	Solstice Lumina™ CGM System	NovaSense GlucoTrack NX-500 CGM System	NovaSense GlucoTrack NX-700 CGM System	Solstice GlucoStrip RX-200 Test Strip Reader
Device Components	Lumina C14 (subcutaneously implantable CGM sensor) + Lumina R7 (wearable reader/transmitter)	Implantable CGM sensor + Handheld receiver	Implantable CGM sensor + Handheld receiver	Test strip reader (standalone)	Lumina system comprises two components submitted as a single 510(k). GlucoStrip RX-200 is a standalone device cited for corporate pedigree only — not a predicate for substantial equivalence.
Manufacturer	Solstice Biomedical Inc., 220 Westbrook Drive, Suite 400, Cambridge, MA 02142 (U.S. subsidiary of Solstice Biomedical Devices Ltd., Ireland, CRO No. 648231)	NovaSense Medical Technologies Inc., 4800 Innovation Parkway, San Diego, CA 92121 (Delaware File No. 5429876)	NovaSense Medical Technologies Inc., 4800 Innovation Parkway, San Diego, CA 92121	Solstice Biomedical Inc., 220 Westbrook Drive, Suite 400, Cambridge, MA 02142
510(k) Number	Pending (target submission April 30, 2026)	K211034	K230489	K192847
510(k) Clearance Date	Target: Q3 2026	June 18, 2022	March 7, 2024	November 14, 2019

--- CLASSIFICATION ---

Product Code	QKQ (anticipated)	QKQ	QKQ	NBW	GlucoStrip RX-200 classified under product code NBW; not a predicate for substantial equivalence for the Lumina CGM System.
Device Class	Class II (anticipated)	Class II	Class II	Class II	All devices are Class II. Subject device classification to be confirmed via Pre-Sub meeting with CDRH.
Regulation Number	21 C.F.R. § 862.1355 (anticipated)	21 C.F.R. § 862.1355	21 C.F.R. § 862.1355	21 C.F.R. § 862.1345	GlucoStrip RX-200 regulated under a different CFR section; not a predicate.
Submission Type	Traditional 510(k) (single submission covering both C14 and R7 as a system)	Traditional 510(k)	Traditional 510(k)	Traditional 510(k)

--- INTENDED USE / INDICATIONS FOR USE ---

Intended Use	Continuous glucose monitoring in persons aged 18 and older with Type 1 or Type 2 diabetes mellitus	Continuous glucose monitoring in persons with diabetes mellitus	Continuous glucose monitoring in persons with diabetes mellitus	In vitro quantitative measurement of glucose in capillary whole blood (test strip-based)	Subject device intended use is substantively equivalent to both predicates. GlucoStrip RX-200 has a fundamentally different intended use.
Target Patient Population	Adults aged ≥18 years with Type 1 or Type 2 diabetes mellitus	Adults with diabetes mellitus	Adults with diabetes mellitus	Adults with diabetes mellitus	Substantially equivalent intended patient population across subject device and both predicates.
Prescription / OTC	Prescription use (Rx)	Prescription use (Rx)	Prescription use (Rx)	OTC

--- SENSOR TECHNOLOGICAL CHARACTERISTICS ---

Sensor Type	Subcutaneously implantable, enzymatic electrochemical biosensor (fourth-generation)	Subcutaneously implantable, enzymatic electrochemical biosensor	Subcutaneously implantable, enzymatic electrochemical biosensor	N/A (test strip-based)	Same fundamental sensor technology (enzymatic electrochemical) across subject device and both predicates.
Sensor Wear Duration	14 days (336 hours)	10 days	14 days	N/A	Subject device sensor wear duration (14 days) differs from primary predicate (10 days) but matches secondary predicate NX-700. Extended wear is supported by performance and biocompatibility data.
Electrode Material	Platinum-iridium (proprietary PtIr-4G coating)	Platinum	Platinum	N/A	Key difference from primary predicate. PtIr-4G uses a different coating architecture. Differences do not raise new questions of safety or effectiveness; performance testing and biocompatibility data demonstrate equivalence.
Measurement Range	40–400 mg/dL	40–400 mg/dL	40–400 mg/dL	20–600 mg/dL	Subject device measurement range identical to both predicates.
Warm-Up Time	≤ 60 minutes	≤ 60 minutes	≤ 60 minutes	N/A	Equivalent warm-up time.
Calibration	Factory-calibrated (no user calibration required)	Factory-calibrated	Factory-calibrated	N/A	Equivalent calibration approach.

--- WIRELESS COMMUNICATION ---

Wireless Protocol	Bluetooth Low Energy (BLE) 5.2	Bluetooth Low Energy (BLE) 5.0	Bluetooth Low Energy (BLE) 5.0	N/A	Subject device uses BLE 5.2 vs. BLE 5.0 in both predicates. BLE 5.2 is backward-compatible; difference is incremental and does not raise new questions of safety or effectiveness.
Data Transmission Range	Up to 10 meters (line of sight)	Up to 10 meters (line of sight)	Up to 10 meters (line of sight)	N/A	Equivalent.

--- READER / DISPLAY ---

Reader Form Factor	Arm-worn integrated reader/transmitter (Lumina R7)	Handheld receiver	Handheld receiver	Handheld test strip reader	Key difference from both predicates. Lumina R7 is arm-worn rather than handheld. Different form factor does not change the fundamental function (receiving, processing, and displaying glucose data). User studies and human factors testing address usability.
Display Features	Real-time glucose values, trend arrows, 8-hour trend graphs, configurable hypo/hyperglycemia alerts	Real-time glucose values, trend arrows, trend graphs	Real-time glucose values, trend arrows, trend graphs, configurable alerts	Glucose value (numeric display)	Subject device display features are equivalent to or enhanced versions of predicate features.
Alert Latency	≤ 5 minutes from sensor reading to user notification	≤ 5 minutes	≤ 5 minutes	N/A	Equivalent alert latency.
Mobile App Connectivity	Solstice Lumina™ Mobile App (iOS and Android) via BLE	Companion mobile app via BLE	Companion mobile app via BLE	N/A	Equivalent mobile connectivity approach.

--- SOFTWARE ---

Sensor Firmware	Lumina Firmware v3.4.2	Proprietary	Proprietary	N/A	Different firmware; functionally equivalent purpose.
Reader Operating System	Lumina Reader OS v2.1.0	Proprietary	Proprietary	N/A
Glucose Prediction Algorithm	LuminaPredict v2.1 (Solstice proprietary)	NovaSense proprietary algorithm	NovaSense proprietary algorithm (updated)	N/A	Key difference. Subject device uses a different proprietary glucose prediction algorithm. Algorithm performance validated through clinical study (MARD and error grid analysis).
Mobile App Version	Lumina Mobile App v1.0.3	Proprietary	Proprietary	N/A
Software Level of Concern	Major	Major	Major	Moderate	Subject device software level of concern consistent with both CGM predicates.

--- PERFORMANCE SPECIFICATIONS ---

MARD Target	≤ 9.0% (overall)	≤ 9.5% (overall, per cleared labeling)	≤ 9.0% (overall, per cleared labeling)	N/A	Subject device MARD target of ≤ 9.0% is consistent with secondary predicate and meets current FDA expectations for iCGM classification per FDA guidance (September 2023).
Consensus Error Grid (Clarke)	≥ 99% of paired data points in Zones A+B	≥ 98.5% in Zones A+B	≥ 99% in Zones A+B	N/A	Subject device target consistent with or exceeds predicate device performance.
Sensor Functional Life	336 hours (14 days × 24 hrs/day)	240 hours (10 days × 24 hrs/day)	336 hours (14 days × 24 hrs/day)	N/A	Subject device functional life matches secondary predicate. Exceeds primary predicate by 4 days; supported by performance and biocompatibility data.

--- BIOCOMPATIBILITY ---

Biocompatibility Standards	ISO 10993-1:2018 and applicable sub-parts	ISO 10993-1 and applicable sub-parts	ISO 10993-1 and applicable sub-parts	ISO 10993-1 (limited scope)
C14 Sensor Biocompatibility Tests	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)	Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Implantation, Hemocompatibility, Genotoxicity	Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Implantation, Hemocompatibility, Genotoxicity	N/A	Comprehensive biocompatibility testing scope for C14 sensor consistent with predicate testing scope and FDA biocompatibility guidance. Testing performed by Whitmore Laboratories Inc. (A2LA Certificate No. 3847.01).
R7 Reader Biocompatibility Tests	Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-23)	Cytotoxicity, Sensitization, Irritation	Cytotoxicity, Sensitization, Irritation	Cytotoxicity, Sensitization, Irritation	Skin-contacting component testing consistent with predicate approach.
Biocompatibility Testing Lab	Whitmore Laboratories Inc., 1625 Shady Grove Road, Suite 300, Gaithersburg, MD 20878	Not publicly disclosed	Not publicly disclosed	Not publicly disclosed

--- EMC / ELECTRICAL SAFETY ---

EMC Standard	IEC 60601-1-2 (4th edition)	IEC 60601-1-2	IEC 60601-1-2	IEC 60601-1-2	Equivalent EMC testing standard.
Electrical Safety Standard	IEC 60601-1 (3rd edition + amendments)	IEC 60601-1	IEC 60601-1	IEC 60601-1

--- CYBERSECURITY ---

Cybersecurity Framework

--- REGULATORY CERTIFICATIONS ---

EU MDR CE Marking	Yes — EU MDR Certificate No. MCA-2024-07319, issued September 12, 2024 by Meridian Conformity Assessment GmbH (NB 0483)	CE marked (MDD/MDR transition)	CE marked (MDR)	CE marked (MDD)	Subject device holds current EU MDR CE certification.
ISO 13485:2016 Certification	Yes — certified by Meridian Conformity Assessment GmbH (NB 0483)	Yes	Yes	Yes
EU Commercial Availability	Since September 2024	Available in EU	Available in EU	Available in EU

--- CLINICAL DATA ---

Pivotal Clinical Study	Protocol SBD-LUM-CL-001 ('LUMINA-US'); prospective, single-arm, multicenter; 350 subjects (175 T1D + 175 T2D); 6 U.S. clinical sites	Prospective multicenter accuracy study (per 510(k) summary)	Prospective multicenter accuracy study (per 510(k) summary)	N/A	Clinical study designed to demonstrate equivalent or superior performance to predicate devices. CRO: Veltrano Clinical Research Organization Inc. IRB: Clearwater Institutional Review Board LLC (Reg. No. IRB-2019-04821).
Clinical Study Primary Endpoint	MARD ≤ 9.0%; ≥ 99% Zones A+B on Clarke Error Grid	MARD; Consensus Error Grid	MARD; Consensus Error Grid	N/A
IDE Status	Anticipated NSR exemption under 21 C.F.R. § 812.2(c)(3); to be confirmed via Pre-Sub	IDE exempt (NSR)	IDE exempt (NSR)	N/A

--- CORPORATE PEDIGREE ---

Prior FDA Clearance History

[sheet: Key Differences Summary]

Difference No.	Parameter	Subject Device — Solstice Lumina™ CGM	Primary Predicate — NovaSense GlucoTrack NX-500 (K211034)	Secondary Predicate — NovaSense GlucoTrack NX-700 (K230489)	Substantial Equivalence Rationale
1	Sensor Wear Duration	14 days (336 hours)	10 days (240 hours)	14 days (336 hours)	Subject device wear duration aligns with secondary predicate (K230489). Extended wear validated through biocompatibility testing (ISO 10993 — including subchronic toxicity and implantation per ISO 10993-6 and -11) and clinical accuracy data over full 14-day wear period. No new safety or effectiveness questions raised.
2	Electrode Material	Platinum-iridium (PtIr-4G proprietary coating)	Platinum	Platinum	Different electrode coating architecture. PtIr-4G technology uses a platinum-iridium alloy with a proprietary fourth-generation enzyme layer deposition process. Biocompatibility of PtIr-4G demonstrated through full ISO 10993 testing program at Whitmore Laboratories Inc. Performance equivalence demonstrated through bench testing (linearity, precision, interference) and clinical MARD data. The difference in electrode material does not raise new questions of safety or effectiveness.
3	BLE Version	Bluetooth Low Energy 5.2	Bluetooth Low Energy 5.0	Bluetooth Low Energy 5.0	BLE 5.2 is an incremental, backward-compatible update to BLE 5.0. Provides improved throughput and coexistence but does not alter fundamental communication architecture. EMC testing per IEC 60601-1-2 confirms compliance. No new safety or effectiveness questions raised.
4	Reader Form Factor	Arm-worn integrated reader/transmitter (Lumina R7)	Handheld receiver	Handheld receiver	Different physical form factor for the reader component. Lumina R7 is worn on the upper arm rather than carried as a handheld device. Fundamental function (receiving, processing, and displaying CGM data) is equivalent. Human factors/usability testing and biocompatibility testing (skin contact) address the form factor change. No new safety or effectiveness questions raised.
5	Glucose Prediction Algorithm	LuminaPredict v2.1 (Solstice proprietary)	NovaSense proprietary algorithm	NovaSense proprietary algorithm (updated)	Different proprietary algorithm. LuminaPredict v2.1 uses a different signal processing and glucose prediction methodology. Algorithm performance validated through clinical study (Protocol SBD-LUM-CL-001) with MARD target ≤ 9.0% and ≥ 99% Zones A+B on Clarke Error Grid. Software documentation per IEC 62304 and FDA software guidance. No new safety or effectiveness questions raised.

[sheet: Device Registry]

Device Name	Role in Analysis	510(k) Number	Clearance Date	Product Code	Regulation Number	Device Class	Manufacturer	Manufacturer Address
Solstice Lumina™ CGM System (C14 + R7)	Subject Device	Pending	Target Q3 2026	QKQ (anticipated)	21 C.F.R. § 862.1355 (anticipated)	Class II (anticipated)	Solstice Biomedical Inc. (Delaware File No. 7834291); U.S. subsidiary of Solstice Biomedical Devices Ltd. (Ireland, CRO No. 648231)	220 Westbrook Drive, Suite 400, Cambridge, MA 02142
NovaSense GlucoTrack NX-500 CGM System	Primary Predicate	K211034	June 18, 2022	QKQ	21 C.F.R. § 862.1355	Class II	NovaSense Medical Technologies Inc. (Delaware File No. 5429876)	4800 Innovation Parkway, San Diego, CA 92121
NovaSense GlucoTrack NX-700 CGM System	Secondary Predicate (Reference Device)	K230489	March 7, 2024	QKQ	21 C.F.R. § 862.1355	Class II	NovaSense Medical Technologies Inc.	4800 Innovation Parkway, San Diego, CA 92121
Solstice GlucoStrip RX-200 Test Strip Reader	Reference Device (Corporate Pedigree Only — Not a Predicate)	K192847	November 14, 2019	NBW	21 C.F.R. § 862.1345	Class II	Solstice Biomedical Inc.	220 Westbrook Drive, Suite 400, Cambridge, MA 02142

[sheet: Device Comparison]
Parameter | Solstice Lumina™ CGM System (Subject Device) | NovaSense GlucoTrack NX-500 — Primary Predicate (K211034) | NovaSense GlucoTrack NX-700 — Secondary Predicate (K230489) | Solstice GlucoStrip RX-200 — Reference (K192847) | Comparison Notes / Substantial Equivalence Discussion
--- DEVICE IDENTIFICATION ---
Device Trade Name | Solstice Lumina™ CGM System | NovaSense GlucoTrack NX-500 CGM System | NovaSense GlucoTrack NX-700 CGM System | Solstice GlucoStrip RX-200 Test Strip Reader
Device Components | Lumina C14 (subcutaneously implantable CGM sensor) + Lumina R7 (wearable reader/transmitter) | Implantable CGM sensor + Handheld receiver | Implantable CGM sensor + Handheld receiver | Test strip reader (standalone) | Lumina system comprises two components submitted as a single 510(k). GlucoStrip RX-200 is a standalone device cited for corporate pedigree only — not a predicate for substantial equivalence.
Manufacturer | Solstice Biomedical Inc., 220 Westbrook Drive, Suite 400, Cambridge, MA 02142 (U.S. subsidiary of Solstice Biomedical Devices Ltd., Ireland, CRO No. 648231) | NovaSense Medical Technologies Inc., 4800 Innovation Parkway, San Diego, CA 92121 (Delaware File No. 5429876) | NovaSense Medical Technologies Inc., 4800 Innovation Parkway, San Diego, CA 92121 | Solstice Biomedical Inc., 220 Westbrook Drive, Suite 400, Cambridge, MA 02142
510(k) Number | Pending (target submission April 30, 2026) | K211034 | K230489 | K192847
510(k) Clearance Date | Target: Q3 2026 | June 18, 2022 | March 7, 2024 | November 14, 2019
--- CLASSIFICATION ---
Product Code | QKQ (anticipated) | QKQ | QKQ | NBW | GlucoStrip RX-200 classified under product code NBW; not a predicate for substantial equivalence for the Lumina CGM System.
Device Class | Class II (anticipated) | Class II | Class II | Class II | All devices are Class II. Subject device classification to be confirmed via Pre-Sub meeting with CDRH.
Regulation Number | 21 C.F.R. § 862.1355 (anticipated) | 21 C.F.R. § 862.1355 | 21 C.F.R. § 862.1355 | 21 C.F.R. § 862.1345 | GlucoStrip RX-200 regulated under a different CFR section; not a predicate.
Submission Type | Traditional 510(k) (single submission covering both C14 and R7 as a system) | Traditional 510(k) | Traditional 510(k) | Traditional 510(k)
--- INTENDED USE / INDICATIONS FOR USE ---
Intended Use | Continuous glucose monitoring in persons aged 18 and older with Type 1 or Type 2 diabetes mellitus | Continuous glucose monitoring in persons with diabetes mellitus | Continuous glucose monitoring in persons with diabetes mellitus | In vitro quantitative measurement of glucose in capillary whole blood (test strip-based) | Subject device intended use is substantively equivalent to both predicates. GlucoStrip RX-200 has a fundamentally different intended use.
Target Patient Population | Adults aged ≥18 years with Type 1 or Type 2 diabetes mellitus | Adults with diabetes mellitus | Adults with diabetes mellitus | Adults with diabetes mellitus | Substantially equivalent intended patient population across subject device and both predicates.
Prescription / OTC | Prescription use (Rx) | Prescription use (Rx) | Prescription use (Rx) | OTC
--- SENSOR TECHNOLOGICAL CHARACTERISTICS ---
Sensor Type | Subcutaneously implantable, enzymatic electrochemical biosensor (fourth-generation) | Subcutaneously implantable, enzymatic electrochemical biosensor | Subcutaneously implantable, enzymatic electrochemical biosensor | N/A (test strip-based) | Same fundamental sensor technology (enzymatic electrochemical) across subject device and both predicates.
Sensor Wear Duration | 14 days (336 hours) | 10 days | 14 days | N/A | Subject device sensor wear duration (14 days) differs from primary predicate (10 days) but matches secondary predicate NX-700. Extended wear is supported by performance and biocompatibility data.
Electrode Material | Platinum-iridium (proprietary PtIr-4G coating) | Platinum | Platinum | N/A | Key difference from primary predicate. PtIr-4G uses a different coating architecture. Differences do not raise new questions of safety or effectiveness; performance testing and biocompatibility data demonstrate equivalence.
Measurement Range | 40–400 mg/dL | 40–400 mg/dL | 40–400 mg/dL | 20–600 mg/dL | Subject device measurement range identical to both predicates.
Warm-Up Time | ≤ 60 minutes | ≤ 60 minutes | ≤ 60 minutes | N/A | Equivalent warm-up time.
Calibration | Factory-calibrated (no user calibration required) | Factory-calibrated | Factory-calibrated | N/A | Equivalent calibration approach.
--- WIRELESS COMMUNICATION ---
Wireless Protocol | Bluetooth Low Energy (BLE) 5.2 | Bluetooth Low Energy (BLE) 5.0 | Bluetooth Low Energy (BLE) 5.0 | N/A | Subject device uses BLE 5.2 vs. BLE 5.0 in both predicates. BLE 5.2 is backward-compatible; difference is incremental and does not raise new questions of safety or effectiveness.
Data Transmission Range | Up to 10 meters (line of sight) | Up to 10 meters (line of sight) | Up to 10 meters (line of sight) | N/A | Equivalent.
--- READER / DISPLAY ---
Reader Form Factor | Arm-worn integrated reader/transmitter (Lumina R7) | Handheld receiver | Handheld receiver | Handheld test strip reader | Key difference from both predicates. Lumina R7 is arm-worn rather than handheld. Different form factor does not change the fundamental function (receiving, processing, and displaying glucose data). User studies and human factors testing address usability.
Display Features | Real-time glucose values, trend arrows, 8-hour trend graphs, configurable hypo/hyperglycemia alerts | Real-time glucose values, trend arrows, trend graphs | Real-time glucose values, trend arrows, trend graphs, configurable alerts | Glucose value (numeric display) | Subject device display features are equivalent to or enhanced versions of predicate features.
Alert Latency | ≤ 5 minutes from sensor reading to user notification | ≤ 5 minutes | ≤ 5 minutes | N/A | Equivalent alert latency.
Mobile App Connectivity | Solstice Lumina™ Mobile App (iOS and Android) via BLE | Companion mobile app via BLE | Companion mobile app via BLE | N/A | Equivalent mobile connectivity approach.
--- SOFTWARE ---
Sensor Firmware | Lumina Firmware v3.4.2 | Proprietary | Proprietary | N/A | Different firmware; functionally equivalent purpose.
Reader Operating System | Lumina Reader OS v2.1.0 | Proprietary | Proprietary | N/A
Glucose Prediction Algorithm | LuminaPredict v2.1 (Solstice proprietary) | NovaSense proprietary algorithm | NovaSense proprietary algorithm (updated) | N/A | Key difference. Subject device uses a different proprietary glucose prediction algorithm. Algorithm performance validated through clinical study (MARD and error grid analysis).
Mobile App Version | Lumina Mobile App v1.0.3 | Proprietary | Proprietary | N/A
Software Level of Concern | Major | Major | Major | Moderate | Subject device software level of concern consistent with both CGM predicates.
--- PERFORMANCE SPECIFICATIONS ---
MARD Target | ≤ 9.0% (overall) | ≤ 9.5% (overall, per cleared labeling) | ≤ 9.0% (overall, per cleared labeling) | N/A | Subject device MARD target of ≤ 9.0% is consistent with secondary predicate and meets current FDA expectations for iCGM classification per FDA guidance (September 2023).
Consensus Error Grid (Clarke) | ≥ 99% of paired data points in Zones A+B | ≥ 98.5% in Zones A+B | ≥ 99% in Zones A+B | N/A | Subject device target consistent with or exceeds predicate device performance.
Sensor Functional Life | 336 hours (14 days × 24 hrs/day) | 240 hours (10 days × 24 hrs/day) | 336 hours (14 days × 24 hrs/day) | N/A | Subject device functional life matches secondary predicate. Exceeds primary predicate by 4 days; supported by performance and biocompatibility data.
--- BIOCOMPATIBILITY ---
Biocompatibility Standards | ISO 10993-1:2018 and applicable sub-parts | ISO 10993-1 and applicable sub-parts | ISO 10993-1 and applicable sub-parts | ISO 10993-1 (limited scope)
C14 Sensor Biocompatibility Tests | 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) | Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Implantation, Hemocompatibility, Genotoxicity | Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Implantation, Hemocompatibility, Genotoxicity | N/A | Comprehensive biocompatibility testing scope for C14 sensor consistent with predicate testing scope and FDA biocompatibility guidance. Testing performed by Whitmore Laboratories Inc. (A2LA Certificate No. 3847.01).
R7 Reader Biocompatibility Tests | Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-23) | Cytotoxicity, Sensitization, Irritation | Cytotoxicity, Sensitization, Irritation | Cytotoxicity, Sensitization, Irritation | Skin-contacting component testing consistent with predicate approach.
Biocompatibility Testing Lab | Whitmore Laboratories Inc., 1625 Shady Grove Road, Suite 300, Gaithersburg, MD 20878 | Not publicly disclosed | Not publicly disclosed | Not publicly disclosed
--- EMC / ELECTRICAL SAFETY ---
EMC Standard | IEC 60601-1-2 (4th edition) | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | Equivalent EMC testing standard.
Electrical Safety Standard | IEC 60601-1 (3rd edition + amendments) | IEC 60601-1 | IEC 60601-1 | IEC 60601-1
--- CYBERSECURITY ---
Cybersecurity Framework | Per FDA guidance (September 2023); STRIDE threat modeling; SBOM provided | Per applicable FDA guidance at time of clearance | Per applicable FDA guidance at time of clearance | N/A | Subject device cybersecurity documentation prepared per current (2023) FDA guidance.
--- REGULATORY CERTIFICATIONS ---
EU MDR CE Marking | Yes — EU MDR Certificate No. MCA-2024-07319, issued September 12, 2024 by Meridian Conformity Assessment GmbH (NB 0483) | CE marked (MDD/MDR transition) | CE marked (MDR) | CE marked (MDD) | Subject device holds current EU MDR CE certification.
ISO 13485:2016 Certification | Yes — certified by Meridian Conformity Assessment GmbH (NB 0483) | Yes | Yes | Yes
EU Commercial Availability | Since September 2024 | Available in EU | Available in EU | Available in EU
--- CLINICAL DATA ---
Pivotal Clinical Study | Protocol SBD-LUM-CL-001 ('LUMINA-US'); prospective, single-arm, multicenter; 350 subjects (175 T1D + 175 T2D); 6 U.S. clinical sites | Prospective multicenter accuracy study (per 510(k) summary) | Prospective multicenter accuracy study (per 510(k) summary) | N/A | Clinical study designed to demonstrate equivalent or superior performance to predicate devices. CRO: Veltrano Clinical Research Organization Inc. IRB: Clearwater Institutional Review Board LLC (Reg. No. IRB-2019-04821).
Clinical Study Primary Endpoint | MARD ≤ 9.0%; ≥ 99% Zones A+B on Clarke Error Grid | MARD; Consensus Error Grid | MARD; Consensus Error Grid | N/A
IDE Status | Anticipated NSR exemption under 21 C.F.R. § 812.2(c)(3); to be confirmed via Pre-Sub | IDE exempt (NSR) | IDE exempt (NSR) | N/A
--- CORPORATE PEDIGREE ---
Prior FDA Clearance History | K192847 (GlucoStrip RX-200, cleared November 14, 2019, product code NBW, Class II) — demonstrates established FDA interaction history for Solstice Biomedical Inc. | Multiple prior 510(k) clearances (NovaSense) | Multiple prior 510(k) clearances (NovaSense) | N/A (this is the prior clearance) | K192847 cited solely for corporate pedigree and prior FDA interaction; not a predicate for substantial equivalence for the Lumina CGM System due to different product code (NBW vs. QKQ), different regulation number, and fundamentally different technology.
[sheet: Key Differences Summary]
Difference No. | Parameter | Subject Device — Solstice Lumina™ CGM | Primary Predicate — NovaSense GlucoTrack NX-500 (K211034) | Secondary Predicate — NovaSense GlucoTrack NX-700 (K230489) | Substantial Equivalence Rationale
1 | Sensor Wear Duration | 14 days (336 hours) | 10 days (240 hours) | 14 days (336 hours) | Subject device wear duration aligns with secondary predicate (K230489). Extended wear validated through biocompatibility testing (ISO 10993 — including subchronic toxicity and implantation per ISO 10993-6 and -11) and clinical accuracy data over full 14-day wear period. No new safety or effectiveness questions raised.
2 | Electrode Material | Platinum-iridium (PtIr-4G proprietary coating) | Platinum | Platinum | Different electrode coating architecture. PtIr-4G technology uses a platinum-iridium alloy with a proprietary fourth-generation enzyme layer deposition process. Biocompatibility of PtIr-4G demonstrated through full ISO 10993 testing program at Whitmore Laboratories Inc. Performance equivalence demonstrated through bench testing (linearity, precision, interference) and clinical MARD data. The difference in electrode material does not raise new questions of safety or effectiveness.
3 | BLE Version | Bluetooth Low Energy 5.2 | Bluetooth Low Energy 5.0 | Bluetooth Low Energy 5.0 | BLE 5.2 is an incremental, backward-compatible update to BLE 5.0. Provides improved throughput and coexistence but does not alter fundamental communication architecture. EMC testing per IEC 60601-1-2 confirms compliance. No new safety or effectiveness questions raised.
4 | Reader Form Factor | Arm-worn integrated reader/transmitter (Lumina R7) | Handheld receiver | Handheld receiver | Different physical form factor for the reader component. Lumina R7 is worn on the upper arm rather than carried as a handheld device. Fundamental function (receiving, processing, and displaying CGM data) is equivalent. Human factors/usability testing and biocompatibility testing (skin contact) address the form factor change. No new safety or effectiveness questions raised.
5 | Glucose Prediction Algorithm | LuminaPredict v2.1 (Solstice proprietary) | NovaSense proprietary algorithm | NovaSense proprietary algorithm (updated) | Different proprietary algorithm. LuminaPredict v2.1 uses a different signal processing and glucose prediction methodology. Algorithm performance validated through clinical study (Protocol SBD-LUM-CL-001) with MARD target ≤ 9.0% and ≥ 99% Zones A+B on Clarke Error Grid. Software documentation per IEC 62304 and FDA software guidance. No new safety or effectiveness questions raised.
[sheet: Device Registry]
Device Name | Role in Analysis | 510(k) Number | Clearance Date | Product Code | Regulation Number | Device Class | Manufacturer | Manufacturer Address
Solstice Lumina™ CGM System (C14 + R7) | Subject Device | Pending | Target Q3 2026 | QKQ (anticipated) | 21 C.F.R. § 862.1355 (anticipated) | Class II (anticipated) | Solstice Biomedical Inc. (Delaware File No. 7834291); U.S. subsidiary of Solstice Biomedical Devices Ltd. (Ireland, CRO No. 648231) | 220 Westbrook Drive, Suite 400, Cambridge, MA 02142
NovaSense GlucoTrack NX-500 CGM System | Primary Predicate | K211034 | June 18, 2022 | QKQ | 21 C.F.R. § 862.1355 | Class II | NovaSense Medical Technologies Inc. (Delaware File No. 5429876) | 4800 Innovation Parkway, San Diego, CA 92121
NovaSense GlucoTrack NX-700 CGM System | Secondary Predicate (Reference Device) | K230489 | March 7, 2024 | QKQ | 21 C.F.R. § 862.1355 | Class II | NovaSense Medical Technologies Inc. | 4800 Innovation Parkway, San Diego, CA 92121
Solstice GlucoStrip RX-200 Test Strip Reader | Reference Device (Corporate Pedigree Only — Not a Predicate) | K192847 | November 14, 2019 | NBW | 21 C.F.R. § 862.1345 | Class II | Solstice Biomedical Inc. | 220 Westbrook Drive, Suite 400, Cambridge, MA 02142

[sheet: Device Comparison]

Record

Parties

Dates

Amounts