FORM FDA 3881 (DRAFT)

FORM FDA 3881 (DRAFT)
INDICATIONS FOR USE STATEMENT
DRAFT — Prepared by Calderwood & Harkness LLP for Solstice Biomedical Inc. Engagement Reference: 1037-00002 Draft dated for inclusion in the 510(k) submission targeted for April 30, 2026
NOTICE: Not for submission — subject to revision pending Pre-Sub feedback and final clinical data. This document constitutes attorney work product prepared in anticipation of regulatory proceedings and is protected by the attorney-client privilege and the work product doctrine. Distribution is restricted to authorized personnel of Solstice Biomedical Inc. and its agents.
SECTION 1
FORM IDENTIFICATION AND ADMINISTRATIVE INFORMATION
1.1 Form Header Fields
Form Designation: FDA Form 3881 (Rev. 09/2023) — Indications for Use
510(k) Number: [To be assigned by FDA upon submission]
The 510(k) premarket notification number will be assigned by the Center for Devices and Radiological Health (CDRH) Document Control Center upon receipt of the complete submission package. All references to the 510(k) number in this document and throughout the submission package will be updated upon assignment. The Applicant's internal tracking number for this submission is SBD-510K-2026-001.
Device Name (Trade/Proprietary Name):
Solstice Lumina™ CGM System
The Solstice Lumina™ CGM System comprises the following integrated components, which together constitute the subject device of this 510(k) premarket notification:
(a) Lumina C14 Implantable Continuous Glucose Monitoring Sensor — a subcutaneously implantable electrochemical biosensor designed for a 14-day (336-hour) continuous wear duration; and
(b) Lumina R7 Wearable Reader/Transmitter — a body-worn reader and wireless transmitter device designed to be worn on the upper arm in proximity to the implanted Lumina C14 sensor, which powers the sensor, receives raw electrochemical signals, processes glucose concentration data, and transmits real-time glucose values and trend information to compatible display devices.
Both components are intended to operate together as a single integrated system and are being submitted together in a single Traditional 510(k) premarket notification. Neither component is intended for standalone use independent of the other.
Common/Usual Name: Electrode, Glucose, Subcutaneous; Continuous Glucose Monitor
Indications for Use: See Section 2 below.
1.2 Applicant Information
Applicant / 510(k) Holder:
Solstice Biomedical Inc. 220 Westbrook Drive, Suite 400 Cambridge, MA 02142 United States of America
Telephone: (617) 555-0148 Facsimile: (617) 555-0149
Entity Type: Corporation organized and existing under the laws of the State of Delaware, United States; Delaware Division of Corporations File No. 7834291.
Relationship to Manufacturer: Solstice Biomedical Inc. is the U.S. subsidiary of Solstice Biomedical Devices Ltd., a corporation organized and existing under the laws of Ireland, with its registered office at Unit 12, Sandyford Business Park, Dublin 18, Ireland (Companies Registration Office No. 648231). Solstice Biomedical Devices Ltd. is the legal manufacturer and design owner of the Solstice Lumina™ CGM System. Solstice Biomedical Inc. serves as the initial importer and U.S. Agent for purposes of FDA establishment registration under 21 C.F.R. Part 807 and will be the 510(k) holder of record. Manufacturing of the Lumina C14 sensor is performed at the Solstice Biomedical Devices Ltd. facility in Galway, Ireland, and final assembly and packaging of the Lumina R7 wearable reader/transmitter is performed at both the Galway facility and a contract manufacturing site operated by Meridian Contract Manufacturing Inc. in Penang, Malaysia, under the quality system of Solstice Biomedical Devices Ltd.
Contact Person (U.S.):
Marcus Hale Vice President, U.S. Operations Solstice Biomedical Inc. 220 Westbrook Drive, Suite 400 Cambridge, MA 02142 Telephone: (617) 555-0151
Email: m.hale@solsticebiomed.com
Regulatory Affairs Contact:
Dr. Niamh Tierney, PhD, RAC Vice President, Regulatory Affairs Solstice Biomedical Devices Ltd. Unit 12, Sandyford Business Park Dublin 18, Ireland Telephone: +353 1 555 0237
Email: n.tierney@solsticebiomed.ie
U.S. Regulatory Counsel:
Calderwood & Harkness LLP 1401 K Street NW, Suite 900 Washington, D.C. 20005
Attention: Miriam Calloway, Partner, Healthcare & Life Sciences Practice
Telephone: (202) 555-0312
Email: m.calloway@calderwoodharkness.com
SECTION 2
INDICATIONS FOR USE STATEMENT
2.1 Full Indications for Use Text (Draft)
The following Indications for Use statement is provided in draft form for internal review and is subject to revision following the Pre-Submission meeting with FDA CDRH currently scheduled for August 14, 2025, as well as upon completion and analysis of clinical study data from Protocol SBD-LUM-CL-001 ("LUMINA-US"). The text below represents the Applicant's current intended Indications for Use and is drafted to be consistent with the indications cleared for the identified predicate devices, modified as appropriate to reflect the specific technological characteristics, performance claims, and intended clinical use of the Solstice Lumina™ CGM System.
INDICATIONS FOR USE:
The Solstice Lumina™ CGM System is a continuous glucose monitoring system indicated for the management of diabetes in persons aged 18 years and older with Type 1 or Type 2 diabetes mellitus.
The Solstice Lumina™ CGM System is intended to continuously measure, record, analyze, and display glucose values derived from interstitial fluid. The system provides real-time glucose values, glucose trend information (including directional trend arrows and 8-hour trend graphs), and configurable hypoglycemia and hyperglycemia alerts to aid the user and healthcare provider in the detection of episodes of hyperglycemia and hypoglycemia, thereby facilitating both acute and long-term therapeutic adjustments to glycemic control.
The Solstice Lumina™ CGM System comprises two components that operate together as an integrated system:
(a) The Lumina C14, a subcutaneously implantable electrochemical biosensor with a 14-day (336-hour) sensor wear duration, designed for self-insertion by the patient using the included single-use applicator into the subcutaneous tissue of the posterior aspect of the upper arm; and
(b) The Lumina R7, a wearable reader/transmitter device worn externally on the upper arm directly over the implanted Lumina C14 sensor, which wirelessly powers the sensor, acquires raw electrochemical signals from the sensor, performs on-board signal processing and glucose concentration calculation using a factory-calibrated algorithm, and transmits processed glucose data via Bluetooth® Low Energy (BLE) to compatible display devices.
The glucose measurement range of the Solstice Lumina™ CGM System is 40–400 mg/dL (2.2–22.2 mmol/L).
The Solstice Lumina™ CGM System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions, including insulin dosing, when used as directed in accordance with the product labeling. The system does not require fingerstick calibration by the user.
The Solstice Lumina™ CGM System is intended to interface with the Solstice Lumina™ mobile application (compatible with iOS and Android mobile devices meeting specified minimum operating system and hardware requirements as set forth in the product labeling) for remote glucose data display, alert notification, and retrospective data review. The Solstice Lumina™ mobile application is provided as an accessory to the Solstice Lumina™ CGM System and is included within the scope of this 510(k) premarket notification.
Interpretation of the Solstice Lumina™ CGM System results should be based on the glucose trends and several sequential readings over time. A single glucose reading from the system should not be used in isolation to make diabetes treatment decisions.
The Solstice Lumina™ CGM System is not intended for use in persons under 18 years of age, in critically ill patients, or in pregnant women. The system is not intended to be used as a diagnostic device for the screening or detection of diabetes mellitus. The system is not intended for use on body sites other than the posterior aspect of the upper arm, as specified in the product labeling.
2.2 Prescription Use Designation
Prescription Use (Rx Only):
Over-the-Counter Use (OTC):
Pursuant to 21 C.F.R. § 801.109, the Solstice Lumina™ CGM System is restricted to prescription use and is indicated for sale by or on the order of a physician or other licensed healthcare practitioner authorized by applicable state law to prescribe such devices.
The following cautionary statement shall appear in the labeling of the device:
"CAUTION: Federal law restricts this device to sale by or on the order of a physician (or other licensed practitioner)."
The prescription use restriction is warranted because the Solstice Lumina™ CGM System involves the subcutaneous insertion of a biosensor component, requires patient training and education on proper insertion technique, sensor wear and care, alert configuration, and interpretation of glucose trend data, and is intended for use in the management of diabetes mellitus, a condition that requires ongoing supervision by a qualified healthcare provider. The safe and effective use of the device requires professional oversight, including appropriate patient selection, initial device setup and configuration guidance, and periodic review of glucose data to inform therapeutic decision-making.
SECTION 3
DEVICE CLASSIFICATION INFORMATION
3.1 Product Code
Product Code: QKQ
Product Code Description: Electrode, Glucose, Subcutaneous
The product code QKQ encompasses subcutaneously implanted or inserted electrochemical glucose sensors intended for continuous or semi-continuous measurement of glucose concentrations in interstitial fluid. This product code has been applied to cleared continuous glucose monitoring systems that operate on electrochemical sensing principles, including the identified predicate devices referenced in Section 4 of this document.
Note: The assignment of product code QKQ to the Solstice Lumina™ CGM System is subject to confirmation during the Pre-Submission (Q-Sub) meeting with the FDA Center for Devices and Radiological Health (CDRH), Office of Health Technology 2 (OHT2), Division of Chemistry and Toxicology Devices. The Pre-Submission meeting is currently scheduled for August 14, 2025, under Q-Sub number [to be assigned upon filing]. The Applicant intends to confirm with FDA the appropriate product code, reviewing division assignment, applicable guidance documents, and the scope of clinical and bench performance data expected to support the submission. Should FDA direct the Applicant to an alternative product code or reviewing division, this document and the submission package will be revised accordingly.
3.2 Regulation Number
Regulation Number: 21 C.F.R. § 862.1355
Regulation Description: Glucose test system
Section 862.1355 identifies a glucose test system as a device intended to measure glucose quantitatively in blood and other body fluids. Continuous glucose monitoring systems that measure interstitial glucose concentrations have been classified under this regulation section pursuant to FDA reclassification orders and special controls guidance documents applicable to integrated continuous glucose monitoring (iCGM) systems and related devices.
The Applicant notes the FDA reclassification order effective March 2024, which updated the classification and applicable special controls for certain continuous glucose monitoring devices under this regulation section. The Applicant will ensure that the submission addresses all applicable special controls identified in that reclassification order, including performance testing requirements, biocompatibility evaluation, electrical safety and electromagnetic compatibility testing, software validation, cybersecurity documentation, human factors/usability evaluation, and labeling requirements.
3.3 Device Classification
Classification: Class II (with Special Controls)
The Solstice Lumina™ CGM System is a Class II medical device subject to general controls under 21 C.F.R. Part 820 (Quality System Regulation), 21 C.F.R. Part 801 (Labeling), 21 C.F.R. Part 807 (Establishment Registration and Device Listing), and 21 C.F.R. Part 803 (Medical Device Reporting), as well as the special controls applicable to devices classified under 21 C.F.R. § 862.1355 and product code QKQ. The applicable special controls include, without limitation, the performance criteria and testing requirements set forth in the FDA guidance document titled "Integrated Continuous Glucose Monitoring Systems — Special Controls" and any successor or supplementary guidance documents, as well as the special controls identified in the De Novo classification order DEN170088 and the March 2024 reclassification order referenced above.
Submission Type: Traditional 510(k) Premarket Notification
The Applicant intends to submit a Traditional 510(k) premarket notification covering the complete Solstice Lumina™ CGM System, including both the Lumina C14 Implantable Continuous Glucose Monitoring Sensor and the Lumina R7 Wearable Reader/Transmitter, as a single integrated system in a single submission. The Solstice Lumina™ mobile application, as an accessory to the system, is also included within the scope of this submission. The Applicant does not intend to pursue a De Novo classification request, an abbreviated 510(k), or a Special 510(k) for this device at this time. The Applicant has identified cleared predicate devices classified under the same product code and regulation number (see Section 4 below) and believes that substantial equivalence can be established through the Traditional 510(k) pathway.
SECTION 4
PREDICATE DEVICE REFERENCE
4.1 Primary Predicate Device
The Applicant identifies the following device as the primary predicate for the purpose of establishing substantial equivalence under Section 510(k) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360(k):
The NovaSense GlucoTrack NX-500 CGM System is a continuous glucose monitoring system indicated for the management of diabetes in persons aged 18 years and older. Like the Solstice Lumina™ CGM System, the NX-500 comprises a subcutaneously inserted electrochemical glucose sensor and an external reader/transmitter component, and is indicated to replace fingerstick blood glucose testing for diabetes treatment decisions, including insulin dosing. The NX-500 received 510(k) clearance based on clinical study data demonstrating accuracy performance meeting iCGM criteria, including a Mean Absolute Relative Difference (MARD) of less than 9.0% overall and consensus error grid performance of greater than 99% of readings in Zones A and B (Clarke Error Grid Analysis).
The Applicant intends to demonstrate that the Solstice Lumina™ CGM System has the same intended use and the same or similar technological characteristics as the NovaSense GlucoTrack NX-500 CGM System, and that any differences in technological characteristics do not raise different questions of safety or effectiveness. A detailed comparison of the subject device and the primary predicate device will be provided in the "Substantial Equivalence Comparison" section of the 510(k) submission.
4.2 Secondary Predicate (Reference Device)
The Applicant identifies the following device as a secondary predicate (reference device) for the purpose of supporting the substantial equivalence determination:
The NovaSense GlucoTrack NX-700 CGM System is a next-generation continuous glucose monitoring system from the same manufacturer as the primary predicate. The NX-700 was cleared by FDA as a successor device to the NX-500, incorporating updated sensor chemistry, an extended sensor wear duration, and enhanced mobile application connectivity features. The NX-700 is cited as a secondary predicate to bridge specific technological features of the Solstice Lumina™ CGM System — including the 14-day sensor wear duration, BLE wireless connectivity architecture, and configurable alert functionality — that may be more directly comparable to the NX-700 than to the NX-500. The inclusion of the NX-700 as a secondary predicate is intended to provide additional support for the substantial equivalence determination with respect to those specific technological characteristics.
4.3 Additional Reference Device (Corporate Pedigree Only)
The following device is cited solely for purposes of establishing the Applicant's corporate pedigree, prior history of FDA interaction, and demonstrated capability in the glucose monitoring device space. This device is not cited as a predicate for the purpose of establishing substantial equivalence of the Solstice Lumina™ CGM System.
The Solstice GlucoStrip RX-200 Test Strip Reader is an in vitro diagnostic blood glucose monitoring system utilizing electrochemical test strips. The RX-200 was cleared via Traditional 510(k) and has been commercially available in the United States since January 2020. While the RX-200 operates on a different technological platform (in vitro capillary blood glucose measurement versus continuous interstitial glucose monitoring) and is classified under a different product code (NBW versus QKQ), it is cited here to demonstrate Solstice Biomedical Inc.'s prior successful FDA submissions, its established quality management system, its experience with FDA regulatory requirements applicable to glucose monitoring devices, and its corporate track record in this therapeutic area. The RX-200 is not being asserted as a predicate device for the Solstice Lumina™ CGM System, and no claim of substantial equivalence to the RX-200 is being made.
SECTION 5
CONCURRENCE STATEMENT / SIGNATURE BLOCK
5.1 Applicant Certification
The undersigned, being an authorized representative of Solstice Biomedical Inc., the applicant identified in this Indications for Use statement, hereby certifies that the above Indications for Use statement accurately reflects the intended use of the Solstice Lumina™ CGM System as described herein, and that the information provided in this form is true, accurate, and complete to the best of the undersigned's knowledge and belief.
The undersigned further acknowledges that the submission of materially false, fictitious, or fraudulent statements or representations to the United States Food and Drug Administration may subject the applicant and its officers, employees, and agents to criminal and civil penalties under applicable federal law, including but not limited to 18 U.S.C. § 1001 and 21 U.S.C. § 331.
SOLSTICE BIOMEDICAL INC.
By: ________
Printed Name: Marcus Hale
Title: Vice President, U.S. Operations
Date: ________
5.2 FDA Use Only
FOR FDA USE ONLY — DO NOT COMPLETE
The section below is reserved for completion by the Food and Drug Administration, Center for Devices and Radiological Health. This section will be completed by the reviewing official upon review of the 510(k) premarket notification submission.
510(k) Number: [To be assigned by FDA]
Concurrence of Center for Devices and Radiological Health (CDRH):
CDRH concurs with the Indications for Use statement as set forth in Section 2 above.
CDRH does not concur with the Indications for Use statement as set forth in Section 2 above. See comments below.
Comments (if any):
________________________________________
________________________________________
________________________________________
FOOD AND DRUG ADMINISTRATION CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
By: ________
Printed Name: ________
Title: ________
Date: ________
SECTION 6
PREPARER'S NOTES
(INTERNAL — NOT FOR FDA SUBMISSION)
PRIVILEGED AND CONFIDENTIAL — ATTORNEY WORK PRODUCT This section constitutes internal notes prepared by counsel in anticipation of regulatory proceedings and is protected by the attorney-client privilege and the work product doctrine. This section must be removed from the document prior to inclusion in any FDA submission package. Distribution is limited to authorized personnel of Solstice Biomedical Inc., Calderwood & Harkness LLP, and Pinnacle Regulatory Consulting Group LLC engaged under the direction of counsel.
6.1 Drafting Notes
This draft of FDA Form 3881 — Indications for Use Statement was prepared by the following individuals in connection with the preparation of the 510(k) premarket notification for the Solstice Lumina™ CGM System:
Primary Drafter:
Amy Whitfield, Esq. Lead Associate, Healthcare & Life Sciences Practice Calderwood & Harkness LLP 1401 K Street NW, Suite 900 Washington, D.C. 20005 Telephone: (202) 555-0318
Email: a.whitfield@calderwoodharkness.com
Reviewing Partner:
Miriam Calloway, Esq. Partner, Healthcare & Life Sciences Practice Calderwood & Harkness LLP 1401 K Street NW, Suite 900 Washington, D.C. 20005 Telephone: (202) 555-0312
Email: m.calloway@calderwoodharkness.com
Regulatory Consulting Coordination:
This draft was prepared in coordination with Pinnacle Regulatory Consulting Group LLC, which is providing regulatory strategy consulting services to Solstice Biomedical Inc. under the direction of Calderwood & Harkness LLP. The following individuals at Pinnacle Regulatory Consulting Group LLC have been consulted in the preparation of this document:
Dr. Sandra Ellison, PhD, RAC Managing Director, Regulatory Strategy Pinnacle Regulatory Consulting Group LLC 9500 Medical Center Drive, Suite 210 Rockville, MD 20850 Telephone: (301) 555-0274
Email: s.ellison@pinnaclereg.com
Thomas Greenbaum Senior Regulatory Consultant Pinnacle Regulatory Consulting Group LLC 9500 Medical Center Drive, Suite 210 Rockville, MD 20850 Telephone: (301) 555-0276
Email: t.greenbaum@pinnaclereg.com
6.2 Open Items and Revision Notes
The following open items, risk areas, and anticipated revision points are identified for tracking and resolution prior to finalization of the 510(k) submission package. Each item is assigned an internal tracking code for cross-reference in Calderwood & Harkness's matter management system.
Item 6.2.1 — Pre-Submission Meeting and FDA Feedback (SC-OPEN-001)
The Indications for Use language set forth in Section 2 of this document is in draft form and is subject to revision following the Pre-Submission (Q-Sub) meeting with FDA CDRH currently scheduled for August 14, 2025. The Q-Sub submission package will include this draft IFU statement along with the proposed testing plan and predicate device comparison. FDA may request modifications to the Indications for Use in several areas, including but not limited to the following:
(a) Population scope — FDA may request expansion or restriction of the intended patient population (e.g., inclusion of pediatric patients aged 2 years and older, or restriction to a specific subpopulation of diabetes patients).
(b) Adjunctive vs. non-adjunctive labeling — FDA may determine that the non-adjunctive claim (i.e., replacement of fingerstick blood glucose testing for treatment decisions including insulin dosing) is not supportable based on the proposed clinical study design or the data available from the identified predicate devices, and may direct the Applicant to adopt adjunctive labeling (i.e., requiring confirmation with a fingerstick blood glucose test before making treatment decisions).
(c) Measurement range claims — FDA may request modification to the stated glucose measurement range of 40–400 mg/dL based on accuracy performance at the extremes of the measurement range, particularly in the hypoglycemic range (< 70 mg/dL) and the severely hyperglycemic range (> 350 mg/dL).
(d) Interoperability and compatibility claims — FDA may request additional specificity regarding the interoperability of the system with automated insulin dosing (AID) systems, insulin pumps, or other connected diabetes management devices.
The team should plan for a post-Pre-Sub debrief within five (5) business days of the meeting to assess FDA feedback and determine necessary revisions to this document and the broader submission strategy.
Item 6.2.2 — iCGM Classification Pathway Considerations (SC-OPEN-002)
The integrated continuous glucose monitoring (iCGM) classification pathway, established pursuant to De Novo classification order DEN170088, may affect the final IFU language for the Solstice Lumina™ CGM System. Under the iCGM special controls, devices that meet defined accuracy performance criteria may be authorized with labeling that permits interoperability with compatible digitally connected medical devices, including automated insulin dosing systems, without the need for a new 510(k) submission for each new compatible device. If the Solstice Lumina™ CGM System meets the iCGM accuracy criteria as demonstrated by clinical study data from Protocol SBD-LUM-CL-001, the Applicant should consider whether to pursue iCGM designation for the device, which would require specific modifications to the IFU statement, including:
(a) Addition of interoperability labeling language specifying that the system is intended to interface with compatible medical devices and electronic interfaces, including automated insulin dosing systems, and that the system is designed to provide real-time glucose data to such devices;
(b) Inclusion of a statement that the system meets the special controls for iCGM devices as set forth in FDA's iCGM special controls memorandum; and
(c) Potential modification of the product code from QKQ to the iCGM-specific product code, if applicable.
This analysis is subject to further review by Dr. Ellison and Mr. Greenbaum at Pinnacle Regulatory Consulting Group LLC and should be resolved prior to the Pre-Submission meeting with FDA.
Item 6.2.3 — Clinical Study Data Requirements (SC-OPEN-003)
The accuracy performance claims implicit in the Indications for Use statement, including the non-adjunctive (replacement) claim, are to be supported by clinical data from the following clinical study:
Study Title: Performance Evaluation of the Solstice Lumina™ Continuous Glucose Monitoring System in Adults with Type 1 and Type 2 Diabetes Mellitus
Protocol Number: SBD-LUM-CL-001
abbreviated Title: LUMINA-US
Study Design: Prospective, multicenter, single-arm, non-randomized clinical accuracy study
Study Population: Approximately 350 subjects aged 18 years and older with a confirmed diagnosis of Type 1 or Type 2 diabetes mellitus
Number of Clinical Sites: Six (6) U.S. clinical sites (to be identified and contracted; site feasibility assessments in progress)
Target Study Commencement Date: September 15, 2025
Target Study Completion Date: March 15, 2026
Primary Accuracy Endpoint: Mean Absolute Relative Difference (MARD) ≤ 9.0% overall, as compared against venous blood glucose reference values (Penrose Software or equivalent)
Secondary Accuracy Endpoint: ≥ 99% of paired glucose values within Zones A and B of the Clarke Error Grid Analysis (Consensus Error Grid)
Supporting Performance Endpoints: Analysis of accuracy performance by glucose concentration range (hypoglycemic, euglycemic, and hyperglycemic ranges); analysis of accuracy performance by sensor wear day (Day 1 through Day 14); analysis of accuracy performance by patient subgroup (Type 1 vs. Type 2 diabetes; BMI subgroups; age subgroups); alert performance (sensitivity and specificity of hypoglycemia and hyperglycemia alerts); sensor survival rate and functional sensor life.
The non-adjunctive claim (replacing fingerstick blood glucose testing for treatment decisions including insulin dosing) requires clinical study data demonstrating sufficient accuracy to support the safety and effectiveness of the device for this intended use. This claim is currently aspirational and may be modified to an adjunctive use claim depending on the results of the LUMINA-US clinical study. Specifically, if the MARD exceeds 9.0%, or if the Clarke Error Grid Zone A+B percentage falls below 99%, the non-adjunctive claim may not be supportable, and the IFU should be revised to include adjunctive labeling requiring confirmation with a fingerstick blood glucose test before making treatment decisions.
Ms. Whitfield and Ms. Calloway should schedule a mid-study data review conference with Dr. Tierney and the clinical study team no later than January 15, 2026, to assess preliminary accuracy data and determine whether the non-adjunctive claim remains viable.
Item 6.2.4 — Warm-Up Time and Alert Latency Specifications (SC-OPEN-004)
The device description provided in the 510(k) submission package references a warm-up time specification of ≤ 60 minutes (i.e., the period after sensor insertion during which the system is calibrating and does not display glucose values) and an alert latency specification of ≤ 5 minutes (i.e., the maximum delay between the time a glucose threshold excursion occurs and the time the alert is displayed to the user). These performance specifications are referenced in the device description and technical specifications sections of the submission but are not currently stated in the Indications for Use text in Section 2 of this document.
It should be confirmed with FDA during the Pre-Submission meeting whether these specifications should appear in the IFU statement or whether they are appropriately addressed in other sections of the labeling (e.g., the Instructions for Use, device description, or performance data sections of the 510(k) submission). If FDA directs that warm-up time or alert latency should be stated in the IFU, the text in Section 2 will be revised accordingly.
Item 6.2.5 — EU MDR Harmonization Considerations (SC-OPEN-005)
The Solstice Lumina™ CGM System has been CE-marked for commercial distribution in the European Union and European Economic Area under the EU Medical Devices Regulation (EU) 2017/745 (MDR). The relevant EU certification information is as follows:
EU MDR CE Certificate Number: MCA-2024-07319
Date of Issue: September 12, 2024
Notified Body: Meridian Conformity Assessment GmbH (NB 0483), Frankfurt am Main, Germany
Commercial Availability in EU: The Solstice Lumina™ CGM System has been commercially available in the European Union since September 2024.
The EU indications for use (intended purpose statement) are to be harmonized with the U.S. IFU where possible to facilitate global labeling consistency. However, differences between the FDA regulatory framework and the EU MDR framework may necessitate deviations in IFU language between the U.S. and EU markets. In all cases, the FDA IFU statement takes precedence for the U.S. market, and any harmonization efforts should not result in the adoption of EU-specific language that is inconsistent with FDA expectations or the cleared indications of the identified predicate devices.
Dr. Tierney's team should prepare a comparative analysis of the U.S. draft IFU and the current EU intended purpose statement for review by Ms. Calloway no later than October 15, 2025.
Item 6.2.6 — Submission Timeline and Commercial Launch Planning (SC-OPEN-006)
The current project timeline for the 510(k) submission and commercial launch is as follows:
This draft will be updated upon completion of the Pre-Submission meeting, upon receipt of preliminary and final clinical study data, and upon completion of the 510(k) submission package. All revisions to this document should be tracked using Calderwood & Harkness's document management and version control system, and each version should be circulated only to authorized personnel in accordance with the firm's privilege protection guidelines.
6.3 Version History
All subsequent revisions to be tracked and maintained in accordance with Calderwood & Harkness LLP document management and privilege protection guidelines, including maintenance of a complete privilege log entry for each version. Prior versions should be retained in the firm's document management system under engagement reference 1037-00002 and should not be destroyed without the express authorization of the responsible partner.
END OF DOCUMENT
FORM FDA 3881 (DRAFT) — Indications for Use Statement Solstice Lumina™ CGM System Prepared by Calderwood & Harkness LLP | Engagement Ref: 1037-00002 PRIVILEGED AND CONFIDENTIAL — ATTORNEY WORK PRODUCT
Field | Information
Device Name | NovaSense GlucoTrack NX-500 CGM System
510(k) Number | K211034
Decision Date | June 18, 2022
Product Code | QKQ
Classification | Class II
Regulation Number | 21 C.F.R. § 862.1355
Applicant/Manufacturer | NovaSense Medical Technologies Inc.
Manufacturer Address | 4800 Innovation Parkway, San Diego, CA 92121
Field | Information
Device Name | NovaSense GlucoTrack NX-700 CGM System
510(k) Number | K230489
Decision Date | March 7, 2024
Product Code | QKQ
Classification | Class II
Regulation Number | 21 C.F.R. § 862.1355
Applicant/Manufacturer | NovaSense Medical Technologies Inc.
Manufacturer Address | 4800 Innovation Parkway, San Diego, CA 92121
Field | Information
Device Name | Solstice GlucoStrip RX-200 Test Strip Reader
510(k) Number | K192847
Decision Date | November 14, 2019
Product Code | NBW
Classification | Class II
Regulation Number | 21 C.F.R. § 862.1345
Applicant/Manufacturer | Solstice Biomedical Inc.
Manufacturer Address | 220 Westbrook Drive, Suite 400, Cambridge, MA 02142
Milestone | Target Date
Pre-Submission (Q-Sub) Meeting with FDA CDRH | August 14, 2025
LUMINA-US Clinical Study Commencement | September 15, 2025
LUMINA-US Clinical Study Completion | March 15, 2026
IFU Statement Finalization | April 1, 2026
510(k) Submission Package Completion | April 15, 2026
510(k) Submission to FDA | April 30, 2026
Target FDA Clearance | Q3 2026
Target U.S. Commercial Launch | Q4 2026
Version | Date | Author | Description
0.1 | [Current Date] | A. Whitfield (C&H) | Initial draft prepared for internal review by Solstice Biomedical Inc. regulatory team and Calderwood & Harkness Healthcare & Life Sciences practice group. Circulated to M. Calloway, M. Hale, Dr. N. Tierney, Dr. S. Ellison, and T. Greenbaum.
0.2 | [TBD — post Pre-Sub meeting] | [TBD] | Revision incorporating FDA feedback from Pre-Submission meeting (August 14, 2025).
0.3 | [TBD — post clinical study interim analysis] | [TBD] | Revision incorporating preliminary clinical study data and updated accuracy claims, if applicable.
1.0 | [TBD — target April 1, 2026] | [TBD] | Final version for inclusion in 510(k) submission package.