Contract analysis

1. Introduction and Purpose of the Pre-Submission Solstice Biomedical Inc. ("SBI"), a Delaware corporation (File No. 7834291) and the U.S. subsidiary of Solstice Biomedical Devices Ltd. ("SBD"), an Irish private limited company (Companies Registration Office No. 648231), respectfully requests a Pre-Submission (Q-Sub) meeting with the Center for Devices and Radiological Health ("CDRH") of the U.S. Food and Drug Admini

1. Predicate device selection and substantial equivalence framework — including the appropriateness of the proposed primary and secondary predicate devices and whether identified technological differences raise new questions of safety or effectiveness;

2. Proposed performance and clinical testing plans — including the design, endpoints, and sample size of the planned pivotal clinical study, as well as the scope of bench performance testing;

3. Software documentation and cybersecurity approach — including the appropriateness of the software level of concern designation, documentation expectations, and cybersecurity considerations specific to the device's wireless architecture;

4. Biocompatibility testing scope — including whether the proposed ISO 10993-series testing program is sufficient for the C14 implantable sensor and R7 wearable reader; and

5. Potential iCGM classification pathway considerations — including whether the Lumina CGM System may be eligible for integrated CGM (iCGM) classification and the applicable special controls. The full Pre-Submission meeting package accompanies this Executive Summary and includes the following separate sections, each of which provides detailed information on the respective topics: • Device Description (detailed techni

2. Sponsor Information The intended 510(k) applicant and device registration holder for the Solstice Lumina™ CGM System is Solstice Biomedical Inc., the U.S. operating subsidiary of Solstice Biomedical Devices Ltd. Key corporate and personnel information is provided below. Intended 510(k) Applicant / Registration Holder: Solstice Biomedical Inc. (SBI) 220 Westbrook Drive, Suite 400 Cambridge, MA 02142 United States D

3. Regulatory History of the Sponsor 3.1 Prior FDA Clearance Solstice has prior experience with the FDA premarket review process. Solstice Biomedical Inc. previously obtained 510(k) clearance for the GlucoStrip RX-200 Test Strip Reader, a Class II in vitro diagnostic glucose test strip reader device, under 510(k) No. K192847. This clearance was issued by FDA on November 14, 2019, under product code NBW (System, Test,

4. Device Overview 4.1 Product Line Product Line Name: Solstice Lumina™ CGM System The Solstice Lumina™ CGM System is an integrated continuous glucose monitoring platform that comprises two device variants designed and intended to function together as a unified system for real-time glucose monitoring in persons with diabetes mellitus. The two device variants — the Lumina C14 implantable sensor and the Lumina R7 weara

5. Intended Use and Indications for Use The proposed intended use and indications for use statement for the Solstice Lumina™ CGM System, as anticipated to be included in the planned 510(k) submission, is as follows: Intended Use: The Solstice Lumina™ Continuous Glucose Monitoring (CGM) System is intended for the continuous monitoring of glucose levels in the interstitial fluid of persons aged 18 and older with Type 1

6. Proposed Regulatory Pathway 6.1 Submission Type and Classification Solstice Biomedical Inc. proposes to submit a traditional 510(k) premarket notification for the Solstice Lumina™ CGM System, covering both the Lumina C14 implantable sensor and the Lumina R7 wearable reader/transmitter as a single integrated system under one submission. Solstice has determined that a traditional 510(k) is the appropriate submission

1. Sensor Wear Duration: The Lumina C14 sensor has a 14-day (336-hour) wear duration compared to the 10-day (240-hour) wear duration of the NX-500. This extended wear duration is consistent with the secondary predicate NX-700 (K230489), which also features a 14-day sensor wear duration and has been cleared by FDA under the same product code and classification. Solstice will provide performance and clinical data demon

2. Electrode Material: The Lumina C14 sensor employs a proprietary platinum-iridium alloy electrode coating (PtIr-4G technology), whereas the NX-500 utilizes a conventional platinum electrode. The PtIr-4G electrode is designed to provide enhanced signal stability and reduced interferent sensitivity. Solstice will provide bench testing data (including interference testing per FDA's glucose monitoring guidance) and bio

3. Bluetooth Low Energy Version: The Lumina CGM System utilizes BLE 5.2 for wireless communication between the C14 sensor and R7 reader/transmitter, whereas the NX-500 uses BLE 5.0. BLE 5.2 provides improved data throughput, enhanced connection stability, and additional security features compared to BLE 5.0. Solstice will provide wireless coexistence testing data and cybersecurity documentation to demonstrate that th

4. Reader Form Factor: The Lumina R7 is an arm-worn integrated reader/transmitter, whereas the NX-500 employs a handheld receiver. The arm-worn form factor of the R7 is designed to enable continuous, passive data reception without requiring the user to actively scan or position a handheld receiver. Solstice will provide human factors data and biocompatibility data for the skin-contacting adhesive to address this diff

5. Glucose Algorithm: The Lumina CGM System employs Solstice's proprietary glucose prediction algorithm (LuminaPredict v2.1), whereas the NX-500 uses NovaSense's proprietary algorithm. The LuminaPredict algorithm processes raw electrochemical data from the C14 sensor and generates calibrated glucose values, trend information, and predictive alerts. Solstice will provide software verification and validation documentat

7. Overview of Proposed Testing and Clinical Strategy 7.1 Performance Testing Solstice has developed a comprehensive performance testing plan designed to demonstrate the safety and effectiveness of the Solstice Lumina™ CGM System and to address each of the identified technological differences from the primary predicate device. The proposed performance testing program encompasses bench testing, biocompatibility testin

8. Software and Cybersecurity Overview The Solstice Lumina™ CGM System incorporates multiple software components that are integral to the device's function. Solstice has developed these software components in accordance with IEC 62304:2006/A1:2015 and has classified the software and cybersecurity risk in accordance with applicable FDA guidance. A detailed software description and cybersecurity documentation plan is p

9. Proposed Regulatory Timeline Solstice has developed the following proposed regulatory timeline for the Lumina CGM System U.S. market entry program. This timeline has been developed with the objective of providing a complete and high-quality 510(k) submission that fully reflects FDA feedback from the Pre-Submission meeting, while maintaining a target for U.S. commercial launch in the fourth quarter of 2026. Solstic

10. Summary of Questions for FDA Solstice Biomedical Inc. is seeking FDA guidance on the following topics in connection with the planned traditional 510(k) submission for the Solstice Lumina™ CGM System. The questions summarized below are presented in full, with supporting context and background information, in the separate Questions for FDA section of the Pre-Sub meeting package. Solstice respectfully requests that

11. Conclusion Solstice Biomedical Inc. respectfully requests the opportunity to meet with CDRH, Office of Health Technology 2, Division of Chemistry and Toxicology Devices, to discuss the topics outlined in this Executive Summary and the accompanying Pre-Submission meeting package in advance of the planned traditional 510(k) submission for the Solstice Lumina™ Continuous Glucose Monitoring System. Solstice is commit

Section 1 | Executive Summary | This document. Provides a comprehensive overview of the sponsor, device, proposed regulatory pathway, testing and clinical strategy, and questions for FDA.

Section 2 | Device Description | Detailed technical description of the Solstice Lumina™ CGM System, including the Lumina C14 implantable sensor and Lumina R7 wearable reader/transmitter. Includes materials descriptions, functional specifications, design drawings, system architecture diagrams, and accessories (Lumina Applicator).

Section 3 | Predicate Comparison and Substantial Equivalence Discussion | Comprehensive predicate comparison table and narrative substantial equivalence analysis. Includes feature-by-feature comparison of the subject device with the primary predicate (NovaSense GlucoTrack NX-500, K211034) and secondary predicate (NovaSense GlucoTrack NX-700, K230489) across all relevant technological and performance parameters, with

Section 4 | Proposed Performance Testing Plan | Detailed proposed bench performance testing plan, including sensor accuracy, linearity, precision, interference, stability/drift, wireless performance, biocompatibility (ISO 10993), EMC/electrical safety, and software verification and validation. Includes specific test protocols, sample sizes, acceptance criteria, test conditions, applicable consensus standards, and tes

Section 5 | Proposed Clinical Study Protocol Summary (Protocol SBD-LUM-CL-001, "LUMINA-US") | Detailed summary of the proposed pivotal clinical study protocol, including study design, subject population, inclusion/exclusion criteria, endpoints, reference method, statistical analysis plan, sample size justification, study sites, and safety monitoring plan.

Section 6 | Questions for FDA | Complete list of specific questions for FDA, organized by topic area, with supporting context and background information for each question.