Contract analysis

I. Executive Summary Calderwood & Harkness LLP ("C&H" or the "Firm") has been engaged to advise Solstice Biomedical Devices Ltd. ("Solstice," "SBD," or the "Company") and its wholly owned U.S. subsidiary, Solstice Biomedical Inc. ("SBI"), on the development and execution of a regulatory strategy for U.S. market entry of the Solstice Lumina™ Continuous Glucose Monitoring System (the "Lumina CGM System" or the "Device"

II. Background A. Client Overview Solstice Biomedical Devices Ltd. Solstice Biomedical Devices Ltd. is a privately held Irish limited company incorporated under the laws of the Republic of Ireland (Companies Registration Office No. 648231), with its principal offices located at Unit 14, Liffey Innovation Park, Chapelizod, Dublin D20 FX72, Ireland. The Company's core competency lies in the design, development, and man

1. FDA Pre-Submission (Pre-Sub) Strategy and Meeting Request Preparation. C&H will prepare the Pre-Submission meeting request, including the meeting request cover letter, FDA Form 3514, and the complete Pre-Sub meeting package with questions for FDA, device description, proposed predicate device analysis, proposed clinical study protocol summary, and proposed testing plan. 2. 510(k) Submission Planning and Drafting.

3. Predicate Device Analysis and Substantial Equivalence Framework. C&H will analyze candidate predicate devices and develop the substantial equivalence argument, including identification and mitigation of differences between the Lumina CGM System and the selected predicates.

4. Clinical Study Regulatory Guidance. C&H will advise on the regulatory requirements for the pivotal clinical study (LUMINA-US), including IDE exemption analysis, study design considerations, and preparation of regulatory components of the study protocol.

5. Coordination with Pinnacle Regulatory Consulting Group LLC. Solstice has separately retained Pinnacle Regulatory Consulting Group LLC ("Pinnacle") as its primary regulatory consultancy for the 510(k) project. Pinnacle's engagement commenced on January 15, 2025. The key contacts at Pinnacle are Dr. Sandra Ellison, Managing Director, and Thomas Greenbaum, Senior Regulatory Specialist. C&H will coordinate with Pinnac

6. Interface with Other Advisors. As needed, C&H will coordinate with Crestline IP Advisory LLC ("Crestline"), Solstice's freedom-to-operate and patent counsel (key contact: Dr. Raymond Cho, Patent Attorney, 75 Federal Street, Suite 1800, Boston, MA 02110), and Hargrove & Endicott LLP ("Hargrove"), Solstice's Irish corporate and regulatory counsel (key contact: Ciara Brennan, Partner, 38 Fitzwilliam Square East, Dubl

III. Recommended Regulatory Pathway A. 510(k) Premarket Notification — Rationale The Lumina CGM System is a Class II medical device that falls within an established classification framework for continuous glucose monitoring systems. After careful analysis of the available regulatory pathways, C&H recommends that Solstice pursue a traditional 510(k) premarket notification under Section 510(k) of the Federal Food, Drug

IV. Device Classification Analysis A. Product Code and Regulation Number Based on our analysis of the FDA product classification database, applicable regulation, and the classification of the identified predicate devices, we anticipate that the Lumina CGM System will be classified under the following: • Product Code: QKQ — Electrode, Glucose, Subcutaneous • Regulation Number: 21 C.F.R. § 862.1355 — Glucose test syste

1. Clinical Performance Requirements. The device must demonstrate clinical accuracy through a well-designed clinical study. Performance metrics include MARD, point accuracy across clinically relevant glucose concentration ranges, and consensus error grid analysis. The specific performance criteria are set forth in applicable FDA guidance documents and in the special controls order, and the LUMINA-US clinical study (d

2. Analytical Performance Requirements. The device must demonstrate analytical performance through bench testing, including accuracy, linearity across the measurement range (40–400 mg/dL), precision (within-sensor and between-sensor), and response to interfering substances. Interference testing must evaluate the effects of common exogenous and endogenous substances (e.g., acetaminophen, ascorbic acid, uric acid, malt

3. Biocompatibility. Materials in direct or indirect contact with the body must be evaluated for biocompatibility in accordance with ISO 10993-1:2018 and applicable parts of the ISO 10993 series, as appropriate for the nature and duration of body contact. The C14 sensor, as a subcutaneously implanted device with limited (14-day) contact duration, requires a comprehensive biocompatibility testing program, as detailed

4. Software Validation. Software contained in or associated with the device must be validated in accordance with FDA guidance and applicable standards, including IEC 62304:2006/A1:2015. The software level of concern and corresponding documentation requirements are addressed in Section VIII.

5. Electromagnetic Compatibility (EMC). The device must be tested for electromagnetic compatibility to demonstrate that it does not emit electromagnetic interference at levels that could adversely affect other devices, and that it is immune to electromagnetic interference from external sources, in accordance with IEC 60601-1-2.

6. Sterility. The C14 sensor, as a sterile implantable device, must demonstrate sterility assurance consistent with applicable standards (e.g., ISO 11135 for EO sterilization). Sterility validation data must be included in the 510(k) submission.

7. Labeling. Device labeling must comply with 21 C.F.R. Part 801 and must include all information required by the special controls, including instructions for use, user warnings and precautions, sensor insertion instructions, reader operation instructions, alert configuration instructions, and information regarding device limitations and potential interfering substances.

8. Cybersecurity. As a wirelessly connected medical device, the Lumina CGM System must satisfy FDA's cybersecurity expectations as set forth in applicable guidance, including threat modeling, cybersecurity risk assessment, and provision of a Software Bill of Materials (SBOM). These requirements are addressed in Section VIII.B. C. Product Code Confirmation Strategy While we have high confidence in the anticipated QKQ

V. Predicate Device Selection and Substantial Equivalence Framework The selection of appropriate predicate devices is foundational to the success of a 510(k) submission. Under 21 C.F.R. § 807.100(b), a device is substantially equivalent to a predicate device if it has the same intended use and the same technological characteristics as the predicate, or, if it has the same intended use but different technological char

1. Sensor Wear Duration The Lumina C14 sensor is designed for a 14-day (336-hour) sensor wear duration, compared to the 10-day sensor wear duration of the NX-500 primary predicate. Mitigation: The secondary predicate, NovaSense GlucoTrack NX-700 (K230489), was cleared by FDA on March 7, 2024 with a 14-day sensor wear duration. This clearance establishes that a 14-day wear duration has been evaluated and accepted by F

2. Electrode Material The Lumina C14 sensor employs Solstice's proprietary platinum-iridium electrode coating (PtIr-4G technology), whereas the NX-500 primary predicate utilizes a platinum electrode. Mitigation: The PtIr-4G coating architecture achieves the same functional purpose as the platinum electrode in the NX-500 — namely, electrochemical sensing of glucose through catalytic oxidation at the electrode surface.

3. BLE Version The Lumina CGM System utilizes Bluetooth Low Energy (BLE) 5.2 for wireless data communication between the C14 sensor and R7 reader, and between the R7 reader and the Lumina mobile application. The NX-500 primary predicate utilizes BLE 5.0. Mitigation: BLE 5.2 is a backward-compatible, incremental upgrade from BLE 5.0 within the Bluetooth specification maintained by the Bluetooth Special Interest Group

4. Reader Form Factor The Lumina R7 reader/transmitter is an arm-worn wearable device, whereas the NX-500 primary predicate includes a handheld receiver. Mitigation: The difference in reader form factor between the Lumina R7 (arm-worn) and the NX-500 receiver (handheld) is primarily an ergonomic and industrial design difference. The functional purpose of the reader — receiving sensor data via BLE, processing the data

5. Algorithm The Lumina CGM System employs Solstice's proprietary LuminaPredict Algorithm v2.1 for converting raw sensor signal data into calibrated glucose values. The NX-500 primary predicate uses NovaSense's proprietary algorithm. Mitigation: Differences in the glucose prediction algorithm between the Lumina CGM System and the NX-500 predicate are expected, as each manufacturer develops its own proprietary signal

VI. Clinical Data Requirements A. Clinical Study Overview Solstice has designed a pivotal clinical study, designated Solstice Protocol SBD-LUM-CL-001 ("LUMINA-US"), to generate the clinical performance data required to support the 510(k) substantial equivalence determination. The LUMINA-US study has been designed in consultation with Pinnacle Regulatory Consulting Group LLC and is intended to be consistent with FDA's

VII. Non-Clinical Testing Requirements A. Biocompatibility Testing Biocompatibility testing of the Lumina CGM System is a critical component of the 510(k) submission and will be conducted in accordance with the requirements of ISO 10993-1:2018, "Biological evaluation of medical devices — Part 1: Evaluation and review within a risk management process." The biocompatibility testing program is tailored to the nature and

VIII. Software and Cybersecurity Documentation A. Software Level of Concern The Lumina CGM System contains multiple software components that play a critical role in the device's intended function and that directly affect the safety and effectiveness of the system. Based on our assessment, the software level of concern for the Lumina CGM System is designated as Major, which is the highest level of concern below the th

IX. Freedom-to-Operate and intellectual Property Considerations A. NovaSense Patent Portfolio NovaSense Medical Technologies Inc. — the manufacturer of both identified predicate devices — holds a substantial portfolio of intellectual property related to CGM technology. Based on our coordination with Crestline IP Advisory LLC and publicly available patent records, NovaSense holds a portfolio of 14 U.S. utility patents