Contract analysis

Section 1: Submission Type Type of Pre-Submission: Q-Submission (Q-Sub) Q-Sub Subtype: Pre-Submission for a planned 510(k) This request is submitted pursuant to FDA guidance entitled "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program" (Revision, January 2023) to obtain formal written feedback from the Agency and, if appropriate, an interactive meeting with the review division

Section 2: Applicant / Sponsor Information Applicant Name: Solstice Biomedical Inc. Entity Type: Corporation, organized and existing under the laws of the State of Delaware (Delaware Division of Corporations File No. 7834291) Principal Place of Business: Solstice Biomedical Inc. 220 Westbrook Drive, Suite 400 Cambridge, MA 02142 United States Applicant Telephone: (617) 555-0194 Applicant Email: regulatory@solsticebio

Section 3: Authorized Representative Information Authorized Representative (Law Firm): Calderwood & Harkness LLP Address: Calderwood & Harkness LLP 1401 K Street NW, Suite 900 Washington, D.C. 20005 United States Primary Contact: Miriam Calloway, Esq. Partner, Healthcare & Life Sciences Practice Calderwood & Harkness LLP Telephone: (202) 555-0733 Email: miriam.calloway@calderwoodharkness.com Additional Contact: Amy W

Section 4: Device Identification Device Trade/Proprietary Name: Solstice Lumina™ CGM System Device Components: The Solstice Lumina™ CGM System consists of the following two principal hardware components, which together constitute a single, integrated continuous glucose monitoring system: The system also includes associated software components, including embedded firmware in the C14 sensor and R7 reader, a predictive

Section 5: Device Description Summary 5.1 System Overview The Solstice Lumina™ CGM System is a prescription-use, real-time continuous glucose monitoring system intended to measure interstitial glucose levels in persons aged 18 years and older with Type 1 or Type 2 diabetes mellitus. The system provides continuous, real-time glucose readings, trend information, and configurable alerts to assist patients and healthcare

Section 6: Predicate Device Information 6.1 Primary Predicate Device The NovaSense GlucoTrack NX-500 CGM System is a continuous glucose monitoring system consisting of a subcutaneously placed electrochemical glucose sensor with a 10-day wear duration and a handheld reader/transmitter device. The NX-500 system employs a third-generation enzymatic electrochemical sensor with a platinum electrode, BLE 4.2 wireless commu

Section 7: Regulatory History of the Applicant Solstice Biomedical Inc. has the following regulatory history with the U.S. Food and Drug Administration and other regulatory authorities relevant to this Pre-Submission request:

1. Prior FDA Clearance — GlucoStrip RX-200 Test Strip Reader. Solstice Biomedical Inc. previously obtained 510(k) clearance for the Solstice GlucoStrip RX-200 Test Strip Reader (510(k) No. K192847, cleared November 14, 2019). The RX-200 is a Class II fingerstick blood glucose test strip reader classified under product code NBW and 21 C.F.R. § 862.1345. The RX-200 is currently marketed in the United States and remains

2. Solstice Lumina™ CGM System — No Existing U.S. Clearance or Approval. The Solstice Lumina™ CGM System has not been the subject of any prior FDA premarket submission, and the device does not hold any existing FDA clearance, approval, or De Novo authorization. This Pre-Submission meeting request represents the Applicant's first formal engagement with the Agency regarding the Lumina CGM System.

3. EU MDR CE Certificate. The Solstice Lumina™ CGM System holds an EU Medical Device Regulation (MDR 2017/745) CE certificate issued by Meridian Conformity Assessment GmbH, a Notified Body designated under EU MDR (Notified Body Identification No. NB 0483). The certificate details are as follows: • Certificate Number: MCA-2024-07319 • Date of Issue: September 12, 2024 • Device Classification (EU MDR): Class IIb (Rule

4. ISO 13485:2016 Certification. Solstice Biomedical Devices Ltd. (parent company) holds ISO 13485:2016 certification for the design, development, manufacture, and servicing of continuous glucose monitoring systems and blood glucose monitoring devices. The ISO 13485 certificate is issued by BSI Group (Certificate No. MD 734822) and covers the manufacturing facility located at Unit 14, Liffey Innovation Park, Chapeliz

5. No Outstanding FDA Enforcement Actions. As of the date of this submission, neither Solstice Biomedical Inc. nor Solstice Biomedical Devices Ltd. is the subject of any pending FDA warning letter, consent decree, import alert, or other enforcement action.

Section 8: Review Division Identification Center: Center for Devices and Radiological Health (CDRH) Office: Office of Health Technology 2 (OHT2) Division: Division of Chemistry and Toxicology Devices Rationale for Division Assignment: The Solstice Lumina™ CGM System is classified under product code QKQ (Electrode, Glucose, Subcutaneous) and regulated under 21 C.F.R. § 862.1355 (Glucose test system). Based on the FDA

Section 9: Meeting Request Details 9.1 Type of Meeting Requested The Applicant hereby requests a Q-Submission (Pre-Submission) meeting with the review division responsible for the planned Traditional 510(k) submission for the Solstice Lumina™ CGM System. Purpose of Meeting: The purpose of the requested Pre-Submission meeting is to obtain FDA feedback on key regulatory, clinical, and technical questions relating to th

Section 10: Summary of Topics and Questions for Discussion The Applicant intends to discuss the following key topics during the Pre-Submission meeting. Detailed questions for each topic area will be set forth in the Pre-Submission meeting package to be submitted by June 16, 2025. The following is a brief enumeration of the key topics for the Agency's planning purposes: Topic 1: Predicate Acceptance and Substantial Eq

Section 11: Pre-Submission Meeting Package Contents (Planned) The Applicant intends to submit the complete Pre-Submission meeting package no later than June 16, 2025, which is at least 60 days prior to the requested meeting date of August 14, 2025. The Pre-Submission meeting package will include the following documents and materials:

1. Executive Summary. A concise summary of the device, the regulatory strategy, and the purpose of the Pre-Submission meeting request.

2. Detailed Device Description (Lumina C14 and Lumina R7). A comprehensive description of both hardware components and all software components of the Solstice Lumina™ CGM System, including device specifications, materials, operating principles, block diagrams, and photographs.

3. Predicate Comparison and Substantial Equivalence Discussion. A detailed comparison of the Solstice Lumina™ CGM System with the primary predicate (NovaSense GlucoTrack NX-500, K211034) and the secondary predicate / reference device (NovaSense GlucoTrack NX-700, K230489), including tabular comparison of intended use, technological characteristics, performance specifications, and identification and discussion of diff

4. Proposed Performance Testing Plan (Bench Testing, Biocompatibility, EMC, Software V&V). A summary of the Applicant's proposed bench testing program, including analytical performance testing, biocompatibility testing (ISO 10993), electromagnetic compatibility testing (IEC 60601-1-2), electrical safety testing (IEC 60601-1), wireless coexistence testing, sterilization validation, shelf life/stability testing, and so

5. Proposed Clinical Study Protocol Summary (Protocol SBD-LUM-CL-001). A summary of the proposed LUMINA-US clinical study protocol, including study objectives, study design, inclusion/exclusion criteria, study endpoints, sample size justification, statistical analysis plan, and study sites.

6. Specific Questions for FDA (Organized by Topic Area). A comprehensive list of specific questions for FDA, organized by the seven topic areas identified in Section 10 of this form, with relevant background information and the Applicant's preliminary position on each question.

7. Supporting Appendices. The following supporting materials will be appended to the meeting package: (a) Predicate comparison tables (detailed side-by-side comparison) (b) Device diagrams and engineering drawings (Lumina C14 and Lumina R7) (c) Software architecture overview and data flow diagrams (d) Summary of EU MDR clinical evaluation and post-market data (if available) (e) ISO 13485:2016 certificate (Solstice Bi

Section 12: Declaration and Signature block I certify that the information provided in this Pre-Submission meeting request is true, accurate, and complete to the best of my knowledge. I understand that any materially false, fictitious, or fraudulent statement or representation may subject the person making such statement to criminal penalties under 18 U.S.C. § 1001. I further certify that Solstice Biomedical Inc. is