Contract analysis

1. Submitter Information Name of Submitter: Solstice Biomedical Inc. Entity Type: Corporation organized under the laws of the State of Delaware (File No. 7834291) Address: 220 Westbrook Drive, Suite 400 Cambridge, MA 02142 United States Contact Person: Marcus Hale, Vice President of U.S. Operations Telephone: (617) 555-0142 Email: mhale@solsticebiomedical.com Regulatory Contact: Dr. Niamh Tierney, Vice President of R

2. Device Identification 2.1 Device Name and Trade Name Trade/Proprietary Name: Solstice Lumina™ Continuous Glucose Monitoring System ("Solstice Lumina™ CGM System" or "Lumina CGM System") Common/Usual Name: Continuous Glucose Monitoring System The Solstice Lumina™ CGM System is composed of the following integrated device components, which together constitute the subject of this 510(k) submission: (a) Lumina C14 Sens

3. Intended Use / Indications for Use The Solstice Lumina™ Continuous Glucose Monitoring System is a prescription-use continuous glucose monitoring device intended for the following use and indications: Intended Use: The Solstice Lumina™ CGM System is intended for the continuous, real-time monitoring of glucose levels in persons aged 18 years and older who have been diagnosed with Type 1 diabetes mellitus (T1D) or Ty

4. Device Description 4.1 Lumina C14 Sensor The Lumina C14 is a subcutaneously implantable continuous glucose monitoring sensor designed for up to 14 days (336 hours) of uninterrupted glucose monitoring in the interstitial fluid. The C14 sensor represents Solstice Biomedical's fourth-generation enzymatic electrochemical biosensor technology and incorporates the company's proprietary platinum-iridium electrode coating

5. Predicate Device Identification and Comparison 5.1 Predicate Devices Primary Predicate Device: The NovaSense GlucoTrack NX-500 CGM System was selected as the primary predicate device because it shares the same intended use (continuous glucose monitoring for persons aged 18 and older with T1D or T2D), the same fundamental technology (enzymatic electrochemical biosensor for glucose measurement in interstitial fluid)

1. Sensor Wear Duration (14 Days vs. 10 Days) The Lumina C14 sensor is designed for a maximum continuous wear duration of 14 days (336 hours), compared to the 10-day (240-hour) wear duration of the NX-500 sensor. This extended wear period is intended to provide patients with a longer monitoring interval per sensor, thereby reducing the frequency of sensor replacements and associated insertion procedures. The 14-day w

2. Electrode Material (Platinum-Iridium PtIr-4G vs. Platinum) The Lumina C14 sensor employs a proprietary platinum-iridium alloy electrode with a fourth-generation surface coating (PtIr-4G technology), whereas the NX-500 predicate device uses a platinum electrode. The platinum-iridium alloy and the PtIr-4G surface coating are designed to enhance electrochemical sensitivity, improve selectivity against common interfer

3. BLE Version (5.2 vs. 5.0) The Solstice Lumina™ CGM System uses Bluetooth Low Energy (BLE) 5.2 for wireless data communication between the Lumina C14 sensor and the Lumina R7 reader/transmitter, as well as between the Lumina R7 and the companion mobile application. The primary and secondary predicate devices both employ BLE 5.0 for wireless communication. BLE 5.2 is an updated version of the BLE 5.0 specification p

4. Reader Form Factor (Arm-Worn vs. Handheld) The Lumina R7 reader/transmitter is designed as an arm-worn integrated reader/transmitter device that is adhered to the patient's upper arm, in contrast to the handheld receiver form factor used in both the NX-500 and NX-700 predicate devices. The arm-worn form factor is intended to provide the user with continuous, hands-free access to glucose readings and alerts without

5. Algorithm (LuminaPredict v2.1 vs. NovaSense Proprietary Algorithm) The Solstice Lumina™ CGM System uses Solstice Biomedical's proprietary glucose prediction algorithm, designated LuminaPredict v2.1, for processing sensor glucose data and generating trend information, predictive glucose alerts, and rate-of-change calculations. The NX-500 and NX-700 predicate devices use NovaSense Medical Technologies' proprietary a

6. Summary of Performance Data — Bench Testing 6.1 Sensor Accuracy / Analytical Performance Analytical performance testing of the Lumina C14 sensor was conducted to evaluate sensor accuracy, linearity, precision, interference rejection, and functional life over the full 14-day (336-hour) wear period. Testing was performed using both in vitro (bench-top) test protocols and clinical (in vivo) paired data from the LUMIN

7. Summary of Performance Data — Biocompatibility 7.1 Testing Standard Biocompatibility evaluation of the Solstice Lumina™ CGM System was conducted in accordance with ISO 10993-1:2018 (Biological evaluation of medical devices — Part 1: Evaluation and review within a risk management process). The biocompatibility evaluation was designed based on the nature, duration, and type of tissue contact associated with each dev

8. Summary of Performance Data — Clinical 8.1 Clinical Study Overview A prospective, single-arm, multicenter clinical study was conducted in the United States to evaluate the safety and performance of the Solstice Lumina™ CGM System in the intended use population. IDE Status: The LUMINA-US clinical study was conducted under the investigational device exemption (IDE) provisions of 21 C.F.R. Part 812. Specifically, the

9. Substantial Equivalence Determination 9.1 Same Intended Use The Solstice Lumina™ CGM System has the same intended use as the primary predicate device, the NovaSense GlucoTrack NX-500 CGM System (K211034), and the secondary predicate device, the NovaSense GlucoTrack NX-700 CGM System (K230489). Specifically, all three devices are intended for the continuous monitoring of glucose levels in persons aged 18 years and