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510(k) Data Aggregation
(167 days)
Recens Medical Inc.
The CryoVIVE(Freezing mode) is indicated for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures
- Molluscum Contagiosum
- Skin Tags
- Actinic Keratosis
- Lentigo
- Verruca Plana
- Verruca Vulgaris
- Verruca Lesions
- Genital Lesions
- Seborrheic Keratosis
The CryoVIVE(Cooling mode) is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sprains or other minor sports injuries, and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).
The CryoVIVE is a handheld device that delivers rapid, precise and controlled cooling temperature to the skin tissue with the use of CO2 gas cartridge. The CryoVIVE consists of main system, nozzles(Cooling nozzle and Freezing nozzle), Guide tip, filter, and CO2 cartridge. The CryoVIVE offers two treatment modes, which can be changed by using different nozzles. In cooling mode, the main device produces controlled cooling based on thermoelectric cooling, which control the temperature (2-4°C) of targeted area. In freezing mode, the main device delivers the CO2 gas of extreme cold temperature (-79°C) , which causes the surgical destruction of target tissue. The CryoVIVE displays the skin temperature measured in real time, the set cooling temperature and time, and the device status through the LCD screen. Also, if the temperature below -1°C lasts for more than 1 second, the front LED blinks in blue with a beep sound.
This document describes the CryoVIVE device, a cryosurgical unit with both freezing and cooling modes. The 510(k) summary (K203481) indicates that the device is substantially equivalent to previously cleared predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a clear, quantitative format for all aspects. However, it does mention specific temperature ranges and safety features as part of its performance data and comparison to predicate devices.
| Feature Type | Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|---|
| Freezing Mode | Surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. | Delivers CO2 gas at -79°C for tissue destruction. |
| Cooling Mode | Temporary reduction of pain, swelling, inflammation, and hematoma; adjunct to rehabilitative treatment. | Reaches 2-4°C within 5 seconds for temporary reduction of pain, swelling, etc. |
| Safety Feature | Alarm/shutdown if skin temperature reaches -1°C or less for 1 second. | Alarm and LED blinking if skin temperature is -1°C or less for 1 second. |
| Biocompatibility | Conformance with established industry standards (ISO 10993). | Performed and demonstrated conformance. |
| Electrical Safety | Compliance with IEC 60601-1. | Complies with IEC 60601-1. |
| EMC | Compliance with IEC 60601-1-2. | Complies with IEC 60601-1-2. |
| Risk Management | Hazard analysis completed, risk control implemented. | Hazard analysis completed and risk control implemented. |
2. Sample Size Used for the Test Set and Data Provenance
No specific sample size for a test set is mentioned for clinical testing because no clinical performance data has been provided. The device's equivalency is based on bench testing and comparison to predicate devices, not on a new clinical study. Therefore, there is no information on data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. As no clinical testing or reader study was performed for this device, no experts were used to establish ground truth for a test set.
4. Adjudication Method
Not applicable. No clinical testing or reader study was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC comparative effectiveness study was not done. The submission relies on substantial equivalence to predicate devices, not on a study evaluating human reader performance with or without AI assistance.
6. Standalone Performance Study
No. A standalone (algorithm-only) study was not done in the context of an AI device. The CryoVIVE is a physical medical device, and its performance was evaluated through bench testing against established standards and comparison to predicate devices, not through an AI algorithm’s standalone performance.
7. Type of Ground Truth Used
The "ground truth" for the CryoVIVE's performance assessment appears to be:
- Engineering specifications and standards: For electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993).
- Predicate device characteristics: The performance (e.g., temperature ranges, safety features, intended use) of the legally marketed predicate devices (CryoLab K190407, CryOmega Flexx K172769, and CRYOFOS K170810) serve as the benchmark for establishing substantial equivalence.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set.
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