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510(k) Data Aggregation
(526 days)
CryoScience North America, Inc.
The CRYO Penguin is indicated for use when cold therapy is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sports injuries and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).
The CRYO Penguin utilizes liquid nitrogen (LN2) to provide supercooled air for localized treatment. There are three main components to the device: Liquid nitrogen vessel with an evaporator, Cryogenic hose with a treatment handle, Electrical box and HMI panel with control software. The CRYO Penguin directs cold gas to the treatment area via a cryogenic hose tipped with a treatment handle. The handle is equipped with a red laser and LED lights to accurately position the treatment handle to provide a readout of the patient's skin temperature. The treatment handle does not physically touch the patient. To assure that the wand maintains the proper distance to the patient (approximately 15cm), there are two small lasers which provide two laser dots. When these dots converge to one dot, the handle is properly distanced. If the handle moves closer to the patient or further away, the dots no longer converge, providing a visual cue to the operator that the handle position has changed and is no longer optimal. Additionally, a temperature sensor and LED lights monitor optimal skin surface temperature; LED lights indicate skin temperature status as follows: GREEN the skin temperature is too high for optimum treatment (above 4°C) and should be further cooled. BLUE - the skin temperature is at the desired temperature (in the range of 2-4℃). RED the skin temperature is too low (below 2°C), and the treatment handle is removed or moved further away from the patient. If the temperature of the skin surface is below -1ºC for 1 second, auto-off function activates. The CRYO Penquin is software driven via pre-programmed protocol. Treatment time is monitored via countdown timer which is adjustable based on the treatment desired. Note: The protocol is selected prior to the session and may not be changed during the session. The CRYO Penquin may only be operated by a trained and authorized person.
Here's a breakdown of the acceptance criteria and the study information for the CRYO Penguin device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What the device is meant to achieve) | Reported Device Performance (How the device measured up) |
|---|---|
| Target Skin Temperature: Achieve and maintain a skin temperature of 2-4°C | Achieved: The skin temperature test on three anatomical locations in three human subjects verified that the temperature of a treatment area on skin dropped to 2-4°C within 30 seconds and was maintained for an additional 30 seconds. |
| Temperature Monitoring Accuracy (LED Indicators): | Verified: LED lights correctly indicated skin temperature status: |
| * Green light when skin temperature is above 4°C | * Green color if skin temperature above 4ºC |
| * Blue light when skin temperature is between 2°C and 4°C | * BLUE color if skin temperature is between 2ºC and 4ºC |
| * Red light when skin temperature is below 2°C | * RED color if skin temperature below 2ºC |
| Auto-off Function: Activation if skin temperature is below -1°C for 1 second | Verified: The device has an auto-off function that activates if the temperature of the skin surface is below -1ºC for 1 second. (This is mentioned as a feature rather than explicitly as a passed test, but it is part of the safety mechanism.) |
| Electrical Safety and Essential Performance: Compliance with IEC 60601-1 | Passed: Testing conducted in accordance with IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012. |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2 | Passed: Testing conducted in accordance with IEC 60601-1-2:2014. No potential deviation. |
| Software Validation: Compliance with IEC 62304 and FDA Guidance Document | Validation Report Contains: Software verification and validation testing as recommended in IEC 62304:2006 and FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005). |
| Proper Distance Positioning (Laser Guidance): Lasers converge when at 15cm from patient | Mechanically Described: Two small lasers provide two dots that converge to one when the handle is properly distanced (approximately 15cm). If the handle moves, the dots no longer converge, providing a visual cue. (No explicit test result for this, but described as a functional aspect of the device). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 3 human subjects.
- Data Provenance: Not explicitly stated, but the testing was "non-clinical" and likely conducted in a controlled environment, specific to the device manufacturer (CryoScience North America, Inc.). It's a prospective study conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not provided in the document. The "Verification Testing" involves measuring skin temperature and observing LED light behavior, which is objective and doesn't explicitly mention expert arbitration for ground truth.
4. Adjudication Method for the Test Set
- This information is not provided. The "Verification Testing" described is objective measurement rather than subjective evaluation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not conducted and is not mentioned in the document.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was done
- Yes, the performance data provided appears to be a standalone (algorithm/device only) study. The "Verification Testing" for skin temperature and LED indicator accuracy directly assesses the device's functional performance independently. There is no mention of human-in-the-loop performance measurement.
7. The Type of Ground Truth Used
- The ground truth for the device's performance (specifically the skin temperature and LED indicator accuracy) was established through direct physical measurement (e.g., of skin temperature) and functional observation of the device's output (LED lights). For electrical safety, EMC, and software, the ground truth is adherence to established international standards (IEC 60601-1, IEC 60601-1-2, IEC 62304) and FDA guidance.
8. The Sample Size for the Training Set
- This information is not provided as the document discusses verification testing for the device's operation, not an AI/machine learning model that would typically have a "training set." The software validation mentioned refers to software verification and validation, not model training.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable/not provided as there is no mention of an AI/machine learning model with a "training set" in the context of this device's submission. The "software" mentioned refers to the device's control software, which is validated against its specifications and relevant standards, not "trained" in the typical ML sense.
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