(526 days)
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 25, 2022
CryoScience North America, Inc. % Kelliann Payne Partner Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, PA 19103
Re: K203661
Trade/Device Name: CRYO Penguin Regulatory Class: Unclassified Product Code: MLY Dated: April 25, 2022 Received: April 25, 2022
Dear Kelliann Payne:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known)
K203661
Device Name
CRYO Penguin
Indications for Use (Describe)
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).
Type of Use (Select one or both, as applicable)
x Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
CRYO PENGUIN
1. Submission Sponsor
CRYO-Science North America Inc. 615 Front Street, Suite 103 Whitehall, PA 18052
Mr. Oktawian Pabian President Tel: +1-484-763-8596 operations@cryosc.com
2. Submission Correspondent
Kelliann Payne Partner Hogan Lovells US LLP 1735 Market Street, Suite 2300
Tel: +1-267-675-4687 Fax: +1-267-675-4601 kelliann.payne@hoganlovells.com
3. Date Prepared
May 25, 2022
4. Device Identification
| Trade or Proprietary Name: | CRYO Penguin |
|---|---|
| Common or Usual Name: | Vapocoolant Device |
| Regulation Number: | N/A |
| Product Code: | MLY |
| Class: | Unclassified |
| Panel: | Physical Medicine |
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5. Legally Marketed Predicate Device(s)
Primary predicate device: Device Name: CRYOTRON 2® Cryotherapy Device 510(k) number: K030281 CRYONIC MEDICAL NORTH AMERICA Manufacturer:
Secondary predicate device: Device name: FROZEN N 510(k) number: K193665 B.M. Tech Worldwide Co., Ltd (formerly Yozma BMTech Co. Ltd.) Manufacturer:
6. Indication for Use Statement
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 sprains or other minor sports injuries and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).
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-
- Device Description CRYO Penguin
Image /page/5/Picture/1 description: The image shows a CRYO Penguin Medical device. The device is white and gray, with a black control panel and a screen that displays information. A thick, dark hose is connected to the top of the device and loops around the control panel. The device has wheels on the bottom, making it easy to move around.
- Device Description CRYO Penguin
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
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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.
8. Substantial Equivalence Discussion
The following table compares the CRYO Penguin to the selected predicate devices `CRYOTRON 2® Cryotherapy Device' and 'FROZEN N' with respect to indications for use, principles of operation, technological characteristics, materials, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness compared to the predicate devices.
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Comparison of Technological Characteristics
| Attribute | CRYO Penguin(Subject Device) | CRYOTRON 2®Cryotherapy Device(Primary PredicateDevice) | FROZEN N(Secondary PredicateDevice) | Comparison |
|---|---|---|---|---|
| 510(k) Number | K203661 | K030281 | K193665 | n/a |
| Product Code | MLY | MLY | GEH, MLY | Same as the primary predicate device(CRYOTRON 2®) |
| RegulationNumber | None | None | 878.4350 | Same as the primary predicate device(CRYOTRON 2®) |
| Indication for Use | The CRYO Penguin isindicated for use when coldtherapy is indicated for thetemporary reduction of pain,swelling, inflammation, andhematoma from minorsurgical procedures, minorsprains or other minor sportsinjuries and as an adjunct torehabilitative treatment (e.g.,intermittent cold withstretch). | The CRYOTRON 2®Cryotherapy Device isindicated for use when coldtherapy is indicated for thetemporary reduction of pain,swelling, inflammation, andhematoma from minorsurgical procedures, minorsprains or other minor sportsinjuries and as an adjunct torehabilitative treatment (e.g.,intermittent cold withstretch). | The 'Frozen N' cryotherapydevice using liquid nitrogenvapor, is for use when coldtherapy is indicated for thetemporary reduction of pain,swelling, inflammation, andhematoma from minorsurgical procedures, minorsprains or other minor sportsinjuries, and as an adjunct torehabilitative treatment (e.g.,intermittent cold withstretch). | Same |
| Attribute | CRYO Penguin(Subject Device) | CRYOTRON 2®Cryotherapy Device(Primary PredicateDevice) | FROZEN N(Secondary PredicateDevice) | Comparison |
| Mechanism ofAction | Liquid nitrogen is used toprovide a flow of cold vapor tothe patient on the body partwhere cryotherapy is to beapplied. Gas temperatures of-162°C can be delivered. | The patented technology ofthe CRYOTRON 2®Cryotherapy Device uses thenatural expansion of liquidCO2 to create a cold spray ofmicro-crystals delivered underpressure. Using a gradualsweeping motion, the userapplies the spray to thetreatment site for 30-60seconds at a distance of 3-5inches. Rapid cooling (thermalshock) occurs when the spraysublimates (passes directlyfrom solid (ice) phase to gasphase) as it contacts the skin. | LN2 gas is delivered to thetreatment site at -196°C toeffect thermal shock. | All three devices function by deliveringa cold gas to cool the intended skinarea: evaporation of liquid nitrogen(LN) for the CRYO Penguin andFROZEN N devices, and naturalexpansion of carbon dioxide for theCRYOTRON 2® Cryotherapy Device. |
| Coolant | Liquid nitrogen | Compressed medical-gradecarbon dioxide | Liquid nitrogen | CRYO Penguin and FROZEN N devicesboth use liquid nitrogen. CRYOTRON 2®uses compressed carbon dioxide. Thedifference does not raise new questionsof safety and effectiveness. |
| Attribute | CRYO Penguin(Subject Device) | CRYOTRON 2®Cryotherapy Device(Primary PredicateDevice) | FROZEN N(Secondary PredicateDevice) | Comparison |
| Product Design | Cylindrical grip handpiece,electronic console forcontrolling the operation. LCDdisplay. Laser for properpositioning mounted on thehandpiece.Temperature is monitored viaIR temperature sensor. | The CRYOTRON 2®Cryotherapy Device consistsof four components that arehoused in a mobile cart:A pistol-grip hand-piece that delivers the carbon dioxide spray. An electronic console/control panel that provides operational information to the user. A rechargeable battery. A cylinder of compressed medical-grade carbon dioxide gas (sold separately). | Cylindrical grip handpiece,electronic console forcontrolling operation (7" LCDscreen).LN2 gas cylinder (included)and Laser pointer mounted onthe hand-piece beside nozzle.Temperature is monitored viaIR temperature sensor. | Essentially identical. Each devicedisplays current treatment parametersduring the cryotherapy treatment. |
| NozzleTemperatures | Temperature can reachMaximum of -196°Cto-162°C. | Not publicly available. | Temperature can reach-196°C | The temperature achieved by CYROPenguin is similar to FROZEN N, whichalso uses cold nitrogen vapors.Because the maximum temperature ofexpanded carbon dioxide is about-78°C, the temperature of sprayedcarbon dioxide would be higher.However, because the targeted skin-temperatures are similar among thesethree devices, difference in the nozzle |
| Attribute | CRYO Penguin(Subject Device) | CRYOTRON 2®Cryotherapy Device(Primary PredicateDevice) | FROZEN N(Secondary PredicateDevice) | Comparison |
| temperatures does not raise newquestions of safety and effectiveness. | ||||
| Treatmentduration | 30-60 seconds | 30-60 seconds | 30-60 seconds | Same |
| Target skintemperature | 2-4°C | Not publicly available | 2-4°C | Similar |
| Distancebetween skinand the nozzle | 15 cm (about 6 inches) | 3-5 inches | 12 cm (about 5 inches) | The distance between skin and thenozzle is similar for each device. |
| Auto-off | -1°C | Not publicly available | -1°C | Auto-off function for CRYO Penguin andFROZEN N devices are the same. |
| Attribute | CRYO Penguin(Subject Device) | CRYOTRON 2ⓇCryotherapy Device(Primary PredicateDevice) | FROZEN N(Secondary PredicateDevice) | Comparison |
| Mobility | Housed in a mobile cart | Housed in a mobile cart | Housed in a mobile cart | Same |
| Electrical SafetyTesting Passed | IEC 60601-1 | Not publicly available | IEC 60601-1 | Same for CRYO Penguin and FROZEN Ndevice |
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Non-Clinical Performance Data
To demonstrate the safety and effectiveness of the CRYO Penquin device and to show substantial equivalence to the predicate devices, CryoScience completed the following non-clinical tests. Results confirm that the design and performance specifications for the device are met. The CRYO Penquin passed test requirements as identified below:
- Electrical Safety and essential performance testing . Testing was conducted in accordance with IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012. Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- Electromagnetic Compatibility ●
Testing was conducted in accordance with IEC 60601-1-2:2014. Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests. There was no potential deviation.
-
. Software
Software validation report contains Software verification and validation testing as recommended in IEC 62304:2006 Medical device software life cycle processes and FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005). -
. Verification Testing
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 as intended and maintained for additional 30 seconds. Temperature sensor and monitoring testing verified that LED lights correctly indicate skin temperature status as follows: 1) Green color if skin temperature above 4ºC; 2) BLUE color if skin temperature is between 2ºC and 4ºC or 3) RED color if skin temperature below 2ºC.
9. Clinical Performance Data
No clinical data is included with this submission.
10. Statement of Substantial Equivalence
The CRYO Penquin devices have identical intended use as the CRYOTRON 2® and FROZEN N devices and similar technological characteristics (delivery of cryogenic temperature gas to affected tissues). Minor differences in technological characteristics do not raise new or different questions of safety or efficacy. Performance testing has demonstrated the CRYO Penguin is as safe and effective as the predicate devices. Therefore, the CRYO Penquin device is substantially equivalent to the predicate devices.
N/A