(526 days)
Not Found
No
The description details a device with pre-programmed protocols, visual cues (laser dots), and temperature-based auto-off functions, none of which indicate the use of AI or ML for learning or adapting.
Yes
The device's intended use is for the temporary reduction of pain, swelling, inflammation, and hematoma, and as an adjunct to rehabilitative treatment, which are all therapeutic purposes.
No
The device is a therapeutic device that provides cold therapy for temporary reduction of pain, swelling, inflammation, and hematoma. While it monitors skin temperature, this is for treatment modulation, not for diagnosing a condition or disease.
No
The device description clearly outlines multiple hardware components including a liquid nitrogen vessel, cryogenic hose, treatment handle with lasers and LED lights, and an electrical box. While it mentions control software and being software-driven, it is not solely software.
Based on the provided information, the CRYO Penguin is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for applying cold therapy to the body for temporary reduction of pain, swelling, inflammation, and hematoma. This is a therapeutic application, not a diagnostic one.
- Device Description: The device description details how the device delivers cold air to the skin surface and monitors skin temperature. It does not involve analyzing biological samples (like blood, urine, or tissue) which is characteristic of IVD devices.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The CRYO Penguin's function is purely therapeutic.
N/A
Intended Use / Indications for Use
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).
Product codes
MLY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
The CRYO Penquin may only be operated by a trained and authorized person.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.
3
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 |
4
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).
5
-
- 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
6
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.
7
Comparison of Technological Characteristics
| Attribute | CRYO Penguin
(Subject Device) | CRYOTRON 2®
Cryotherapy Device
(Primary Predicate
Device) | FROZEN N
(Secondary Predicate
Device) | Comparison |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K203661 | K030281 | K193665 | n/a |
| Product Code | MLY | MLY | GEH, MLY | Same as the primary predicate device
(CRYOTRON 2®) |
| Regulation
Number | None | None | 878.4350 | Same as the primary predicate device
(CRYOTRON 2®) |
| Indication for Use | 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). | The CRYOTRON 2®
Cryotherapy Device 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). | The 'Frozen N' cryotherapy
device using liquid nitrogen
vapor, is 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). | Same |
| Attribute | CRYO Penguin
(Subject Device) | CRYOTRON 2®
Cryotherapy Device
(Primary Predicate
Device) | FROZEN N
(Secondary Predicate
Device) | Comparison |
| Mechanism of
Action | Liquid nitrogen is used to
provide a flow of cold vapor to
the patient on the body part
where cryotherapy is to be
applied. Gas temperatures of
-162°C can be delivered. | The patented technology of
the CRYOTRON 2®
Cryotherapy Device uses the
natural expansion of liquid
CO2 to create a cold spray of
micro-crystals delivered under
pressure. Using a gradual
sweeping motion, the user
applies the spray to the
treatment site for 30-60
seconds at a distance of 3-5
inches. Rapid cooling (thermal
shock) occurs when the spray
sublimates (passes directly
from solid (ice) phase to gas
phase) as it contacts the skin. | LN2 gas is delivered to the
treatment site at -196°C to
effect thermal shock. | All three devices function by delivering
a cold gas to cool the intended skin
area: evaporation of liquid nitrogen
(LN) for the CRYO Penguin and
FROZEN N devices, and natural
expansion of carbon dioxide for the
CRYOTRON 2® Cryotherapy Device. |
| Coolant | Liquid nitrogen | Compressed medical-grade
carbon dioxide | Liquid nitrogen | CRYO Penguin and FROZEN N devices
both use liquid nitrogen. CRYOTRON 2®
uses compressed carbon dioxide. The
difference does not raise new questions
of safety and effectiveness. |
| Attribute | CRYO Penguin
(Subject Device) | CRYOTRON 2®
Cryotherapy Device
(Primary Predicate
Device) | FROZEN N
(Secondary Predicate
Device) | Comparison |
| Product Design | Cylindrical grip handpiece,
electronic console for
controlling the operation. LCD
display. Laser for proper
positioning mounted on the
handpiece.
Temperature is monitored via
IR temperature sensor. | The CRYOTRON 2®
Cryotherapy Device consists
of four components that are
housed 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 for
controlling operation (7" LCD
screen).
LN2 gas cylinder (included)
and Laser pointer mounted on
the hand-piece beside nozzle.
Temperature is monitored via
IR temperature sensor. | Essentially identical. Each device
displays current treatment parameters
during the cryotherapy treatment. |
| Nozzle
Temperatures | Temperature can reach
Maximum of -196°C
to-162°C. | Not publicly available. | Temperature can reach
-196°C | The temperature achieved by CYRO
Penguin is similar to FROZEN N, which
also uses cold nitrogen vapors.
Because the maximum temperature of
expanded carbon dioxide is about
-78°C, the temperature of sprayed
carbon dioxide would be higher.
However, because the targeted skin-
temperatures are similar among these
three devices, difference in the nozzle |
| Attribute | CRYO Penguin
(Subject Device) | CRYOTRON 2®
Cryotherapy Device
(Primary Predicate
Device) | FROZEN N
(Secondary Predicate
Device) | Comparison |
| | | | | temperatures does not raise new
questions of safety and effectiveness. |
| Treatment
duration | 30-60 seconds | 30-60 seconds | 30-60 seconds | Same |
| Target skin
temperature | 2-4°C | Not publicly available | 2-4°C | Similar |
| Distance
between skin
and the nozzle | 15 cm (about 6 inches) | 3-5 inches | 12 cm (about 5 inches) | The distance between skin and the
nozzle is similar for each device. |
| Auto-off | -1°C | Not publicly available | -1°C | Auto-off function for CRYO Penguin and
FROZEN N devices are the same. |
| Attribute | CRYO Penguin
(Subject Device) | CRYOTRON 2Ⓡ
Cryotherapy Device
(Primary Predicate
Device) | FROZEN N
(Secondary Predicate
Device) | Comparison |
| Mobility | Housed in a mobile cart | Housed in a mobile cart | Housed in a mobile cart | Same |
| Electrical Safety
Testing Passed | IEC 60601-1 | Not publicly available | IEC 60601-1 | Same for CRYO Penguin and FROZEN N
device |
8
9
10
11
12
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.