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).

Device Description

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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.

May 13, 2021

Recens Medical Inc. % Dave Kim President Mtech Group 7707 Fannin Street Ste 200-V111 Houston, Texas 77054

Re: K203481

Trade/Device Name: CryoVIVE Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH, MLY Dated: March 15, 2021 Received: March 15, 2021

Dear Dave Kim:

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.

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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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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 (QS) 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-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH Leam (https://www.fda.gov/training-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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE website assistance/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.

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203481

Device Name CryoVIVE

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K203481

5/12/2021

1. ADMINISTRATIVE INFORMATION

Manufacturer Name	Recensmedical Inc.908, SK V1 center, 830 Dongtansunhwan-daero, Hwaseong-si, Gyeonggi-do,Republic of Korea
Phone:	+82 31 8043 3064
Fax:	+82 31 630 2092
Contact person:	Yeonui Lee / Regulatory Affairs Manageryui.lee@recensmedical.com
Office Correspondent:	Dave Kim, MBAMtech Group7505 Fannin St. Ste 610, Houston, TX 77054+1-713-467-2607davekim@mtech-inc.net

2. DEVICE NAME AND CLASSIFICATION

Trade name:	CryoVIVE
Common name :	Cryosurgical Device
Classification name:	Cryosurgical Unit and Accessories
Classification Regulations:	21 CFR 878.4350
Class:	Class II
Classification Panel:	General & Plastic Surgery
Product code:	GEH, MLY

3. PRIMARY PREDICATE DEVICE

510(k) Number:	K190407
Trade name:	CryoLab
Classification name:	Cryosurgical Unit and Accessories

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Classification Regulations:	21 CFR 878.4350
Class:	Class II
Classification Panel:	General & Plastic Surgery
Product code:	GEH

4. SECOND PREDICATE DEVICE

510(k) Number:	K170810
Trade name:	Cryofos
Classification name:	Cryosurgical Unit and Accessories
Classification Regulations:	21 CFR 878.4350
Class:	Class II
Classification Panel:	General & Plastic Surgery
Product code:	GEH, MLY

5. REFERENCE DEVICE INFORMATION

510(k) Number:	K172769
Trade name:	CryOmega Flexx
Classification name:	Cryosurgical Unit and Accessories
Classification Regulations:	21 CFR 878.4350
Class:	Class II
Classification Panel:	General & Plastic Surgery
Product code:	GEH

6. INDICATIONS FOR USE

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

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Verruca Lesions
Genital Lesions
Seborrheic Keratosis

7. DEVICE DESCRIPTION

8. PERFORMANCE DATA

The Company's Performance Data for the CryoVIVE is as follows:

Bench Testing

The CryoVIVE complies with all applicable standards, including ISO 13485:2003, IEC 60601-1 for electrical safety and IEC 60601-1-2 for electromagnetic compatibility.

Biocompatibility (ISO 10993) was also performed to demonstrate conformance with established industry standards. The device Hazard analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all the specifications have met the acceptance criteria of each module and interaction of processes.

The CryoVIVE passed all testing and supports the claims of substantial equivalence and safe operation.

Clinical Testing

No performance data has been provided since the CryoVIVE is equivalent to the previously cleared predicate devices with no new issues regarding safety and effectiveness.

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9. SUBSTANTIAL EQUIVALENCE

The comparison chart below provides evidence to facilitate the substantial equivalence determination between the CryoVIVE and the predicate devices (K190407, K172769) as well as the reference device (K170810) with respect to intended use, technological characteristics and principles of operation. The CryoVIVE shares the same indications for use, device operation, technical and functional capabilities, and therefore is substantially equivalent to both devices.

CryoVIVE, the subject device, the predicate and the reference devices are all cryosurgical instruments ; these devices can be used to cool tissue or freeze tissue in dermatologic procedures of the skin. Since the CryoVIVE has two operating modes: Cooling mode and Freezing mode, the predicate device and the reference device were selected and compared for freezing mode and cooling mode, respectively.

Product Name	CryoVIVE(K203481)	Cryolab(K190407)	CryOmega Flexx(K172769)
Indications forUse/ Intended Use	The CryoVIVE(Freezingmode) intended for thesurgical destruction of targettissue by applying cryogenicgases at extreme lowtemperatures- Molluscum Contagiosum- Skin Tags- Actinic Keratosis- Lentigo- Verruca Plana- Verruca Vulgaris- Verruca Lesions- Genital Lesions- Seborrheic Keratosis	The CryoLab® is intendedfor the surgical destructionof target tissue by applyingcryogenic gases at extremelow temperatures• Molluscum Contagiosum• Skin Tags• Actinic Keratosis• Lentigo• Verruca Plana• Verruca Vulgaris• Verruca Lesions• Genital Lesions• Seborrheic Keratosis	The CryOmega Flexx isintended for the surgicaldestruction of tissue oftarget tissue by applyingcryogenic gases atextreme lowtemperatures.The List below showsexamples of the types oflesions that may betreated:• Molluscum Contagiosum• Skin Tags• Actinic Keratosis• Lentigo• Verruca Plana• Verruca Vulgaris• Verruca Plantaris• Genital Lesions• Seborrheic Keratosis
Component	Main system, Control button,LCD, Nozzle(Cooling andFreezing), Guide tip, filter,CO2 cartridge	Housing, Filter, O-rings,Gas(CO2 or N2O) Cylinder	Housing, spray tipapplicator, gas cartridge(N2O) with internal valve
Mechanism of	Cryogen,CO2 is delivered to	Cryogen, N2O or CO2 is	N2O gas is delivered to

[CryoVIVE - Freezing mode]

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action	the treatment site to effectcellular destruction	delivered to the treatmentsite to effect cellulardestruction	the treatment site at -89°Cto effect cellulardestruction
Temperature	CO2 (-79°C)	N2O (-89°C) , CO2 (-79°C)	N2O (-89°C)
Gas Volume	60g cartridge	20 oz cylinders	16g or 25g cartridge
Gas dispensingrate	0.581 g/sec	Unidentified	Unidentified
Tissue damage	Cell necrosis occurs onlyinside the ice ball (Ice ballsize is margin(1~3mm)freeze beyond the lesion)	Cell necrosis occurs onlyinside the ice ball (Ice ballsize is margin(1~3mm)freeze beyond the lesion)	Cell necrosis occurs onlyinside the ice ball (Ice ballsize is margin (1~3mm)freeze beyond the lesion)

Cryoablation is the fundamental technological principle for the freezing mode of the subject device, CryoVIVE, and the predicate devices (Cryolab and CryOmega Flexx). The subject and marketed predicate devices are used to ablate unwanted tissue by application of extreme cold. The technological differences that exist between the subject device and the predicate devices. However, these differences do not significantly affect safety and/or effectiveness.

[CryoVIVE – Cooling mode]

Product Name	CryoVIVE(Subject Device)	CRYOFOS(K170810)	Comparison
Indications forUse/ Intended Use	The CryoVIVE(Coolingmode) is indicated for thetemporary reduction of pain,swelling, inflammation, andhematoma from minorsurgical procedures, minorsprains or other minorsports injuries, and as anadjunct to rehabilitativetreatment (e.g., intermittentcold with stretch).	TheCRYOFOSandAccessories indicated for usewhen cold therapy isindicated for the temporaryreduction of pain, swelling,inflammation, and hematomafrom minor surgicalprocedures, minor sprains orother minor sports injuries,and as an adjunct torehabilitative treatment (e.g.,intermittent cold with stretch).	The intended use of bothdevices are similar.
Component	Main system, Control button,LCD, Nozzle(Cooling andFreezing), Guide tip, filter,CO2 cartridge	Pistol grip handpiece, controlconsole, battery and CO2 gascylinder	Different (the CryoVIVEis a handheld deviceusing CO2 cartridgewhile the Cryofos uses agas cylinder.)
Mechanism ofaction	The unit blows very low-temperature gas at	The unit blows very low-temperature air onto the	same

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	temperature and timesettings, onto the desiredtreatment area	desired treatment area
Cryogen Type	CO2	CO2	same
Temperature	Reaching 2-4 °C within 5 sec	Reaching 2-4 °C within 30 sec	Similar
Treatment duration	0~60 sec	30~60 sec	Similar
Gas dispensing rate	0.148g/sec	Unidentified
Safety feature	Alarm and LED blinking ifthe temperature of the skinis -1 °C or less for 1second.	CRYOFOS shuts down if thetemperature of the skin isless than -1 °C for 1 second.	Similar

The Cooling mode of CryoVIVE is substantially equivalent in intended use, principles of operation, and performance temperature to Cryofos (K170810) and raises no new issues of safety or effectiveness. The only difference to the marketed reference is the type of a gas container. The performance benchmark testing confirmed the temperature of 2~4 °C is reached by the subject device while the lowest temperature is -79 °C for the subject device and -78.5 °C for the predicate device. The subject device has a warning alarm when the temperature of the skin is -1 °C or less for 1 second. The principle of pain relief through skin cooling is as follows. As the skin cools by spraying the cryogen onto the skin, the nerve conduction velocity (NCV) of the skin decreases, increasing the Pain threshold (PTH) and pain tolerance (PTO)1. Through this mechanism, pain in the skin is relieved.

The type of a gas container does not affect the pain relief application. It does not raise any new questions of safety and effectiveness. It was proved by the performance test that the temperature range at the target skin area was the same as that of the predicate device and the reference device. Therefore, CryoVIVE, the subject device, is equivalent to the predicate device and the reference device.

8. CONCLUSION

The CryoVIVE and the legally marketed predicated devices have intended use and Indications for Use statement. While the technological characteristics differ between the two systems, the differences are minor. Performance testing data established that the CryoVIVE is safe and effective as the leqally marked predicate devices and that the CryoVIVE does not raise any different questions of safety and effectiveness than the predicate. On this basis and in accordance with 21 CFRS 807.100(b), the CryoVIVE is substantially equivalent to the predicate device and the reference device.

Regulation Number and Section

§ 878.4350 Cryosurgical unit and accessories.

(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.