TargetCool™ 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

TargetCool™ is a handheld device that can deliver rapid, precise, and controlled cooling to the skin tissue. The TargetCool™ device consists of a main device Cooling-Nozzle, a guard, a filter, and a cartridge,

In Cooling mode, the main device produces controlled cooling based on thermoelectric cooling. which controls the temperature (2-4℃) of the targeted area. TargetCool™ displays the skin temperature measured in real time, the set cooling temperature and time, and the device status through the LCD display. Also, if the measured temperature is below -19C and lasts for more than 1 second, the status light blinks in blue with a beep sound.

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 (PT). Through this mechanism, pain in the skin is relieved. The advances represented by TargetCool™ lie in the fact that the device executes this process in a precise, controlled, and rapid way.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the TargetCool™ device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Skin surface temperature reaches 2-4℃	Skin surface temperature reached 2-4℃ within 5 seconds.
Skin surface temperature is maintained at 2-4℃ for the maximum spraying time (60 seconds)	Skin surface temperature was maintained at 2-4℃ for the maximum spraying time (60 seconds).
Compliance with ISO 13485:2016 (Quality management systems for medical devices)	TargetCool™ complies with all applicable standards, including ISO 13485:2016.
Compliance with IEC 60601-1 (Electrical safety)	TargetCool™ complies with all applicable standards, including IEC 60601-1.
Compliance with IEC 60601-1-2 (Electromagnetic compatibility)	TargetCool™ complies with all applicable standards, including IEC 60601-1-2.
Biocompatibility (ISO 10993)	Biocompatibility testing (ISO 10993) was deemed not applicable for TargetCool™ because the only patient-contacting material (polycarbonate on the guard) is the exact same material used in the predicate device, CryoVIVE (K203481), which was previously FDA-cleared and presumably met biocompatibility requirements.
Device hazard analysis completed and risk-control implemented to mitigate identified hazards	A device hazard analysis was completed and risk-control implemented to mitigate identified hazards.
All specifications met acceptance criteria of each module and interaction of processes	Testing results support that all the specifications have met the acceptance criteria of each module and interaction of processes.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The text states, "TargetCool Temperature accuracy tests were conducted targeting three different treas (wrist, arm, back of neck) by three physicians at three different temperature settings (-10, -5, 5 degree C)." This implies the "test set" for temperature accuracy involved 3 anatomical areas and 3 temperature settings. The number of individual measurements or subjects is not explicitly stated beyond these categories.
Data Provenance: Not explicitly stated (e.g., country of origin). The study seems to be a prospective bench test/performance test conducted by the company to confirm device specifications rather than a clinical trial with patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Three physicians were involved in conducting the temperature accuracy tests.
Qualifications of Experts: The specific qualifications (e.g., years of experience, specialty) of these three physicians are not specified in the provided text.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not mentioned. The study described is a performance test, not one that requires adjudication of expert interpretations. The physicians conducted the tests and observed the device's output.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document describes bench testing and a comparison to a predicate device based on technical specifications and indications for use, not a study evaluating human readers' improvement with or without AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance test was done. The "Performance Data" section details bench testing where the device's temperature accuracy and compliance with various standards were evaluated directly. This is a standalone performance assessment of the device's physical function.

7. The Type of Ground Truth Used

Type of Ground Truth: For the temperature accuracy tests, the ground truth was based on the measured skin surface temperature using presumably calibrated instruments in a controlled testing environment, compared against the device's set temperature. For the other performance criteria (electrical safety, EMC, etc.), the ground truth was adherence to established international standards (e.g., ISO, IEC).

8. The Sample Size for the Training Set

Not applicable/not mentioned. The TargetCool™ device is a cryosurgical unit, a physical medical device that applies cold therapy. It is not an AI/ML algorithm that requires a training set in the conventional sense. The "training" or development of the device would involve engineering design and iterative testing, not data-driven machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable/not mentioned. As explained in point 8, this is not an AI/ML device requiring a training set with established ground truth from data.

Summary

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March 31, 2022

RecensMedical, Inc. % Dave Kim, MBA President Mtech Group 7505 Fannin Street, Suite 610 Houston, Texas 77054

Re: K220674

Trade/Device Name: TargetCool Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH, MLY Dated: February 11, 2022 Received: March 8, 2022

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/cdrb/ofdocs/ofpmn/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

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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 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-devices/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,

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) K220674

Device Name TargetCool™

Indications for Use (Describe)

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

K220674

1. ADMINISTRATIVE INFORMATION

Manufacturer Name	RecensMedical, Inc.908, SK V1 center, 830 Dongtansunhwan-daeroHwaseong-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:	TargetCool™
Common name :	Cryosurgical Device
Classification name:	Cryosurgical Unit and Accessories
Classification Regulations:	21 CFR 878.4350 / 21 CFR 878.4810
Class:	Class II
Classification Panel:	General & Plastic Surgery
Product code:	GEH, MLY

3. PRIMARY PREDICATE DEVICE

510(k) Number:	K203481
Trade name:	CryoVIVE
Classification name:	Cryosurgical Unit and Accessories
Classification Regulations:	21 CFR 878.4350
Class:	Class II
Classification Panel:	General & Plastic Surgery
Product code:	GEH, MLY

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4. INDICATIONS FOR USE

5. DEVICE DESCRIPTION

6. PERFORMANCE DATA

The Company's Performance Data for TargetCool™ is as follows:

Bench Testing

TargetCool™ complies with all applicable standards, including ISO 13485:2016, 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 only patient-contacting material on TargetCool is the guard, which is comprised of polycarbonate. The polycarbonate is the exact same material used in CryoVIVE, which was FDA-cleared under K203481. Therefore, the biocompatibility test is not applicable for the TargetCoolTM. The device hazard analysis was completed and risk-control implemented to mitigate identified hazards.

TargetCool Temperature accuracy tests were conducted targeting three different treas (wrist, arm, back of neck) by three physicians at three different temperature settings (-10, -5, 5 degree C).

It was confirmed that the skin surface temperature reached 2~4℃ within 5 seconds, also it was maintained at 2 to 4 ℃ for the maximum spraying time (60 seconds).

The testing results support that all the specifications have met the acceptance criteria of each module and interaction of processes.

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TargetCool™ passed all testing and supports the claims of substantial equivalence and safe operation.

7. TECHNOLOGY COMPARISON and SUBSTANTIAL EQUIVALENCE Discussion

Product Name	TargetCool™(K220674)	CryoVIVE(K203481)	Comparison
Indications forUse/ Intended Use	TargetCool™ is indicated for thetemporary reduction of pain, swelling,inflammation, and hematoma fromminor surgical procedures, minorsprains or other minor sports injuries,and as an adjunct to rehabilitativetreatment (e.g., intermittent cold withstretch).	The CryoVIVE (Freezing mode) isindicated for the surgical destruction oftarget tissue by applying cryogenicgases at extreme low temperatures- Molluscum Contagiosum- Skin Tags- Actinic Keratosis- Lentigo- Verruca Plana- Verruca Vulgaris- Verruca Lesions- Genital Lesions- Seborrheic KeratosisCryoVIVE (Cooling mode) is indicatedfor the temporary reduction of pain,swelling, inflammation, and hematomafrom minor surgical procedures, minorsprains or other minor sports injuries,and as an adjunct to rehabilitativetreatment (e.g., intermittent cold withstretch).	Same(Cooling mode)
Component	Main system, Trigger, LCD Display,Cooling-Nozzle, Guard tip, Filter,Cartridge	Main system, Control button, LCD,Nozzle (Cooling and Freezing), Guidetip, filter, CO2 cartridge	Similar

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Mechanism of Action	The unit blows very low-temperature gas at temperature and time settings, onto the desired treatment area	(Cooling mode)The unit blows very low-temperature gas at temperature and time settings, onto the desired treatment area(Freezing mode)Cryogen, CO2 is delivered to the treatment site to affect cellular destruction	Same(Cooling mode)
Cryogen Type	CO2	CO2	Same
Temperature	Reaching 2-4 °C within 5 sec	(Cooling mode) Reaching 2-4 °C within 5 sec(Freezing mode) -79°C	Same(Cooling mode)
Treatment Duration	0~60 sec	0~60 sec	Same
Gas Volume	65g cartridge	60g cartridge	Similar
Safety feature	Alarm and status light blinking if the temperature of the skin is determined to be less than -1 °C for 1 second.	Alarm and status light blinking if the temperature of the skin is less than - 1 °C for 1 second.	Same

Compared with the predicate device, the subject device has the following modifications: 1). the freezing mode is removed; 2). the subject device can be driven by the internal battery, but not external AC Mains; 3). when the target temperature is reached, the status light and beep sound activate; 4) when continuous spraying is used, a beep sound occurs at set time intervals.

However, these differences do not significantly affect safety and/or effectiveness. Therefore, TargetCool™ is substantially equivalent to the predicate device.

8. CONCLUSION

TargetCoolTM is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and performance temperature to CryoVIVE (K203481) for cooling mode operation. Performance testing data established that TargetCool™ is as safe and effective as the legally marketed predicate device for the proposed indications. On this basis and in accordance with 21 CFRS 807.100(b), TargetCool is substantially equivalent to the predicate 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.