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°C) 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 -1 ℃ and lasts for more than 1 second, the status light blinks in blue with a beep sound.

AI/ML Overview

The provided document is a 510(k) Summary for the medical device TargetCool™ (K221234). It compares this device to a predicate device, also named TargetCool (K220674).

Here's an analysis of the acceptance criteria and the study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comparison between the subject device (TargetCool™ K221234) and its predicate (TargetCool K220674) to establish substantial equivalence. While explicit acceptance criteria are not tabulated with numerical performance, the comparison acts as a de facto set of criteria since the subject device is stated to be "Same" as the predicate for all listed characteristics.

Acceptance Criteria (from Predicate Device K220674)	Reported Device Performance (TargetCool™ K221234)	Satisfied?
Indications for Use: 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).	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).	Yes
Component: Main system, Trigger, LCD Display, Cooling-Nozzle, Guard, Filter, Cartridge	Main system, Trigger, LCD Display, Cooling-Nozzle, Guard, Filter, Cartridge	Yes
Mechanism of Action: The unit blows very low-temperature gas at temperature and time settings, onto the desired treatment area	The unit blows very low-temperature gas at temperature and time settings, onto the desired treatment area	Yes
Cryogen Type: CO2	CO2	Yes
Temperature: Reaching 2-4 °C within 5 sec	Reaching 2-4 °C within 5 sec	Yes
Treatment Duration: 0~60 sec	0~60 sec	Yes
Gas Volume: 65g cartridge	65g cartridge	Yes
Safety feature: Alarm and status light blinking if the temperature of the skin is less than -1 °C for 1 second.	Alarm and status light blinking if the temperature of the skin is determined to be less than -1 °C for 1 second.	Yes

Study Proving Device Meets Acceptance Criteria:

The document states: "TargetCool™ is the same as the device cleared in K220674. No changes have been made to the device to change the contraindication. TargetCool™, the subject device, is equivalent to the predicate device."
This indicates that the "study" proving the device meets the acceptance criteria is primarily a direct comparison and declaration of sameness to a previously cleared device (K220674), rather than new, independent performance testing for the subject device against the listed criteria.

2. Sample size used for the test set and the data provenance

The document does not describe a separate "test set" in the context of a clinical study for the K221234 device. Instead, it relies on the predicate device's clearance. It mentions "Clinical publications and clinical data demonstrated the safety and effectiveness of the TargetCoolTM for treatment of pediatric patient" but does not provide details on the sample size or provenance of this data. Given the context of establishing substantial equivalence to an identical device, new clinical testing specific to K221234 for comparing against acceptance criteria is not detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No new test set for the K221234 device is described, as the substantial equivalence is based on the device being functionally identical to the predicate (K220674). The ground truth for the safety and effectiveness of the predicate device (and thus implicitly the subject device) would have been established during its regulatory review, likely based on scientific principles of cryotherapy and any historical clinical data available for similar devices, but this document does not provide details about that.

4. Adjudication method for the test set

Not applicable. There is no new "test set" with expert adjudication described for K221234 in this document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a cryosurgical unit, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device, not an algorithm, so standalone algorithm performance testing is not relevant.

7. The type of ground truth used

The ground truth for the functionality and safety of the subject device (K221234) is established by its direct equivalence to the predicate device (K220674), which itself would have been cleared based on a combination of bench testing, adherence to standards (electrical safety, EMC, biocompatibility), and existing clinical literature/data for cryotherapy devices. The statement "Clinical publications and clinical data demonstrated the safety and effectiveness of the TargetCoolTM" refers to the scientific basis for the predicate device's (and thus the subject device's) application.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would require a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 22, 2022

RecensMedical Inc. Yeonui Lee Regulatory Affairs Manager 908, SK V1 center, 830 Dongtansunhwan-daero Hwaseong-si. Gyeonggi-do 18468 Korea. South

Re: K221234

Trade/Device Name: TargetCool Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH Dated: May 26, 2022 Received: May 26, 2022

Dear Yeonui Lee:

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/cdth/cfdocs/cfpmn/pmn.cfm 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical

{1}------------------------------------------------

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-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) 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-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,

for 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 Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K221234

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)

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

K221234

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
Date of the summary preparation	May 23, 2022
Contact person:	Yeonui Lee / Regulatory Affairs Manageryui.lee@recensmedical.com
Office Correspondent:	Dave Kim, MBAMtech Group7707 Fannin St. Ste 200, Houston, TX 77054+1-713-467-2607

davekim@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:	K220674
Trade name:	TargetCool
Classification name:	Cryosurgical Unit and Accessories
Classification Regulations:	21 CFR 878.4350
Class:	Class II
Classification Panel:	General & Plastic Surgery
Product code:	GEH, MLY

{4}------------------------------------------------

4. INDICATIONS FOR USE

5. DEVICE DESCRIPTION

In Cooling mode, the main device produces controlled cooling based on thermoelectric cooling, which controls the temperature (2-4°C) 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 -1 ℃ 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 the skin cools by spraying the cryogen onto the skin, the nerve conduction velocity (NCV) of the skin decreasing 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.

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 TargetCool™.

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.

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

Clinical Testing

Clinical publications and clinical data demonstrated the safety and effectiveness of the TargetCoolTM for treatment of pediatric patient.

{5}------------------------------------------------

7. SUBSTANTIAL EQUIVALENCE

The comparison chart below provides evidence to support the equivalence determination between TargetCool™ and the predicate device (K220674) with respect to intended use, technological characteristics and principles of operation. TargetCool™ shares the same indications for use, device operation, technical and functional capabilities, and therefore is substantially equivalent to the predicate device.

Product Name	TargetCool™(Subject Device)	TargetCool(K220674)	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).	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).	Same
Component	Main system, Trigger, LCD Display,Cooling-Nozzle, Guard, Filter,Cartridge	Main system, Trigger, LCD Display,Cooling-Nozzle, Guard, Filter,Cartridge	Same
Mechanism ofAction	The unit blows very low-temperaturegas at temperature and time settings,onto the desired treatment area	The unit blows very low-temperaturegas at temperature and time settings,onto the desired treatment area	Same
Cryogen Type	CO2	CO2	Same
Temperature	Reaching 2-4 °C within 5 sec	Reaching 2-4 °C within 5 sec	Same
TreatmentDuration	0~60 sec	0~60 sec	Same
Gas Volume	65g cartridge	65g cartridge	Same
Safety feature	Alarm and status light blinking if thetemperature of the skin is determined tobe less than -1 °C for 1 second.	Alarm and status light blinking if thetemperature of the skin is less than -1 °C for 1 second.	Same

TargetCool™ is the same as the device cleared in K220674. No changes have been made to the device to change the contraindication. TargetCool™, the subject device, is equivalent to the predicate device.

8. CONCLUSION

TargetCool™ and the legally marketed predicate devices have the same intended use, Indications for Use statement and the technological characteristics. While the contraindication differs between the two systems. Clinical literatures and clinical data demonstrate that TargetCool™ is as safe and effective as the legally marketed predicate devices and that TargetCool™ does not raise any different questions of safety or effectiveness than the predicate. On this basis and in accordance with 21 CFR$ 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.