TargetCool™ (Cooling mode / Boosting 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).

TargetCool™ (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

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, nozzle, a guard, a filter, and a cartridge.

The main device produces controlled cooling based on thermoelectric cooling, which controls the temperature of the targeted area. TargetCool™ displays the skin temperature measured in real time, the set cooling temperature 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 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

The provided text describes the 510(k) premarket notification for the TargetCool™ device. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria with performance metrics, sample sizes, or ground truth establishment relevant to AI/ML device evaluations.

The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and safety. The performance data section refers to bench testing (compliance with standards, biocompatibility, hazard analysis) and mentions "Clinical publications and clinical data demonstrated the safety and effectiveness of the TargetCoolTM for treatment of pediatric patient," but it does not provide specifics about these clinical studies in the context of acceptance criteria.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's what can be inferred and what is missing:

1. A table of acceptance criteria and the reported device performance:

Feature/Test	Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
Cooling Mode	Temperature of 2-4 °C within 5 seconds	Achieves 2-4 °C within 5 seconds
Boosting Mode	Temperature of 2-4 °C, sustained for 3-4 minutes (for saline solution)	Achieves 2-4 °C, sustained for 3-4 minutes (for saline solution)
Freezing Mode (CO2 cryoablation)	Temperature of -79°C (using CO2)	Achieves -79°C (using CO2)
Gas dispensing rate (Freezing Mode)	0.578 g/sec	0.578 g/sec
Gas Volume	65g cartridge capacity	Uses 65g cartridge
Safety Feature (Temperature monitoring)	Alarm and status light blinking if skin temperature is determined to be less than -1 °C for 1 second.	Alarm and status light blinks if skin temp is < -1 °C for 1 sec.
Electrical Safety	Compliance with IEC 60601-1	Complies with IEC 60601-1
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2	Complies with IEC 60601-1-2
Biocompatibility	Conformance with ISO 10993 (for patient-contacting materials)	Not applicable as material is identical to cleared predicate.
Hazard Analysis	Identified hazards mitigated	Device hazard analysis completed and risk-control implemented to mitigate identified hazards.
Overall Performance (Bench Testing)	All specifications met acceptance criteria; supports substantial equivalence and safe operation.	Testing results support all specifications met acceptance criteria; passed all testing.
Clinical Safety and Effectiveness (Pediatric Use)	Demonstrated safety and effectiveness (details not provided)	Clinical publications and clinical data demonstrated safety and effectiveness for pediatric patients.

Missing Information (Not found in the provided text):

Sample size used for the test set and the data provenance: Not mentioned. The document refers to "Clinical publications and clinical data" but does not detail the nature, size, or origin of this data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
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/ML diagnostic or assistive device that would typically involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an AI algorithm in the typical sense of standalone performance. Its performance relates to its physical parameters (temperature, flow rate) and clinical outcomes, not an algorithm's output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For clinical effectiveness, it would likely be based on clinical outcomes data (e.g., successful tissue destruction for freezing mode, pain/swelling reduction for cooling mode). However, the document doesn't specify how ground truth was established for the "clinical data" it refers to.
The sample size for the training set: Not applicable and not mentioned, as this is not an AI/ML device requiring a training set in the conventional sense.
How the ground truth for the training set was established: Not applicable and not mentioned.

Summary of the Study and Evidence Presented:

The core of the submission (K230599) is a substantial equivalence (SE) demonstration for the TargetCool™ device against two predicate devices (K221234 - an earlier version of TargetCool™ and K203481 - CryoVIVE). The study to prove acceptance criteria primarily seems to be a combination of:

Bench Testing: Demonstrating compliance with recognized standards (ISO 13485, IEC 60601-1, IEC 60601-1-2, ISO 10993 for biocompatibility-by-proxy). These tests verify the device's physical and electrical safety and performance parameters like temperature accuracy within specified ranges.
Safety Features Validation: Proving the alarm system for low skin temperature functions as designed.
Clinical Data/Publications Review: The document states that "Clinical publications and clinical data demonstrated the safety and effectiveness of the TargetCoolTM for treatment of pediatric patient." However, it does not elaborate on the specifics of these studies (e.g., study design, sample size, primary endpoints, results). This clinical evidence likely serves to support the overall safety and effectiveness claims rather than precise numerical acceptance criteria.

The substantial equivalence argument is based on comparing the intended use, technological characteristics, and principles of operation to the predicate devices. Differences, such as the Boosting mode and modifications to the freezing nozzle, are addressed by arguing they "do not raise new questions of safety and effectiveness."

Summary

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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 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.

June 22, 2023

RecensMedical, Inc. Lee Yeonui Regulatory Affairs Manager #507, #908, SK V1 center, 830 Dongtansunhwan-daero Hwaseong-si, Gyeonggi-do 18468 Korea. South

Re: K230599

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: Mav 26, 2023 Received: May 26, 2023

Dear Lee Yeonui:

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 (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,

Image /page/1/Picture/6 description: The image shows the name "Mark Trumbore -S" in a large font on the left side of the image. On the right side of the image, it says "Digitally signed by Mark Trumbore -S" and "Date: 2023.06.22 11:57:21 -04'00'". The text on the right side of the image is smaller than the text on the left side of the image.

Mark Trumbore Assistant Director, THT4A1: Robotically-Assisted Surgical Devices Team 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) K230599

Device Name TargetCool™

Indications for Use (Describe)

TargetCool™ (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

1. ADMINISTRATIVE INFORMATION

Manufacturer Name	RecensMedical, Inc.
	#507, #908, SK V1 center, 830 Dongtansunhwandaero, Hwaseong-si, Gyeonggi-do,
	Republic of Korea
Phone:	+82 31 8043 3064
Fax:	+82 31 630 2092
Date of the summary preparation	March 01, 2023
Contact person:	Yeonui Lee / Regulatory Affairs Manageryui.lee@recensmedical.com

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

4. SECOND PRIDICATE DEVICE

510(k) Number: Trade name: Classification name:

K221234 TargetCool™ Cryosurgical Unit and Accessories

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Image /page/4/Picture/0 description: The image shows the logo for "TargetCool" with the word "Target" in a bright blue color and the word "Cool" in a light gray color. The letters are in a sans-serif font. There is a trademark symbol in superscript next to the word "Cool".

Classification Regulations:	21 CFR 878.4350
Class:	Class 11
Classification Panel:	General & Plastic Surgery
Product code:	GEH, MLY

5. INDICATIONS FOR USE

TargetCool™ (Cooling mode, Boosting) 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).

TargetCool™ (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

6. DEVICE DESCRIPTION

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7. 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.

8. 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 TM(Subject Device)	TargetCool TM(K221234)	Comparison
Indications for Use / Intended Use	TargetCoolTM 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).	TargetCoolTM 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, Control button, LCD,Cooling nozzle, Freezing nozzle,Cooling guard, filter, CO2 cartridgeand Boosting accessories (Boostingnozzle, a Boosting guard, and a	Main system, Trigger, LCD Display,Cooling-Nozzle, Guard, Filter, CO2Cartridge	Difference

[TargetCool™-Cooling mode, Boosting mode]

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	Boosting Container).
Mechanism ofAction	The unit blows very low-temperaturegas and cold-water at temperature andtime settings, onto the desiredtreatment area		The unit blows very low-temperaturegas at temperature and time settings,onto the desired treatment area	Similar
Mode type	Cooling Mode, Boosting Mode		Cooling mode	Difference
Cryogen Type	CO2, Cold-water (Saline solution)		CO2	Same
Temperature	2-4 °C within 5 sec		2-4 °C within 5 sec	Same
TreatmentDuration	Cooling Mode	Continuous (0 sec)PL (2 sec pre-set)1~60sec	0~60 sec	Similar
	Boosting Mode	3~4 min
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 determined tobe less than -1 °C for 1 second.	Same

The Cooling mode & Boosting mode of TargetCool™ is equivalent in intended use, principles of operation, and performance temperature to TargetCool™ (K221234) and raises no new issues of safety or effectiveness.

The differences are the Boosting mode and the Boosting accessories for the Boosting mode.

In Boosting mode, saline cooled by CO2 gas is sprayed onto the skin. The saline solution is used for the purpose of keeping the skin temperature constant at 2-4℃ for 3-4 minutes and for safety purposes to prevent the skin temperature from dropping below freezing.

Cooling mode uses CO2 gas and Boosting mode uses cold-water, but the temperature of Cooling mode and Boosting mode is the same (2~4℃). Therefore, the difference does not raise new questions of safety and effectiveness

Product Name	TargetCool™(Subject Device)	CryoVIVE(K203481)	Comparison
Indications forUse/ Intended Use	TargetCool™ are intended for thesurgical destruction of target tissue byapplying cryogenic gases at extremelow temperatures- Molluscum Contagiosum- Skin Tags- Actinic Keratosis- Lentigo- Verruca Plana- Verruca Vulgaris- Verruca Lesions- Genital Lesions- Seborrheic Keratosis	The CryoVIVE are intended for thesurgical destruction of target tissue byapplying cryogenic gases at extremelow temperatures- Molluscum Contagiosum- Skin Tags- Actinic Keratosis- Lentigo- Verruca Plana- Verruca Vulgaris- Verruca Lesions- Genital Lesions- Seborrheic Keratosis	Same
	Component	Main system, Control button, LCD,Cooling nozzle, Freezing nozzle,Cooling guard, filter, CO2 cartridgeand Boosting accessories (BoostingNozzle, a Boosting guard, and a	Main system, Control button, LCD,Nozzle (Cooling and Freezing), Guidetip, filter, CO2 cartridge

[TargetCoolTM-Freezing mode]

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	Boosting Container).
Mechanism ofAction	Cryogen, CO2 is delivered to thetreatment site to effect cellulardestruction	Cryogen, CO2 is delivered to thetreatment site to effect cellulardestruction	Same
Temperature	CO2 (-79°C)	CO2 (-79°C)	Same
Gas dispensingrate	0.578 g/sec	0.578 g/sec	Same
Gas Volume	65g cartridge	65g cartridge	Same
Tissue damage	Cell necrosis occurs only inside the iceball	Cell necrosis occurs only inside the iceball	Same

Cryoablation is the fundamental technological principle for the freezing mode of the subject device, TargetCool™, and the predicate devices (CryoVIVE).

The Freezing mode of TargetCool™ is equivalent in intended use, principles of operation, and performance temperature to TargetCool™ (K221234) and raises no new issues of safety or effectiveness. The only difference is that the freezing nozzle's length is shortened and the guard is not inserted during the procedure in the freezing mode. Because of this the device can be placed closer to the lesion, so that it can be applied to smaller lesion sizes. However, these differences do not significantly affect safety and/or effectiveness.

8. CONCLUSION

TargetCool™ and the legally marketed predicate devices have the same intended use, Indications for Use statement and the technological characteristics. While the technological characteristics differ between the two systems, the differences are minor. Performance testing data established that the TargetCool™ is safe and effective as the legally marked predicate devices and that the TargetCool™ does not raise any different questions of safety and 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.