The Freeze 'n Clear Skin Clinic for Warts and Skin Tags product utilizes extreme cold to facilitate the removal of warts and skin tags by freezing. Each kit contains a container of cryogen gas, foam applicators, tweezers and instructions for use. The device is for OTC use and utilizes a combination of dimethyl ether, propane and isobutane delivered from the canister into a foam applicator which acts as a reservoir for the cryogen gas. The gas rapidly evaporates and cools the applicator to approximately -55°C. The applicator is then placed against the wart or skin tag for 40 seconds which freezes the targeted tissue. The frozen skin tag or wart falls away over time and new epidermis grows in its place. One to four treatments with intervals of two weeks may be required.

AI/ML Overview

The provided text describes the Freeze 'n Clear Skin Clinic for Warts and Skin Tags device (K211099), a cryosurgical unit intended for the over-the-counter (OTC) treatment of common warts, plantar warts, and skin tags.

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

The document does not explicitly state quantitative acceptance criteria in a table format for performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices and fulfilling safety and usability requirements for an OTC product.

However, based on the performance data section, implicit criteria and reported performance can be inferred:

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Device materials meet safety standards.	Passed cytotoxicity, sensitivity, irritation tests according to FDA's biocompatibility 2020 guidance and ISO 10993.
Cryogenic Efficacy (Temperature): Device achieves equivalent freezing temperatures to predicate.	Bench testing demonstrated equivalent temperatures to the Histofreezer Professional predicate device.
Cryogenic Efficacy (Cell Destruction): Device is equivalent in ability to freeze and destroy target cells as predicate.	Bench testing using an in vitro model demonstrated equivalence in freezing and destroying target cells compared to Histofreezer Professional.
Self-Diagnosis/Self-Selection: Majority of users can accurately self-diagnose and determine if the product is suitable for their condition.	Clinical study and human factors usability study demonstrated the majority of subjects were able to self-diagnose and self-select for the product.
Label Comprehension: Majority of users can understand the product directions.	Clinical study and human factors usability study demonstrated the majority of subjects understood the directions.
Appropriate Use: Majority of users can appropriately use the product as instructed.	Clinical study and human factors usability study demonstrated the majority of subjects appropriately used the product.
Safety (Post-Market): Low incidence of complaints and adverse events in existing markets.	Historical data showed a low number of complaints and adverse events outside the US with the Freeze 'n Clear product for warts or skin tags.

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

Clinical Study Test Set: Over 300 subjects.
Data Provenance: Conducted at 3 US dermatology offices (prospective clinical study). Historical data on complaints and adverse events was also considered, which would be retrospective data from outside the US.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the clinical study's subjects (e.g., confirming the nature of warts or skin tags). It mentions that the study was performed at dermatology offices, implying clinical oversight, but details on expert review for ground truth are not provided. For the "self-diagnosis" aspect, the ground truth would presumably be the dermatologists' diagnoses compared to the subjects' self-diagnoses.

4. Adjudication method for the test set

The document does not describe a specific adjudication method (e.g., 2+1, 3+1). It states a clinical study was performed at dermatology offices, which implies physician oversight and potentially consensus on diagnoses if multiple practitioners were involved, but details are not given.

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

No, an MRMC comparative effectiveness study was not done. This device is a cryosurgical unit, not an AI-assisted diagnostic tool for human readers.

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

Yes, aspects of "standalone" performance were assessed through bench testing.

Bench Testing (Temperature): Compared temperatures attained by the subject device and a predicate device.
Bench Testing (Cell Destruction): Used an in vitro model to compare the ability of the subject device and a predicate device to freeze and destroy target cells.

7. The type of ground truth used

Biocompatibility: Established by adherence to ISO 10993 standards.
Cryogenic Efficacy (Bench Testing): Ground truth was based on objective physical measurements (temperature) and in vitro cell destruction models.
Clinical Study: Ground truth for self-diagnosis and self-selection would likely be the dermatologists' clinical diagnoses of warts and skin tags, against which subject self-assessments were compared. Usability and label comprehension ground truth would be based on subjects' ability to follow instructions and correctly operate the device.
Post-Market Safety: Ground truth derived from historical complaint and adverse event data.

8. The sample size for the training set

The document does not refer to a "training set" as this device is a physical cryosurgical unit and not an AI/machine learning algorithm requiring a distinct training phase.

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

Not applicable, as there is no training set in the context of this device.

Summary

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June 17, 2022

CryoConcepts LP Sam Niedbala PhD CEO 205 Webster St Bethlehem, Pennsylvania 18015

Re: K211099

Trade/Device Name: Freeze'n Clear Skin Clinic Warts & Tags Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH Dated: April 7, 2021 Received: May 16, 2021

Dear Sam Niedbala PhD:

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

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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 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-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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,

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) K211099

Device Name

Freeze 'n Clear Skin Clinic for Warts and Skin Tags

Indications for Use (Describe)

The Freeze 'n Clear Skin Clinic for Warts and Skin Tags product is intended for the OTC treatment of common warts, plantar warts, and skin tags.

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)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

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K211099 510(K) SUMMARY

I. SUBMITTER

CryoConcepts LP, 205 Webster St. Bethlehem PA 18015 Phone: 855-355-2796 Contact: Sam Niedbala, Ph.D. June 16, 2022

II. DEVICE

Name of Device: Freeze 'n Clear Skin Clinic for Warts and Skin Tags

Usual Name - Cryosurgical unit and accessories

Classification Name - General & Plastic Surgery

Regulatory Class: II

Code of Federal Regulation: 878.4350

Product Code: GEH

III. PREDICATE DEVICES

OTC Wart Removal System K023487

Histofreezer Professional K933327

Claritag K190747

IV. DEVICE DESCRIPTION

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foam applicator which acts as a reservoir for the cryogen gas. The gas rapidly evaporates and cools the applicator to approximately -55°C. The applicator is then placed against the wart or skin tag for 40 seconds which freezes the targeted tissue. The frozen skin tag or wart falls away over time and new epidermis grows in its place. One to four treatments with intervals of two weeks may be required.

V. INDICATIONS FOR USE

The Freeze 'n Clear Skin Clinic for Warts and Skin Tags product is intended for the OTC treatment of common warts, plantar warts, and skin tags.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

A summary of the technological characteristics for the Freeze 'n Clear Skin Clinic for Warts vs Freeze 'n Clear Skin Clinic for Warts and Skin Tags as well as the Histofreezer professional and Claritag predicates are provided in the following table. Each of these products utilize the same technological characteristics and cryogens as shown in the table below.

TechnologicalCharacteristics	Freeze 'n ClearSkin Clinic forWarts (K023487)	HistofreezerProfessional(K933327)	Claritag(K190747)	Freeze 'n ClearSkin Clinic forWarts and SkinTags (SubjectDevice)
-Intended Use	The Freeze 'n ClearSkin ClinicAdvanced Wartproduct is intendedfor consumer usefor the removal ofcommon warts andplantar warts	For thecryosurgicaltreatment of lesionsincluding warts andskin tags. Rx Only.	Claritag isindicated for use inthe treatment ofacrochordons (skintags)	The Freeze 'n ClearSkin Clinic forWarts and SkinTags product isintended forconsumer use forthe treatment ofcommon warts,plantar warts andskin tags
-Cryogen	Mixture of DMEP	Mixture of DMEP	Mixture of DMEP	Mixture of DMEP
TechnologicalCharacteristics	Freeze 'n ClearSkin Clinic forWarts (K023487)	HistofreezerProfessional(K933327)	Claritag(K190747)	Freeze 'n ClearSkin Clinic forWarts and SkinTags (SubjectDevice)
-Materials	-canister containingcryogen-Foam tippedapplicators	-canister containingcryogen-Foam tippedapplicators	-canister containingcryogen anddisposable foampads, Tweezers	-canister containingcryogen-Foam tippedapplicators and-Tweezers
-Mode of Use	Cryogen dispensedinto foamapplicator which isthen applied to thelesion	Cryogen dispensedinto foamapplicator which isthen applied to thelesion	Cryogen dispensedinto foam padswhich are thenapplied to thelesion	Cryogen dispensedinto foamapplicator which isthen applied to thelesion
-Mechanism ofaction	Extreme colddestroys the targettissue	Extreme colddestroys the targettissue	Extreme colddestroys the targettissue	Extreme colddestroys the targettissue
-Storage &SafetyConditions	-Keep away fromfire or flame-Do not smokewhile using theproduct-Do not puncture orincinerate canister	-Keep away fromfire or flame-Do not smokewhile using theproduct-Do not puncture orincinerate canister	-HighlyFlammable-Store at roomtemperaturebetween 68°-77°Fand away fromheat.	-Keep away fromfire or flame-Do not smokewhile using theproduct-Do not puncture orincinerate canister
	-Do not expose toheat or store attemperatures above120°F.-Store at roomtemperature awayfrom heat	-Do not expose toheat or store attemperatures above120°F.-Store at roomtemperature awayfrom heat	-Protect fromsunlight and do notexpose totemperature above120°F-Contents underpressure.-Do not puncture orincinerate	-Do not expose toheat or store attemperatures above120°F.-Store at roomtemperature awayfrom heat
TechnologicalCharacteristics	Freeze 'n ClearSkin Clinic forWarts (K023487)	HistofreezerProfessional(K933327)	Claritag(K190747)	Freeze 'n ClearSkin Clinic forWarts and SkinTags (SubjectDevice)
			container, even ifempty
-TreatmentProcedure	Spray the cryogeninto the applicatorto saturate it andthen place itdirectly onto thelesion for aspecified number ofseconds	Spray the cryogeninto the applicatorto saturate it andthen place itdirectly onto thelesion for aspecified numberof seconds	Spray the cryogeninto the foam padsto saturate themand then placethem directly ontothe lesion for aspecified numberof seconds	Spray the cryogeninto the applicatorto saturate it andthen place itdirectly onto thelesion for aspecified numberof seconds
-Disposal	Entire unit isdisposable afteremptied ofcryogen.	Entire unit isdisposable afteremptied ofcryogen.	Entire unit isdisposable afteremptied ofcryogen.	Entire unit isdisposable afteremptied ofcryogen.
-DefinedOperators	OTC for consumeruse	Rx Use Only	Rx Use Only	OTC for consumeruse
-Service /Repair	None	None	None	None

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VII. PERFORMANCE DATA

This submission added the indication to the Freeze 'n Clear Skin Clinic product to treat skin tags. As part of the data provided, the product was tested for biocompatibility including cytotoxicity, sensitivity, irritation according to FDA's biocompatibility 2020 guidance and meets the requirements of ISO 10993.

Bench testing compared the temperatures attained by the Histofreezer Professional predicate device and Freeze 'n Clear Skin Clinic product to demonstrate that they were equivalent. Additional bench testing using an in vitro model also demonstrated the Histofreezer Professional and Freeze 'n Clear Skin Clinic products were equivalent in their ability to freeze and destroy target cells.

A clinical study and human factors usability study was performed in support of the over-thecounter indication for skin tags. The clinical study was performed at 3 US, dermatology offices with over 300 subjects. It consisted of two parts, a label comprehension part for self-diagnosis and self-selection and an actual use part. Human factors usability testing also evaluated label

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comprehension and simulated use. The studies demonstrated the majority of subjects were able to self-diagnosis, self-select for the product, understand the directions, and appropriately use the product. Additionally, historical data was presented showing the low number of complaints and adverse events seen outside the US with the Freeze 'n Clear product used either for warts or skin tags

VIII. CONCLUSIONS

The Freeze 'n Clear Skin Clinic K023487 predicate device is indicated for OTC treatment of common and plantar warts. This submission adds the indication for the treatment of skin tags to the Freeze 'n Clear Skin Clinic K211099 device. The combination of studies and performance data presented demonstrates the subject device is as safe and effective as the predicate device(s) as indicated for use.

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.