Compound W® Skin Tag Remover is a cryogenic device intended to remove acrochordons (skin tags) via epidermal cryotherapy, destroying target epidermal cells by using extremely cold temperatures. The device contains a non-replaceable, non-refillable aluminum canister holding the gases dimethyl ether and propane. Activation of the device ejects a dose of the gases into a disposable polyurethane foam applicator tip, resulting in freezing of the applicator to approximately -30°C. The cold applicator tip is placed on the skin tag, thus destroying the target tissue. Each Compound W® Skin Tag Remover device is supplied in a paperboard carton with eight disposable tips, plastic tweezers, adhesive "Tag Target" skin-protecting discs, and an Instructions-for-Use leaflet.

AI/ML Overview

The provided document is a 510(k) premarket notification from Medtech Products Inc. to the FDA for their product "Compound W Skin Tag Remover." It details the device's characteristics and compares it to a predicate device to demonstrate substantial equivalence.

Based on the information provided, here's a description of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Study Name/Description
Cryogenic Performance: Deliver extreme cold to destroy target tissue effectively.	Temperatures ranging from -30.9°C (T=0 seconds) to -30.1°C (T=55 seconds, 15 seconds post-treatment). Average temperature 2.4 degrees colder than predicate at the end of 40-second treatment (-30.5°C vs -28.1°C).	"in vitro experiment to determine the temperature generated by Compound W® Skin Tag Remover in comparison to the cited predicate device."
Biocompatibility: Device components (canister, adhesive Tag Target discs) are safe for contact with human skin.	Components are "appropriate for their intended uses."	Biocompatibility testing (cytotoxicity, skin irritation, and sensitization) in accordance with ISO 10993.
Usability/Human Factors: Intended users can self-diagnose and safely use the device based on the user interface and labeling.	User interface for Compound W® Skin Tag Remover, including the labeling, "supports safe and effective use for the intended users in the intended use environment."	Human Factors Validation testing.
Substantial Equivalence: Demonstrate that differences from the predicate device do not raise new questions of safety or effectiveness.	Non-clinical data and Human Factors Validation demonstrate the device delivers comparable temperature, is as safe and effective as the predicate, and supports safe and effective use.	Combination of cryogenic performance, biocompatibility, and human factors studies.

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

Cryogenic Performance Study (in vitro): The document does not specify the exact sample size for the "product samples" tested. It only states "Product samples were tested."
- Provenance: This was an in vitro experiment, meaning it was conducted in a lab setting, not on human subjects. The origin of the products themselves (Compound W device and predicate) would be from the respective manufacturers. There is no mention of country of origin for test data, but the submission is to the US FDA.
- Retrospective/Prospective: This appears to be a prospective bench test designed specifically for this submission.
Biocompatibility Testing: The document does not specify the sample size for the materials tested (canister, adhesive Tag Target discs).
- Provenance: This is lab-based testing.
- Retrospective/Prospective: This appears to be prospective lab testing.
Human Factors Validation Testing:
- Sample Size: 50 participant volunteers.
- Data Provenance: The document states participants were from the "general population," including "15 intended users and 35 non-intended users." The location of this study (e.g., country, specific site) is not specified.
- Retrospective/Prospective: This was a prospective usability study specifically conducted to validate the device's human factors.

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

Cryogenic Performance: No external experts were used for ground truth establishment. The ground truth (temperature readings) was established directly by the measuring instrument (thermocouple sensor).
Biocompatibility Testing: The ground truth for biocompatibility is established by the test results against the criteria of ISO 10993. This would typically be conducted by certified lab personnel, but "experts" in the sense of adjudicating human-generated data are not applicable here.
Human Factors Validation Testing: No explicit mention of external experts establishing a "ground truth" for the test set. The study aimed to assess if users could safely and effectively use the device, and the findings are reported at a high level. Human factors studies are more about observing user interaction and identifying potential use errors rather than adjudicating a "truth" like a medical diagnosis. The "ground truth" here is the observed user behavior and the successful completion of tasks based on the product's design and labeling.

4. Adjudication Method for the Test Set

Cryogenic Performance & Biocompatibility: Not applicable, as these were objective bench/lab tests with quantifiable outputs from measurements or standard protocols.
Human Factors Validation Testing: The document does not describe a specific adjudication method like "2+1" or "3+1." Human factors studies involve direct observation, task analysis, and error collection. The assessment of whether the user interface "supports safe and effective use" would be based on the data collected during these observations and the analysis by the human factors specialists conducting the study.

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

No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for diagnostic imaging AI, where multiple readers interpret cases with and without AI assistance to measure improvement in diagnostic accuracy. The "Compound W Skin Tag Remover" is a cryogenic device for physical removal of skin tags, not a diagnostic imaging device. The studies focused on physical performance, biocompatibility, and usability.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable in the context of an AI algorithm. This device does not contain an AI algorithm. Its "performance" is mechanical/chemical (freezing capacity) and user interface design. The cryogenic performance and biocompatibility tests can be considered "standalone" in the sense that they assess the device's physical properties independently of human interaction during the test, but this refers to the product's physical function, not an AI algorithm.

7. The Type of Ground Truth Used

Cryogenic Performance: Objective physical measurement (temperature, in degrees Celsius) using a thermocouple sensor.
Biocompatibility Testing: Results compared against established ISO 10993 standards and criteria for cytotoxicity, skin irritation, and sensitization.
Human Factors Validation Testing: Observed user behavior, success/failure in task completion, and identification of use errors based on pre-defined criteria.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product (cryosurgical unit), not a machine learning or AI model. Therefore, there is no "training set" in the context of AI.

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

Not applicable. As there is no AI/ML component, there is no training set or ground truth establishment for such a set.

Summary

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November 6, 2024

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Medtech Products Inc. Vincent Argiro Associate Vice President. Regulatory Affairs 660 White Plains Road Suite 250 Tarrytown, New York 10591

Re: K242803

Trade/Device Name: Compound W Skin Tag Remover Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH Dated: September 17, 2024 Received: September 17, 2024

Dear Vincent Argiro:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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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,

Image /page/2/Picture/3 description: The image shows a digital signature of James H. Jang -S. The signature includes the date 2024.11.06 and the time 06:19:59 -05'00'. The signature is for James H. Jang -S.

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) K242803

Device Name Compound W Skin Tag Remover

Indications for Use (Describe)

Compound W Skin Tag Remover is intended for the OTC treatment of skin tags in adults age 22 years or older.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Section 5 – 510(k) Summary

Compound W® Skin Tag Remover

K # K242803

1. Submitter Name & Address: Medtech Products Inc. 660 White Plains Road Tarrytown, NY, 10591 Contact: Vincent Argiro, RAC Title: Associate Vice President, Regulatory Affairs Phone number: (914) 524-8721 Email: vargiro@prestigebrands.com 2. Date Prepared 06 November 2024 3. Device Identification Compound W® Skin Tag Remover Trade/Proprietary Name: Common/Usual Name: Over-the-counter cryogenic skin tag remover Classification Name: Cryosurgical unit and accessories 21 C.F.R. § 878.4350 Regulation Number: Product Code: GEH [Unit, Cryosurgical, Accessories] Device Class: Class II Classification Panel: General & Plastic Surgery Devices

4. Legally Marketed Predicate Device(s)

Freeze'n Clear Skin Clinic Warts & Tags (K211099, currently marketed in the U.S. as "Dr. Scholl's Freeze Away Skin Tag Remover"), Product Code GEH

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K242803

5. Device Description

6. Intended Use/Indications for Use

Compound W® Skin Tag Remover has the same intended use as the predicate device: to allow consumers direct access to a safe and effective means to remove skin tags. The specific wording of the proposed Compound W® Skin Tag Remover Indications for Use statement is nearly identical to that associated with the predicate device-with the only difference being that the predicate is labeling for both wart and skin tag removal while the proposed Compound W device will be labeled only for skin tags, and the addition of a specific lower age limit—and therefore does not create an intended use for the device that differs from the predicate.

The Compound W® Skin Tag Remover bears the following Indications for Use statement:

Compound W® Skin Tag Remover is intended for over-the-counter treatment of skin tags in adults age 22 years or older.

In summary, Compound W® Skin Tag Remover has the same intended use as the predicate device and very minor differences in the wording of the Indications for Use statements between Compound W® Skin Tag Remover and the predicate do not alter the devices' intended therapeutic effect.

7. Substantial Equivalence Discussion

The following table compares Compound W® Skin Tag Remover to the predicate device with respect to intended use and technological characteristics. This comparison of the devices provides detailed information demonstrating the basis for the determination of substantial equivalence.

	Proposed Device	Predicate Device	Differences
Trade Name/Device Name	Compound W® Skin TagRemover	Freeze'n Clear Skin ClinicWarts & Tags	N/A
510(k) Number	TBD	K211099	N/A

Table 5-1: Comparison of Characteristics

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Date Cleared	90 days from date of receipt by FDA¹	06/17/2022	N/A
Original applicant	Medtech Products Inc.	CryoConcepts LP	N/A
REGULATORY CLASSIFICATION
Regulatory Class	Class II	Class II	None
Name of Generic Device Type	Cryogenic skin tag remover	Cryogenic skin tag remover	None
Regulation	21 CFR § 878.4350	21 CFR § 878.4350	None
Product Code	GEH	GEH	None
Applicable Performance Standards or Special Controls	N/A	N/A	None
DEVICE DESCRIPTION – SUBSTANTIAL EQUIVALENCE COMPARATORS
Intended Use	Allow consumers direct access to a safe and effective means to remove skin tags.	Allow consumers direct access to a safe and effective means to remove skin tags.	None
OTC or Rx	OTC	OTC	None
Indications for Use	For the OTC treatment of skin tags in adults age 22 years and older.	For the OTC treatment of common warts, plantar warts, and skin tags.	Minor: The predicate has an additional intended use for wart removal (though the marketed version has only the skin tag indication) with no specified age limit.
Technological Characteristics	Pressurized gas blend to generate extreme cold at an applicator tip	Pressurized gas blend to generate extreme cold at an applicator tip	None
DEVICE DESCRIPTION - DESIGN FEATURES
Energy	Thermal (removal of heat from treated skin)	Thermal (removal of heat from treated skin)	None
Package Contents	Table-top device with disposable foam applicators, tweezers, Tag Targets, and IFU leaflet	Table-top device with disposable foam applicators, tweezers, and IFU leaflet	Minor: The proposed device has the adhesive paper Tag Targets as an additional safety feature.
Directions for use	Attach applicator tip tohandle; press actuatordown for 2-3 seconds; pullskin tag away from thebody with suppliedtweezers and applyapplicator tip to skin tagbase continuously for 40seconds	Attach applicator tip tohandle; press actuatordown for 3-5 seconds;wait 15 seconds; pull skintag away from the bodywith supplied tweezersand apply applicator tip toskin tag base continuouslyfor 40 seconds	Minor
Duration oftreatments for SkinTags	40 seconds	40 seconds	None
Cryogen andApplicator	Dimethyl ether andpropane delivered viafoam applicator	Dimethyl ether, propane,and isobutane deliveredvia foam applicator	Yes (see discussion inSection 8 of thissummary)
Average Temp at tip(end of treatmenttime)	-30.5°C	-28.1°C	Minor
Sterile Device	No	No	None
Leaflet included	Yes	Yes	None
Use environment	Home	Home	None
Anatomical site ofuse	Skin	Skin	None
Electricity orradiation used	No	No	None

1 Projected based on Section 510(k) of the FDCA

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In accordance with section 513(i)(1)(A) of the FDCA, a device is substantially equivalent (SE) when it has the same intended use and technological characteristics as a legally marketed predicate device. As demonstrated in this traditional 510(k), any differences between the subject device and the cited predicate do not raise different questions of safety or effectiveness and bench testing data establishes that the device is as safe and effective as the predicate. It is on this basis that Compound W® Skin Tag Remover is SE to the cited predicate device.

8. Non-Clinical Performance Data

To validate the cryogenic performance of Compound W® Skin Tag Remover, an in vitro experiment was conducted to determine the temperature generated by Compound W® Skin Tag Remover in comparison to the cited predicate device. Product samples were tested at room temperature after being activated and introduced to a measuring instrument with a thermocouple sensor. This study clearly demonstrated the superior freezing performance of Compound W® Skin Tag Remover

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K242803

throughout the maximum treatment time of 40 seconds; the proposed product generated temperatures ranging from -30.9℃ (T=0 seconds) to -30.1℃ (T=55 second, or 15 seconds post treatment) versus -28.8°C to -27.8°C (predicate). Further, Compound W® Skin Tag Remover delivered an average temperature 2.4 degrees colder than the predicate in this study at the end of the 40second treatment (-30.5℃ at 40 seconds for Compound W® Skin Tag Remover vs -28.1℃ for the predicate at 55 seconds due to its 15-second pre-treatment hold time).

Additionally, in accordance with ISO 10993, biocompatibility testing (cytotoxicity, skin irritation, and sensitization) was done on the canister as well as the adhesive Tag Target discs, showing the components are appropriate for their intended uses.

Finally, to confirm the ability of intended users to self-diagnose, and safely use the device, Human Factors Validation testing was conducted. The findings of that study (50 participant volunteers from the general population, including 15 intended users and 35 non-intended users) demonstrate that the user interface for Compound W Skin Tag Remover, including the labeling, supports safe and effective use for the intended users in the intended use environment.

The non-clinical testing of Compound W® Skin Tag Remover demonstrates the device's freezing performance, the suitability of its user interface, and the biocompatibility of its components and therefore supports the substantial equivalence of Compound W® Skin Tag Remover to the cited predicate.

9. Clinical Performance Data

There are no differences in intended use and technological characteristics between the Compound W Skin Tag Remover and the predicate that necessitates conducting a clinical trial to establish substantial equivalence.

10. Statement of Substantial Equivalence

Compound W® Skin Tag Remover has the same intended use as the predicate device, Freeze'n Clear Skin Clinic Warts & Tags (K211099, currently marketed in the U.S. as "Dr. Scholl's Freeze Away Skin Tag Remover") and utilizes the same basic principle of operation (introduction of extreme cold to destroy target tissue). Like the predicate, Compound W® Skin Tag Remover uses a combination of pressurized gases as a cryogen, which it delivers using a disposable foam applicator - the same delivery method employed by the predicate. Compound W® Skin Tag Remover and the predicate device are of roughly the same size and shape and require depression of a device component for a few seconds to release the cryogen and charge the applicator tip, and both employ the same application time for skin tags.

Although the design of Compound W® Skin Tag Remover relies on one fewer gas than the predicate (dimethyl ether and propane vs. dimethyl ether, propane, and isobutane), that difference does not raise any new questions of safety and effectiveness that are not associated with the predicate device. The non-clinical data provided in this submission demonstrate that Compound W® Skin Tag

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K242803

Remover delivers a comparable temperature and is therefore as safe and effective as the predicate device, and the Human Factors Validation test demonstrates that the product interface supports safe and effective use for the intended users in the intended use environment.

As such, Compound W® Skin Tag Remover is substantially equivalent to the cited 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.