K Number

Device Name

Compound W Skin Tag Remover

Manufacturer

Medtech Products Inc.

Date Cleared

2024-11-06

(50 days)

Product Code

GEH

Regulation Number

878.4350

Intended Use

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

Device Description

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K211099

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the cryogenic mechanism of action and human factors validation, with no mention of AI or ML technologies.

Therapeutic

Yes
The device is intended for the OTC treatment of skin tags in adults aged 22 years or older, which is a medical condition, making it a therapeutic device.

Diagnostic

No
The device is intended for the treatment (removal) of skin tags, not for diagnosis.

SaMD (Software as a Medical Device)

The device description clearly states it is a "cryogenic device" containing an aluminum canister, gases, and disposable applicator tips, indicating it is a hardware-based device for delivering cryotherapy.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
Compound W® Skin Tag Remover's Function: This device directly treats a condition on the body (skin tags) by applying cold temperatures. It does not analyze any bodily fluids or tissues to diagnose or monitor a condition.

The description clearly states its purpose is for the "OTC treatment of skin tags" and that it "removes acrochordons (skin tags) via epidermal cryotherapy." This is a therapeutic device, not a diagnostic one.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

GEH

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Skin

Indicated Patient Age Range

adults age 22 years or older.

Intended User / Care Setting

consumers / Home

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Non-Clinical Performance Data:

In vitro experiment to determine the temperature generated by Compound W® Skin Tag Remover compared to the predicate device.
Study demonstrated superior freezing performance of Compound W® Skin Tag Remover, generating temperatures from -30.9℃ to -30.1℃, versus -28.8°C to -27.8°C for the predicate.
Compound W® Skin Tag Remover delivered an average temperature 2.4 degrees colder than the predicate at the end of the 40-second treatment (-30.5℃ for Compound W® Skin Tag Remover vs -28.1℃ for the predicate).
Biocompatibility testing (cytotoxicity, skin irritation, and sensitization) was done on the canister and adhesive Tag Target discs, in accordance with ISO 10993, showing components are appropriate for intended uses.
Human Factors Validation testing was conducted with 50 participant volunteers (15 intended users and 35 non-intended users) from the general population. The findings demonstrated that the user interface, including labeling, supports safe and effective use for intended users in the intended use environment.

Clinical Performance Data: Not Found

Key Metrics

Average Temp at tip (end of treatment time): -30.5°C
Duration of treatments for Skin Tags: 40 seconds

Predicate Device(s)

K211099

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

November 6, 2024

Image /page/0/Picture/1 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.

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.

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

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

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

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 Tag
Remover	Freeze'n Clear Skin Clinic
Warts & Tags	N/A
510(k) Number	TBD	K211099	N/A

Table 5-1: Comparison of Characteristics

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 to
handle; press actuator
down for 2-3 seconds; pull
skin tag away from the
body with supplied
tweezers and apply
applicator tip to skin tag
base continuously for 40
seconds	Attach applicator tip to
handle; press actuator
down for 3-5 seconds;
wait 15 seconds; pull skin
tag away from the body
with supplied tweezers
and apply applicator tip to
skin tag base continuously
for 40 seconds	Minor
Duration of
treatments for Skin
Tags	40 seconds	40 seconds	None
Cryogen and
Applicator	Dimethyl ether and
propane delivered via
foam applicator	Dimethyl ether, propane,
and isobutane delivered
via foam applicator	Yes (see discussion in
Section 8 of this
summary)
Average Temp at tip
(end of treatment
time)	-30.5°C	-28.1°C	Minor
Sterile Device	No	No	None
Leaflet included	Yes	Yes	None
Use environment	Home	Home	None
Anatomical site of
use	Skin	Skin	None
Electricity or
radiation used	No	No	None

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

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

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

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.