Compound W Wart Removal System Dual Power

K161294 · Medtech Products, Inc. · GEH · Sep 15, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K161294
• Device Name: Compound W Wart Removal System Dual Power
• Applicant: Medtech Products, Inc.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Sep 15, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Compound W® Wart Removal System Dual Power is intended for the over-the-counter removal of common and plantar warts.

Device Story

Compound W Wart Removal System Dual Power is an OTC cryosurgical kit for wart removal. It utilizes a pressurized aerosol canister containing a dimethyl ether and propane cryogen mixture; a reusable actuator/cap; and disposable foam applicators to apply cryogen to warts. The kit also includes a 17% salicylic acid gel in a squeeze tube for topical application. The device is intended for patient self-use at home. The cryogen freezes the wart tissue, while the salicylic acid gel provides a secondary treatment. The combination of cryotherapy and topical acid is designed to remove common and plantar warts. The device is non-sterile and uses single-use disposable applicators.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and established safety of the components.

Technological Characteristics

Cryosurgical system; aerosol pressurized canister (dimethyl ether/propane); reusable actuator; disposable foam applicators; 17% salicylic acid gel. Biocompatibility per ISO 10993. Non-sterile. OTC use.

Indications for Use

Indicated for the over-the-counter removal of common and plantar warts in adults and children 4 years or older.

Regulatory Classification

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.

Predicate Devices

• Dr Scholl's® Dual Action Freeze Away™ Wart Remover (K052259)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 15, 2016

MedTech Products, Inc. % Ms. Kathryn Coressel Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400. Austin, Texas 78701

Re: K161294

Trade/Device Name: Compound W Wart Removal System Dual Power Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: July 29, 2016 Received: August 2, 2016

Dear Ms. Coressel:

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. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR Part 803); good manufacturing practice requirements as set forth

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in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Christopher J. Ronk -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K161294

Device Name

Compound W® Wart Removal System Dual Power

Indications for Use (Describe) For the over-the-counter removal of common and plantar warts.

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® Wart Removal System Dual Power

K # _161294

## 1. Submission Sponsor

MedTech Products Inc. 660 White Plains Road

Tarrytown, NY, 10591

USA

Phone number: [phone]

Contact: Czarina Ochoa

Title: Regulatory Affairs Manager

#### 2. Submission Correspondent

Emergo Global Consulting, LLC

816 Congress Avenue, Suite 1400

Austin, TX 78701

Cell Phone: PHONE

Office Phone: [phone]

Contact: Kathryn A Coressel, Senior Consultant, RA

Email: [e-mail]

#### 3. Date Prepared

September 14, 2016

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# 4. Device Identification

| Trade/Proprietary Name: | Compound W® Wart Removal System Dual Power |
|-------------------------|--------------------------------------------|
| Common/Usual Name: | OTC Wart Removal System |
| Classification Name: | Cryosurgical unit and accessories |
| Regulation Number: | 878.4350 |
| Product Code: | GEH |
| Device Class: | Class II |
| Classification Panel: | General & Plastic Surgery |

# 5. Legally Marketed Predicate Device(s)

Dr Scholl's® Dual Action Freeze Away™ Wart Remover (K052259)

# 6. Device Description

The Compound W® Wart Removal System Dual Power is a cryosurgical system for the over-the-counter removal of common and plantar warts.

Compound W® Wart Removal System Dual Power consists of the following:

- O Pressurized aerosol spray canister with a mixture of dimethyl ether and propane (K032271)
- o Reusable actuator/cap that releases the cryogen onto the disposable applicators
- Disposable foam applicators O
- Salicylic acid gel wart remover provided in a squeeze tube (in compliance with OTC O monograph 21 CFR 358 subpart B)
- O Comfort pads
- Instruction Leaflet o

## 7. Indication for Use Statement

Compound W® Wart Removal System Dual Power is intended for the over-the-counter removal of common and plantar warts.

## 8. Substantial Equivalence Discussion

The following table compares the Compound W® Wart Removal System Dual Power to the predicate device with respect to indications for use, principles of operation, technological characteristics, and materials . The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

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| Manufacturer | Schering-Plough<br>HealthCare Products, Inc. | MedTech Products, Inc. | Significant<br>Differences | | |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------|--|--|
| Trade Name | Dr Scholl's Dual Action<br>Freeze Away Wart<br>Remover | Compound W® Wart<br>Removal System Dual<br>Power | | | |
| 510(k) Number | K052259 | TBD | Not Applicable | | |
| Product Code | GEH | SAME | NONE | | |
| Regulation Number | 878.4350 | SAME | NONE | | |
| Regulation Name | Cryosurgical unit and<br>accessories | SAME | NONE | | |
| Indications for Use | Dr. Scholl's® Dual Action<br>Freeze Away TM Wart<br>Remover is indicated for<br>the over-the-counter<br>removal of common and<br>plantar warts. | Compound W® Wart<br>Removal System Dual<br>Power is indicated for the<br>over-the-counter removal<br>of common and plantar<br>warts. | SAME | | |
| Presentation of kit | Kit contains both the<br>cryogen spray and salicylic<br>acid components in the<br>same kit. | SAME | NONE | | |
| Sterile | No components are<br>provided as sterile. | SAME | NONE | | |
| Single-Use | Only the disposable<br>applicators are single-use. | SAME | NONE | | |
| Target Population | Adults and children 4 or<br>older | SAME | NONE | | |
| Biocompatibility | Complies with ISO 10993 | SAME | NONE | | |
| Cryogen spray | | | | | |
| Application | Portable cryosurgical<br>system comprised of an<br>aerosol pressurized<br>canister containing cryogen<br>and an applicator that<br>applies the cryogen to the<br>wart. | SAME | NONE | | |

# Table 5A – Comparison of Characteristics

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| Manufacturer | Schering-Plough<br>HealthCare Products, Inc. | MedTech Products, Inc. | Significant<br>Differences |
|------------------|---------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Trade Name | Dr Scholl's Dual Action<br>Freeze Away Wart<br>Remover | Compound W® Wart<br>Removal System Dual<br>Power | |
| Formulation | A mixture of dimethyl ether<br>and propane | SAME | NONE |
| Freeze time | Dependent upon type and<br>size of wart | Identical treatment times<br>as predicate | NONE |
| Salicylic Acid | | | |
| Application | Post cryo-treatment with a<br>reusable applicator to<br>apply the acid to the wart. | Application is via a<br>squeezable tube | Difference does<br>not raise new<br>concerns for<br>safety or<br>effectiveness. |
| Formulation | A 17% /salicylic acid<br>solution | A 17% /salicylic acid gel | Difference does<br>not raise new<br>concerns for<br>safety or<br>effectiveness. |
| Frequency of Use | One drop of the liquid can<br>be applied to the wart 24<br>hours post cryo-treatment. | Apply 1 drop at a time to<br>cover the wart. Repeat<br>once or twice a day as<br>needed. | Difference does<br>not raise new<br>concerns for<br>safety or<br>effectiveness. |