WARTNER WART REMOVAL SYSTEM, MODEL 66715 82000 (PRODUCT CODE NUMBER 52E022)

K032271 · Wartner USA B.V. · GEH · Sep 10, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032271
• Device Name: WARTNER WART REMOVAL SYSTEM, MODEL 66715 82000 (PRODUCT CODE NUMBER 52E022)
• Applicant: Wartner USA B.V.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Sep 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

WARTNER® Wart Removal System is indicated for the over-the-counter treatment of common warts and plantar warts.

Device Story

The WARTNER® Wart Removal System is an over-the-counter cryosurgical device used for the removal of common and plantar warts. The device functions by applying a freezing agent to the wart tissue, causing localized destruction of the lesion through cryotherapy. It is intended for patient self-use at home. The device provides a non-prescription alternative to professional clinical cryosurgery, allowing patients to treat warts without physician intervention. The output is the physical application of the cryogen to the target site, which facilitates the removal of the wart tissue.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Cryosurgical unit (21 CFR 878.4350, Product Code GEH). The device utilizes a freezing agent for localized tissue destruction. It is designed for OTC use.

Indications for Use

Indicated for over-the-counter treatment of common warts and plantar warts in patients.

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

• Wartner® Wart Removal System for OTC use (Primary Predicate)
• Histofreezer® Portable Cryosurgical System (KC? 2499)
• Tinamed® Plantar Patch
• DuoFilm® Salicylic Acid Wart Remover
• Clear Away® System Planiar Wart Remover for Feet
• Wartner Pro®

Submission Summary (Full Text)

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Wartner USA b.v.

WARTNER® Wart Removal System - Plantar Warts Indication

# 510(k) Summary

### 1. Submitter's Name, Address and Contact Person

| Submitter | Contact Person |
|----------------------------|---------------------------|
| Wartner USA b.v. | Nancy Lum-Wilson |
| World Trade Center | N. Wilson Consulting Inc. |
| Beursplein 37 (Room 405) | 65 Ava Crescent |
| The Netherlands | Richmond Hill, Ontario |
| | CANADA L4B 2X5 |
| Telephone: [phone] | Telephone: [phone] |
| Facsimile: [phone] | Facsimile: 905-508-8599 |

Date Summary Prepared: June 30, 2003

### 2. Name of Device

## WARTNER® Wart Removal System (for OTC use)

#### 3. Name of Predicate Device(s)

- Wartner® Wart Removal System for OTC use, by Wartner Medical Products . (Primary Predicate)
- Histofreezer® Portable Cryosurgical System, by Orasure Technologies Inc. . KC? 2499 (Labeling predicate)
- Tinamed® Plantar Patch, by Stiefel laboratories, Inc. (Labeling predicate) .
- DuoFilm® Salicylic Acid Wart Remover indicated for common warts and plantar . warts, by Schering-Plough HealthCare Products, Inc. (Labeling predicate)
- Clear Away® System Planiar Wart Remover for Feet, by Schering-Plough . HealthCare Products, Inc. (Labeling predicate)
- Wartner Pro®, by Wartner Medical Products (Labeling predicate) ●

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized depiction of an eagle or bird, with three curved lines forming the body and wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 2003

Wartner USA b.v. c/o Ms. Nancy Lum-Wilson N. Wilson Consulting, Inc. 65 Ava Crescent Richmond Hill, Ontario Canada L4B 2X5

Re: K032271

Trade/Device Name: WARTNER® Wart Removal System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II Product Code: GEH Dated: July 18, 2003 Received: July 23, 2003

Dear Ms. Lum-Wilson:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Nancy Lum-Wilson

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

For Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Wartner USA b.v. WARTNER® Wart Removal System - Plantar Warts Indication

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## STATEMENT OF INDICATIONS FOR USE

K032271 510(k) Number:

WARTNER® Wart Removal System Device Name:

Indications for Use: WARTNER® Wart Removal System is indicated for the over-the-counter treatment of common warts and plantar warts.

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K032271

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use (Optional Format 1-2-96)