MODIFICATION TO WARTNER WART REMOVAL SYSTEM

K011708 · Wartner Medical Products · GEH · Feb 20, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K011708
• Device Name: MODIFICATION TO WARTNER WART REMOVAL SYSTEM
• Applicant: Wartner Medical Products
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Feb 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Wartner Wart Removal System is intended for the over-the-counter treatment of common warts.

Device Story

Wartner Wart Removal System is a cryosurgical device for OTC treatment of common warts. System components include a canister containing a liquid mixture of dimethyl ether and propane, ten foam applicators, and an applicator stick/key. Operation involves saturating a foam applicator with the cryogen mixture via the applicator stick; the applicator is then applied directly to the wart. The device utilizes a safety valve that prevents actuation unless the applicator and holder are correctly positioned. The cryogen reaches temperatures of approximately -56.4°C, maintaining < -50°C for up to five minutes to induce cryotherapy. The device is intended for patient self-use. The healthcare provider or consumer uses the device to freeze the wart tissue, potentially leading to wart removal. The system is designed for home use, with labeling providing instructions for self-diagnosis and guidance on when to seek professional medical attention.

Clinical Evidence

Bench testing only. Testing confirmed applicator surface temperature of -56.4°C and duration of < -50°C for up to five minutes. Foam material (S616) is well-characterized in published literature. No clinical trial data presented.

Technological Characteristics

Cryosurgical unit; cryogen: dimethyl ether and propane mixture; applicator: S616 foam; safety valve mechanism; canister-based delivery system; non-powered; manual operation.

Indications for Use

Indicated for OTC treatment of common warts in patients requiring wart removal.

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 (Primary Predicate)
• Compound W Gel (K011708)
• Compound W Pads for Kids (K011708)
• Clear Away Gel (K011708)
• Clear Away Liquid (K011708)
• Rite Aid Wart Liquid (K011708)
• Suave Hairspray (K011708)

Submission Summary (Full Text)

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K011708

#### Wartner Medical Products Wartner Wart Removal System

# FEB 2 0 2002

## Safety and Effectiveness Summary

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

Submitter

Contact Person

| Wartner Medical Products | Nancy Lum-Wilson |
|------------------------------|---------------------------|
| Europark 20 | N. Wilson Consulting Inc. |
| 4904 SX Oosterhout | 25 Bellini Ave. |
| Netherlands | Brampton, Ontario |
| | L6T 3Z8 CANADA |
| Telephone: [phone] | Telephone: [phone] |
| Facsimile: 00 31 162 437 269 | Facsimile: 905-794-0633 |

Date Summary Prepared: May 25, 2001

#### 2. Name of Device

Wartner Wart Removal System

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

Wartner Wart Removal System, by Wartner Medical Products (Primary Predicate) Compound W Gel, by Medtech (labeling only) Compound W Pads for Kids, by Medtech (labeling only) Clear Away Gel, by Schering-Plough HealthCare Products, Inc., (labeling only) Clear Away Liquid, by Schering-Plough HealthCare Products, Inc., (labeling only) Rite Aid Wart Liquid, by Rite Aid Corporation (labeling only) Suave Hairspray, by Helene Curtis (Flammability label only)

### 4. Description of Device

Wartner Wart Removal System is a cryosurgical system for the treatment of warts. It consists of

- A canister filled with 35 ml of a liquid mixture of the compressed gases . dimethyl ether and propane. This gas mixture does not harm the ozone layer, and has a four-year shelf life.
- . Ten foam applicators
- . An applicator stick/key for holding a foam applicator, required to dispense the liquid to the applicator, and held by the person during treatment
- An illustrated description of how to use the product .

#### 5. Statement of Intended Use

Wartner Wart Removal System is intended for the over-the-counter treatment of common warts.

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K011708

## 6. Statement of Technological Characteristics of the Device

- a) Laboratory Testing:
The average temperature of the applicator surface after saturation is -56.4° C.

Several lengths, sizes, and shapes of foam were tested to identify the optimum characteristics of liquid retention (minimal dripping) and versatile shape for treating various sizes of warts.

- b) Biocompatibility:
The cryogen used is a mixture of dimethylether and propane, which is the same as cryogen used in the predicate device, Wartner Wart Removal System for prescription use.

The material used to transfer the cold to the patient in both Wartner Wart Removal System OTC and the predicate device is a foam material. The foam used in Wartner which has contact with the wart is S616 foam which is well characterized chemically and physically in the published literature.

- c) Comparison to Predicate Device(s):
## Application

Wartner for OTC use provides an applicator, which is removed from the tube of cryogen after saturation and can be easily manipulated to treat warts of various sizes.

The Wartner prescription use predicate device applicator is identical.

#### Applicator Effectiveness Duration

Wartner's foam applicator maintains a temperature of less than minus 50℃ for up to five minutes.

The Wartner predicate device effectiveness is identical

### Cryogen

Wartner uses a cryogen composed of dimethylether and propane.

The Wartner predicate device cryogen is identical.

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K011708

### Safety/Ease of Use:

Wartner's design incorporates the use of a safety valve that cannot be actuated unless the foam applicator and holder are in place. The Wartner prescription use predicate device has an identical safety valve.

### Indications for Use:

Wartner Wart Removal System is indicated for OTC treatment of common warts. The predicate device, Wartner Wart Removal System for prescription use is indicated for the treatment of common warts by a physician.

### Labeling:

The labeling of Wartner Wart Removal System has been developed to ensure the consumer has adequate directions for use and for safety. Wartner labeling has also been developed to provide adequate information for the consumer to make a self diagnosis and to ensure they contact their doctor if in any doubt, if stinging or aching persists after treatment or if the wart does not improve after three treatments.

The safety and warning statements for the primary predicate device (Wartner Wart Removal System for prescription use) and for all of the labeling predicate devices (Compound W Gel, Compound W pads, Clear Away Gel, Clear Away Liquid, Rite Aid Wart Liquid) is essentially similar. In addition, Wartner contains an essentially similar flammability statement to Suave Hairspray (Flammability label predicate), which uses an aluminum container and contains dimethyl ether and alcohol for use by the general public.

### 7. Conclusion

Based on the information presented above it is concluded that the proposed Wartner Wart Removal System is safe and effective for its intended use and is substantially equivalent to the primary predicate device. It is also substantially equivalent in intended use, safety, and labeling to the labeling predicate devices.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2002

Wartner Medical Products c/o Ms. Nancy Lum-Wilson N. Wilson Consulting, Inc. 25 Bellini Avenue Brampton, Ontario L6T 3Z8 Canada

Re: K011708

Trade/Device Name: Wartner Wart Removal System Regulation Number: 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II Product Code: GEH Dated: January 18, 2002 Received: January 22, 2002

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained 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.

Muriam 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 Medical Products Wartner Wart Removal System

## STATEMENT OF INDICATIONS FOR USE

510(k) Number:

K011708

Device Name:

Wartner Wart Removal System

Indications for Use : Wartner Wart Removal System is intended for the treatment of common warts.

Miriam C. Provost

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________

(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

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