POLAR WAND

K021387 · Chek-Med Systems · GEH · Jul 31, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021387
• Device Name: POLAR WAND
• Applicant: Chek-Med Systems
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Jul 31, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Polar Wand Cryotherapy System is used for ablation of unwanted tissue in the fields of dermatology, gynecology, general surgery, urology, and gastroenterology. The system may be used with a variety of cryogens, e.g. carbon dioxide, nitrous oxide, argon, krypton.

Device Story

Polar Wand Cryotherapy System; handheld device for tissue ablation via cryosurgery. Operates by delivering cryogens (carbon dioxide, nitrous oxide, argon, or krypton) to target tissue sites. Used by clinicians in dermatology, gynecology, general surgery, urology, and gastroenterology. Device facilitates controlled freezing to destroy unwanted tissue. Clinical benefit includes minimally invasive removal of lesions or abnormal tissue. No complex electronics or software involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cryosurgical unit; handheld applicator; utilizes various cryogens (CO2, N2O, Argon, Krypton). Mechanical operation; no software or electronic sensing components.

Indications for Use

Indicated for ablation of unwanted tissue in dermatology, gynecology, general surgery, urology, and gastroenterology. No specific patient population or contraindications provided.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that suggest movement and flight. The overall design is simple and clean, with a focus on conveying the department's mission of protecting the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 3 1 2002

Chek-Med Systems, Inc. c/o Robert G. Whalen Mycoscience, Inc. 25 Village Hill Road Willington, Connecticut 06279

Re: K021387

Trade Name: Polar Wand Cryotherapy System Regulation Number: 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II Product Code: GEH Dated: May 1, 2002 Received: May 2, 2002

Dear Mr. Whalen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 – Mr. Robert G. Whalen

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.

Sincerely, yours,

Mark A. Millhiser

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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Section 8.2

Intended Use Statement

## 510k INDICATION FOR USE STATEMENT

| 510(k) Number (if known): | K021387 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Polar Wand Cryotherapy System |
| Applicant Name: | GI Supply division of Chek-Med Systems Inc.* |
| Indication for Use: | The Polar Wand Cryotherapy System is used for ablation of unwanted tissue in the fields of dermatology, gynecology, general surgery, urology, and gastroenterology. The system may be used with a variety of cryogens, e.g. carbon dioxide, nitrous oxide, argon, krypton. |

GI Supply/Chek-Med Signature:

Date:
Frank Carter - CEO

Frank Carter - CEO

Date: 5-1-02

Mark H Wilkerson
(Division Sign-Off)
Division of Coastal Protection

Division of General, Restorative and Neurological Devices

510(k) Number K021387