POLAR WAND

K041783 · Chek-Med Systems · GEH · Sep 28, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041783
• Device Name: POLAR WAND
• Applicant: Chek-Med Systems
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Sep 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Polar Wand Cryotherapy System is indicated for the endoscopic ablation of tissue in the gastrointestinal tract.

Device Story

Polar Wand Cryotherapy System is a cryosurgical device used for endoscopic ablation of GI tract tissue. Device utilizes cryotherapy to destroy targeted tissue via extreme cold. Operated by physicians during endoscopic procedures. System provides controlled freezing to achieve therapeutic ablation; benefits include targeted tissue destruction with minimal damage to surrounding healthy structures. Device is a standalone surgical instrument.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and intended use.

Technological Characteristics

Cryosurgical unit and accessories (21 CFR 878.4350). Operates via cryotherapy (cold-based tissue ablation). Standalone device.

Indications for Use

Indicated for endoscopic ablation of gastrointestinal tract tissue. No specific age or gender restrictions 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

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SEP 2 8 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Chek-Med Systems, Inc. c/o Mr. Rob Whalen Regulatory Correspondent Mycoscience, Inc. 25 Village Hill Road Willington, Connecticut 06279

Re: K041783

Trade/Device Name: Polar Wand Cryotherapy System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II Product Code: GEH Dated: July 1, 2004 Received: July 1, 2004

Dear Mr. Whalen:

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 - Mr. Rob 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), 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

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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## Intended Use Statement

Section 8.2

## 510k INDICATION FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

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 indicated for the endoscopic ablation of tissue in the gastrointestinal tract.

GI Supply/Chek-Med Signature:

Frank Carter - CEO

Date: 6-30-04

Muriam C. Provost

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

**510(k) Number** K041783

Section 8.3

Truth and Accuracy Statement