CAUTERY TIP CLEANER, MODEL-TC-100

K030339 · Aspen Surgical Products, Inc. · GEI · Mar 7, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030339
• Device Name: CAUTERY TIP CLEANER, MODEL-TC-100
• Applicant: Aspen Surgical Products, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

The disposable Cautery Tip Cleaner is a single use sterile product. It is intended to be used as an electrosurgical accessory. The Cautery Tip Cleaner provides a method of removing eschar build-up from the tip of electro surgical instruments during the course of a surgical procedure.

Device Story

Disposable, single-use, sterile electrosurgical accessory; used to remove eschar build-up from electrosurgical instrument tips during surgical procedures. Operated by surgical staff in clinical settings. Mechanical cleaning action; no electronic or software components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable, single-use, sterile electrosurgical accessory. Mechanical cleaning mechanism. No energy source, software, or complex materials specified.

Indications for Use

Indicated for use as an electrosurgical accessory to remove eschar build-up from the tips of electrosurgical instruments during surgical procedures.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Debbie Daly Director of Quality Aspen Surgical Products, Inc. 7425 Clyde Park, Suite G Byron Center, Michigan 49315

MAR 0 7 2003

Re: K030339

Trade/Device Name: Electro-Cautery Tip Cleaner Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 29, 2003 Received: January 31, 2003

Dear Ms. Daly :

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 nisbranding 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. Debbie Daly

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]. 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) you may obtain. 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

tol 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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510(k) Number (if known): K030339

Device Name: Electro-Cautery Tip Cleaner

Indications for Use:

The disposable Cautery Tip Cleaner is a single use sterile product. It is intended to be used as an electrosurgical accessory. The Cautery Tip Cleaner provides a method of removing eschar build-up from the tip of electro surgical instruments during the course of a surgical procedure.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Miriam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number K030339