CAUTERIZATION SMOKE EVACUATOR

K971758 · Applied Medical Technologies · GEI · Jul 21, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971758
• Device Name: CAUTERIZATION SMOKE EVACUATOR
• Applicant: Applied Medical Technologies
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

The Cauterization Smoke Evacuator is an accessory device used to provide an air suction path for the reduction of gasses, body fluids, and smoke associated with the use of most electro-cauterization systems. The Cauterization Smoke Evacuator is meant to be an accessory add-on device to currently designed and distributed electro-cauterization systems, and most standard operating room suction systems.

Device Story

Cauterization Smoke Evacuator functions as accessory add-on to electro-cauterization and standard operating room suction systems; provides air suction path for removal of surgical smoke, body fluids, and gases generated during electro-cautery procedures. Device used in operating room environments by surgical staff. Output is suction flow; benefits patient and staff by reducing exposure to hazardous surgical byproducts.

Technological Characteristics

Accessory suction device; connects to existing electro-cauterization and OR suction systems. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for use as an accessory to electro-cauterization and standard operating room suction systems to reduce gases, body fluids, and smoke. Prescription use only.

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

Mr. Thomas W. Parkinson Leader-Ouality Assurance/Regulatory Affairs Applied Medical Technology, Inc. 15653 Neo Parkway Cleveland, Ohio 44128

JUL 21 1997

Re: K971758

Trade Name: Cauterization Smoke Evacuator Regulatory Class: II Product Code: GEI Dated: May 10, 1997 Received: May 13, 1997

Dear Mr. Parkinson:

We have reviewed your Section 510(k) 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Thomas W. Parkinson

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

sincerely, yours,

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

Enclosure

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9717158

## SECTION - I

## 1.5. - INDICATIONS FOR USE STATEMENT

The Cauterization Smoke Evacuator is an accessory device used to provide an air suction path for the reduction of gasses, body fluids, and smoke associated with the use of most electro-cauterization systems. The Cauterization Smoke Evacuator is meant to be an accessory add-on device to currently designed and distributed electro-cauterization systems, and most standard operating room suction systems.

Prescription Use (Per 21 CFR 801.109)

Dcostello

Applied Medical Technology, Inc. - 510(k) Submission Cauterization Smoke Evacuator Section 1 - Page 1.7.