ELECTROSURGICAL TIP CLEANER, TIP CLEANING PAD, LECTROBRASIVE TIP CLEANER, ELECTROSURGICAL TIP CLEANER, ELECTRODE TIP CLE

K971805 · Aaron Medical Industries · GEI · Jun 13, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971805
• Device Name: ELECTROSURGICAL TIP CLEANER, TIP CLEANING PAD, LECTROBRASIVE TIP CLEANER, ELECTROSURGICAL TIP CLEANER, ELECTRODE TIP CLE
• Applicant: Aaron Medical Industries
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

The subject device of this premarket notification submission is indicated for use as an electrosurgical accessory for removal by scraping of eschar build up on the electrosurgical electrode. This product is designed for use with all stainless steel electrodes and is not indicated for use with coated "reduced stick" electrodes.

Device Story

Electrosurgical tip cleaner functions as manual accessory for electrosurgical units. Device used by clinicians in surgical settings to remove eschar buildup from stainless steel electrodes via mechanical scraping. Simple physical design facilitates electrode maintenance during procedures; ensures continued electrical conductivity and performance of electrosurgical instruments. Not intended for use with coated electrodes.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manual electrosurgical accessory; designed for use with stainless steel electrodes. Mechanical scraping mechanism. No electronic components, software, or energy source.

Indications for Use

Indicated for use as an electrosurgical accessory to remove eschar from stainless steel electrosurgical electrodes. Contraindicated for use with coated "reduced stick" electrodes.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 3 097

Mr. J. Robert Saron President AARON Medical Industries, Inc. ---------7100 30th Avenue North St. Petersburg, Florida 33710-2902

参 Re:

K971805 Trade Name: AARON Electrosurgical Tip Cleaner Regulatory Class: II Product Code: GEI Dated: May 13, 1997 Received: May 15, 1997

Dear Mr. Saron:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.

{1}------------------------------------------------

Page 2 - Mr. J. Robert Saron

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,

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

{2}------------------------------------------------

Page 1 of 1

K971805 510(k) Number (if known):_

Device Name: _Electrosurgical_Tip_Cleaner

Indications For Use:

The subject device of this premarket notification submission is indicated for use as an electrosurgical accessory for removal by scraping of eschar build up on the electrosurgical electrode. This product is designed for use with all stainless steel electrodes and is not indicated for use with coated "reduced stick" electrodes.

ત્ત્વ

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K971805 |

| Prescription Use | |
|----------------------|--|
| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter Use | |
|--------------------------|--|
| (Optional Format 1-2-96) | |