AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03

K020579 · Aaron Medical Industries · GEI · May 13, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020579
• Device Name: AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03
• Applicant: Aaron Medical Industries
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Aaron Arthroscopy Electrodes are sterile, single-use electrosurgical electrodes, used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and excise tissue or to coagulate blood vessels during arthroscopic surgical procedures.

Device Story

Aaron Arthroscopy Electrodes are sterile, single-use electrosurgical accessories. Device connects to an electrosurgical handpiece and generator to deliver RF energy. Used by surgeons during arthroscopic procedures to cut/excise tissue or coagulate blood vessels. Operation involves manual manipulation of the electrode tip within the arthroscopic field to apply energy to target tissue. Benefits include precise tissue management and hemostasis during minimally invasive joint surgery.

Clinical Evidence

Bench testing only.

Technological Characteristics

Sterile, single-use electrosurgical electrodes. Includes hook (45° and 90° angles) and blade (insulated and non-insulated) configurations. Energy source: RF energy via external electrosurgical generator. Connectivity: manual connection to electrosurgical handpiece.

Indications for Use

Indicated for use in arthroscopic surgical procedures to cut and excise tissue or coagulate blood vessels. Intended for use with electrosurgical handpieces and generators.

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.

Predicate Devices

• Unimed Arthroscopy Electrode (K970066)

Submission Summary (Full Text)

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# MAY 13 2002

### AARON MEDICAL INDUSTRIES, A BOVIE COMPANY AARON ARTHROSCOPY ELECTRODE

510 (K) NOTIFICATION PAGE 24 OF 24

## 510(k) SAFETY AND EFFECTIVENESS SUMMARY KO20579

Trade Name: Common Name: Classification Name:

AARON ARTHROSCOPY ELECTRODE Electrosurgical Electrode Electrosurgical Cutting and Coagulation Devices and Accessories (per 21CFR 878.4400)

Aaron Arthroscopy Electrodes sterile, single-use electrodes that are used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and excise tissue or to coagulate blood vessels during arthroscopic surgical procedures.

Aaron Arthroscopy Electrodes are substantially equivalent to the Unimed Arthroscopy Electrode (K970066) in operation, intended use, energy source, and method of preparation.

Testing performed on Aaron Arthroscopy Electrodes indicate that the devices are substantially equivalent in method of operation, safety, and performance.

In conclusion, Aaron Arthroscopy Electrodes are substantially equivalent to predicate devices in methods of operation, intended use, and results derived from operation.

| Submitted By: | Richard Kozloff<br>Vice-President; Quality Assurance<br>Aaron Medical a Bovie Company<br>St. Petersburg, FL 33710 |
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Richard Kozloff Contact Person: Date: February 19 2002

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 2002

Mr. Richard Kozloff Vice President, Quality Assurance Aaron Medical Industries 7100 30th Avenue North St. Petersburg, FL 33710-2902

Re: K020579

Trade/Device Name: Aaron Arthroscopy Electrodes Regulation Number: 888.1100 and 878.4400 Regulation Name: Arthroscope; Electrosurgical cutting and coagulation device and accessories

Regulatory Class: II Product Code: HRX, GEI Dated: February 19, 2002 Received: February 21, 2002

Dear Mr. Kozloff:

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 (OS) 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. Richard Kozloff

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 vour 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,

Muriam 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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### INDICATIONS FOR USE

510(k) Number (if known): KO20579

Device Name: Aaron Arthroscopy Electrodes

(Arthroscopy Hook Electrode; 90° Angle, Arthroscopy Hook Electrode; 45° Angle, Arthroscopy Blade Electrode; Insulated, Arthroscopy Blade Electrode; Non-Insulated)

Indications for Use:

Aaron Arthroscopy Electrodes are sterile, single-use electrosurgical electrodes, used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and excise tissue or to coagulate blood vessels during arthroscopic surgical procedures.

uriam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number_K020579

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)