AARON REUSABLE ELECTROSURGICAL ELECTRODE

K014201 · Aaron Medical Industries · GEI · Feb 25, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K014201
• Device Name: AARON REUSABLE ELECTROSURGICAL ELECTRODE
• Applicant: Aaron Medical Industries
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Aaron Reusable Electrosurgical Electrodes are non-sterile, reusable 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 surgery.

Device Story

Device consists of reusable electrosurgical electrodes (loop, blade, needle, ball configurations) used with electrosurgical handpieces and generators. Electrodes deliver RF energy to cut/excise tissue or coagulate blood vessels during surgery. Operated by surgeons in clinical settings. Unlike single-use predicates, these are non-sterile and designed for reprocessing; loop configurations validated for 5 reuses; blade, needle, and ball configurations validated for 25 reuses. Cleaning and steam sterilization performed per ANSI/AAMI ST46:1993 and AAMI TIR 12:1994 standards.

Clinical Evidence

Bench testing only. Validation of cleaning and steam sterilization processes performed in accordance with ANSI/AAMI ST46:1993 and AAMI TIR 12:1994.

Technological Characteristics

Reusable electrosurgical electrodes (loop, blade, needle, ball). Energy source: RF energy from external generator. Reprocessing: Steam sterilization under pressure. Validated for 5 (loop) or 25 (blade/needle/ball) cycles. Compliant with ANSI/AAMI ST46:1993 and AAMI TIR 12:1994.

Indications for Use

Indicated for use in surgical procedures requiring tissue cutting, excision, or coagulation of blood vessels via RF energy delivered through an electrosurgical handpiece and generator.

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

• Aaron Reusable Electrosurgical Electrodes (K931338)
• Aaron Reusable Electrosurgical Electrodes (K942986)

Submission Summary (Full Text)

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## AARON MEDICAL INDUSTRIES, A BOVIE COMPANY AARON REUSABLE ELECTROSURGICAL ELECTRODES

KO14201

# FEB 2 5 2002

## 510(k) SAFETY AND EFFECTIVENESS SUMMARY

Trade Name: Common Name: Classification Name: Aaron Reusable Electrosurgical Electrode Electrosurgical Electrode Electrosurgical Cutting and Coagulation Devices and Accessories (per 21CFR 878.4400)

Aaron Reusable Electrosurgical Electrodes are non-sterile, reusable electrosurgical electrodes 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 surgery.

Electrosurgical is substantially equivalent to Aaron Reusable The Aaron Electrosurgical Electrodes (K931338 and K942986) in operation, intended use, energy source, and method of preparation. Performance claims for the reusable electrodes differ from the predicate device in that they are not sold sterile and that they may be cleaned and resterilized by steam under pressure. Aaron Reusable Electrosurgical Electrodes in the loop configuration may be cleaned and sterilized up to 5 times. Aaron Reusable Electrosurgical Electrodes in the blade, needle, and ball configurations may be cleaned and sterilized up to 25 times. Cleaning and resterilization processes are validated in accordance with Good Hospital Practice: Steam Sterilization and Sterility Assurance (ANSI/AAMI ST46: 1993) and Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Healthcare Facilities: A Guide for Device Manufacturers (AAMI TIR 12: 1994). The validated cleaning and sterilization processes are provided in device labeling and instructions.

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

In conclusion, Aaron Reusable Electrosurgical Electrodes substantially equivalent to predicate devices (Aaron Electrosurgical Electrodes) in methods of operation, intended use, and results derived from operation.

| Submitted By: | Richard Kozloff<br>Vice-President ; Quality Assurance<br>Aaron Medical Industries<br>7100 30th Avenue North<br>St. Petersburg, FL 33710 |
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Contact Person: Richard Kozloff Date: December 17, 2001

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 2002

Mr. Richard Kozloff Vice President, Quality Assurance and Regulatory Affairs Aaron Industries 7100 30th Avenue North St. Petersburg, Florida 33710

Re: K014201

Trade/Device Name: Aaron Reusable Electrosurgical Electrodes Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 20, 2001 Received: December 21, 2001

Dear Mr. Kozloff:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your been wind the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfor 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, de neces that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, aterest, mains of the Act include requirements for annual registration, listing of general controls proficituring 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. 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 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). 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,

Mark A Miller

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) NOTIFICATION

## AARON MEDICAL INDUSTRIES AARON REUSABLE ELECTROSURGICAL ELECTRODE

#### INDICATIONS FOR USE

510(k) Number (if known): KO14201

Device Name: Aaron Reusable Electrosurgical Electrodes

Indications for Use:

A aron Reusable Electrosurgical Electrodes are non-sterile, reusable 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 surgery.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative and Neurological Devices Koly201

(Optional Format 3-10-98)

510(k) Number ***_***