AARON ESU FOOT-CONTROL ADAPTER #A1205A

K984236 · Aaron Medical Industries · GEI · Feb 10, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K984236
• Device Name: AARON ESU FOOT-CONTROL ADAPTER #A1205A
• Applicant: Aaron Medical Industries
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aaron ESU Foot-Controll Adapter will allow a single pin foot controlled pencil or suction / coagulator to be used with the Aaron 1200 Electrosurgical Generator for cutting or coagulating procedures.

Device Story

The Aaron ESU Foot Control Adapter is a non-sterile, reusable accessory plug; it enables the connection of single-pin foot-controlled electrosurgical pencils or suction/coagulation tubes to the Aaron 1200 Electrosurgical Generator. The device functions as a physical interface adapter; it does not alter the electrical design, operation, or performance of the generator. It is used in clinical settings by physicians or surgical staff to provide flexibility in choosing between standard reusable pencils and disposable foot-controlled accessories. The adapter facilitates the activation of the generator via foot control, potentially improving ergonomics or procedural workflow during electrosurgical interventions.

Clinical Evidence

Bench testing only. Hazard analysis evaluations were performed to ensure the adapter does not introduce new risks or alter the operation of the Aaron 1200 generator or connected foot-controlled devices.

Technological Characteristics

Non-sterile, reusable adapter plug; insert-molded body; single-pin connector interface. Designed for use with Aaron 1200 electrosurgical generator. No active electronic components; purely mechanical interface.

Indications for Use

Indicated for use with the Aaron 1200 Electrosurgical Generator to enable the use of single-pin foot-controlled pencils or suction/coagulation devices during electrosurgical cutting and coagulation 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.

Predicate Devices

• Aaron 1200 electrosurgical generator (K980366)

Submission Summary (Full Text)

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2/10/99

K 984236

## AARON MEDICAL INDUSTRIES, INC. Aaron ESU Foot Control Adapter #A1205A

510(K) NOTIFICATION

## 510(k) SAFETY AND EFFECTIVENESS SUMMARY

TRADE NAME: Aaron ESU Foot Control Adapter #A1205A COMMON NAME: Adapter Plug CLASSIFICATION NAME: Electrosurgical cutting and Coagulation Devices and Accessories (21 CFR 878:4400)

The Aaron ESU Foot Control Adapter is a non-sterile, reusable device. It utilizes an insert-molded body that allows a foot-controlled pencil or suction/coagulation tube. The foot control adapter plug allows activation of the Aaron 1200 electrosurgical generator cleared under K980366 dated January 29, 1998. It is an accessory to the Aaron 1200 electrosurgical generator.

The Aaron ESU Foot Control Adapter is intended to be used with the Aaron 1200 electrosurgical generator. The adapter will allow the use of a disposable foot-controlled pencil or suction irrigator with a single pin connector with the Aaron 1200 electrosurgical generator. It is non-sterile and is reusable.

The Aaron ESU Foot Control Adapter while allowing the use of single pin foot controlled pencils, does not change the design, operation, intended use, materials, components and performance claims of the Aaron 1200 electrosurgical generator cleared under K980366 dated January 29, 1998.

Testing which has been performed on the Aaron ESU Foot Control Adapter indicates that the use of the Adapter does not change the operation of either the Aaron 1200 or the foot controlled devices. Consequently, the devices remain substantially equivalent in their performance and method of operation.

Hazard analysis evaluations were performed on the Aaron ESU Foot Control Adapter. Test results indicated that there are no new hazards presented with the use of the Aaron ESU Foot Control Adapter.

In conclusion, the Aaron ESU Foot Control Adapter is an accessory to the Aaron 1200 and will allow the doctor to choose between the reusable pencil included with the Aaron 1200 or a single use disposable foot controlled pencil or suction coagulator.

Submitted By: J. Robert Saron President & CEO Official Correspondent

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 1999

Mr. J. Robert Saron President and Chief Executive Officer, Official Correspondent Aaron Medical Industries 7100 30ª Avenue North St. Petersburg, Florida 33710

K984236 Re: Trade Name: Aaron ESU Foot-Control Adapter #A1205A Regulatory Class: II Product Code: GEI Dated: November 23, 1998 Received: November 25, 1998

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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) 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. 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,

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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K984236 510(k) Number (if known):

Aaron ESU Foot-Control Adapter Device Name:

Indications For Use:

The Aaron ESU Foot-Controll Adapter will allow a single pin foot controlled pencil or suction / coagulator to be used with the Aaron 1200 Electrosurgical Generator for cutting or coagulating procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices K984236
510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

510(k) Number

Over-The-Counter Use

(Optional Format 1-2-96)