AARON ELECTROSURGICAL HANDCONTROL PENCIL, MODEL ESP5

K983761 · Aaron Medical Industries · GEI · Dec 30, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K983761
• Device Name: AARON ELECTROSURGICAL HANDCONTROL PENCIL, MODEL ESP5
• Applicant: Aaron Medical Industries
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aaron Electrosurgical Handcontrol Pencil is intended to be used in general electrosurgical applications for cutting and coagulating during surgical procedures. It is provided sterile and is intended for limited reuse.

Device Story

Sterile, limited-reuse electrosurgical handcontrol pencil; accessory to electrosurgical generator. Device features insert-molded body containing printed circuit board; senses CUT or COAG button activation to trigger generator output. Used by surgeons during surgical procedures for tissue cutting and coagulation. Provides manual control of electrosurgical energy delivery to the surgical site.

Clinical Evidence

Bench testing only; no clinical data provided. Hazard analysis evaluations performed.

Technological Characteristics

Sterile, limited-reuse electrosurgical handpiece. Features insert-molded body with internal printed circuit board for button activation sensing. Monopolar configuration. Class II device.

Indications for Use

Indicated for use in general electrosurgical applications for cutting and coagulating during surgical procedures. Intended for use by clinicians in a surgical setting.

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

• Medtrex Encore Electrosurgical Handcontrol Pencil (K970039)
• Valleylab Model E2502B (K914400)
• Aaron Medical Industries, Inc Model A801 monopolar handpiece (K955681)

Submission Summary (Full Text)

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AARON MEDICAL INDUSTRIES, INC. Aaron Electrosurgical Handcontrol Pencil 510(K) NOTIFICATION

## K983761

## 510(k) SAFETY AND EFFECTIVENESS SUMMARY

TRADE NAME: Aaron Electrosurgical Handcontrol Pencil COMMON NAME: Electrosurgical Handcontrol Pencil CLASSIFICATION NAME: Electrosurgical cutting and Coagulation Devices and Accessories (21 CFR 878:4400)

The Aaron Electrosurgical Handcontrol Pencil is a sterile, limited reuse electrosurgical handcontrol pencil. It utilizes an insert-molded body that encapsulates a printed circuit board used to sense either CUT or COAG button activation thus activating an electrosurgical generator. It is an accessory to an electrosurgical generator.

The Aaron Electrosurgical Handcontrol Pencil is intended to be used in general electrosurgical applications for cutting and coagulating during surgical procedures. It is provided sterile and is intended for limited reuse.

The Aaron Electrosurgical Handcontrol Pencil is IDENTICAL to the Medtrex Encore Electrosurgical Handcontrol Pencil, cleared under K970039 dated February 26, 1997. It is substantially equivalent to the Valleylab Model E2502B cleared under 510(k) K914400, and the Aaron Medical Industries, Inc Model A801 monopolar handpiece cleared under 510(k) K955681in design, operation, intended use, materials, components and performance claims.

Testing which has been performed on the Aaron Electrosurgical Handcontrol Pencil indicates that the devices are substantially equivalent in their performance and method of operation.

Hazard analysis evaluations where performed on the Aaron Electrosurgical Handcontrol Pencil. Test results indicated that there are no new hazards presented with the use of the Aaron Electrosurgical Handcontrol Pencil as compared with the predicate devices.

In conclusion, the Aaron Electrosurgical Handcontrol Pencil is substantially equivalent to the predicate devices, the Medtrex Encore Model 35001-001, the Aaron Medical Industries, Inc Model A801 monopolar handpiece and the Valleylab Model #2502B.

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 30 1998

Mr. J. Robert Saron President and Chief Executive Officer Aaron Medical Industries, Inc. 7100 30th Avenue North St. Petersburg, Florida 33710-2902

K983761 Re: Trade Name: Aaron Electrosurgical Handcontrol Pencil Regulatory Class: II Product Code: GEI Dated: October 23, 1998 Received: October 26, 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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,

Murle M. Millerson

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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510(k) Number (if known):

Aaron Electrosurgical Handcontrol Pencil Device Name:

## Indications For Use:

The Aaron Electrosurgical Handcontrol Pencil is intended to be used in general electrosurgical applications for cutting and coagulating during surgical procedures. It is provided sterile and is intended for limited reuse.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use **__**

Mark N melkein

(Optional Format 1-2-96)

for (Division Sign-Off)
CMW Division of General Restorative Devices

510(k) Number **__**