MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND CURVED); GRASPER (AGGRESSIVE, ALLIS, ATAUMATIC; DISSECTOR

K062337 · Aaron Medical Industries · GEI · Oct 5, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K062337
• Device Name: MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND CURVED); GRASPER (AGGRESSIVE, ALLIS, ATAUMATIC; DISSECTOR
• Applicant: Aaron Medical Industries
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Laparoscopic Electrodes and Handle are used to grasp, hold, coagulate, and cut tissue during laparoscopic surgical procedures

Device Story

Laparoscopic electrodes and handles are surgical instruments designed for minimally invasive procedures. The device consists of an insulated, reusable handle and interchangeable tip inserts, introduced through a 5.5mm or larger cannula. The system connects to an electrosurgical generator to deliver radiofrequency energy to the tip for tissue cutting and coagulation. A rotary knob on the handle allows for tip positioning. Used by physicians or nurses in a surgical setting, the device facilitates tissue manipulation and electrosurgery. The modular design allows for easier cleaning, disinfection, and cost-effective replacement of worn tips. The device benefits patients by providing a versatile, reusable tool for laparoscopic interventions.

Clinical Evidence

Bench testing only. The device conforms to the safety standard ANSI/AAMI HF-18 Electrosurgical Devices.

Technological Characteristics

Reusable insulated handle and electrode tips; radiofrequency energy delivery; 5.5mm minimum cannula diameter; rotary knob for tip positioning; steam sterilization; conforms to ANSI/AAMI HF-18.

Indications for Use

Indicated for use in laparoscopic surgical procedures to grasp, hold, coagulate, and cut tissue.

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

• Aesculap USA: Modular Monopolar Electrodes (K970541)
• ACMI Circon: Surgical Instrument for Minimally Invasive Surgery (K914883)

Submission Summary (Full Text)

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510(k) SUMMARY (per CFR21 807.92(c))

062337

- 5 2006

## DEVICE DESCRIPTION:

Predicate Devices:

Aesculap USA: Modular Monopolar Electrodes K970541

ACMI Circon: Surgical Instrument for Minimally Invasive Surgery K914883

## INTENDED USE:

Laparoscopic Electrodes and Handle are used to grasp, hold, coagulate, and cut tissue during laparoscopic surgical procedures

## DEVICE COMPONENTS AND OPERATION:

Laparoscopic electrodes and handles are surgical instruments with interchangeable tip inserts designed to be introduced through a 5.5mm diameter (or larger) cannula, during laparoscopic surgical procedures. The devices can be used with electrosurgical generators. The interchange ability of the tip inserts allows for three main benefits:

- . A removable insert allows for easier cleaning and disinfection of the instrument components.
- Versatility of the instrument is greatly increased as one handle can accept many tip configurations,
- Semi-disposability allows for multiple uses of one tip insert with cost effective replacement when worn or damaged.

The device consists of two components: an insulated, reusable handle and a series of reusable tips. Radiofrequency energy is passed to the tip through the handle and shaft by using a powered lead from an electrosurgical generator to a connector port on the handle. The insulated handle is the device that will be used by the physician or nurse to attach the tip and control the action of the tip via the grip. A rotary knob allows the tip to be positioned (rotated) while in the cannula.

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These devices use technology substantially equivalent to the Aesculap USA Modular Monopolar Electrodes (K970541) and the ACMI Circon Surgical Instrument for Minimally Invasive Surgery (K914883). Each consists of handles and a series of electrodes that are used to cut and coagulate tissue through the utilization of high frequency radiofrequency energy.

Laparoscopic electrodes are reusable and are resterilized using steam sterilization.

Aaron Laparoscopic Electrodes and Handle conform to the requirements of safety standard ANSI/AAMI HF-18 Electrosurgical Devices.

There are no significant differences in technology, performance, or intended use between the Aaron Laparoscopic Electrodes and Handle and the given predicate devices. There are no new questions raised regarding safety or effectiveness.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 5 2006

Aaron Medical % Mr. Richard A. Kozloff Vice President, Quality Assurance Regulatory Affairs 7100 30th Avenue North St. Petersburg, Florida 33710-2902

Re: K062337

Trade/Device Name: Laparoscopic Electrodes and Handle Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 9, 2006 Received: August 10, 2006

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 complics 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 A. 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Karbay Buchner
for

Mark N. Melkerson 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): K062337

Laparoscopic Electrodes and Handle Device Name:

Indications for Use:

Laparoscopic Electrodes and Handle are used to grasp, hold, coagulate, and cut tissue during laparoscopic surgical procedures

Prescription Use _ > (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buchm

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

510(k) Number K062337