RESISTICK SOLID LAPAROSCOPIC ELECTRODES

K971621 · Aaron Medical Industries · KNF · Jun 20, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K971621
• Device Name: RESISTICK SOLID LAPAROSCOPIC ELECTRODES
• Applicant: Aaron Medical Industries
• Product Code: KNF · Obstetrics/Gynecology
• Decision Date: Jun 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject device of this premarket notification submission is indicated for use to cut and or coagulate during laparoscopic surgical procedures.

Device Story

Resistick Solid Laparoscopic Electrodes are electrosurgical accessories used during laparoscopic surgery. Device functions as an electrode to deliver electrical energy to tissue for cutting and coagulation. Operated by surgeons in an operating room environment. Device connects to standard electrosurgical generators. Provides clinical benefit by enabling precise tissue management during minimally invasive procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Solid laparoscopic electrode for electrosurgery. Designed for use with electrosurgical generators. Form factor is a laparoscopic instrument tip.

Indications for Use

Indicated for use in laparoscopic surgical procedures for cutting and/or coagulation of tissue.

Regulatory Classification

Identification

A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 20 1997

Mr. J. Robert Saron President Aaron Medical Industries, Inc. 7100 30th Avenue North St. Petersburg, Florida 33710-2902 Re: K971621 Resistick Solid Laparoscopic Electrodes Dated: April 30, 1997 Received: May 1, 1997 Regulatory class: II 21 CFR §884.4160/Product code: 85 KNF

Dear Mr. Saron:

We have reviewed your Section 510(k) notification of intent to market the device 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 53 1 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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,

hillian Yi

Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat/ and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/1/Picture/0 description: The image shows the logo for AARON MEDICAL INDUSTRIES, INC. The word "AARON" is in large, bold, outlined letters. Below the word "AARON" is the text "MEDICAL INDUSTRIES, INC."

Resistick Solid Laparoscopic Electricies

INDICATION FOR USE

K971621

The subject device of this premarket notification submission is indicated for use to cut and or coagulate during laparoscopic surgical procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Satting

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Formal 1-2-96)

7100 - 30th Avenue North, St. Petersburg, FL 33710-2902 (S13) 384-2323 Fax: [phone]