ELECTROSURGICAL CAUTERY PROBES

K981188 · Microline Pentax, Inc. · GEI · May 20, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981188
• Device Name: ELECTROSURGICAL CAUTERY PROBES
• Applicant: Microline Pentax, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Microline reusable 3 mm and 5 mm diameter Electrosurgical Cautery Probes are intended to deliver energy from an independent monopolar electrosurgical generator to cauterize tissues during laparoscopic (inclusive of endoscopic) surgical procedures where instruments are introduced into the body through a cannula.

Device Story

Microline Electrosurgical Cautery Probes are reusable 3 mm and 5 mm diameter instruments; designed for laparoscopic and endoscopic surgery. Device functions as a conduit for monopolar electrosurgical energy; energy is supplied by an independent, external electrosurgical generator. Surgeon operates the probe through a cannula to perform tissue cauterization. Device facilitates hemostasis and tissue management during minimally invasive procedures. Benefits include reusable design for surgical utility.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reusable 3 mm and 5 mm diameter probes; monopolar electrosurgical energy delivery; compatible with independent monopolar electrosurgical generators; non-sterile.

Indications for Use

Indicated for use in laparoscopic and endoscopic surgical procedures requiring tissue cauterization via monopolar electrosurgical energy delivery. Intended for prescription use.

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

• Olsen Electrosurgical reusable laparoscopic electrodes (K913108)

Submission Summary (Full Text)

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MAY 20 1998

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## 10. SMDA Summary of Safety and Effectiveness - "510(k) Summary"

- A. Submittor Information
Microline. Inc. 100 cummings Center Suite 350-G Beverly, MA 01915

[phone] Telephone: Contact Person: Mr. Huges de Laforcade President

March 31, 1998 Date Prepared:

- B. Device Identification
Common/Usual Name: Proprietary Name:

Electrosurgical Cautery Probes Not Yet Determined

- C. Identification of Predicate Device(s)
The Microline Electrosurgical Cautery Probes are substantially equivalent to those offered by Olsen Electrosurgical Inc. (K913108) previously cleared and currently marketed.

## D. Device Description

The Microline Electrosurgical Cautery Probes are a line of non-sterile, reusable 3 mm and 5 mm diameter instruments used to deliver energy from an independent monopolar electrosurgical generator to cauterize tissue during laparoscopic (inclusive of endoscopic) surgical procedures where instruments are introduced into the body through a cannula.

## ند Substantial Equivalence

The Microline Electrosurgical Cautery Probes are substantially equivalent to the Olsen Electrosurgical reusable lapasocopic electrodes (K913108). Differences that exist between these devices relating to technical specifications, materials, and physical appearance do not affect the relative safety or effectiveness of the Microline Electrosurgical Cautery Probes relative to its predicate.

The Microline Electrosurgical Cautery Probes are intended to delivery energy from an independent monopolar electrosurgical generator to cauterize tissue during laparoscopic (inclusive of endoscopic) surgical procedures where instruments are introduced into the body through a cannula.

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11. Premarket Notification: Truthful and Accurate Statement

Premarket Notification

Truthful and Accurate Statement (As required by 21 CFR 807.87(j))

I certify that, in my capacity as President of Microline, Inc., I believe to the best of my knowledge, that all data and information submitted in the Premarket Notification are truthful and accurate, and that no material fact has been omitted.

H del forado

Signature

Hughes de Laforcade

March 31, 1998

Date

'981188

Premarket Notification Number

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 20 1998

Microline, Incorporated ·C/O Ms. Jacqueline E. Masse Senior Consultant Interactive Consulting 70 Walnut Street Wellesley, Massachusetts 02181

Re: K981188 Microline Electrosurgical Cautery Probes Trade Name: Regulatory Class: II Product Code: GEI Dated: March 31, 1998 Received: April 2, 1998

Dear Ms. Masse:

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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ 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 (QS) inspections, the Frod and Drug Administration (FDA) will verify such assimptions. Failure to comply with the GMP requlation may result in requlatory 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 - Ms. Masse

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,

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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(Optional Format 1-2-96)

510(k) Number (if known):

Device Name: Electrosurgical Cautery Probes

Indications For Use:

The Microline reusable 3 mm and 5 mm diameter Electrosurgical Cautery Probes are intended to deliver energy from an independent monopolar electrosurgical generator to cauterize tissues during laparoscopic (inclusive of endoscopic) surgical procedures where instruments are introduced into the body through a cannula.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices K981108
510(k) Number

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use