ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS

K982984 · Microline Pentax, Inc. · GEI · Oct 21, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K982984
• Device Name: ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS
• Applicant: Microline Pentax, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cutting and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparoscopic) Surgical Procedures where instruments are introduced into the body through a cannula.

Device Story

ACCUSHEAR Laparoscopic Surgical Instruments are 5 mm diameter, reusable, nonsterile surgical scissors. Used in endoscopic and laparoscopic procedures to cut and dissect abdominal tissue. Device connects to independent monopolar electrosurgical generators to deliver energy. Operated by surgeons in clinical settings; introduced into the body via cannula. Modification from predicate involves shaft and handpiece connection. Provides mechanical cutting and electrosurgical dissection capabilities to facilitate tissue management during minimally invasive surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

5 mm diameter reusable surgical instrument. Monopolar electrosurgical energy delivery. Mechanical cutting/dissecting action. Nonsterile. Manual operation.

Indications for Use

Indicated for cutting and dissecting abdominal tissue during endoscopic and laparoscopic surgical procedures requiring cannula access.

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

• Microline Re-New (K962119)
• Microline Selec-Tip (K980758)

Submission Summary (Full Text)

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OCT 21 1998

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

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

| Telephone: | [phone] |
|-----------------|-----------------------------------|
| Contact Person: | Mr. Huges de Laforce<br>President |

Date Prepared: August 24, 1998

## B. Device Identification

| Common/Usual Name: | Manual Detachable Surgical Instruments |
|--------------------|--------------------------------------------|
| Proprietary Name: | ACCUSHEAR Laparoscopic Surgical Instrument |

## C. Identification of Predicate Device(s)

The Microline ACCUSHEAR Laparoscopic Surgical Scissors Instruments are substantially equivalent to their predicates offered by Microline Inc. "Re-New" (K962119) and "Selec-Tip" (K980758) previously cleared and currently marketed.

#### D. Device Description

The Microline ACCUSHEAR Laparoscopic Surgical Instruments are a line of nonsterile, reusable 5 mm diameter instruments used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula. The device is used with monopolar electrosurgical generators.

## E. Substantial Equivalence

The Microline ACCUSHEAR Laparoscopic Surgical Scissors Instruments are a modified version of the predicate Microline "Re-New" (K962119) with a minor device modification related to the shaft and handpiece connection and does not affect the relative safety or effectiveness of the Microline ACCUSHEAR Laparoscopic Surgical Scissors Instruments relative to their predicate.

The Microline ACCUSHEAR Laparoscopic Surgical Instruments are intended to delivery energy from an independent monopolar electrosurgical generator to cut and dissect various abdominal tissue for use during laparoscopic, inclusive of endoscopic surgical procedures where instruments are introduced into the body through a cannula.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 1998

Microline, Inc. Ms. Jacqueline E. Masse Senior Consultant c/o Interactive Consulting, Inc. 70 Walnut Street Wellesley, Massachusetts 02481

K982984 Re: Trade Name: ACCUSHEAR Laparoscopic Surgical Instruments Requlatory Class: II Product Code: GEI Dated: Auqust 24, 1998 Received: August 26, 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 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 Requlations, Title 21, Parts 800 to 895. प्र substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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

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Page 2 - Ms. Jacqueline E. Masse

Product Radiation Control provisions, or other Federal laws or requlations.

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 labelinq 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,

CeNia M. Witten, Ph.D., M.D.
Director
Division of General and

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): ___ K982984

Device Name: ACCUSHEAR Laparoscopic Surgical Scissors Instruments

Indications For Use:

Cutting and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparoscopic) 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)

Prescription Use V (Per 21 CFR 801 109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. L982904

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