3 MM SELEC-TIP LAPAROSCOPIC SCISSORS

K980758 · Microline Pentax, Inc. · GEI · Mar 27, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980758
• Device Name: 3 MM SELEC-TIP LAPAROSCOPIC SCISSORS
• Applicant: Microline Pentax, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 27, 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.

Device Story

3 MM Selec-Tip Laparoscopic Scissors are non-sterile, reusable small-diameter surgical instruments. Used in endoscopic and laparoscopic procedures to cut and dissect abdominal tissue. Compatible with monopolar electrosurgical generators. Operated by surgeons in clinical/OR settings. Device provides mechanical cutting action; electrosurgical capability allows for tissue cauterization. Benefits include small diameter for minimally invasive access.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reusable small-diameter laparoscopic scissors; compatible with monopolar electrosurgical generators. Materials and physical dimensions are consistent with predicate devices.

Indications for Use

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

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

• Selecta-Tip (K970826)
• Richard Wolf Medical Instruments (K973648)

Submission Summary (Full Text)

{0}------------------------------------------------

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

MAR 2 7 1998

- A. Submitter Information
Microline, Inc. 100 Cumminas Center Suite 350-G Beverly, MA 01915

[phone] Telephone:

Contact Person: Mr. Huges de Laforcade President

Date Prepared: February 25, 1998

### B. Device Identification

Common/Usual Name: Proprietary Name:

Manual Detachable Surgical Instruments "3 MM Selec-Tip" Laparoscopic Instruments

### C. Identification of Predicate Device(s)

The "3 MM Selec-Tip" Laparoscopic Instruments are substantially equivalent to their predicate, "Selecta-Tip (K970826) and Richard Wolf Medical Instruments (K973648), previously cleared and currently marketed.

### D. Device Description

The "3 MM Selec-Tip" Laparoscopic Surgical Instruments are a line of non-sterile, reusable small diameter instruments used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic, surgical procedures. The device can be used with monopolar electrosurgical generators.

## E. Substantial Equivalence

The Microline "3 MM Selec-Tip" Laparoscopic Scissors Instruments are substantially equivalent to the Microline "Selecta-Tip (K970826) and Richard Wolf Medical Instruments (K973648). Differences that exist between these devices relating to technical specifications, materials, and physical appearance do not affect the relative safety or effectiveness of the "3 MM Selec-Tip" relative to its predicates.

"3 MM Selec-Tip" Laparoscopic scissors tips are intended for use to cut and dissect various abdominal tissue in endoscopic, including laparoscopic surgical procedures where small diameter instruments are introduced into the body through a cannula.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 7 1998

Ms. Jacqueline E. Masse Sr. Consultant Microline, Incorporated c/o Interactive Consulting Incorporated 70 Walnut Street Wellesley, Massachusetts 02181

K980758 Re: 3MM Selec-Tip Laparoscopic Scissors Trade Name: Regulatory Class: II Product Code: GEI February 25, 1998 Dated: February 27, 1998 Received:

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, Druq, 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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. 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.

{2}------------------------------------------------

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

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

510(k) Number (if known):

Device Name: "3 MM Selec-Tip" Laparoscopic Scissors

Indications For Use:

**

- Cutting and Dissecting Various Abdominal Tissue during . Endoscopic (inclusive of laparoscopic) Surgical Procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

lleza

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K980758

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)