RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS

K974066 · Microline Pentax, Inc. · GEI · Jan 22, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K974066
• Device Name: RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS
• Applicant: Microline Pentax, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The "Re-New Forceps" Laparoscopic Surgical Tips are intended to cut, grasp, and dissect various abdominal issue for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula. CAUTION: Federal Law (USA) restricts this device to use or sales by or on order of a physician.

Device Story

Re-New Forceps are reusable laparoscopic surgical tips designed for attachment to a handle/shaft component via a double-thread mechanism. Configurations include grasper, fenestrated forceps, "Dolphin Nose" dissector, "Babcock", and "Maryland" dissector. Used by surgeons in endoscopic/laparoscopic procedures to cut, grasp, and dissect abdominal tissue. Devices are introduced into the body through a cannula. Compatible with various electrosurgical generators (Bovie, Valley Lab, CIRCOM ACMI, Elmed, Leisegang).

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reusable stainless steel laparoscopic surgical tips. Features double-thread attachment mechanism for handle/shaft integration. Compatible with multiple electrosurgical generator brands. Supplied non-sterile.

Indications for Use

Indicated for use in endoscopic and laparoscopic surgical procedures for cutting, grasping, and dissecting abdominal tissue. Intended for use by physicians.

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

• Re-New (K962119)

Submission Summary (Full Text)

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974066

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

JAN 2 2 1998

A. Submittor Information

> Microline, Inc. 181 Elliott Street Suite 915 Beverly, MA 01915

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

Date Prepared: October 24, 1997

- B. Device Identification
Common/Usual Name: Manual Detachable Surgical Instruments Proprietary Name: "Re-New Forceps" Laparoscopic Surgical Tips

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

The "Re-New Forceps" Laparoscopic Surgical Tips are substantially equivalent to their predicate, "Re-New" (K962119), previously cleared and currently marketed.

### D. Device Description

The "Re-New Forceps" Laparoscopic Surgical Tips are an extension of the "Re-New" Laparoscopic Instruments product line used to cut, grasp, and dissect various abdominal tissue during Endoscopic (inclusive of laparoscopic) surgical procedures.

The "Re-New Forceps" Laparoscopic Surgical Tips consist of a series reusable tip configurations. The tip assembly, designed with a double thread, permits simple and reliable attachment and detachment of the desired tip to the shaft of the handle/shaft component. Tip configurations include:

- · Grasper,
- · Fenestreded Forceps.
- · "Dolphin Nose" Dissector,
- · "Babcock", and
- · "Maryland" Dissector

# E. Substantial Equivalence

The technical characteristics of the "Re-New Forceps" Laparoscopic Surgical Tips are almost identical to those of the Microline "Re-New" (K962119). Differences that exist between these devices relating to technical specifications, materials, and physical appearance do not affect the relative safety or effectiveness of the "Re-New Forceps" relative to its predicate.

The "Re-New Forceps" Laparoscopic Surgical Tips are intended for use to cut, grasp, and dissect various abdominal tissue in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula .

050007

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 222 1998

Mr. Hughes de Laforcade President Microline, Incorporated 181 Elliott Street, Suite 915 Beverly, Massachusetts 01915

Re: K974066

> Trade Name: "RE-NEW FORCEPS" Laparoscopic Surgical Tips Regulatory Class: II Product Code: GEI Dated: October 24, 1997 Received: October 27, 1997

Dear Mr. de Laforcade:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 requirements , 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 Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions 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 - Mr. de Laforcade

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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.

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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The generator manufacturers which are compatible with the "Re-New Forceps" Laparoscopic Surgical Tips are as follows:

- 1. Bovie
- 2. Valley Lab, Inc.
- CIRCOM ACMI 3.
- 4. Elmed, inc.
- 5. Leisegang Medical

## 6.5 Intended Use

The "Re-New Forceps" Laparoscopic Surgical Tips are intended to cut, grasp, and dissect various abdominal issue for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula.

> CAUTION: Federal Law (USA) restricts this device to use or sales by or on order of a physician.

#### 7. Packaging

The "Re-New Forceps" stainless steel reusable laparoscopic surgical tips are packaged nonsterile in a plastic blister with 5 blisters in a carton. A copy of the labeling for this carton is located in Appendix A.