DISPOSABLE RE-NEW FORCEPS

K981389 · Microline Pentax, Inc. · GEI · May 29, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981389
• Device Name: DISPOSABLE RE-NEW FORCEPS
• Applicant: Microline Pentax, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cutting, Grasping, and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparoscopic) Surgical Procedures.

Device Story

Disposable Re-New Forceps Laparoscopic Surgical Tips are manual surgical instruments designed for endoscopic and laparoscopic procedures. The device consists of various disposable tip configurations, including graspers, fenestrated forceps, 'Dolphin Nose' dissectors, 'Babcock' forceps, and 'Maryland' dissectors. These tips are used by surgeons to cut, grasp, and dissect abdominal tissue. The instruments are introduced into the body through a cannula. The device functions as a mechanical extension of the surgeon's hand, facilitating tissue manipulation during minimally invasive surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual surgical instruments; disposable tip configurations (Grasper, Fenestrated Forceps, 'Dolphin Nose' Dissector, 'Babcock', 'Maryland' Dissector); mechanical actuation; intended for use through a cannula.

Indications for Use

Indicated for cutting, grasping, 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

• Re-New Forceps (K974066)

Submission Summary (Full Text)

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

### A. Submittor Information

Microline, Inc. 1100 Cummings Center Suite 350-G Beverly, MA 01915

| Telephone: | [phone] |
|-----------------|-------------------------|
| Contact Person: | Mr. Hughes de Laforcade |
| | President |

April 13, 1997 Date Prepared:

# B. Device Identification

| Common/Usual Name: | Manual Detachable Surgical Instruments |
|--------------------|------------------------------------------------------|
| Proprietary Name: | Disposable Re-New Forceps Laparoscopic Surgical Tips |

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

The Disposable Re-New Forceps Laparoscopic Surgical Tips are substantially equivalent to their predicate. Re-New Forceps (K974066), previously cleared and currently marketed.

#### D. Device Description

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

The Disposable Re-New Forceps Laparoscopic Surgical Tips consist of a series disposable tip configurations. Tip configurations include: Grasper, Fenestreded Forceps, "Dolphin Nose" Dissector, "Babcock", and "Maryland" Dissector.

### E. Substantial Equivalence

The technical characteristics of the Disposable Re-New Forceps Laparoscopic Surgical Tips are identical to those of the Microline Re-New Forceps (K974066). Differences that exist between these devices relating to technical specifications, materials, and physical appearance do not affect the relative safety or effectiveness of the Disposable Re-New Forceps relative to its predicate.

The Disposable 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 .

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 1998

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

K981389 Re : Trade Name: Disposable Re-New Forceps Regulatory Class: II Product Code: GEI April 13, 1998 Dated: April 16, 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, 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 requlations 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 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 regulation may result in regulatory 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 requlations.

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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

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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Disposable Re-New Forceps Laparoscopic Surgical Tips

Indications For Use:

Cutting, Grasping, and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparoscopic) Surgical Procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

coee

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K981399

Prescription Use -(Per 21 CFR 801.109)

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OR

Over-The-Counter Use

(Optional Format 1-2-96)