MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS

K993655 · Xomed, Inc. · GEI · Dec 21, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K993655
• Device Name: MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS
• Applicant: Xomed, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The electrosurgical instruments are intended to remove tissue and control bleeding.

Device Story

Micro-France electrosurgical instruments consist of unipolar and bipolar scissors, forceps, and probes. Designed for laparoscopic, endoscopic, and open field surgery. Accessories include unipolar and bipolar cables up to 3 meters in length. Operated by surgeons in clinical or OR settings. Devices function by delivering electrosurgical energy to target tissue to facilitate cutting or coagulation. Output is controlled by the surgeon to achieve desired tissue effect, aiding in surgical precision and hemorrhage management.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and intended use comparison to legally marketed predicate devices.

Technological Characteristics

Unipolar and bipolar electrosurgical instruments including scissors, forceps, and probes. Available for laparoscopic, endoscopic, and open surgery. Includes cables up to 3M. Energy source: external electrosurgical generator (not included).

Indications for Use

Indicated for use in surgical procedures requiring tissue removal and hemostasis (control of bleeding) via electrosurgical cutting and coagulation.

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

• Richard Wolf Medical Instruments (K980129)
• Concept (K792365)
• Instrument Maker (K890972)
• Linvatec (K944992)
• Megadyne Medical Products (K903302)
• New England Surgical Instrument (K895331)
• Kirwan Surgical Products (K913514)

Submission Summary (Full Text)

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DEC 21 1999

# 510(k) Summary

## 1.0 Date Prepared

October 28, 1999

## 2.0 Submitter (Contact)

Martin D. Sargent Xomed Surgical Products Jacksonville, FL [phone]

#### 3.0 Device Name

| Proprietary Name: | Micro-France electrosurgical instruments |
|-------------------------|-----------------------------------------------------|
| Common Name(s): | Electrosurgical cutting and coagulation accessories |
| Classification Name(s): | Electrosurgical cutting and coagulation accessories |

### 5.0 Device Classification

Electrosurgical cutting and coagulation accessories: Procode JOS Class II 21 CFR 878.4400

#### 6.0 Device Description

The various unipolar and bipolar Micro-France electrosurgical instruments consist of scissors, forceps, and probes, and are available in configurations for laparoscopic / endoscopic access and open field surgery. Accessories include unipolar and bipolar cables available in lengths up to 3 M.

#### 7.0 Intended Use

The Electrosurgical instruments are used to remove tissue and control bleeding.

## 8.0 Substantial Equivalence

The Electrosurgical instruments are substantially equivalent to devices marketed by Richard Wolf Medical Instruments (K980129), Concept (K792365), Instrument Maker (K890972), Linvatec (K944992), Megadyne Medical Products (K903302), New England Surgical Instrument (K895331), and Kirwan Surgical Products (K913514).

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 1999

Mr. Martin D. Sargent Senior Regulatory Affairs Specialist Xomed Surgical Products 6743 Southpoint Drive, North Jacksonville, Florida 32216-0980

K993655 Re:

Trade Name: Micro-France Electrosurgical Instruments, Various Regulatory Class: II Product Code: GEI Dated: October 28, 1999 Received: October 29, 1999

Dear Mr. Sargent:

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 Devices 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), it 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 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 action. In addition, FDA may publish further announcements concerning your devices 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.

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.

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Page 2 - Mr. Martin D. Sargent

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,

Stephen Purden
James E. Dillard III

Aa Ja

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

Enclosure

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510(k) Number (if known): Device Name: Electrosurgical Cutting and Coagulation Accessories Indications for Use:

The electrosurgical instruments are intended to remove tissue and control bleeding.

(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Hupt Rhodes

(Division Sign-Off) Division of General Restorative Devices K993655 510(k) Number _

Prescription Use
(Per 21 CFR 801.109)

Or

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)