REPOSABLE INSTRUMENT SYSTEM, MODELS MF001-MF083

K014207 · Aesculap, Inc. · GEI · Mar 21, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K014207
• Device Name: REPOSABLE INSTRUMENT SYSTEM, MODELS MF001-MF083
• Applicant: Aesculap, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 21, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Aesculap's Reposable Instrument System is designed to cut, dissect, manipulate and/or cauterize various tissue during endoscopic/laparoscopic, general, vascular, gynecological, and thoracic surgical procedures.

Device Story

Reposable Instrument System consists of reusable handles with monopolar electrocautery connection terminals and interchangeable jaw inserts (blades, shaft, locking nut). System includes both reusable and single-use endoscopic scissors. Handles available in ratcheted or non-ratcheted configurations. Used by surgeons in OR settings for endoscopic/laparoscopic procedures. Device facilitates tissue manipulation and electrosurgical cutting/coagulation. Benefits include modularity through combination of reusable handles and disposable/reusable inserts.

Clinical Evidence

Bench testing only. Device conforms to electromedical standards IEC/EN 60601-2-2 and IEC/EN 60601-2-18.

Technological Characteristics

Modular electrosurgical instrument system. Components: reusable handles, reusable/single-use jaw inserts (blades, shaft, locking nut). Monopolar energy source. Connectivity: underside connection terminal for electrosurgical unit. Standards: IEC/EN 60601-2-2, IEC/EN 60601-2-18.

Indications for Use

Indicated for cutting, dissecting, manipulating, and/or cauterizing tissue during endoscopic, laparoscopic, general, vascular, gynecological, and thoracic 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

• Microline 3 MM Selec-Tip Laparoscopic Instrument System (K980758)
• Microline Selecta-tip Laparoscopic Instrument System (K970826)
• Weck's Endoscopic Instrument System (Disposable/Reusable) (K926203)

Submission Summary (Full Text)

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# K014207

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### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS in Accordance with SMDA of 1990

### REPOSABLE INSTRUMENT SYSTEM

December 19, 2001

| COMPANY: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Lisa M. Millington, Regulatory Associate<br>800-258-1946 (phone) x5072<br>610-791-6882 (fax)<br>[e-mail] (email) |
| TRADE NAME: | Reposable Instrument System |
| COMMON NAME: | Disposable / Reusable Instrument System |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | GEI |
| CLASSIFICATION: | 878.4800<br>Device, Electrosurgical, Cutting & Coagulation & Accessories |
| REVIEW PANEL: | General & Plastic Surgery |

#### INTENDED USE

Aesculap's Reposable Instrument System is designed to cut, dissect, manipulate and/or cauterize various tissue during endoscopic/laparoscopic, general, vascular, gynecological, and thoracic surgical procedures.

#### DEVICE DESCRIPTION

Aesculap's Reposable Instrument System is comprised of non-sterile, reusable handles which are capable of monopolar electrocautery, via a underside connection terminal, reusable jaw inserts which come in different sizes and one single use endoscopic scissors. The jaw inserts include the blades, shaft and locking nut. The reusable scissors insert is supplied non-sterile, and the single use scissors insert is supplied sterile. The reusable and single use jaw inserts are intended to be use with either the non-ratcheted or ratcheted handle.

#### PERFORMANCE DATA

No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The Reposable Instrument System, however, conform to the following electromedical standard: IEC/EN 60601-2-2 and IEC/EN 60601-2-18.

#### SUBSTANTIAL EQUIVALENCE

The Reposable Instrument System are substantially equivalent in their intended use, material composition, labeling, design and basic operating principles to the following predicate devices:

- Microline: .
- 3 MM Selec-Tip Laparoscopic Instrument System (K980758) .
- "Selecta-tip" Laparoscopic Instrument System (K970826)
- Weck's Endoscopic Instrument System (Disposable/Reusable) (K926203)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ·

## MAR 2 1 2002

Ms. Lisa M. Millington Regulatory Associate Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K014207

Trade/Device Name: Reposable Instrument System Regulation Number: 878.4400 Regulation Name: Electrosurgical, Cutting and Coagulation Devices and Accessories Regulatory Class: II

Product Code: GEI Dated: December 20, 2001 Received: December 21, 2001

Dear Ms. Millington:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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### Page 2 - Ms. Lisa M. Millington

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification

Reposable Instrument System

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### INDICATIONS FOR USE STATEMENT

**510(k) Number (if known):**

510(k) Number (if known):

Device Name: Reposable Instrument System

Indication for Use:

Assoulap's Reposable Instrument System is designed to cut, dissect, manipulate and/or cauterize various tissue during endoscopic general, vascular, gynecological, and thoracic surgical procedures.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span style="text-decoration: underline;">\/</span> | or Over-the-Counter Use | <span style="text-decoration: underline;"></span> |
|------------------|-----------------------------------------------------|-------------------------|---------------------------------------------------|
|------------------|-----------------------------------------------------|-------------------------|---------------------------------------------------|

(per 21 CFR 801.109)

(Optional Format 3-10-98)

Miriam C. Provost

(Division of General, Restorative Division of Neurological Devices

510(k) Number K014207