SOVEREIGN BIPOLAR INSTRUMENTS

K001330 · Aesculap, Inc. · GEI · May 30, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K001330
• Device Name: SOVEREIGN BIPOLAR INSTRUMENTS
• Applicant: Aesculap, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 30, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sovereign Bipolar Instruments are intended to facilitate grasping, cutting and manipulation of soft tissue and blood vessels during laparoscopic procedures with the use of high-frequency electrical current (bipolar electrocautery).

Device Story

Sovereign Bipolar Instruments are reusable, non-sterile endoscopic scissors and forceps; used in laparoscopic procedures to grasp, cut, and manipulate soft tissue and blood vessels. Instruments connect to standard electrosurgical generators via bipolar cables to deliver high-frequency electrical current for bipolar electrocautery. Operated by surgeons in clinical/OR settings. Output is mechanical tissue manipulation combined with thermal coagulation/cutting effect. Benefit includes controlled tissue management during minimally invasive surgery. Sterilized via steam.

Clinical Evidence

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

Technological Characteristics

Reusable endoscopic scissors and forceps; modular design; bipolar energy delivery; compatible with standard electrosurgical generators using flat-plug cables; steam sterilizable; conforms to IEC 60601-2-18.

Indications for Use

Indicated for grasping, cutting, and manipulation of soft tissue and blood vessels during laparoscopic procedures using bipolar electrosurgical energy.

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

• Aesculap Bipolar Forceps (K954652)
• Jarit Detach® Bipolar System
• Enable Endoscopic Bipolar Scissors (K992996)
• Valleylab BiSure™ Laparoscopic Bipolar Forceps (K983743)

Submission Summary (Full Text)

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SOVEREIGN™ BIPOLAR INSTRUMENTS

# MAY 3 0 2000

K001330

Page 1 of 1

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

## SOVEREIGN™ BIPOLAR INSTRUMENTS

April 26, 2000

- Aesculap®, Inc. COMPANY: 1000 Gateway Blvd. So. San Francisco, CA 94080
- CONTACT: Lia S. Jones, Regulatory Associate 650-624-5073 (phone) 650-589-3007 (fax) [e-mail] (email)
- TRADE NAME: SOVEREIGN™ Bipolar Instruments
- COMMON NAME: Bipolar Instrument

DEVICE CLASS: Class II

- PRODUCT CODE: GEI
- CLASSIFICATION: 878.4400
- Electrosurgical cutting and coagulation device and accessories
- General & Plastic Surgery REVIEW PANEL:

### INTENDED USE

The Sovereign Bipolar Instruments are intended to facilitate grasping, cutting and manipulation of soft tissue and blood vessels during laparoscopic procedures with the use of high-frequency electrical current (bipolar electrocautery).

#### DEVICE DESCRIPTION g

Aesculap's Sovereign Bipolar Instruments are comprised of a variety of non-sterile, reusable endoscopic scissors and forceps. The modular instruments utilize standard bipolar cables (with flat plugs) connected to compatible electrosurgical generators that supply bipolar energy. The instruments may be sterilized by steam sterilization.

### PERFORMANCE DATA

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

### SUBSTANTIAL EQUIVALENCE

The Sovereign Bipolar Instruments are substantially equivalent in their intended use, material composition, labeling, design and basic operating principles to the following predicate devices:

- Aesculap Bipolar Forceps (K954652) .
- Jarit Detach® Bipolar System ●
- Enable Endoscopic Bipolar Scissors (K992996) .
- · Valleylab BiSure™ Laparoscopic Bipolar Forceps (K983743)

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a symbol consisting of three stylized human profiles facing right, with flowing lines beneath them.

# MAY 3 0 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lia S. Jones Regulatory Associate Aesculap, Inc. 1000 Gateway Boulevard South San Francisco. California 94080-7028

K001330 Re: Trade Name: SOVEREIGN Bipolar Instruments Regulatory Class: II Product Code: GEI Dated: April 26, 2000 Received: April 27, 2000

Dear Ms. Jones:

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 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 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 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.

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Page 2 - Ms. Lia S. Jones

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,

Dune R. Lochner.

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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Page 1 of 1

# INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K00133 0

SOVEREIGN™ Bipolar Instruments Device Name:

Indication for Use:

The Sovereign Bipolar Instruments are intended to facilitate grasping, cutting and manipulation of soft tissue and blood vessels during laparoscopic procedures with the use of high-frequency electrical current (bipolar electrocautery).

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

Danne R. be Ams.

(Division Sign-Off) Division of General Restorative Devices 10(k) Number KOQ133 C

Prescription Use

(per 21 CFR 801.109)

or Over-the-Counter Use

(Optional Format 3-10-98)