AESCULAP ENDOSCOPIC CLIP SYTEM

K080753 · Aesculap, Inc. · FZP · Apr 2, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K080753
• Device Name: AESCULAP ENDOSCOPIC CLIP SYTEM
• Applicant: Aesculap, Inc.
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Apr 2, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The devices presented in this submission are intended for use in endoscopic and/or open surgery for ligating and marking vessels and tubular structures wherever a ligating clip is used/indicated.

Device Story

Reusable stainless steel endoscopic and open surgery clip appliers; used with disposable clip magazine cartridges (holding 2, 6, or 8 clips). Laparoscopic appliers: 10-12mm diameter, 310mm length. Open surgery appliers: 150-280mm length, various jaw angles (25, 65, 90 degrees). Operated by surgeons in OR. Device functions by manual actuation to deploy clips for vessel ligation or tissue marking. Benefits include secure vessel closure and anatomical marking during surgical procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: Stainless steel and titanium. Form factor: Reusable manual instruments (10-12mm laparoscopic; 150-280mm open). Energy source: Manual. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients undergoing endoscopic or open surgery requiring ligation or marking of vessels and tubular structures.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• Aesculap Endoscopic Clip Appliers (K962493)

Submission Summary (Full Text)

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KC80753 Page 1/2
Endoscopic Clip System

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#### B. 510(k) SUMMARY (as required by 21 CFR 807.92)

# Endoscopic Clip System March 17, 2008

APR - 2 2008 COMPANY: Aesculap®, Inc. 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 2916714

- CONTACT: Lisa M. Boyle 800-258-1946 (phone) 610-791-6882 (fax) [e-mail] (email)
- COMMON NAME: Endoscopic Clips and Appliers

CLASSIFICATION NAME: Clips, Implantable

REGULATION NUMBER: 878.4300/870.3250

PRODUCT CODE: FZP/DSS

## SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the Endoscopic Clips and Applier modifications are substantially equivalent to the existing components of the Aesculap Endoscopic Clip Appliers (K962493).

### DEVICE DESCRIPTION

Aesculap's Clip Appliers are reusable stainless steel instruments. The clip appliers can be used in either laparoscopic or open surgery. The laparoscopic appliers are available in either a 10 or 12mm diameter with a length of 310mm. The Clip Appliers are a nonmodular, one-piece, design for single fire use.

The Open Surgery Appliers are available in lengths of 150mm (small) to 280mm (Xlarge) with jaw angles of 25, 65, and 90 degrees. The handles of the open surgery appliers will be color coded for easy identification of the matching clip size.

Both types of appliers are designed for use with a disposable clip magazine. The new clip magazine cartridge hold either 8, 6, or 2 clips per cartridge based on the size of the clip.

# INDICATIONS FOR USE

The devices presented in this submission are intended for use in endoscopic and/or open surgery for ligating and marking vessels and tubular structures wherever a ligating clip is used/indicated.

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K080753 page2/2
Endoscopic Clip System

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# TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s)}

The new clip appliers and clips of the Endoscopic Clip System are offered in similar in shapes and sizes as the predicate device. All the components are manufactured from Stainless Steel / Titanium, which is the same material as the predicate devices.

## PERFORMANCE DATA

No applicable performance standards have been promulgated under Section 514 of the Food, Drug, and Cosmetic Act for these devices.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 2 2008

Aesculap, Inc. % Ms. Lisa M. Boyle Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K080753

Trade/Device Name: Aesculap Endoscopic Clip Appliers with Disposable Clip Magazine Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP Dated: March 17, 2008 Received: March 17, 2008

Dear Ms. Boyle:

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 (QS) 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. Boyle

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours.

Mark M. Melleman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### A. INDICATIONS FOR USE STATEMENT

510(k) Number: K060753

# Device Name: Aesculap Endoscopic Clip Appliers with Disposable Clip Magazine

#### Indications for Use:

The devices presented in this submission are intended for use in endoscopic and open surgery for ligating and marking vessels and tubular structures whenever ligating clips are used/poir oand

X _____ and/or Over-the-Counter Use _ Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

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Division of General, Restorative, and Neurological Devices

**510(k) Number** K080753