ENDOSCOPIC CLIP SYSTEM

K102081 · Aesculap, Inc. · FZP · Aug 6, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K102081
• Device Name: ENDOSCOPIC CLIP SYSTEM
• Applicant: Aesculap, Inc.
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Aug 6, 2010
• 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 whenever ligating clips are used/indicated.

Device Story

Aesculap Endoscopic Clip Appliers are reusable, non-modular, stainless steel instruments used in laparoscopic or open surgery. The system utilizes a disposable clip magazine cartridge holding 4 clips. The device is operated by a surgeon to ligate and mark vessels or tubular structures. The mechanical action of the applier fires the clip onto the target tissue. The device provides a permanent mechanical closure of vessels, aiding in hemostasis or tissue marking during surgical procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reusable stainless steel endoscopic clip appliers; 12mm diameter, 330mm length; non-modular, one-piece design; disposable clip magazine cartridge (4-clip capacity); clips manufactured from stainless steel/titanium.

Indications for Use

Indicated for use in endoscopic and/or open surgery for ligating and marking vessels and tubular structures in patients requiring surgical ligation.

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 Appliers and Double Ligating Clips (K080753)

Submission Summary (Full Text)

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KIO2081

SPECIAL 510(k) Premarket Notification

Endoscopic Clip System- Line Extension

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510(k) SUMMARY (as required by 21 CFR 807.92) B. Endoscopic Clip System July 23, 2010 AUG - 6 2010 Aesculap®, Inc. COMPANY: 3773 Corporate Parkway Center Vallev, PA 18034 Establishment Registration Number: 2916714 Denise R. Adams CONTACT: 800-258-1946 (phone) 610-791-6882 (fax) [e-mail] (email) COMMON NAME: Endoscopic Clips and Appliers CLASSIFICATION NAN.E: Clips, Implantable REGULATION NUMBER: 878.4300/870.3250 PRODUCT CODE: FZP/DSS

### SUBSTANTIAL EQUIVALENCE

Aesculabo, Inc. believes that the Endoscopic Clips and Applier modifications are substantially equivalent to the existing components of the Aesculap Endoscopic Appliers and Double Ligating Clips (K080753).

# DEVICE DESCRIPTION

Aescular's Clip Appliers are reusable stainless steel instruments. The clip appliers can be used in laparoscopic surgery. The clip appliers are available in 12mm diameter with a length of 330mm. The clip appliers are a non-modular, one-piece design for single fire use. These appliers are designed for use with a disposable clip magazine. The new clip magazine cartridge holds 4 clips.

#### 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 whenever ligating clips are used/indicated.

# TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))

The new clip appliers and clips of the Endoscopic Clip System are offered in similar 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.

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# PERFORMANCE DATA

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

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Aesculap®, Inc. % Ms. Denise R. Adams Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

AUG - 6 2010

Re: K102081

Trade/Device Name: Aesculap Endoscopic Clip Appliers with Disposable Clip Magazine Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: FZP Dated: July 23, 2010 Received: July 26, 2010

Dear Ms. Adams:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Ms. Denise R. Adams

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1102081

# Indications for Use

AUG - 6 2010

K102081 510(k) Number (if known):

Device Name: 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/or open surgery for ligating and marking vessels and tubular structures whenever ligating clips are used/indicated.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dainl Kree fan MKM
(Division Sign Off)

Division of Surgical, Onhopedic, and Restorative Devices

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510(k) Number K102081

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