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 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.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for an endoscopic clip system, specifically a line extension for Aesculap's Endoscopic Clip Appliers with Disposable Clip Magazine.

Based on the information provided, no specific acceptance criteria or a study proving that the device meets acceptance criteria are detailed in the document.

The document states:

"No applicable performance standards have been promulgated under Section 514 of the Food, Drug, and Cosmetic Act for these devices." This indicates that there are no specific, formally established performance standards that the device needs to meet for regulatory approval.
The submission focuses on establishing substantial equivalence to an existing predicate device (K080753). This means the primary argument for approval is that the new device is as safe and effective as a legally marketed device, rather than a demonstration of meeting new, specific performance criteria through a dedicated study.

Therefore, the following points, which would typically be included in a description of acceptance criteria and study results, cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: Not provided.
Sample size used for the test set and the data provenance: No test set or associated study is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set or ground truth establishment is described.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a mechanical surgical tool, not an AI-assisted diagnostic device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The document primarily describes the device, its intended use, and argues for substantial equivalence to a predicate device based on similar technological characteristics (shape, size, materials). Regulatory approval in this case relies on demonstrating that the modified device does not raise new questions of safety or effectiveness compared to the already approved predicate device.

Summary

{0}------------------------------------------------

KIO2081

SPECIAL 510(k) Premarket Notification

Endoscopic Clip System- Line Extension

Page 1 of 2

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) denise.adams@aesculap.com (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

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.

{1}------------------------------------------------

:
:

Page 2 of 2

PERFORMANCE DATA

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

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

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

{3}------------------------------------------------

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 (800) 638-2041 or (301) 796-7100 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

{4}------------------------------------------------

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

Page 1 of

510(k) Number K102081

Regulation Number and Section

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.