The NiTi Laparoscopic Compression Anastomosis Clip (LapCAC) is intended to be used to facilitate side-to-side anastomosis of the alimentary tract yielding an inverted serosa-to-serosa anastomosis. Once wound strength is sufficient to maintain the anastomosis, the NiTi Clip is wassed from the body. The LapCAC is indicated for open, minimally invasive or laparoscopic procedures.

Device Description

The Laparoscopic Compression Anastomosis Clip (LapCAC) device is a sterile single patient use device. The LapCAC provides a simple method for the creation of side-to-side compression anastomosis of the alimentary tract in open, minimally invasive and laparoscopic procedures. The LapCAC device is comprised of two components: Clip Reload double ring clip that is inserted into the two cut segments and performs the required compression on the tissue, and Applier/Handle with which the Clip is introduced into the treated area. The LapCAC device has an extended 35 or 45 cm. long shaft and is designed to pass through a 12 mm standard trocar. After a period of 7-10 days, a compression-induced necrosis of the tissue undernouth the was compressed by the rings, detaches and is naturally expelled with the stool.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner one might expect for an AI/ML device (e.g., performance metrics like accuracy, sensitivity, specificity).

The document is a 510(k) summary for a medical device called the "Laparoscopic Compression Anastomosis Clip (LapCAC)". This device is a surgical CLIP, not an AI/ML diagnostic or assistive technology. Therefore, the questions related to AI/ML device performance, ground truth, expert adjudication, MRMC studies, and training/test set sample sizes are not applicable to the content provided.

The 510(k) process for this type of device relies on demonstrating "substantial equivalence" to predicate devices, primarily through comparison of intended use, technological characteristics, and performance testing often related to biological safety and mechanical functionality, rather than diagnostic accuracy.

Summary based on the provided text:

Acceptance Criteria and Reported Device Performance: Not applicable/not provided in the context of diagnostic performance metrics for an AI/ML device. The document states a belief of substantial equivalence based on "performance testing results," but the specific criteria or results of these tests (e.g., mechanical strength, biocompatibility, deployment success rate) are not detailed.
Sample size used for the test set and the data provenance: Not applicable. The device is a surgical clip, not a software algorithm tested on a dataset.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
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.

What is present in the document is information related to regulatory clearance for a hardware medical device:

Device Name: Laparoscopic Compression Anastomosis Clip (LapCAC)
Intended Use: To facilitate side-to-side anastomosis of the alimentary tract, yielding an inverted serosa-to-serosa anastomosis. Once wound strength is sufficient, the clip is passed from the body. Indicated for open, minimally invasive, or laparoscopic procedures.
Classification: Class II device, product code FZP, Regulation No. 21 C.F.R. § 878.4300 (Implantable Clip).
Predicate Devices: CAC, Compression Anastomosis Clip (K033324, K041751) and Universal Stapler System (K892233, K913802).
Performance Standards: "No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act."
Substantial Equivalence: Applicant "believes that the Laparoscopic Compression Anastomosis Clip (LapCAC) is substantially equivalent to the predicate device cited above without raising new safety and/or effectiveness issues," based on "performance testing results." (However, the details of these tests are not provided in this summary.)

Summary

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DEC = 1 2004

510(K) Summary

Laparoscopic Compression Anastomosis Clip (LapCAC) 510(k) Number Ko43 || S

Applicant's Name:

NiTi Medical Technologies Ltd. 1 Hatzoran st., P.O.Box 8634 Netanya 42506, Israel Tel .: 972-9-865-0610 Fax: 972-9-835-0127

Contact Person:

Orly Maor NiTi Medical Technologies Ltd. 1 Hatzoran st., P.O.Box 8634 Netanya 42506, Israel Tel .: 972-9-865-0610 Fax: 972-9-835-0127 orly@nitimed.com

And / or

Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109 Tel: (202) 637-5794 Fax: (202) 637-5910

Date Prepared:

November, 2004

Trade Name:

Laparoscopic Compression Anastomosis Clip (LapCAC)

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Classification Name:

IMPLANTABLE CLIP

Classification:

The FDA has classified implantable clip as class II device (product code FZP, Regulation No. 21 C.F.R. § 878.4300) and they are reviewed by the Division of General and Restorative Devices.

Predicate Device:

· CAC, Compression Anastomosis Clip (NiTi Medical Technologies Ltd.) cleared under K033324.
· CAC, Compression Anastomosis Clip (NiTi Medical Technologies Ltd.) cleared under K041751.
Universal Stapler System (United Surgical States GIA • Endo Cooperation, USA) originally cleared under K892233 and K913802.

Performance Standards:

No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act.

Intended Use:

Device Description:

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▶ Clip Reload double ring clip that is inserted into the two cut segments Chp Reload - abusic ining to sees and performs the required compression on the tissue.
▶ Applier/Handle with which the Clip is introduced into the treated area.

The LapCAC device has an extended 35 or 45 cm. long shaft and is designed to pass through a 12 mm standard trocar.

After a period of 7-10 days, a compression-induced necrosis of the tissue Alter a period on I To days, a oursend the whole device, together with the Slucs undernouth the was compressed by the rings, detaches and is naturally expelled with the stool.

Substantial Equivalence:

Based on performance testing results NiTi Medical Technologies Ltd. Dascu on performance - count Compression Anastomosis Clip (LapCAC) is believes that the Eaparooosps predicate device cited above without raising new safety and/or effectiveness issues.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 1 2004

NiTi Medical Technologies Ltd c/o Mr. Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, D.C. 20004

Re: K043115

Trade/Device Name: Laparoscopic Compression Anastomosis Clip (LapCAC) Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP Dated: November 4, 2004 Received: November 10, 2004

Dear Mr. Kahan:

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 - Mr. Jonathan S. Kahan, Esq

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provoost

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

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Laparoscopic Compression Anastomosis Clip (LapCAC) Device Name:

Indications for Use:

The NiTi Laparoscopic Compression Anastomosis Clip (LapCAC) is intended to be used to facilitate side-to-side (Baperie) is the alimentary tract yielding an inverted serosa-to-serosa anastomosis. Once wound strength is sufficient to maintain the anastomosis, the NiTi Clip is passed from the body. The LapCAC is indicated for open, minimally invasive or laparoscopic procedures

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

Over-The-Counter Use _ (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)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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.