The NiTi CAC (Compression Anastomosis Clip) is intended to be used to facilitate colonic side-to-side anastomosis yielding an inverted serosa-to-serosa anastomosis. Once wound strength is sufficient to maintain the anastomosis, the NiTi CAC is passed from the body. The NiTI CAC is not applicable through trocars in laparoscopic procedures.

Device Description

The Compression Anastomosis Clip (CAC) device is a sterile single use device. The CAC provides a simple method for the creation of side-to-side compression anastomosis of the intestine. The CAC device is comprised of two components: CLIP - DOUBLE RING CLIP THAT IS INSERTED INTO THE TWO CUT SEGMENTS OF THE INTESTINE AND PERFORMS THE REQUIRED COMPRESSION ON THE TISSUE. APPLIER - WITH WHICH THE CLIP IS INTRODUCED INTO THE TREATED AREA. After a period of 7-10 days, a compression-induced necrosis of the intestine sides underneath the rings occurs and the whole device, together with the necrosed tissue that was compressed by the rings, detaches and is naturally expelled with the stool.

AI/ML Overview

This looks like a medical device submission, specifically a 510(k) summary for a Compression Anastomosis Clip (CAC). I will extract the information you requested based on the provided text.

It's important to note that the provided 510(k) summary primarily focuses on establishing substantial equivalence to predicate devices and describes the device's design and intended use. It mentions "comparative animal and clinical studies" in the "Substantial Equivalence" section, but it does not provide details about those studies, their acceptance criteria, or their results within the provided text. Therefore, much of the requested information cannot be found in this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The provided 510(k) summary does not detail specific acceptance criteria or performance metrics derived from studies for the CAC device itself. It states that "validations and performance testing results, including comparative animal and clinical studies" were used to establish substantial equivalence, but the actual data, success/failure criteria, or performance outcomes are not reported here.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document states "comparative animal and clinical studies" were conducted, but it does not specify the sample sizes for these studies, nor does it detail their design (retrospective/prospective) or data provenance (country of origin).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Cannot be provided. This question typically applies to studies where expert interpretation (e.g., image reading) is a primary outcome. For a surgical device like an anastomosis clip, "ground truth" would likely be established through surgical observation, pathological examination of tissue healing, and patient follow-up, rather than expert interpretation of a "test set" in the traditional sense of diagnostic devices. The document does not describe how ground truth was established for its comparative studies, nor does it mention any experts involved in such a process.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Cannot be provided. Similar to point 3, this question is typically relevant for diagnostic studies involving multiple readers. The nature of the studies for a surgical clip (animal and clinical studies focusing on surgical outcomes like anastomotic integrity, healing, and device expulsion) would not typically involve an adjudication method as described.

5. 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 question is specific to AI-assisted diagnostic devices. The Compression Anastomosis Clip is a surgical device, not an AI-powered diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not relevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This question is specific to AI/algorithmic performance. The Compression Anastomosis Clip is a physical surgical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Cannot be determined from the provided text. While it's highly probable that ground truth in the "comparative animal and clinical studies" would involve outcomes data (e.g., anastomotic leakage rates, healing, patency, device expulsion success) and potentially pathology (histological assessment of tissue healing), the document does not explicitly state what type of ground truth was used.

8. The sample size for the training set

Not applicable / Cannot be provided. A "training set" is relevant for machine learning algorithms. This device is a physical surgical instrument, not an AI model.

9. How the ground truth for the training set was established

Not applicable / Cannot be provided. As above, "training set" and "ground truth for the training set" are concepts related to machine learning and AI, which are not applicable to this physical medical device.

Summary of what is present:

The 510(k) summary provides:

Device name, applicant, contact, and date.
Classification information (Class II, implantable clip, FZP).
Predicate devices used for comparison (Valtrac Biofragmentable Anastomosis Ring, Proximate™ Linear Cutter and Stapler, U-Clip™, Murphy's Button).
Intended Use statement: "The NiTi CAC (Compression Anastomosis Clip) is intended to be used to facilitate colonic side-to-side anastomosis yielding an inverted serosa-to-serosa anastomosis. Once wound strength is sufficient to maintain the anastomosis, the NiTi CAC is passed from the body. The NiTI CAC is not applicable through trocars in laparoscopic procedures."
Device Description: A sterile, single-use device comprised of a double ring clip and an applier, designed to create side-to-side compression anastomosis. It explains the mechanism of action (compression-induced necrosis and natural expulsion after 7-10 days).
A general statement about substantial equivalence being based on "validations and performance testing results, including comparative animal and clinical studies." However, the details of these studies are not provided in this summary.

This document serves as a regulatory filing to establish substantial equivalence for market clearance, rather than a detailed publication of device performance study results.

Summary

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K033334
page 1/3

510(K) SUMMARY

Compression Anastomosis Clip (CAC) 510(k) Number K033324

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 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:

May 2004

Trade Name:

Compression Anastomosis Clip (CAC)

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KO{{{ Y4
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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 CFR § 878.4300) and they are reviewed by the Division of General and Restorative Devices.

Predicate Device:

Valtrac Biofregmentable Anastomosis Ring (Devis + Geck) cleared under K931056
Proximate™ Linear Cutter and Stapler (Ethicon Endo-Surgery, Inc. USA) cleared under K020779.
U-Clip™, (Coalescent Surgical, Inc. USA) cleared under K024366.

Murphy's Button, preamendments device.

Performance Standards:

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

Intended Use:

The NiTi CAC (Compression Anastomosis Clip) is intended to be used to facilitate colonic side anastomosis yielding an inverted serosa-toserosa anastomosis. Once wound strength is sufficient to maintain the anastomosis, the NiTi CAC is passed from the body. The NiTI CAC is not applicable through trocars in laparoscopic procedures.

Device Description:

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Page 3 > CLIP - DOUBLE RING CLIP THAT IS INSERTED INTO THE TWO CUT SEGMENTS OF THE INTESTINE AND PERFORMS THE REQUIRED COMPRESSION ON THE TISSUE.

> APPLIER - WITH WHICH THE CLIP IS INTRODUCED INTO THE TREATED AREA.

After a period of 7-10 days, a compression-induced necrosis of the intestine sides underneath the rings occurs and the whole device, together with the necrosed tissue that was compressed by the rings, detaches and is naturally expelled with the stool.

Substantial Equivalence:

Based on validations and performance testing results, including comparative animal and clinical studies, NiTi Medical Techologies Ltd. believes that the Compression Anastomosis Clip (CAC) is substantially equivalent to its 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" arranged around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine. The caduceus in the logo is depicted with a staff and a serpent winding around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 0 2004

NiTi Medical Technologies Ltd. c/o Mr. Randy J. Prebula Regulatory Affairs Specialist Hogan & Hartson, L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004

Re: K033324

Trade/Device Name: Compression Anastomosis Clip (CAC) Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP Dated: February 10, 2004 Received: February 12, 2004

Dear Mr. Prebula:

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 classificd (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 CHR 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. Randy J. Prebula

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w yourse of substantial equivalence of your device to a legally premated 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 (301) 594-4659. 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 other generals, 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

Sincercly yours,

Miriam C. Provost

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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ss334

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K033324

Compression Anastomosis Clip (CAC) Device Name:

Indications for Use:

The NiTi CAC (Compression Anastomosis Clip) is intended to be used to facilitate colonic side-to-side anastomosis vielding an inverted serosa-to-serosa anastomosis. Once wound strength is sufficient to maintain the anastomosis, the NiTi CAC is passed from the body. The NiTI CAC is not applicable through trocars in 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_________________________________________________________________________________________________________________________________________________________________

Page 1 of 1

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.