COMPRESSION ANASTOMOSIS CLIP (CAC)

K033324 · Niti Medical Technologies , Ltd. · FZP · May 10, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K033324
• Device Name: COMPRESSION ANASTOMOSIS CLIP (CAC)
• Applicant: Niti Medical Technologies , Ltd.
• Product Code: FZP · General, Plastic Surgery
• Decision Date: May 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Sterile, single-use device for side-to-side intestinal compression anastomosis; consists of double-ring clip and applier. Physician inserts clip into two cut intestinal segments; clip performs tissue compression. Compression-induced necrosis occurs over 7-10 days; device and necrosed tissue detach and are naturally expelled via stool. Facilitates inverted serosa-to-serosa anastomosis; eliminates need for permanent sutures or staples. Used in clinical settings by surgeons.

Clinical Evidence

Evidence includes comparative animal and clinical studies. No specific performance metrics (e.g., sensitivity, AUC) provided in summary.

Technological Characteristics

Sterile, single-use implantable clip. Comprised of double-ring clip and applier. Operates via compression-induced necrosis of intestinal tissue. Not for laparoscopic use.

Indications for Use

Indicated for patients requiring colonic side-to-side anastomosis. Not for use in laparoscopic procedures via trocars.

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

• Valtrac Biofregmentable Anastomosis Ring (K931056)
• Proximate™ Linear Cutter and Stapler (K020779)
• U-Clip™ (K024366)

Reference Devices

• Murphy's Button

Submission Summary (Full Text)

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K033334
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# 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 .: [phone] Fax: [phone]

## Contact Person:

Orly Maor 1 Hatzoran st., P.O.Box 8634 Netanya 42506, Israel Tel.: [phone] Fax: [phone] [e-mail]

And / or

Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109 Tel: [phone] Fax: [phone]

## Date Prepared:

May 2004

## Trade Name:

Compression Anastomosis Clip (CAC)

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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:

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:

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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

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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 [phone]. 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 [phone] or [phone] 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_________________________________________________________________________________________________________________________________________________________________

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