COMPRESSION ANASTOMOSIS RING (CAR)

K050356 · Niti Medical Technologies , Ltd. · FZP · May 5, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050356
• Device Name: COMPRESSION ANASTOMOSIS RING (CAR)
• Applicant: Niti Medical Technologies , Ltd.
• Product Code: FZP · General, Plastic Surgery
• Decision Date: May 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NiTi Compression Anastomosis Ring (CAR) is intended for use throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries. Once wound strength is sufficient to maintain the anastomosis, the NiTi Compression Anastomosis Ring is passed from the body.

Device Story

Compression Anastomosis Ring (CAR) is a sterile, single-use implantable device for creating circular compression anastomoses in the alimentary tract. Used in open or laparoscopic surgeries by surgeons. Device functions by compressing tissue sides; compression-induced necrosis occurs over 5-10 days; device and necrosed tissue detach and are naturally expelled via stool once wound strength is sufficient. Provides mechanical alternative to traditional stapling or suturing methods.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing and animal studies.

Technological Characteristics

Implantable clip (Product Code FZP). Sterile, single-use device. Operates via compression-induced tissue necrosis. No specific materials or standards cited.

Indications for Use

Indicated for patients requiring alimentary tract anastomoses (end-to-end, end-to-side, side-to-side) during open or laparoscopic surgery.

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

• Compression Anastomosis Clip (CAC) (NiTi Medical Technologies Ltd.) (K033324, K041751, K043115)
• Proximate™ ILS Circular Stapler (Ethicon Endo-Surgery, Inc. USA) (K920752, K983536)
• Premium Plus CEEA Circular Stapler (Auto Suture-United States Surgical, USA) (K024275)

Submission Summary (Full Text)

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# MAY - 5 2005

#### 510(K) SUMMARY

# Compression Anastomosis Ring (CAR)

#### 510(k) Number K_

#### 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:

February 9, 2005

#### Trade Name:

Compression Anastomosis Ring (CAR)

#### Classification Name:

IMPLANTABLE CLIP

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#### Classification:

The FDA has classified implantable clips as class II devices (product code FZP, 21 C.F.R. § 878.4300) and they are reviewed by the Division of General and Restorative Devices.

### Predicate Device:

- · Compression Anastomosis Clip (CAC) (NiTi Medical Technologies Ltd.) cleared under K033324, K041751 and K043115.
- · Proximate™ ILS Circular Stapler (Ethicon Endo-Surgery, Inc. USA) cleared under K920752 and K983536.
- · Premium Plus CEEA Circular Stapler (Auto Suture-United States Surgical, USA) cleared under K024275.

## 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 Compression Anastomosis Ring (CAR) is intended for use throughout the alimentary tract for the creation of end-to-end, end-toside and side-to-side anastomoses in both open and laparoscopic surgeries. Once wound strength is sufficient to maintain the anastomosis, the NiTi Compression Anastomosis Ring is passed from the body.

## Device Description:

The Compression Anastomosis Ring (CAR) device is a sterile single use device. The CAR provides a simple method for the creation circular compression anastomosis of the alimentary tract.

After a period of 5-10 days, a compression-induced necrosis of the tissue sides underneath the ring occurs and the whole device, together with the necrosed tissue that was compressed by the ring, detaches and is naturally expelled with the stool.

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## Substantial Equivalence:

Based on validations and performance testing results, including animal studies, NiTi Medical Technologies Ltd. believes that the Compression Anastomosis Ring (CAR) 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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

MAY - 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Orly Maor Regulatory Manager NiTi Medical Technologies, Ltd. 1 Hatzoran Street, P.O. Box 8634 Netanya 42506, Israel

Re: K050356

Trade/Device Name: Compression Anastomosis Ring (CAR) Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP Dated: February 9, 2005 Received: February 14, 2005

Dear Ms. Maor:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) is regars actment date of the Medical Device Amendments, or to conninered province to May 20, 1978, the ecordance with the provisions of the Federal Food, Drug, de vices mat have been receability in avire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mercere, mance one act include requirements for annual registration, listing of general controls provisions of victive, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (660 abs (0) trols. Existing major regulations affecting your device it may be subject to saon additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Over in the Overning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Teast of advised that I Drivisantes syour device complies with other requirements of the Act that I Drinas made a aved regulations administered by other Federal agencies. You must or any I coclar stututes and registernents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quality byevelle (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Ms.Orly Maor

This letter will allow you to begin marketing your device as described in your Section 510(k) This leter will anow you to begin mailing of substantial equivalence of your device to a legally premation notification - 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 If you desire spocific advise at [phone] . Also, please note the regulation entitled, eonidor the Office of Cremarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miorination on 500 Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Austin

Miriam C. Provost, Ph.D. Acting 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):

Device Name: Compression Anastomosis Ring (CAR)

Indications for Use:

The NiTi Compression Anastomosis Ring (CAR) is intended for use throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries. Once wound strength is sufficient to maintain the anastomosis, the NiTi Compression Anastomosis Ring is passed from the body.

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)

morel, Restorative Devices

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