(23 days)
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.
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 7-10 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 rings, detaches and is naturally expelled with the stool.
This document is a 510(k) summary for the Compression Anastomosis Ring (CAR) and does not contain any information regarding acceptance criteria or a study proving device performance against such criteria. It details the device's classification, predicate device, intended use, and substantial equivalence claim based on validations and performance testing, including animal studies.
Therefore, I cannot provide the requested information.
{0}------------------------------------------------
510(K) SUMMARY
Compression Anastomosis Ring (CAR)
510(k) Number K_()(22008
Applicant's Name:
AUG - 9 2006
NiTi Medical Technologies Ltd. 4 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:
July 6, 2006
Trade Name:
Compression Anastomosis Ring (CAR)
{1}------------------------------------------------
Classification Name:
IMPLANTABLE CLIP
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 Ring (CAR) (NiTi Medical Technologies Ltd.) cleared under K050356.
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 Once wound strength is sufficient to maintain the surgeries. 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 7-10 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 rings, detaches and is naturally expelled with the stool.
{2}------------------------------------------------
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.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff and two snakes intertwined around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 9 2006
Niti Medical Technologies, Ltd. % Orly Maor RA/CA Manager 4 Hatzoran Street P.O. Box 8634 Netanyz, Israel 42506
Re: K062008
Trade/Device Name: CAR Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP Dated: July 23, 2006 Received: July 27, 2006
Dear Orly Maor:
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 x read of as 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
{4}------------------------------------------------
Page 2 -- Orly Maor
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. product radiation of our 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 promated 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Bonellm
to
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Compression Anastomosis Ring (CAR) Device Name:
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.
イ 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)
Barbara Brehm for MKM
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K062008
§ 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.