(80 days)
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.
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.
The provided document, a 510(k) summary for the Compression Anastomosis Ring (CAR), does not contain specific acceptance criteria or a detailed study description with performance outcomes. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against predefined criteria.
However, based on the information provided, here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
This information is not available in the provided document. The 510(k) summary states, "No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act." Therefore, specific acceptance criteria and detailed device performance metrics (e.g., success rate of anastomosis, incidence of leakage, time to expulsion of the device) are not presented in this document.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "validations and performance testing results, including animal studies" (Section {2}). However, it does not specify the sample size for any test set or the provenance of this data. It's only stated that these studies were conducted by NiTi Medical Technologies Ltd.
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)
This information is not available in the provided document. The summary only refers to "animal studies" as part of the performance testing, but no details regarding expert involvement or ground truth establishment are given.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not available in the provided document.
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
This information is not applicable/available. The device is a surgical implant (Compression Anastomosis Ring), not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable/available. The device is a physical surgical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the mention of "animal studies," the ground truth likely involved observational outcomes and possibly pathological examination of the anastomoses in the animal subjects. However, the specific type and methodology are not detailed in this document.
8. The sample size for the training set
This information is not applicable/available. The device is a physical surgical implant, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/available. The device is a physical surgical implant, not a machine learning model.
{0}------------------------------------------------
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 .: 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:
February 9, 2005
Trade Name:
Compression Anastomosis Ring (CAR)
Classification Name:
IMPLANTABLE CLIP
{1}------------------------------------------------
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.
{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}------------------------------------------------
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.
{4}------------------------------------------------
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 (240) 276-0115 . 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 (800) 638-2041 or (301) 443-6597 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
{5}------------------------------------------------
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
R
7-7
§ 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.