(208 days)
Not Found
No
The description focuses on a mechanical device for surgical anastomosis and does not mention any computational or data-driven components.
Yes
The device is described as facilitating surgical anastomosis in the colon and is intended to be passed from the body after wound strength is sufficient, directly interacting with human tissue to achieve a medical outcome.
No
This device is a surgical instrument used to create an anastomosis (connection) within the colon, not to diagnose a condition. It facilitates a physical procedure rather than providing diagnostic information.
No
The device description clearly states it is comprised of two physical components: a clip and an applier, both of which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, diagnose conditions, or monitor treatment.
- Device Function: The NiTi CAC is a surgical device used within the body to facilitate a surgical procedure (colonic anastomosis). It directly interacts with and modifies tissue.
- Intended Use: The intended use clearly states it's used "to facilitate colonic side-to-side anastomosis." This is a surgical function, not a diagnostic one based on analyzing specimens.
- Device Description: The description details a mechanical device that performs compression on tissue and is eventually expelled from the body. This is consistent with a surgical implant or device, not an IVD.
The information provided describes a surgical device used for creating a connection between two parts of the colon. It does not involve the analysis of biological samples for diagnostic purposes.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
FZP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
colonic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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 .: 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
page 2/3
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:
2
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.
3
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.
4
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_________________________________________________________________________________________________________________________________________________________________
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