(21 days)
Not Found
No
The summary describes a mechanical device for surgical anastomosis and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device facilitates anastomosis by compressing tissue and is expelled naturally from the body, rather than directly treating a disease or condition.
No
The device is intended to facilitate surgical anastomosis, not to diagnose a condition.
No
The device description clearly states it is comprised of physical components: a Clip Reload and an Applier/Handle, 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. This information is used for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Laparoscopic Compression Anastomosis Clip (LapCAC) is a surgical device used to physically join segments of the alimentary tract. It performs a mechanical function within the body.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens or providing diagnostic information based on such analysis.
The device is a surgical instrument used for a specific procedure within the body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The NiTi Laparoscopic Compression Anastomosis Clip (LapCAC) is intended to be used to facilitate side-to-side anastomosis of the alimentary tract yielding an inverted serosa-to-serosa anastomosis. Once wound strength is sufficient to maintain the anastomosis, the NiTi Clip is wassed from the body. The LapCAC is indicated for open, minimally invasive or laparoscopic procedures.
Product codes
FZP
Device Description
The Laparoscopic Compression Anastomosis Clip (LapCAC) device is a sterile single patient use device. The LapCAC provides a simple method for the creation of side-to-side compression anastomosis of the alimentary tract in open, minimally invasive and laparoscopic procedures. The LapCAC device is comprised of two components:
- ▶ Clip Reload double ring clip that is inserted into the two cut segments Chp Reload - abusic ining to sees and performs the required compression on the tissue.
- ▶ Applier/Handle with which the Clip is introduced into the treated area.
The LapCAC device has an extended 35 or 45 cm. long shaft and is designed to pass through a 12 mm standard trocar.
After a period of 7-10 days, a compression-induced necrosis of the tissue Alter a period on I To days, a oursend the whole device, together with the Slucs undernouth the 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
alimentary tract
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 performance testing results NiTi Medical Technologies Ltd. Dascu on performance - count Compression Anastomosis Clip (LapCAC) is believes that the Eaparooysps predicate device cited above without raising new safety and/or effectiveness issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K033324, K041751, K892233, K913802
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
DEC = 1 2004
510(K) Summary
Laparoscopic Compression Anastomosis Clip (LapCAC) 510(k) Number Ko43 || S
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 NiTi Medical Technologies Ltd. 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:
November, 2004
Trade Name:
Laparoscopic Compression Anastomosis Clip (LapCAC)
1
Classification Name:
IMPLANTABLE CLIP
Classification:
The FDA has classified implantable clip as class II device (product code FZP, Regulation No. 21 C.F.R. § 878.4300) and they are reviewed by the Division of General and Restorative Devices.
Predicate Device:
- · CAC, Compression Anastomosis Clip (NiTi Medical Technologies Ltd.) cleared under K033324.
- · CAC, Compression Anastomosis Clip (NiTi Medical Technologies Ltd.) cleared under K041751.
- Universal Stapler System (United Surgical States GIA • Endo Cooperation, USA) originally cleared under K892233 and K913802.
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 Laparoscopic Compression Anastomosis Clip (LapCAC) is intended to be used to facilitate side-to-side anastomosis of the alimentary tract yielding an inverted serosa-to-serosa anastomosis. Once wound strength is sufficient to maintain the anastomosis, the NiTi Clip is wassed from the body. The LapCAC is indicated for open, minimally invasive or laparoscopic procedures.
Device Description:
The Laparoscopic Compression Anastomosis Clip (LapCAC) device is a sterile single patient use device. The LapCAC provides a simple method for the creation of side-to-side compression anastomosis of the alimentary tract in open, minimally invasive and laparoscopic procedures. The LapCAC device is comprised of two components:
2
- ▶ Clip Reload double ring clip that is inserted into the two cut segments Chp Reload - abusic ining to sees and performs the required compression on the tissue.
- ▶ Applier/Handle with which the Clip is introduced into the treated area.
The LapCAC device has an extended 35 or 45 cm. long shaft and is designed to pass through a 12 mm standard trocar.
After a period of 7-10 days, a compression-induced necrosis of the tissue Alter a period on I To days, a oursend the whole device, together with the Slucs undernouth the was compressed by the rings, detaches and is naturally expelled with the stool.
Substantial Equivalence:
Based on performance testing results NiTi Medical Technologies Ltd. Dascu on performance - count Compression Anastomosis Clip (LapCAC) is believes that the Eaparooosps 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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 1 2004
NiTi Medical Technologies Ltd c/o Mr. Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, D.C. 20004
Re: K043115
Trade/Device Name: Laparoscopic Compression Anastomosis Clip (LapCAC) Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP Dated: November 4, 2004 Received: November 10, 2004
Dear Mr. Kahan:
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 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 CFR 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. Jonathan S. Kahan, Esq
This letter will allow you 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 marketed 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provoost
Celia M. Witten, Ph.D., M.D.
Director 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):
Laparoscopic Compression Anastomosis Clip (LapCAC) Device Name:
Indications for Use:
The NiTi Laparoscopic Compression Anastomosis Clip (LapCAC) is intended to be used to facilitate side-to-side (Baperie) is the alimentary tract yielding an inverted serosa-to-serosa anastomosis. Once wound strength is sufficient to maintain the anastomosis, the NiTi Clip is passed from the body. The LapCAC is indicated for open, minimally invasive or 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_________________________________________________________________________________________________________________________________________________________________