(217 days)
Not Found
No
The description focuses on the mechanical function and materials of the device, with no mention of AI or ML capabilities.
No
The device is described as an anastomotic device intended to create connections between blood vessels during bypass procedures, which is a surgical tool, not a therapeutic device meant to treat a condition directly.
No
The device is an anastomotic device intended to create connections between blood vessels during surgical procedures, not to diagnose medical conditions.
No
The device description clearly describes a physical implant made of nitinol with self-expanding and flexible components, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to create vascular anastomoses between blood vessels during a surgical procedure (CABG). This is a surgical device used in vivo (within the body).
- Device Description: The device is an implantable, self-expanding nitinol device designed to physically connect blood vessels. This is a surgical implant, not a diagnostic tool.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide diagnostic information about a patient's condition.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly does not fit that description.
N/A
Intended Use / Indications for Use
The ByPass CorLink™ Anastomotic Device is intended to create vascular anastomoses between blood vessels. Specifically, the device is indicated for creation of a sutureless proximal anastomosis between a venous graft conduit and the aorta for coronary artery bypass grafting (CABG) procedures.
Product codes
NCA, FZP
Device Description
The ByPass CorLinkTM Automated Anastomotic Device (CorLinkTMAAD) intended use is to create the proximal graft-aorta anastomosis during a CABG procedure.
The CorLinkTM AAD, delivered with an introducer kit, is a single use system. The implant is made of self-expanding nitinol and composed of two main elements: the self-expandable center area and the flexible pins at both ends.
The center is made of connected elliptic arches, which upon implant expansion exert a radial force on the everted vein end and the aortic wall. The flexible pins from both ends of the device fold and "bite" the aortic wall in a way that connects and compresses the grafted vessel against the aorta. This procedure stabilizes the implant at the desired location and creates a sealing surface around the anastomosis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessel, aorta
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
Bench and animal testing has demonstrated that the CorLinkTM AAD is safe and effective and that its performance is substantially equivalent to its predicate devices.
Key Metrics
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 8 2003
ByPass Maakafim, Ltd. c/o Mr. Jonathan Kahan Hogan and Hartson 555 Thirteenth Street, NW Washington, DC 20004-1109
Re: K011589
Trade/Device Name: CorLink™ AAD Regulation Number: 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NCA Dated: November 8, 2001 Received: November 8, 2001
Dear Mr. Kahan:
This letter corrects our substantially equivalent letter of December 26, 2001 regarding the CorLink™ AAD. We have corrected the product code from FZP to NCA.
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 (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 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Miriam C. Provost
for S.J.M. Witte, Ph.D., M.D.
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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coronary artery bypass grafting (CABG) procedures.
INDICATIONS FOR USE
K011589 510(k) Number (if known):
ByPass CorLink™ Automated Anastomotic Device Device Name: (CorLinkTM AAD), consisting of the Implant, Inserter, Punch, Handle, Sizers and everting tool. The ByPass CorLink™ Anastomotic Device is Indications for Use: intended to create vascular anastomoses between blood vessels. Specifically, the device is indicated for creation of a sutureless proximal anastomosis between a venous graft conduit and the aorta for
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-off) Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices
510(k) Number K011589
× Prescription Use (Per 21 CFR 801.109) OR
Over the Counter Use
NRo for cmw
(Division Sign-Off) Division of Gener Restorative and Neurological revices
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510(k) Notification for ByPass CorLink™ AAD
DEC 2 6 2001
510(k) Summary for the ByPass CorLink™ AAD 510(k) Number K011589
Submitter's Name:
Amir Loshakove, Ph.D. ByPass Ltd. 3 Hasadnaot Street Herzelia Israel Telephone: 972-9-9704321 / Fax: 972-9-9704355
Device:
Trade name: ByPass CorLink™ AAD Classification Name: Implantable Clip Product Code: FZP
Predicate Devices:
The ByPass CorLink™ AAD is substantially equivalent to the USSC One-Shot Sutureless System (K970793), the USSC Auto Suture Vascular Anastomosis Clip (K933887) and the Deknatel Gwathmey Vascular Stapling Kit (K864146).
Indication for Use:
The ByPass CorLink™ Anastomotic Device is intended to create vascular anastomoses between blood vessels. Specifically, the device is indicated for creation of a sutureless proximal anastomosis between a venous graft conduit and the aorta for coronary artery bypass grafting (CABG) procedures.
Device Description:
The ByPass CorLinkTM Automated Anastomotic Device (CorLinkTMAAD) intended use is to create the proximal graft-aorta anastomosis during a CABG procedure.
The CorLinkTM AAD, delivered with an introducer kit, is a single use system. The implant is made of self-expanding nitinol and composed of two main elements: the self-expandable center area and the flexible pins at both ends.
The center is made of connected elliptic arches, which upon implant expansion exert a radial force on the everted vein end and the aortic wall. The flexible pins from both ends of the device fold and "bite" the aortic wall in a way that connects
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and compresses the grafted vessel against the aorta. This procedure stabilizes the implant at the desired location and creates a sealing surface around the anastomosis.
Technological Characteristics and Performance:
All materials used in the ByPass CorLink™ AAD are either commonly used in medical applications or have been proven to be biocompatible through biocompatibility testing. Bench and animal testing has demonstrated that the CorLinkTM AAD is safe and effective and that its performance is substantially equivalent to its predicate devices.
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