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 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.

AI/ML Overview

This document describes a 510(k) premarket notification for the ByPass CorLink™ Automated Anastomotic Device (AAD). The information provided focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and detailed study results for the device itself. Therefore, many of the requested details about acceptance criteria, specific performance metrics, and study design are not explicitly available in the provided text.

Based on the available information, here's what can be extracted and what remains unknown:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated/Implied)	Reported Device Performance as per Submission
Biocompatibility	All materials commonly used in medical applications or proven biocompatible through testing.
Safety & Effectiveness	Demonstrated through bench and animal testing.
Substantial Equivalence to Predicate Devices (USSC One-Shot Sutureless System, USSC Auto Suture Vascular Anastomosis Clip, Deknatel Gwathmey Vascular Stapling Kit)	Performance demonstrated as substantially equivalent to predicate devices.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The document states "Bench and animal testing" but does not provide numbers for either.
Data Provenance: Not specified. The submission is from ByPass Ltd. in Herzelia, Israel, but the location of the animal testing and bench testing is not mentioned. The document does not specify if the data is retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method for the test set

Adjudication Method: Not specified.

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

MRMC Study: No, this is not an AI-assisted device and therefore an MRMC study is not applicable. The device is a physical medical implant/instrument for surgical procedures.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This is a physical medical device, not an algorithm. Bench testing and animal testing were performed, which can be considered "standalone" in the sense of evaluating the device's physical performance independently, but not in the context of an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: For the "bench and animal testing" to demonstrate safety and effectiveness, the ground truth would likely involve:
- Bench Testing: Engineering measurements, force testing, leak testing, material properties analysis, etc.
- Animal Testing: Surgical outcomes, histopathology of anastomotic sites, patency rates, observation of adverse events, etc.
- The document does not detail specific metrics or the "ground truth" definition for the equivalence to predicate devices, beyond demonstrating comparable safety and effectiveness.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is not a machine learning or AI device. The concept of a "training set" as understood in AI is not relevant here.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable (see point 8).

Summary of what is known and unknown:

Known: The device is the ByPass CorLink™ Automated Anastomotic Device (AAD) for creating sutureless proximal anastomoses in CABG procedures. It's an implantable clip. Bench and animal testing were conducted to demonstrate biocompatibility, safety, effectiveness, and substantial equivalence to three predicate devices (USSC One-Shot Sutureless System, USSC Auto Suture Vascular Anastomosis Clip, and Deknatel Gwathmey Vascular Stapling Kit).
Unknown: Specific numerical acceptance criteria, detailed results from bench and animal testing (e.g., number of animals, specific outcomes measured, statistical results), sample sizes for testing, exact methodologies for establishing safety/effectiveness beyond the general statement, and any information regarding expert involvement in ground truth determination.

Summary

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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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	ByPass
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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:

Device Description:

The ByPass CorLinkTM Automated Anastomotic Device (CorLinkTMAAD) intended use is to create the proximal graft-aorta anastomosis during a CABG procedure.

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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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Regulation Number and Section

§ 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.