The ByPass CorLink™ Aortic Anastomotic Device (CorLink™ AAD) is intended to be used in CABG procedures for creating a sutureless proximal anastomosis between the Aorta and a venous graft conduit.

Device Description

This 510(k) notification describes a device intended for use in Coronary Artery Bypass Grafting procedures for creating a rapid sutureless proximal anastomosis between a grafted vessel and the aorta. The C-Punch device is intended for creating the aortotomy in which the implanted device will be deployed. The C-Punch device is equivalent to the Linear Punch already cleared as a component of the CorLink AAD (K011589) with respect to intended use, materials and performance of the aortotomy. The major difference between the two systems is the method by which the punch creates the aortotomy. The Linear Punch creates an aortotomy by insertion of the punch tip to the aortic wall and retraction of the punch tip against the cutting tube. The cut piece of the aortic wall is contained within the cutting tube. The C-Punch achieves the same aortotomy sizes and quality by insertion of a central needle and cutting/coring the tissue by rotating the punch device clockwise and counterclockwise. The cut piece of the aortic wall is contained within the cutting/coring tube.

AI/ML Overview

The provided text is a 510(k) summary for the ByPass LTD, CorLinkTM Automated Anastomotic System. This document focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria or specific study results in the format requested.

The document states: "Information on risk analysis of the modifications and performance testing provided in the application demonstrates equivalence to the predicate device with respect to performance." and "Based on the performance data gathered, the device modifications do not raise any new questions of safety or effectiveness." However, it does not elaborate on what "performance data" was gathered, what specific metrics were used, or what acceptance criteria were applied.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated based on the text provided:

1. A table of acceptance criteria and the reported device performance

Cannot be provided definitively from the given text. The document only generally states that "performance testing provided in the application demonstrates equivalence to the predicate device with respect to performance." It also mentions "same aortotomy sizes and quality" for the C-Punch compared to the Linear Punch, implying these are performance characteristics considered. No specific quantitative criteria or reported values are given.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Cannot be provided from the given text. The document mentions "performance testing" but does not specify the sample size or the nature/provenance of the data.

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)

Not applicable / Cannot be provided from the given text. This 510(k) summary does not describe a study involving expert-established ground truth for a test set in the context of diagnostic performance. It focuses on the comparison of a new surgical device component (C-Punch) to an existing one (Linear Punch) based on its mechanical performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable / Cannot be provided from the given text. As above, no such adjudication method is relevant or mentioned for the type of testing described.

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

No, an MRMC study was not done. This document describes a surgical device, not an AI-based diagnostic tool that would involve human readers or AI assistance in interpretation.

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

Not applicable. This device is a manual surgical tool (a punch), not an algorithm or an AI system.

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

Inferable: The "ground truth" or comparative standard for the C-Punch's performance seems to be its ability to achieve "the same aortotomy sizes and quality" as the predicate Linear Punch. This would likely be assessed through direct measurement and visual inspection of the aortotomies created by the devices in a laboratory or ex-vivo setting.

8. The sample size for the training set

Not applicable. This device is not an AI model requiring a training set.

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

Not applicable. This device is not an AI model requiring a training set.

Summary

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8 2002 MAR

510(k) Summary of Safety and Effectiveness ByPass LTD, CorLinkTM Automated Anastomotic System 510(k) Number KO20470

This 510(k) notification is submitted by ByPass LTD.3 Hasadnaot St.Herzelia B 46728 Israel

The contact person is Amir Loshakove, General Manager.

The C-Punch device is equivalent to the Linear Punch already cleared as a component of the CorLink AAD (K011589) with respect to intended use, materials and performance of the aortotomy. The major difference between the two systems is the method by which the punch creates the aortotomy. The Linear Punch creates an aortotomy by insertion of the punch tip to the aortic wall and retraction of the punch tip against the cutting tube. The cut piece of the aortic wall is contained within the cutting tube. The C-Punch achieves the same aortotomy sizes and quality by insertion of a central needle and cutting/coring the tissue by rotating the punch device clockwise and counterclockwise. The cut piece of the aortic wall is contained within the cutting/coring tube.

Information on risk analysis of the modifications and performance testing provided in the application demonstrates equivalence to the predicate device with respect to performance.

Based on the performance data gathered, the device modifications do not raise any new questions of safety or effectiveness.

Based on the information provided the modification of the CorLink™ AAD to include the C-Punch is substantially equivalent to the cleared CorLink™ AAD using the Linear Punch with respect to intended use, technological characteristics, and performance.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with three overlapping wing-like shapes. The bird is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 8 2002

ByPass, Ltd. c/o Jonathan Kahan Hogan and Hartson 555 Thirteenth Street, N.W. Washington, D.C. 20004 -1109

Re: K020470

Trade Name: CorLink™ AAD Regulation Number: 878.4300; 878.4300 Regulation Name: Implantable Clip; Aortic Stapling Device Regulatory Class: II Product Code: FZP, NCA Dated: February 19, 2002 Received: February 20, 2002

Dear Mr. Kahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.

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Page 2 – Mr. Jonathan S. Kahan

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 and additionally 21 CFR 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. Provoort

for 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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INDICATIONS FOR USE ENCLOSURE

510(k) Number (if known):	K020470
Device Name:	CorLink™ Automated Anastomotic Device
Indications for Use:	The ByPass CorLink™ Aortic Anastomotic Device (CorLink™ AAD) is intended to be used in CABG procedures for creating a sutureless proximal anastomosis between the Aorta and a venous graft conduit.

(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 General and Restorative Devices

510(k) Number K020470

Prescription Use
(Per 21 CFR 801.109)

Over the Counter Use

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K620470

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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.