CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK AAD (2.0 TO 4.0 MM OUTER DIAMETER VESSELS), M

K011589 · Bypass , Ltd. · NCA · Dec 26, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K011589
• Device Name: CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK AAD (2.0 TO 4.0 MM OUTER DIAMETER VESSELS), M
• Applicant: Bypass , Ltd.
• Product Code: NCA · General, Plastic Surgery
• Decision Date: Dec 26, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 Story

CorLink™ AAD is a single-use system for creating sutureless proximal anastomoses during CABG. System components include an implant, inserter, punch, handle, sizers, and everting tool. The implant consists of self-expanding nitinol with a center area of connected elliptic arches and flexible pins at both ends. During operation, the device is deployed to exert radial force on the everted vein end and the aortic wall; flexible pins fold to bite the aortic wall, stabilizing the implant and compressing the graft against the aorta to create a seal. Used by surgeons in an OR setting. Benefits include simplified, sutureless graft-to-aorta connection, potentially reducing procedure time and improving anastomosis stability.

Clinical Evidence

Bench and animal testing performed. Results demonstrated the device is safe and effective, with performance substantially equivalent to predicate devices.

Technological Characteristics

Implant material: self-expanding nitinol. System components: inserter, punch, handle, sizers, everting tool. Mechanism: radial force exertion via elliptic arches and mechanical fixation via flexible pins. Single-use. Biocompatible materials.

Indications for Use

Indicated for patients undergoing coronary artery bypass grafting (CABG) procedures requiring a sutureless proximal anastomosis between a venous graft conduit and the aorta.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• USSC One-Shot Sutureless System (K970793)
• USSC Auto Suture Vascular Anastomosis Clip (K933887)
• Deknatel Gwathmey Vascular Stapling Kit (K864146)

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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

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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: [phone] / Fax: [phone]

#### 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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