The Aortic Connector System is a mechanical device used to facilitate an aortic vein graft anastomosis. The connector replaces sutures to create a secure, patent, and reproducible anastomosis. The Symmetry Aortic Connector System consists of a self expanding implantable connector and delivery system.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Aortic Connector System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Performance equivalent to standard suture anastomoses	Mechanical, In Vitro, and animal testing demonstrates that the performance of the Aortic Connector System is equivalent to standard suture anastomoses.
Secure, patent, and reproducible anastomosis	Not explicitly stated as a separate acceptance criterion, but implied as a design goal the device aims to achieve, as it "replaces sutures to create a secure, patent, and reproducible anastomosis." The testing demonstrating equivalence to sutures would implicitly cover this.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for the mechanical, in vitro, or animal testing.

Test Set Sample Size: Not specified.
Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. Given the context of a 510(k) submission in the US, it's highly likely the testing was conducted in the US and involved a mix of in vitro (laboratory), mechanical (simulated conditions), and in vivo (animal) studies. The type of testing suggests it was prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of human experts to establish ground truth for the device's performance. The testing described focuses on objective mechanical and biological endpoints rather than expert-derived assessments.

4. Adjudication Method for the Test Set

Not applicable, as expert adjudication is not mentioned in the testing described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study compares the device's performance to "standard suture anastomoses" through mechanical, in vitro, and animal testing, not against human readers' performance with and without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, the testing described is effectively "standalone" in the sense that it evaluates the device's inherent mechanical and biological performance without human intervention in the loop for assessment. The "device" in this context is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the study was established through objective measurements and observations from mechanical, in vitro, and animal testing, comparing the Aortic Connector System's performance to "standard suture anastomoses." This would include metrics such as:

Mechanical strength/integrity (e.g., burst pressure, tensile strength of the anastomosis)
Patency (e.g., flow characteristics in in vitro models or animal studies)
Biocompatibility and tissue response in animal models
Reproducibility of the anastomosis

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here, as this device is a physical medical implant and delivery system, not an artificial intelligence/machine learning algorithm that requires training data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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MAY 21 2001

K00344651

510(k) Summary

Aortic Connector System

Common/Classification Name: Implantable Clip and delivery system as classified under 21 CFR 878.4300 and 4800

St. Jude Medical Anastomotic Technology Group 6500 Wedgwood Rd. Maple Grove, MN 55311

Telephone: (763) 383-2559 (763) 383-2771 Fax: Contact: Milana Solganik, Director of Regulatory Affairs

Prepared: November 1, 2000

A. Legally Marketed Predicate Devices

The Aortic Connector System is substantially equivalent to the U.S. Surgical AutoSuture Vascular Anastomosis Clip Cartridge and Applier (K970793).

B. Device Description

C. Indications for Use

The Aortic Connector System is intended to create the aortic anastomosis of aortic autologous vein grafts.

D. Substantial Equivalence Summary

Both devices are intended to be used in creating vascular anastomoses. The St. Jude Medical Anastomotic Technology Group Mechanical Anastomosis Connector is made of a Nickel Titanium alloy (Nitinol) in a "U" shape with rounded ends. The U.S. Surgical clip is made of Titanium in a "C" shape with blunted ends. The ends of both clips pinch the edges of the vessels together without penetrating the vessel wall.

The primary difference between the devices is the delivery method. The U.S. Surgical applier fires the clips one at a time, and the applier must be manually moved circumferentially around the anastomosis site. The St. Jude Medical Anastomotic

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K003446S1

Technology Group Mechanical Anastomosis Connector is a unitary device with all clipping elements being deployed simultaneously around the circumference.

E. Technological Characteristics

See Device Description above.

F. Testing

Mechanical, In Vitro, and animal, testing has been conducted which demonstrates that the performance of the Aortic Connector System is equivalent to standard suture anastomoses.

G. Conclusion

St. Jude Medical has demonstrated through its comparison of performance with standard suture anastomoses that the Aortic Connector System is equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

MAY 2 1 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Al Flory Vice President, Clinical and Regulatory Affairs St. Jude Medical Cardiac Surgery Division Anastomotic Technology Group 6500 Wedgwood Road Maple Grove, Minnesota 55311

Re: K003446

Trade/Device Name: Symmetry Aortic Clip System Regulation Number: 878.4300 Regulatory Class: II Product Code: FZP Dated: February 16, 2001 Received: February 20, 2001

Dear Mr. Sheridan:

We have reviewed your Section 510(k) 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 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Robert L. Sheridan

This letter will allow you to begin marketing your device as described in your 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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.

Mude M. Mulle

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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K@@344651

Page _ of _1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K003446

Device: Mechanical Anastomosis System

Indications for Use:

The Aortic Connector System is intended to create the aortic anastomosis of aortic autologous vein grafts.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use __

(Optional Format 1-2-96)

Mark N. Mellman

ivision of General, Restorative and Neurological Devices

510(k) Number K003446

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.