The VesseLink is to be used in the anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. Excluded is the use for coronary artery anastomosis.

Device Description

The VesseLink Microvascular Anastomotic Coupler (VesseLink) is a mechanical method for anastomosis, or connection, of small vessels ranging in size from 0.8 mm to 4.3 mm in outer diameter. The VesseLink is intended for use in the end-to-end and end to side vessel anastomosis as well as arterial/venous vein grafts. It is to be used in veins and arteries that are normally encountered in microsurgical and vascular reconstructive procedures. Excluded is the use for coronary artery anastomosis.

AI/ML Overview

The provided document does not contain information about acceptance criteria and a study proving a device meets these criteria in the typical sense of a clinical or analytical performance study with specific metrics, sample sizes, and ground truth establishment.

Instead, the document is a 510(k) premarket notification for the "VesseLink Microvascular Anastomotic Coupler System." The core of this submission is to demonstrate substantial equivalence to a predicate device, not to prove performance against predetermined acceptance criteria through a standalone study.

Here's an breakdown based on the provided text, addressing your points where possible, and highlighting what's not present:

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

Acceptance Criteria: Not explicitly stated as quantifiable metrics with pass/fail thresholds in the provided document. The overarching "acceptance criterion" for this submission is demonstrating substantial equivalence to the predicate device.
Reported Device Performance: The document states:
- "Bench testing was performed to demonstrate the product functions as intended and is shown to be substantially equivalent."
- This is a general statement and does not provide specific performance metrics (e.g., burst pressure, patency rates, leakage rates, etc.) or quantitative results from the bench testing.

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

The document mentions "bench testing" but does not specify any sample size for this testing.
It does not mention data provenance (country of origin, retrospective/prospective) for any test 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)

This information is not applicable and not present in the document. The substantial equivalence claim is based on technological characteristics and intended use, not on expert-adjudicated ground truth from a test set of patient data.

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

This information is not applicable and not present. No multi-reader adjudication process is mentioned for any test set.

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 MRMC or comparative effectiveness study involving human readers or AI assistance was conducted or reported. This device is a mechanical anastomotic coupler, not an AI or diagnostic imaging device.

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

This is not applicable as the device is a mechanical medical device, not an algorithm or AI.

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

For this type of device and submission (510k, substantial equivalence), the "ground truth" essentially refers to documented performance and characteristics of the predicate device, against which the new device's characteristics are compared (e.g., materials, dimensions, mechanism of action, intended use). There is no "ground truth" derived from patient outcomes or expert consensus in the typical sense for this submission.

8. The sample size for the training set

Not applicable as this is a mechanical device, not an AI or machine learning model that requires a training set.

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

Not applicable for the same reason as point 8.

In summary:

The provided document details a 510(k) submission for a medical device (VesseLink Microvascular Anastomotic Coupler System) seeking clearance based on substantial equivalence to a predicate device. The "study" mentioned is "bench testing," but no specific quantitative results, sample sizes, or methods for establishing ground truth as would be relevant for an AI or diagnostic device performance study are provided. The focus is on demonstrating similar technological characteristics and intended use to a legally marketed device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for ViOptix. The logo consists of the text "ViOptix" in a simple, sans-serif font. To the right of the text, there is a stylized graphic that resembles a person with outstretched arms forming a "V" shape, with a circle representing the head. The graphic is bold and black, contrasting with the white background.

APR 1 7 2009

47224 Mission Falls Ct. Fremont, CA 94539 510-360-7523 info@vioptix.com

SUMMARY

Submitter's name: Address:

Phone: Fax number: Name of contact person: ViOptix, Inc. 47224 Mission Falls Ct. Fremont, CA 94539 510-360-7523 510-226-5864 Grace Holland Requiatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411

March 13, 2009 Date the summary was prepared:

Name of the device: Classification name: Product code

Device Class

VesseLink Microvascular Anastomotic Coupler System Microvascular Anastomotic Coupler MVR 878.4300

The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:

Reference #	Device Name	Applicant
K040163	Microvascular Anastomotic Device	Synovis Micro Companies

Description of the device:

REGULATORY SPECIALISTS, INC.

Page 13

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vein grafts. It is to be used in veins and arteries that are normally encountered in microsurgical and vascular reconstructive procedures. Excluded is the use for coronary artery anastomosis.

Indications:

To be used in the anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. Excluded is the use for coronary artery anastomosis.

Summary of the technological characteristics of our device compared to the predicate device:

Technological Characteristics

proposed device has the same technological This characteristics as the predicate device.

Indications for Use

The Indications for Use for this proposed device had the same Indications for Use as the predicate device.

Performance Testing

Bench testing was performed to demonstrate the product functions as intended and is shown to be substantially equivalent.

CONCLUSION

Based on the design, technology, performance, functional testing, and intended use, the VesseLink is substantially equivalent to the devices currently marketed under the Federal Food. Drug and Cosmetic Act. The VesseLink raises no new issues of safety or effectiveness. Therefore, safety and effectiveness are reasonably assured, and substantial equivalence is supported, justifying 510(k) clearance of VesseLink.

REGULATORY SPECIALISTS, INC.

Page 14

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 7 2009

ViOptix, Inc. % Regulatory Specialist, Inc. Ms. Grace Holland 3722 Avenue Sausalito Irvine, California 92606

Re: K090679

Trade/Device Name: Microvascular Anastomotic Coupler System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: MVR Dated: March 13, 2009 Received: March 16, 2009

Dear Ms. Holland:

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 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 - Ms. Grace Holland

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

for

Mark N. Moll

Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indications for Use Statement

Indications for Use

く、

510(k) Number (if known): ____K090679

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The VesseLink is to be used in the anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. Excluded is the use for coronary artery anastomosis.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Keane for MXM
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K090679

Page 1 of 1

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.