VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM

K090679 · Vioptix, Inc. · MVR · Apr 17, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090679
• Device Name: VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM
• Applicant: Vioptix, Inc.
• Product Code: MVR · General, Plastic Surgery
• Decision Date: Apr 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

VesseLink Microvascular Anastomotic Coupler System is a mechanical device for end-to-end and end-to-side vessel anastomosis. It connects small vessels (0.8 mm to 4.3 mm outer diameter) in microsurgical and vascular reconstructive procedures. Used by surgeons in clinical settings. Device facilitates vessel connection, potentially reducing procedure time and improving outcomes in reconstructive surgery. Excludes coronary artery applications.

Clinical Evidence

Bench testing only.

Technological Characteristics

Mechanical anastomotic coupler for vessels 0.8 mm to 4.3 mm in diameter. Design and technology are identical to the predicate device.

Indications for Use

Indicated for anastomosis of veins and arteries in microsurgical and vascular reconstructive procedures. Excluded: coronary artery anastomosis.

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

• Microvascular Anastomotic Device (K040163)

Submission Summary (Full Text)

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APR 1 7 2009

47224 Mission Falls Ct. Fremont, CA 94539 510-360-7523 [e-mail]

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: [phone]

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:

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

REGULATORY SPECIALISTS, INC.

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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.

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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 [phone]. 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 [phone]. 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 [phone] or [phone] 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

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