GEM FLOW COUPLER DEVICE AND SYSTEM

K132727 · Synovis Life Technologies, Inc. · MVR · Oct 22, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K132727
• Device Name: GEM FLOW COUPLER DEVICE AND SYSTEM
• Applicant: Synovis Life Technologies, Inc.
• Product Code: MVR · General, Plastic Surgery
• Decision Date: Oct 22, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended Use

The Flow COUPLER Device and System is intended to be used in the anastomosis of veins and arteries normally encountered in microvascular and vascular reconstructive procedures and in the detection of blood flow and confirmation of vessel patency following end-to-end anastomosis of vessels.

Device Story

System comprises implantable rings and external Doppler monitor; rings molded from high-density polyethylene with stainless steel pins; probe-holder feature allows press-fit attachment of 20 MHz Doppler probe. Device used in microvascular/vascular reconstructive surgery for end-to-end vessel anastomosis. Doppler probe provides pulsed ultrasound to detect blood flow; produces audible signal via monitor. Physician uses audible feedback to confirm vessel patency intra-operatively and post-operatively. Rings are permanent implants; probe is temporary, removed via external lead 3-14 days post-operatively. Modifications to probe wire material/insulation addressed via bench testing and biocompatibility assessment.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included Doppler probe signal functionality, wire tensile/connection strength, electrical safety (IEC 60601-1), and biocompatibility (ISO 10993-1).

Technological Characteristics

Implantable rings: high-density polyethylene with stainless steel pins. Doppler probe: 20 MHz pulsed ultrasound. Connectivity: wired connection to external monitor. Sterilization: sterile, single-use. Standards: EN ISO 14971:2012 (risk management), IEC 60601-1 (electrical safety), ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for patients undergoing microvascular and vascular reconstructive procedures requiring end-to-end anastomosis of veins and arteries. Used for intra-operative and post-operative (up to 7 days) detection of blood flow and confirmation of vessel patency at the anastomotic site.

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

• GEM Flow COUPLER Device and System (K093310)

Submission Summary (Full Text)

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## 510(K) SUMMARY

Submitted by Synovis Micro Companies Alliance, Inc. A Subsidiary of Synovis Life Technologies, Inc. 439 Industrial Lane Birmingham, AL 35211-4464

FDA Registration #1062741

Tel: [phone] Fax: [phone]

OCT 2 2 2013

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Contact Person Troy Thome Synovis Surgical Innovations, A Division of Synovis Life Technologies, Inc. 2575 University Avenue West St. Paul, MN 55114-1024

> Tel: [phone] Fax: [phone]

August 30, 2013 Date Prepared

Device Trade Name GEM™ Flow COUPLERTM Device and System

Common Name

- Microvascular Anastomotic Coupler . . Cardiovascular Blood Flowmeter
- Classification Name Microvascular Anastomotic Coupler Regulation Number: 21 CFR § 878.4300 Regulation Name: Implantable Clip Regulatory Class: II Product Code: MVR, DPW

Predicate Device(s) GEM Flow COUPLER Device and System; K093310

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## K132727 Page 2/3

#### Device Description

The Flow COUPLER System consists of a Flow COUPLER Device and a Flow COUPLER Monitor. The Flow COUPLER Device is a sterile, single-use implantable pair of rings molded out of high density polyethylene with six stainless steel pins on each ring. The Flow COUPLER Device is designed to serve as a mechanical, sutureless device for connecting veins or arteries. A probe-holder feature is molded on one Flow COUPLER ring and serves as the press-fit point of attachment for a pre-attached 20 MHz Doppler probe. The Doppler probe connects to the Flow COUPLER Monitor unit, via the external lead.

The Flow COUPLER Monitor and Doppler probe is a pulsed Doppler ultrasound system designed for the detection of blood flow in vessels. An audible ultrasonic signal is produced when the Doppler probe detects blood flow.

The Flow COUPLER Device and System has been specifically designed for use in end-to-end anastomosis of blood vessels and the detection of blood flow at the anastomotic site. On an as needed basis, blood flow can be detected for up to 7 days. The Flow COUPLER rings are intended to be a permanent implant. The Flow COUPLER probe is not intended to be a permanent implant; the probe should be removed, by gentle traction on the external lead, 3 to 14 days post-operatively.

## Statement of Intended use

The Flow COUPLER Device and System is intended to be used in the anastomosis of veins and arteries normally encountered in microvascular and vascular reconstructive procedures and in the detection of blood flow and confirmation of vessel patency following end-to-end anastomosis of vessels.

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## Technological Comparisons

The Flow Coupler Device and System is acting as its own predicate and is therefore substantially equivalent having the same technological characteristics including:

- Intended use �
- Indications for use .
- . Device functionality
- Device method of operation o
- . Device finished specifications
- Device dimensions .
- . Device size range
- Power supply requirements .
- Device monitor .
- . Packaging
- Sterilization method .
- Shelf life .

The modified Flow Coupler device has the following differences as compared to the predicate device:

- Doppler probe (wire material, wire diameter, and insulation . material)
## Technology/Device Testing

A risk assessment of the modifications in the form of a Design FMEA and Health Hazard Analysis has been conducted in accordance with EN ISO 14971: 2012.

Non-clinical testing on the modified device was performed to verify that the functional specifications were not affected by the modification to the Doppler wire. Testing included: Doppler probe signal functionality. Doppler probe wire tensile and connection strength testing, electrical testing conformance to IEC 60601-1.

The Doppler wire is tissue contacting (duration > 24 hours but < than 30 days); therefore, biocompatibility testing was performed in accordance to ISO 10993-1 (Biological Evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process.)

The risk assessment, biocompatibility and component qualification of this device demonstrates that the device is substantially equivalent to the predicate device.

Summary

The device is substantially equivalent to the predicate device with respect to biocompatibility, manufacturing process, product performance, indications, sterilization, shelf life, packaging, and safety and efficacy.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

October 22, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Synovis Life Technologies, Incorporated Mr. Troy Thome Regulatory Affairs Specialist 2575 University Avenue, West Suite 180 Saint Paul, Minnesota 55114

Re: K132727

Trade/Device Name: GEM™ Flow COUPLER™ Device and System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: MVR. DPW Dated: September 30, 2013 Received: October 7, 2013

Dear Mr. Thome:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRFI does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

1f 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 Tound 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Troy Thome

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

## Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K 132727

GEM™ Flow COUPLERTM Device and System Device Name:

### Indications for Use:

The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Postoperatively, blood flow can be detected on an as needed basis for up to 7 days. The FlowCOUPLER Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days post-operatively.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

# David Krause -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K132727

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