GEM Flow COUPLER Device and System

K143589 · Synovis Life Technologies, Inc. · MVR · Jan 16, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K143589
• Device Name: GEM Flow COUPLER Device and System
• Applicant: Synovis Life Technologies, Inc.
• Product Code: MVR · General, Plastic Surgery
• Decision Date: Jan 16, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Indications for Use

The Flow COUPLER 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 Flow COUPLER 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 Flow COUPLER Device is used in conjunction with the Flow COUPLER Monitor, the Flow COUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Post-operatively, blood flow can be detected on an as needed basis for up to 7 days. The Flow COUPLER Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days post-operatively. 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 coupler rings and external Doppler monitor; used in microsurgical/vascular reconstructive procedures. Coupler rings (high-density polyethylene, stainless steel pins) provide sutureless end-to-end vessel anastomosis; permanent implant. 20 MHz Doppler probe press-fits onto ring; connects to monitor via external lead. Monitor provides pulsed Doppler ultrasound; produces audible signal upon blood flow detection. Used intra-operatively and post-operatively (up to 7 days) to confirm vessel patency. Probe removed 3-14 days post-op via gentle traction. Clinicians use audible output to assess anastomotic site health; aids in early detection of vascular compromise; facilitates timely clinical intervention.

Clinical Evidence

Bench testing only. No clinical data presented. Testing validated functional specifications for the 4.0mm line extension, including shock/vibration, pin alignment, ring retention, probe signal, and separation forces.

Technological Characteristics

Implantable rings: high-density polyethylene with stainless steel pins. Doppler probe: 20 MHz pulsed ultrasound. System: sterile, single-use implantable coupler + external monitor. Connectivity: wired probe to monitor. Sterilization: not specified. Software: not specified. Standards: EN ISO 14971:2012 (risk management).

Indications for Use

Indicated for patients undergoing microsurgical 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 (K142609)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, representing health and human services.

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

January 16, 2015

Synovis Life Technologies Incorporated Ms. Jodi Jorgenson Manager, Regulatory Affairs 2575 University Avenue West, Suite 180 Saint Paul, Minnesota 55114

Re: K143589

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: December 17, 2014 Received: December 18, 2014

Dear Ms. Jorgenson:

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 note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical

{1}------------------------------------------------

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

for

Sincerely yours,

# David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K143589

## Device Name

GEM™ Flow COUPLERTM Device and System

#### Indications for Use (Describe)

The Flow COUPLER 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 Flow COUPLER 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 Flow COUPLER Device is used in conjunction with the Flow COUPLER Monitor, the Flow COUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Post-operatively, blood flow can be detected on an as needed basis for up to 7 days. The Flow COUPLER Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days post-operatively.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

EF

{3}------------------------------------------------

#### 2.0 510(K) SUMMARY

| Submitted by: | Synovis Micro Companies Alliance, Inc.<br>A Subsidiary of Synovis Life Technologies, Inc.<br>439 Industrial Lane<br>Birmingham, AL 35211-4464 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | FDA Registration #1062741 |
| | Tel: [phone]<br>Fax: [phone] |
| Contact Person: | Jodi Jorgenson<br>Synovis Micro Companies Alliance, Inc.,<br>A Subsidiary of Synovis Life Technologies, Inc.<br>2575 University Avenue West<br>St. Paul, MN 55114-1024 |
| | Tel: [phone]<br>Fax: [phone] |
| Date Prepared: | December 17, 2014 |
| Device Trade Name: | GEM™ Flow COUPLER™ Device and System |
| Common Name: | Microvascular Anastomotic Coupler<br>Cardiovascular Blood Flowmeter |
| Classification Name: | Microvascular Anastomotic Coupler<br>Regulation Number: 21CFR § 878.4300<br>Regulation Name: Implantable Clip<br>Regulatory Class: II<br>Product Code: MVR, DPW |
| Predicate Device: | GEM Flow COUPLER Device and System: K142609 |

{4}------------------------------------------------

| Device Description: | The Flow COUPLER System consists of a Flow COUPLER Device<br>and a Flow COUPLER Monitor. The Flow COUPLER Device is a<br>sterile, single-use implantable pair of rings molded out of high<br>density polyethylene with stainless steel pins on each ring. The<br>Flow COUPLER Device is designed to serve as a mechanical,<br>sutureless device for connecting veins or arteries. A probe-holder<br>feature is molded on one Flow COUPLER ring and serves as the<br>press-fit point of attachment for a pre-attached 20 MHz Doppler<br>probe. The Doppler probe connects to the Flow COUPLER<br>Monitor unit, via the external lead.<br><br>The Flow COUPLER Monitor and Doppler probe is a pulsed<br>Doppler ultrasound system designed for the detection of blood flow<br>in vessels. An audible ultrasonic signal is produced when the<br>Doppler probe detects blood flow.<br><br>The Flow COUPLER Device and System has been specifically<br>designed for use in end-to-end anastomosis of blood vessels and the<br>detection of blood flow at the anastomotic site. On an as needed<br>basis, blood flow can be detected for up to 7 days. The Flow<br>COUPLER rings are intended to be a permanent implant. The Flow<br>COUPLER probe is not intended to be a permanent implant; the<br>probe should be removed, by gentle traction on the external lead,<br>3 to 14 days post-operatively. |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Statement of<br>Intended use: | The Flow COUPLER Device and System is intended to be used in<br>the anastomosis of veins and arteries normally encountered in |
| Technological<br>Comparisons: | The Flow Coupler Device and System is acting as its own predicate<br>and is therefore substantially equivalent having the same<br>technological characteristics including:<br>Intended use Indications for use Device functionality Device method of operation Device finished specifications Doppler probe (wire material, wire diameter, and insulation material) 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: Device size range Device dimension |
| Technology/Device<br>Testing: | A risk assessment of the size range extension in the form of a Design FMEA and Health Hazard Analysis has been conducted in accordance with EN ISO 14971: 2012.<br><br>Bench testing on the 4.0mm Flow COUPLER line extension was performed to validate that the functional specifications were not affected by the line extension. Testing included: shock and vibration, pin alignment, ring retention, probe signal, ring separation, and probe to COUPLER separation force.<br><br>The risk assessment and bench testing of this device demonstrate 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. |

microvascular and vascular reconstructive procedures and in the detection of blood flow and confirmation of vessel patency following end-to-end anastomosis of vessels.

{5}------------------------------------------------

{6}------------------------------------------------

#### Standards Data Report for 510(k)s – FDA 3654 3.0

Form FDA 3654 FDA Standards Data Report Forms is provided in Attachment A.