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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or a direct performance table. Instead, it focuses on demonstrating substantial equivalence to a predicate device by verifying that modifications did not affect functional specifications and that the device meets relevant standards.

However, based on the types of testing performed, we can infer the performance areas that would have had internal acceptance criteria:

Performance Area	Inferred Acceptance Criteria (Not explicitly stated, but implied by testing)	Reported Device Performance (Summary from text)
Doppler Probe Signal Functionality	Signal should be detectable and accurate for blood flow.	Testing included "Doppler probe signal functionality." The submission concludes that "functional specifications were not affected by the modification to the Doppler wire." The system is designed for "detection of blood flow and confirmation of vessel patency." An audible ultrasonic signal is produced when blood flow is detected. The device can detect blood flow for up to 7 days post-operatively.
Doppler Probe Wire Tensile Strength	Wire should withstand specified tensile forces without breaking.	Testing included "Doppler probe wire tensile and connection strength testing." The submission concludes that "functional specifications were not affected by the modification to the Doppler wire."
Doppler Probe Wire Connection Strength	Connections should remain secure under specified forces.	Testing included "Doppler probe wire tensile and connection strength testing." The submission concludes that "functional specifications were not affected by the modification to the Doppler wire."
Electrical Safety (IEC 60601-1 Conformance)	Device should meet all applicable electrical safety standards.	Testing included "electrical testing conformance to IEC 60601-1." The submission indicates this testing was successful in showing functional specifications were not affected.
Biocompatibility (ISO 10993-1)	Device materials should not cause adverse biological reactions.	"Biocompatibility testing was performed in accordance to ISO 10993-1." The submission states that "biocompatibility... of this device demonstrates that the device is substantially equivalent to the predicate device."
Risk Management (EN ISO 14971:2012)	Risks should be identified, analyzed, and mitigated to acceptable levels.	"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." The successful completion of this indicates risks are managed.

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

Sample Size for Test Set: The document does not specify a sample size for the non-clinical testing performed. It refers to "testing" performed to verify functional specifications.
Data Provenance: The data provenance is not explicitly stated beyond being "non-clinical testing on the modified device." There's no mention of country of origin or whether it was retrospective or prospective, though "non-clinical" usually implies laboratory or bench testing rather than human clinical trials.

3. Number of Experts and Qualifications for Ground Truth

The document does not refer to experts establishing ground truth for any test set in the context of this 510(k) submission. The testing described is primarily engineering and materials-based to confirm functional specifications and safety, not related to expert interpretation of diagnostic output.

4. Adjudication Method for the Test Set

Not Applicable: Since no human interpretation or diagnostic ground truth establishment is described, no adjudication method is mentioned or relevant.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size

No: The document does not mention or describe an MRMC comparative effectiveness study. This submission is for a device that detects blood flow, not an imaging or diagnostic algorithm that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study

The device being submitted (GEM Flow COUPLER) is a hardware device (coupler with an integrated Doppler probe and a monitor unit). While the monitor unit processes the Doppler signal, the submission focuses on the device's functional specifications and safety. Therefore, a standalone "algorithm only" performance study, as typically understood for AI/software, is not applicable to this type of device and is not mentioned. The "detection of blood flow" is an inherent function of the Doppler technology, not a distinct AI algorithm.

7. Type of Ground Truth Used

The ground truth for the non-clinical testing appears to be based on engineering specifications and established regulatory standards. For example, for "Doppler probe signal functionality," the ground truth would be the expected and accurate detection of a simulated or actual blood flow signal. For electrical safety, the ground truth is conformance to IEC 60601-1 standards. For biocompatibility, it's conformance to ISO 10993-1. These are not typically "expert consensus," "pathology," or "outcomes data" in the diagnostic sense.

8. Sample Size for the Training Set

Not Applicable / Not Mentioned: This device is not an AI/ML algorithm that requires a training set in the conventional sense. The "training" of the device is through its design, manufacturing to specifications, and calibration, not through data input.

9. How Ground Truth for the Training Set was Established

Not Applicable / Not Mentioned: As this is not an AI/ML device with a training set, the concept of establishing ground truth for a training set does not apply.

Summary

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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: 205-941-0111 Fax: 205-941-1522

OCT 2 2 2013

17 11:22 1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Tel: 651-796-7550 Fax: 651-603-5211

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

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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:

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

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.