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.

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 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

The provided document is a 510(k) Premarket Notification from the FDA for the GEM™ Flow COUPLER™ Device and System. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics of a new device.

Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, ground truth establishment, and expert involvement are not explicitly present in the provided text. The document states that the modified Flow Coupler device is considered substantially equivalent to its own predicate (K142609), which is the GEM Flow COUPLER Device and System.

Here's an attempt to answer the questions based on the information available:

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

The document does not provide a table with quantitative acceptance criteria and reported device performance in the way a clinical study or performance verification study for a new device might. Instead, it states that "functional specifications were not affected by the line extension" for the 4.0mm Flow COUPLER. The acceptance criteria would broadly be that the modified device performs equivalently to the predicate device across the listed tests.

Acceptance Criteria (Inferred)	Reported Device Performance
Functional specifications not affected by size range extension	"functional specifications were not affected by the line extension" (for 4.0mm Flow COUPLER)
Shock and vibration performance maintained	Testing included: "shock and vibration" (implies performance was acceptable/equivalent to predicate)
Pin alignment maintained	Testing included: "pin alignment" (implies performance was acceptable/equivalent to predicate)
Ring retention maintained	Testing included: "ring retention" (implies performance was acceptable/equivalent to predicate)
Probe signal maintained	Testing included: "probe signal" (implies performance was acceptable/equivalent to predicate)
Ring separation maintained	Testing included: "ring separation" (implies performance was acceptable/equivalent to predicate)
Probe to COUPLER separation force maintained	Testing included: "probe to COUPLER separation force" (implies performance was acceptable/equivalent to predicate)
Device is substantially equivalent to predicate device	"The risk assessment and bench testing of this device demonstrate that the device is substantially equivalent to the predicate device."

2. Sample sizes 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 on the 4.0mm Flow COUPLER line extension," but it does not specify the sample size for any of these tests. The data provenance is not mentioned, but given it's a submission to the US FDA and the company is based in the US, it's highly likely the testing was conducted in the US. The nature of "bench testing" implies it's a prospective series of tests performed on physical devices.

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 provided in the document. For bench testing of physical properties, "experts" in the clinical sense are typically not involved; rather, engineering and quality assurance personnel conduct the tests against specifications.

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

This information is not provided. Adjudication methods are highly relevant for clinical studies or studies involving human interpretation. For bench testing of functional specifications, the results are usually objective measurements against predefined engineering tolerances.

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

There is no mention of an MRMC study or AI assistance in this document. The device is a mechanical coupler with an ultrasonic Doppler probe, not an AI diagnostic tool.

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

This is not applicable. The device is not an algorithm, but a physical medical device. It has a "standalone" function in the sense that the Doppler probe detects blood flow independently, but it is not an AI algorithm.

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

For the bench tests, the "ground truth" would be the engineering specifications and established functional parameters of the predicate device or industry standards for similar devices. For example, for "ring retention" or "probe signal," there would be quantifiable metrics and tolerances that the device must meet.

8. The sample size for the training set

There is no mention of a training set. This type of test is for a physical device, not a machine learning model.

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

This is not applicable as there is no training set mentioned.

Summary

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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

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

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Indications for Use

510(k) Number (if known) K143589

Device Name

GEM™ Flow COUPLERTM Device and System

Indications for Use (Describe)

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)

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2.0 510(K) SUMMARY

Submitted by:	Synovis Micro Companies Alliance, Inc.A Subsidiary of Synovis Life Technologies, Inc.439 Industrial LaneBirmingham, AL 35211-4464
	FDA Registration #1062741
	Tel: 205-941-0111Fax: 205-941-1522
Contact Person:	Jodi JorgensonSynovis Micro Companies Alliance, Inc.,A Subsidiary of Synovis Life Technologies, Inc.2575 University Avenue WestSt. Paul, MN 55114-1024
	Tel: 651-796-7399Fax: 651-642-9018
Date Prepared:	December 17, 2014
Device Trade Name:	GEM™ Flow COUPLER™ Device and System
Common Name:	Microvascular Anastomotic CouplerCardiovascular Blood Flowmeter
Classification Name:	Microvascular Anastomotic CouplerRegulation Number: 21CFR § 878.4300Regulation Name: Implantable ClipRegulatory Class: IIProduct Code: MVR, DPW
Predicate Device:	GEM Flow COUPLER Device and System: K142609

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Device Description:	The Flow COUPLER System consists of a Flow COUPLER Deviceand a Flow COUPLER Monitor. The Flow COUPLER Device is asterile, single-use implantable pair of rings molded out of highdensity polyethylene with stainless steel pins on each ring. TheFlow COUPLER Device is designed to serve as a mechanical,sutureless device for connecting veins or arteries. A probe-holderfeature is molded on one Flow COUPLER ring and serves as thepress-fit point of attachment for a pre-attached 20 MHz Dopplerprobe. The Doppler probe connects to the Flow COUPLERMonitor unit, via the external lead.The Flow COUPLER Monitor and Doppler probe is a pulsedDoppler ultrasound system designed for the detection of blood flowin vessels. An audible ultrasonic signal is produced when theDoppler probe detects blood flow.The Flow COUPLER Device and System has been specificallydesigned for use in end-to-end anastomosis of blood vessels and thedetection of blood flow at the anastomotic site. On an as neededbasis, blood flow can be detected for up to 7 days. The FlowCOUPLER rings are intended to be a permanent implant. The FlowCOUPLER probe is not intended to be a permanent implant; theprobe should be removed, by gentle traction on the external lead,3 to 14 days post-operatively.
Statement ofIntended use:	The Flow COUPLER Device and System is intended to be used inthe anastomosis of veins and arteries normally encountered in
TechnologicalComparisons:	The Flow Coupler Device and System is acting as its own predicateand is therefore substantially equivalent having the sametechnological characteristics including: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/DeviceTesting:	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.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.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.

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

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

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.