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 Device and System consists of a FLOW COUPLER Device and a FLOW COUPLER Monitor. The FLOW COUPLER Monitor is a pulsed Doppler ultrasound system designed for the detection of blood flow in vessels. The FLOW COUPLER Device includes a 20MHz ultrasonic Doppler transducer (probe) attached to one of the FLOW COUPLER rings, and an external lead. The probe via the external lead connects to the monitor and emits a pulsed ultrasonic signal. A varying audible signal is produced when the probe detects flow.

AI/ML Overview

The provided text describes the GEM™FLOW COUPLER™ Monitor (GEM2010M-2), a cardiovascular blood flowmeter, and its substantial equivalence to a predicate device. However, the document does not detail specific acceptance criteria, a study that quantifies device performance against those criteria, or the methodology for ground truth establishment, sample sizes, or multi-reader studies in the manner typically required for AI/algorithm-driven device evaluations. The information provided focuses on the regulatory submission process (510(k)) and comparisons to a predicate device, rather than a detailed performance study with quantifiable metrics.

Based on the provided text, here's what can be extracted and what information is not available:

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

The document states that "The testing was completed with passing results per the pass/fail criteria defined for each test case." However, the exact acceptance criteria (e.g., specific accuracy, sensitivity, specificity thresholds) and the reported device performance for each are not explicitly listed. Instead, it broadly states that the modified monitor "meets the same performance specifications as the predicate device" and that the "performance data described in this submission confirm that the modified monitor meets the same performance specifications." The performance data categories include:

Test Category	Reported Device Performance (as stated in the document)
EMC Testing	Passing results per the pass/fail criteria defined for each test case.
Electrical Safety Testing	Passing results per the pass/fail criteria defined for each test case.
Acoustic Output Testing	Passing results per the pass/fail criteria defined for each test case.
AC Power Continuous Use	Passing results per the pass/fail criteria defined for each test case.
Battery Life Testing	Passing results per the pass/fail criteria defined for each test case.
User Interface Functional Testing	Passing results per the pass/fail criteria defined for each test case.
Flow Velocity Testing	Passing results per the pass/fail criteria defined for each test case.
Functional Performance Testing	Passing results per the pass/fail criteria defined for each test case.
Packaging Validation Testing	Passing results per the pass/fail criteria defined for each test case.
Software Verification	Passing results per the pass/fail criteria defined for each test case.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "bench testing" and "performance data described in this submission" but does not detail the size of any test sets or the origin/nature of the data.

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. The device is a "pulsed Doppler ultrasound system designed for the detection of blood flow in vessels" that produces an "audible signal" when flow is detected, and the modified monitor "adds a qualitative visual display as a secondary indicator of blood flow." Therefore, the ground truth would likely relate to the presence/absence or characteristics of blood flow, which would typically involve highly specialized experts or direct measurement. However, details of any human expert involvement are absent.

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

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the document. The device is a monitor for detecting blood flow, not an AI-driven image interpretation system.

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

The document describes the "FLOW COUPLER Monitor" as a "pulsed Doppler ultrasound system designed for the detection of blood flow in vessels." While it includes "software for digital filtering of the returned audio signal for noise reduction" and a "qualitative visual display," it is presented as a medical device providing information to a human user (e.g., producing a "varying audible signal" and a "qualitative visual display"). The question of "standalone" algorithm performance in the context of typical AI algorithms is not directly applicable or addressed here, as the device is a measurement tool, not an autonomous diagnostic algorithm. Its function is to detect blood flow, which is then interpreted by a human user.

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

The type of ground truth used to validate the device's ability to "detect blood flow and confirm vessel patency" is not explicitly stated. Given the nature of a Doppler ultrasound, the ground truth would typically be established through direct physiological measurements or other highly reliable methods for confirming blood flow and vessel patency, rather than expert consensus on images. However, the document does not specify.

8. The sample size for the training set

The document does not describe any training sets for the device. The device is a monitor, not a machine learning model that undergoes training in the typical sense.

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

Since there is no mention of a training set, this information is not provided.

Summary

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July 9, 2019

Baxter/Synovis Micro Companies Alliance, Inc. % Ms. Julie Carlston Senior Regulatory Affairs Manager Synovis Micro Companies Alliance, Inc. 2875 University Avenue West St. Paul, Minnesota 55114

Re: K191252

Trade/Device Name: GEM™FLOW COUPLER™ Monitor (GEM2010M-2) Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: MVR, DPW Dated: May 8, 2019 Received: May 9, 2019

Dear Ms. Carlston:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Nina Mezu-Nwaba, PharmD., MPH., MSc. CAPT., United States Public Health Service Assistant Director (Acting), Plastic Surgery Implant Devices Team Division of Infection Control and Plastic Surgery Devices Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191252

Device Name Flow Coupler Device

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)

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510(K) Summary

I. Submitter

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

Julie Carlston Synovis Micro Companies Alliance, Inc. A Subsidiary of Synovis Life Technologies, Inc. 2575 University Avenue West St. Paul, MN 55114-1024 Tel: 651-796-7511 Fax: 651-642-9018 julie_carlston@baxter.com

Date of preparation: May 8, 2019

II. Device

Device TradeName	GEM FLOW COUPLER Monitor (GEM1020M-2)
Common Name	Cardiovascular Blood Flowmeter
ClassificationName	Implantable clipRegulation Number: 21CFR §878.4300Classification: Class II
Product Code	MVR, DPW

III. Predicate Device

Predicate Device	GEM FLOW COUPLER Device and System; K093310(includes GEM FLOW COUPLER Monitor - GEM1020M)
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IV. Device Description

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signal is produced when the probe detects flow.

V. Indication for Use

The indications for use of the FLOWCOUPLER device are the same as those cleared previously in K093310:

VI. Comparison of Technological Characteristics with the Predicate Device

The most notable technological differences between the predicate and proposed device are that the modified monitor includes a color LCD touchscreen as the user interface, adds a qualitative visual display as a secondary indicator of blood flow, and has wireless capability for remote access to previously recorded audio. While both monitors have the same analog front end for generating the electrical signal to the probe, the modified monitor also includes software for digital filtering of the returned audio signal for noise reduction. In addition, an internal rechargeable lithium battery pack replaces AA (LR6) batteries as the alternate power source.

Bench testing of the modified device showed that these technological differences do not impact the safety and essential performance of the monitor. The performance data described in this submission confirm that the modified monitor meets the same performance specifications as the predicate device.

VII. Performance Data

Testing of the FLOW COUPLER Monitor includes the following:

. EMC Testing

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Electrical Safety Testing ●
Acoustic Output Testing ●
AC Power Continuous Use
Battery Life Testing
User Interface Functional Testing
. Flow Velocity Testing
. Functional Performance Testing
Packaging Validation Testing
Software Verification

The results of testing have been provided for the modified monitor. The testing was completed with passing results per the pass/fail criteria defined for each test case. These results support that the modified monitor is substantially equivalent to the predicate device.

The intended use of the modified FLOW COUPLER Monitor is identical to the predicate device. This submission includes information on the technological characteristics of the modified monitor, as well as performance data demonstrating that the proposed monitor is as safe and effective as the predicate device, and does not raise different questions of safety and effectiveness for its intended use.

VIII. Conclusions

The FLOW COUPLER device and system has the same indications for use and principles of operation as the predicate device. The modified monitor has the same indications for use as the predicate device, meets the same performance specifications, and applies the same fundamental scientific technology for audio observation of the anastomosis. Testing supports that the device is as safe and effective for its intended use as the predicate device. Synovis MCA concludes that the modified FLOW COUPLER Monitor is substantially equivalent to the predicate device

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.