(121 days)
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 GEM FLOW COUPLER System is designed for the detection of blood flow in vessels. The GEM FLOW COUPLER System consists of components as described below:
- FLOW COUPLER Device (Product Code MVR) - single-use implantable rings used to secure anastomosis of small vessels. This includes a 20MHz ultrasonic Doppler transducer (probe) which attaches to one of the FLOW COUPLER rings, and an external lead.
- FLOW COUPLER Monitor (Product Code DPW) - portable monitor that provides the audible output of the FLOW COUPLER Device's pulsed Doppler ultrasound signal. A varying audible signal is produced when the FLOW COUPLER Device (probe) detects flow.
The medical device in question is the GEM FLOW COUPLER Monitor (GEM1020M-2).
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| FLOW COUPLER Monitor cleaning per IEC 60601-1:2005+AMD1:2012 section 11.6.6 and Cleaning Conditioning | Passing inspection for the damage and post-test leakage and dielectric test. Functioning monitor after the cleaning. | Pass |
| FLOW COUPLER Monitor Design Inspection and Functional Demonstration | The power switch meets design and functional specifications. | Pass |
| FLOW COUPLER Monitor Audio Quality Testing | Audio level greater than 70dB. Signal to Noise ratio of the output electrical signal to the speaker shall be greater than 20 at all tested frequencies. Total Harmonic Distortion (THD) within specification at varying frequencies. | Pass |
| FLOW COUPLER Monitor EMC Testing | IEC 60601-1-2 Edition 4.1: 2020 Class A for Emissions, Immunity for Professional Healthcare Facility Environment. And 47 CFR, Part 15:2022. §15.107 and §15.109. Class A. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for each specific test set (e.g., how many monitors were tested for cleaning, how many for audio quality). However, the tests described are primarily non-clinical performance tests of the device's hardware, firmware, and cleaning protocols. Therefore, the "data provenance" is typically within a controlled laboratory or manufacturing environment, rather than clinical patient data. There is no information regarding country of origin of data or whether it was retrospective or prospective, as these are not relevant to these types of engineering/performance tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
For the types of tests conducted (e.g., cleaning, design, audio quality, EMC), the "ground truth" is established by industry standards (e.g., IEC 60601-1:2005, IEC 60601-1-2 Edition 4.1: 2020, 47 CFR, Part 15:2022) and the manufacturer's internal design and functional specifications. These are objective measures rather than subjective expert consensus. Therefore, the concept of "experts establishing ground truth" in the manner of medical image interpretation is not directly applicable here. The "experts" would be the engineers and technicians performing the tests and verifying compliance with the established standards and specifications. Their qualifications are implicitly in their ability to perform such tests and interpret the standards.
4. Adjudication Method for the Test Set
Not applicable in the conventional sense for non-clinical performance and engineering tests. The tests are designed with objective acceptance criteria, and the results (e.g., measured values, pass/fail based on a threshold) are typically directly compared against these criteria.
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
No. This document describes a 510(k) Pre-market Notification for modifications to an existing device, the GEM FLOW COUPLER Monitor. The changes are primarily hardware and firmware updates (power management, power button, audio system, remote monitoring disabling) and labeling updates (cleaning solutions). The device itself (a cardiovascular blood flowmeter) provides audible output to a human user to detect blood flow and confirm vessel patency. It does not involve AI or image interpretation, and therefore, an MRMC study or an assessment of human reader improvement with AI assistance is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This device is a monitor that provides audible output to a human user (surgeon, nurse) for the detection of blood flow. It is intrinsically a "human-in-the-loop" device in its intended use. It does not operate as a standalone algorithm for diagnosis or decision-making.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance tests is based on:
- International and Federal Standards: e.g., IEC 60601-1, IEC 60601-1-2, 47 CFR Part 15.
- Manufacturer's Design and Functional Specifications: These are internal objective criteria derived from engineering requirements.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm or a diagnostic tool that requires a "training set" in the machine learning sense. The performance tests are for hardware and software functionality, not for training a model.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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April 20, 2022
Synovis Micro Companies Alliance, Inc. Julie Carlston Senior Manager, Regulatory Affairs (a Subsidiary of Baxter International Inc.) 439 Industrial Lane Birmingham, Alabama 35211
Re: K213974
Trade/Device Name: GEM FLOW COUPLER Monitor (GEM1020M-2) Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II Product Code: DPW, MVR Dated: March 11, 2022 Received: March 14, 2022
Dear Julie 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.
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
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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 (OS) 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,
for Deborah Fellhauer, RN, BSN Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: 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) K213974
Device Name GEM FLOW COUPLER Monitor (GEM1020M-2)
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)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
-Submitter Synovis Micro Companies Alliance, Inc. (A Subsidiary of Baxter International, Inc.) 439 Industrial Lane Birmingham, AL 35211-4464 Establishment Registration Number: 1062741
Julie Carlston Senior Regulatory Affairs Manager at Synovis Micro Companies Alliance, Inc. (a subsidiary of Baxter International Inc.) Telephone: 651.796.7511 Fax: 651.642.9018 Email: Julie Carlston@baxter.com
Date Prepared: April 14, 2022
II. Subject Device
| Device Trade Name | GEM FLOW COUPLER Monitor (GEM1020M-2) |
|---|---|
| Common Name | Cardiovascular Blood Flowmeter |
| Classification Name | Flowmeter, Blood, CardiovascularRegulation Number: 21 CFR 870.2100Classification: Class IIImplantable ClipRegulation Number: 21 CFR 878.4300Classification: Class II |
| Product Code | MVR, DPW |
III. Predicate Device
| Device Trade Name | GEM FLOW COUPLER System; K191252 |
|---|---|
| Common Name | Cardiovascular Blood Flowmeter |
| Classification Name | Flowmeter, Blood, CardiovascularRegulation Number: 21 CFR 870.2100Classification: Class IIImplantable ClipRegulation Number: 21 CFR 878.4300Classification: Class II |
| Product Code | MVR, DPW |
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IV. Device Description
The GEM FLOW COUPLER System is designed for the detection of blood flow in vessels. The GEM FLOW COUPLER System consists of components as described below:
- FLOW COUPLER Device (Product Code MVR) - single-use implantable rings used to secure anastomosis of small vessels. This includes a 20MHz ultrasonic Doppler transducer (probe) which attaches to one of the FLOW COUPLER rings, and an external lead.
FLOW COUPLER Monitor (Product Code DPW) - portable monitor that provides the 2. audible output of the FLOW COUPLER Device's pulsed Doppler ultrasound signal. A varying audible signal is produced when the FLOW COUPLER Device (probe) detects flow.
The predicate device (K191252) submission included an additional remote monitoring capability for the remote retrieval of FLOW COUPLER Monitor data via the GEMflow App (which is part of the GEM Cloud System). This optional remote monitoring capability was not extensively utilized and has been excluded from the subject device. The remote monitoring capability is not available with the subject devic.
V. Intended Use / Indications for Use
The Intended Use and Indications for Use remain the same as the predicate device (K191252).
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.
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 intraoperatively 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 postoperatively.
VI. Comparison of Technological Characteristics with the Predicate Device
The overall functionality and features necessary to support the device's intended use remain unchanged from the previous device clearance (K191252). Minor modifications to the product hardware, firmware and labeling have been made in this submission:
. Power management update (monitor firmware update): revised logic for handling a battery-protection shutdown scenario.
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Power button update (monitor hardware update): recessed the button to be . flush with the device bezel and increased the contact force.
Audio system update (monitor hardware update): updated speaker assembly ● and capacitors on Printed Circuit Board Assembly to reduce background noise and enhance overall audio clarity.
List of approved cleaning solutions update (labeling update): updated . Instructions for Use with an expanded list of approved cleaning solutions.
. Disabling of the optional remote monitoring capability: updated monitor firmware to disable the connection to the cloud backend server (GEM Cloud System) to disable the optional remote monitoring capability.
The technological characteristics and specifications of the FLOW COUPLER Monitor have been evaluated against its predicate device (previous version of the subject device) to determine equivalence.. A summary of the comparison between the predicate and subject devices is provided in Table 1 below.
| Attribute | Predicate Device | Subject Device |
|---|---|---|
| Product Name | GEM FLOW COUPLER System | Same |
| 510(k)-holder | Synovis Micro Companies Alliance, Inc.(A Subsidiary of Baxter International, Inc.) | Same |
| 510(k) Number | K191252 | K213974 |
| Product Code | MVR, DPW | Same |
| Regulation | 21 CFR 878.430021 CFR 870.2100 | Same |
| Classification | Class II | Same |
| Intended Use | The FLOW COUPLER Device and System is intended to be usedin the anastomosis of veins and arteries normally encounteredin microvascular and vascular reconstructive procedures andin the detection of blood flow and confirmation of vesselpatency following end-to-end anastomosis of vessels. | Same |
| Indications for Use | The FLOW COUPLER Device is a single use, implantable devicethat is intended to be used in the end-to-end anastomosis ofveins and arteries normally encountered in microsurgical andvascular reconstructive procedures. The FLOW COUPLERDevice includes a pair of permanently implanted rings whichsecure the anastomosis and a removable Doppler probe that ispress-fit onto one of the rings. When the FLOW COUPLERDevice is used in conjunction with the FLOW COUPLERMonitor, the FLOW COUPLER System is intended to detectblood flow and confirm vessel patency intra-operatively andpost-operatively at the anastomotic site. Post-operatively,blood flow can be detected on an as needed basis for up to 7days. The FLOW COUPLER Doppler probe is not intended to bea permanent implant and should be removed 3 to 14 dayspostoperatively. | Same |
| Product UseEnvironment | Hospital Operating Room and Post-Anesthesia Care Unit | Same |
| End Users of Product | Nurses and surgeons | Same |
| Dimensions | 6.17" D x 8.18" W x 3.20" H | Same |
| Weight | 1.8 lb. (0.8 kg) | Same |
| Acoustical Output | Acoustical Power will be less than 94 mW/cm2 | Same |
| Depth | Not selectable | Same |
| TransmissionFrequency | 20 MHz | Same |
| TransmissionCharacteristic | Pulsed wave transmission, continuous reception | Same |
| Pulse RepetitionFrequency | 156.25 KHz | Same |
| Energy Used and/orDelivered | 12 Volts direct current supplied by A/C to D/C converterRechargeable internal lithium ion battery pack | Same |
| Power Input | Input Voltage: 90-264 VACFrequency: 47-63 Hz | Same |
| Power Output | Total Output Power: 30 wattsVoltage: 12VDCCurrent: 2.5AOutput Regulation ± 5% | Same |
| Power management update | ||
| Monitor firmware | Analog Front End, Doppler phase shift detection, plus FFTfiltering, noise reduction, and background noise reduction | Revised logic for handling aproper battery-protectionshutdown scenario to preventcomplete battery drainage andinoperable monitor |
| Power button update | ||
| Power button | Location: rear of unitElevation: raised (3.50 mm) | Location: rear of unitElevation: flush with devicebezelActivation force: 400gf |
| Audio system update | ||
| Printed Circuit BoardAssembly (PCBA) | PCBA per K191252 | PCBA components have beenchanged to improve audioquality |
| Speaker Assembly | 57.5mm wide, 3W Max. Power speakerConcave speaker grill | 60mm wide, 4W Max. PowerspeakerConvex speaker grill |
| List of approved cleaning solutions update | ||
| Cleaning instructions | Wipe the Monitor with a dry or water-moistened soft cloth.Ensure any residual organic material is removed.Do not pour or spray liquid directly on the Monitor. Allow toair dry before use. | Wipe the Monitor with a dry orwater-moistened soft cloth,Isopropyl Alcohol, AmmoniumHydroxide based surfacecleanser, Ammonium Chloridebased surface cleanser or 2%bleach solution. Ensure anyresidual organic material isremoved. Do not pour or sprayliquid directly on the Monitor.Allow to air dry before use. |
| Disabling of the optional remote monitoring capability | ||
| Remote AccessFunction (Optional) | Android and iOS App to access audio files remotely | Disabled optional remotemonitoring capability |
Table 1 - FLOW COUPLER Monitor Predicate and Subject Devices - Comparison Table
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VII.Performance Data
Synovis conducted performance testing to evaluate safety and effectiveness of the FLOW COUPLER Monitor to support substantial equivalence to the predicate device, as well as to evaluate that product requirements are met. The following testing of the FLOW COUPLER Monitor has been performed.
| Performance Testing | Acceptance Criteria | Result |
|---|---|---|
| FLOW COUPLER Monitor cleaning perIEC 60601-1:2005+AMD1:2012 section11.6.6FLOW COUPLER Monitor CleaningConditioning | Passing inspection for the damage and post-test leakage and dielectric test. Functioning monitor after the cleaning. | Pass |
| FLOW COUPLER Monitor DesignInspection and FunctionalDemonstration | The power switch meets design and functional specifications | Pass |
| FLOW COUPLER Monitor Audio QualityTesting | Audio level greater than 70dB Signal to Noise ratio of the output electrical signal to the speaker shall be greater than 20 at all tested frequencies Total Harmonic Distortion (THD) within specification at varying frequencies | Pass |
| FLOW COUPLER Monitor EMC Testing | IEC 60601-1-2 Edition 4.1: 2020 Class A for Emissions, Immunity for Professional Healthcare Facility Environment And 47 CFR, Part 15:2022. §15.107 and §15.109. Class A | Pass |
Applicable verification and validation testing was completed with passing results per the predefined acceptance criteria for each test case. These results support that the modified device performs as intended, and meets all functional requirements and performance specifications.
VIII.Conclusions
The FLOW COUPLER System indications for use and principles of operation remain unchanged (are the same as the predicate device). Performance testing has been completed to evaluate safety and effectiveness of the subject device as it compares to its predicate. The conclusion drawn from the riskbenefit assessment and nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device. No new issues of safety and effectiveness have been identified.
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).