GEM FLOW COUPLER Monitor (GEM1020M-2)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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. 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You must comply with all the Act's {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) # CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {3}------------------------------------------------ # 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, Cardiovascular<br>Regulation Number: 21 CFR 870.2100<br>Classification: Class II<br><br>Implantable Clip<br>Regulation Number: 21 CFR 878.4300<br>Classification: 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, Cardiovascular<br>Regulation Number: 21 CFR 870.2100<br>Classification: Class II<br>Implantable Clip<br>Regulation Number: 21 CFR 878.4300<br>Classification: Class II | | Product Code | MVR, DPW | {4}------------------------------------------------ # 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: 1. 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. {5}------------------------------------------------ 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.<br>(A Subsidiary of Baxter International, Inc.) | Same | | 510(k) Number | K191252 | K213974 | | Product Code | MVR, DPW | Same | | Regulation | 21 CFR 878.4300<br>21 CFR 870.2100 | Same | | Classification | Class II | Same | | Intended Use | The FLOW COUPLER Device and System is intended to be used<br>in the anastomosis of veins and arteries normally encountered<br>in microvascular and vascular reconstructive procedures and<br>in the detection of blood flow and confirmation of vessel<br>patency following end-to-end anastomosis of vessels. | Same | | Indications for Use | The FLOW COUPLER Device is a single use, implantable device<br>that is intended to be used in the end-to-end anastomosis of<br>veins and arteries normally encountered in microsurgical and<br>vascular reconstructive procedures. The FLOW COUPLER<br>Device includes a pair of permanently implanted rings which<br>secure the anastomosis and a removable Doppler probe that is<br>press-fit onto one of the rings. When the FLOW COUPLER<br>Device is used in conjunction with the FLOW COUPLER<br>Monitor, the FLOW COUPLER System is intended to detect<br>blood flow and confirm vessel patency intra-operatively and<br>post-operatively at the anastomotic site. Post-operatively,<br>blood flow can be detected on an as needed basis for up to 7<br>days. The FLOW COUPLER Doppler probe is not intended to be<br>a permanent implant and should be removed 3 to 14 days<br>postoperatively. | Same | | Product Use<br>Environment | 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 | | Transmission<br>Frequency | 20 MHz | Same | | Transmission<br>Characteristic | Pulsed wave transmission, continuous reception | Same | | Pulse Repetition<br>Frequency | 156.25 KHz | Same | | Energy Used and/or<br>Delivered | 12 Volts direct current supplied by A/C to D/C converter<br>Rechargeable internal lithium ion battery pack | Same | | Power Input | Input Voltage: 90-264 VAC<br>Frequency: 47-63 Hz | Same | | Power Output | Total Output Power: 30 watts<br>Voltage: 12VDC<br>Current: 2.5A<br>Output Regulation ± 5% | Same | | Power management update | | | | Monitor firmware | Analog Front End, Doppler phase shift detection, plus FFT<br>filtering, noise reduction, and background noise reduction | Revised logic for handling a<br>proper battery-protection<br>shutdown scenario to prevent<br>complete battery drainage and<br>inoperable monitor | | Power button update | | | | Power button | Location: rear of unit<br>Elevation: raised (3.50 mm) | Location: rear of unit<br>Elevation: flush with device<br>bezel<br>Activation force: 400gf | | Audio system update | | | | Printed Circuit Board<br>Assembly (PCBA) | PCBA per K191252 | PCBA components have been<br>changed to improve audio<br>quality | | Speaker Assembly | 57.5mm wide, 3W Max. Power speaker<br>Concave speaker grill | 60mm wide, 4W Max. Power<br>speaker<br>Convex speaker grill | | List of approved cleaning solutions update | | | | Cleaning instructions | Wipe the Monitor with a dry or water-moistened soft cloth.<br>Ensure any residual organic material is removed.<br>Do not pour or spray liquid directly on the Monitor. Allow to<br>air dry before use. | Wipe the Monitor with a dry or<br>water-moistened soft cloth,<br>Isopropyl Alcohol, Ammonium<br>Hydroxide based surface<br>cleanser, Ammonium Chloride<br>based surface cleanser or 2%<br>bleach solution. Ensure any<br>residual organic material is<br>removed. Do not pour or spray<br>liquid directly on the Monitor.<br>Allow to air dry before use. | | Disabling of the optional remote monitoring capability | | | | Remote Access<br>Function (Optional) | Android and iOS App to access audio files remotely | Disabled optional remote<br>monitoring capability | Table 1 - FLOW COUPLER Monitor Predicate and Subject Devices - Comparison Table {6}------------------------------------------------ {7}------------------------------------------------ #### 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 per<br>IEC 60601-1:2005+AMD1:2012 section<br>11.6.6<br>FLOW COUPLER Monitor Cleaning<br>Conditioning | Passing inspection for the damage and post-test leakage and dielectric test. Functioning monitor after the cleaning. | Pass | | FLOW COUPLER Monitor Design<br>Inspection and Functional<br>Demonstration | The power switch meets design and functional specifications | Pass | | FLOW COUPLER Monitor Audio Quality<br>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 | 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.