Device Information
The GEM FLOW NOW is composed of an implantable silicone vessel sleeve and a 20 MHz ultrasonic Doppler transducer (probe), which monitors blood flow in peripheral vessels.
Indications
GEM FLOW NOW monitors blood flow in peripheral vessels during and after reconstructive microvascular procedures, re-implantations, and free flap transfers. Blood flow monitoring can continue for up to 7 days after the operation, but the device must be removed within 3 to 14 days.
Intended Use
The GEM FLOW NOW is intended for monitoring blood flow in vessels. It is designed for use in reconstructive microvascular surgeries, re-implantations, and free flap transfers. The device can only be used by trained healthcare professionals in surgical settings.
Availability
- Prescription use only.
Contraindications
There are no specific contraindications listed for the GEM FLOW NOW device.
Limitations
- The device is not a permanent implant.
- It should be removed within 3 to 14 days post-operation.
Study Results
Bench testing was conducted to evaluate the device. It met all predefined criteria and showed comparable performance to the predicate device.
Regulatory Information
- Regulation Number: 21 CFR 892.1550
- Regulatory Class: Class II
- Product Code: IYN, ITX
- 510(k) Number: K233394
The GEM FLOW NOW is a Class II medical device with 510(k) clearance (K233394) and complies with FDA’s Quality System regulations (21 CFR Part 820) and general controls, including labeling, registration, and adverse event reporting. It is sterilized using ethylene oxide (EtO) and meets ISO 10993 biocompatibility standards for safe use in monitoring blood flow during surgeries.
Manufacturer Information:
- Synovis Micro Companies Alliance, Inc.
- 439 Industrial Lane, Birmingham, Alabama 35211
- Contact: Julie Carlston
Predicate Device Information
- Predicate Device: GEM Flow Coupler Device and System (K143589)
- Reference device: Cook-Swartz DopplerProbe (K171272)
- Is Predicate an Earlier Version? Yes, it is an earlier version of the GEM FLOW NOW.
- Differences: The primary difference between the devices is that the current device uses a silicone vessel sleeve, and there have been some improvements in probe assembly and monitoring capabilities.
Implications
This device offers a reliable option for post-surgical blood flow monitoring. It is easy to remove and compatible with existing FLOW COUPLER monitors. By allowing continuous monitoring of blood flow, it ensures better outcomes in vascular surgeries.
References
- GEM FLOW NOW (GEM2770-FN). 510k Number: K233394. FDA Summary Link https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K233394
- https://www.synovismicro.com/
- https://www.baxter.com/
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