(49 days)
Not Found
No
The description focuses on mechanical coupling and Doppler ultrasound for blood flow detection, with no mention of AI or ML algorithms for analysis or interpretation.
No.
The device's primary function is to secure anastomoses and detect blood flow and vessel patency; it does not treat a disease or condition.
Yes
Explanation: The device, when used with the FlowCOUPLER Monitor, is intended to "detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site," which are diagnostic functions.
No
The device description clearly states that the system consists of both a Flow COUPLER Device (implantable rings and Doppler probe) and a Flow COUPLER Monitor. This includes significant hardware components beyond just software.
Based on the provided information, the FlowCOUPLER Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- FlowCOUPLER Function: The FlowCOUPLER Device is an implantable device used for the mechanical anastomosis of blood vessels within the body. The Doppler component detects blood flow in vivo at the surgical site.
The device's function is to facilitate a surgical procedure and then monitor blood flow directly within the patient's body, not to analyze samples taken from the body in a laboratory setting.
N/A
Intended Use / Indications for 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.
The FlowCOUPLER 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 FlowCOUPLER 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 FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Postoperatively, blood flow can be detected on an as needed basis for up to 7 days. The FlowCOUPLER Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days post-operatively.
Product codes
MVR, DPW
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 six 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Pulsed Doppler ultrasound
Anatomical Site
Veins and arteries, anastomotic site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing on the modified device was performed to verify that the functional specifications were not affected by the modification to the Doppler wire. Testing included: Doppler probe signal functionality. Doppler probe wire tensile and connection strength testing, electrical testing conformance to IEC 60601-1.
The Doppler wire is tissue contacting (duration > 24 hours but
§ 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.
0
510(K) SUMMARY
Submitted by Synovis Micro Companies Alliance, Inc. A Subsidiary of Synovis Life Technologies, Inc. 439 Industrial Lane Birmingham, AL 35211-4464
FDA Registration #1062741
Tel: 205-941-0111 Fax: 205-941-1522
OCT 2 2 2013
17 11:22 1
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Contact Person Troy Thome Synovis Surgical Innovations, A Division of Synovis Life Technologies, Inc. 2575 University Avenue West St. Paul, MN 55114-1024
Tel: 651-796-7550 Fax: 651-603-5211
August 30, 2013 Date Prepared
Device Trade Name GEM™ Flow COUPLERTM Device and System
Common Name
- Microvascular Anastomotic Coupler . . Cardiovascular Blood Flowmeter
- Classification Name Microvascular Anastomotic Coupler Regulation Number: 21 CFR § 878.4300 Regulation Name: Implantable Clip Regulatory Class: II Product Code: MVR, DPW
Predicate Device(s) GEM Flow COUPLER Device and System; K093310
1
K132727 Page 2/3
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 six 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.
Statement of 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.
2
Technological Comparisons
The Flow Coupler Device and System is acting as its own predicate and is therefore substantially equivalent having the same technological characteristics including:
- Intended use �
- Indications for use .
- . Device functionality
- Device method of operation o
- . Device finished specifications
- Device dimensions .
- . Device size range
- 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:
- Doppler probe (wire material, wire diameter, and insulation . material)
Technology/Device Testing
A risk assessment of the modifications in the form of a Design FMEA and Health Hazard Analysis has been conducted in accordance with EN ISO 14971: 2012.
Non-clinical testing on the modified device was performed to verify that the functional specifications were not affected by the modification to the Doppler wire. Testing included: Doppler probe signal functionality. Doppler probe wire tensile and connection strength testing, electrical testing conformance to IEC 60601-1.
The Doppler wire is tissue contacting (duration > 24 hours but