(49 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria or a direct performance table. Instead, it focuses on demonstrating substantial equivalence to a predicate device by verifying that modifications did not affect functional specifications and that the device meets relevant standards.
However, based on the types of testing performed, we can infer the performance areas that would have had internal acceptance criteria:
| Performance Area | Inferred Acceptance Criteria (Not explicitly stated, but implied by testing) | Reported Device Performance (Summary from text) |
|---|---|---|
| Doppler Probe Signal Functionality | Signal should be detectable and accurate for blood flow. | Testing included "Doppler probe signal functionality." The submission concludes that "functional specifications were not affected by the modification to the Doppler wire." The system is designed for "detection of blood flow and confirmation of vessel patency." An audible ultrasonic signal is produced when blood flow is detected. The device can detect blood flow for up to 7 days post-operatively. |
| Doppler Probe Wire Tensile Strength | Wire should withstand specified tensile forces without breaking. | Testing included "Doppler probe wire tensile and connection strength testing." The submission concludes that "functional specifications were not affected by the modification to the Doppler wire." |
| Doppler Probe Wire Connection Strength | Connections should remain secure under specified forces. | Testing included "Doppler probe wire tensile and connection strength testing." The submission concludes that "functional specifications were not affected by the modification to the Doppler wire." |
| Electrical Safety (IEC 60601-1 Conformance) | Device should meet all applicable electrical safety standards. | Testing included "electrical testing conformance to IEC 60601-1." The submission indicates this testing was successful in showing functional specifications were not affected. |
| Biocompatibility (ISO 10993-1) | Device materials should not cause adverse biological reactions. | "Biocompatibility testing was performed in accordance to ISO 10993-1." The submission states that "biocompatibility... of this device demonstrates that the device is substantially equivalent to the predicate device." |
| Risk Management (EN ISO 14971:2012) | Risks should be identified, analyzed, and mitigated to acceptable levels. | "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." The successful completion of this indicates risks are managed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a sample size for the non-clinical testing performed. It refers to "testing" performed to verify functional specifications.
- Data Provenance: The data provenance is not explicitly stated beyond being "non-clinical testing on the modified device." There's no mention of country of origin or whether it was retrospective or prospective, though "non-clinical" usually implies laboratory or bench testing rather than human clinical trials.
3. Number of Experts and Qualifications for Ground Truth
- The document does not refer to experts establishing ground truth for any test set in the context of this 510(k) submission. The testing described is primarily engineering and materials-based to confirm functional specifications and safety, not related to expert interpretation of diagnostic output.
4. Adjudication Method for the Test Set
- Not Applicable: Since no human interpretation or diagnostic ground truth establishment is described, no adjudication method is mentioned or relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
- No: The document does not mention or describe an MRMC comparative effectiveness study. This submission is for a device that detects blood flow, not an imaging or diagnostic algorithm that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study
- The device being submitted (GEM Flow COUPLER) is a hardware device (coupler with an integrated Doppler probe and a monitor unit). While the monitor unit processes the Doppler signal, the submission focuses on the device's functional specifications and safety. Therefore, a standalone "algorithm only" performance study, as typically understood for AI/software, is not applicable to this type of device and is not mentioned. The "detection of blood flow" is an inherent function of the Doppler technology, not a distinct AI algorithm.
7. Type of Ground Truth Used
- The ground truth for the non-clinical testing appears to be based on engineering specifications and established regulatory standards. For example, for "Doppler probe signal functionality," the ground truth would be the expected and accurate detection of a simulated or actual blood flow signal. For electrical safety, the ground truth is conformance to IEC 60601-1 standards. For biocompatibility, it's conformance to ISO 10993-1. These are not typically "expert consensus," "pathology," or "outcomes data" in the diagnostic sense.
8. Sample Size for the Training Set
- Not Applicable / Not Mentioned: This device is not an AI/ML algorithm that requires a training set in the conventional sense. The "training" of the device is through its design, manufacturing to specifications, and calibration, not through data input.
9. How Ground Truth for the Training Set was Established
- Not Applicable / Not Mentioned: As this is not an AI/ML device with a training set, the concept of establishing ground truth for a training set does not apply.
§ 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.