(248 days)
Remington Medical, Inc. VascuChek™ device is intended for the intraoperative and transcutaneous evaluation of blood flow in the following clinical applications:
- · Intraoperative (Microvascular and Vascular)
- · Intraoperative Neurological
- · Transrectal and Peripheral Vascular
VascuChek™ is a cardiovascular blood flowmeter comprised of two components: a sterile VascuChek™ Surgical Probe with sheath which connects to the reusable, nonsterile VascuChek™ Transceiver. The sheath is deployed over, and encapsulates the transceiver, allowing it to be used within the sterile field.
The VascuChek™ device follows Track 1.
A transmitter in the transceiver drives the ultrasonic transmitting crystal located at the tip of the probe component. The ultrasonic waves generated by the sensor travel through the tissue just under the probe tip in a narrow beam. The reflected ultrasonic waves are received by the transducer and are converted via the piezoelectric effect into a high frequency electronic signal. The received electronic signal is amplified and detected. The result is a base band audio Doppler shifted signal which is filtered and converted to audio via a speaker. During the intervals when the unit is not transmitting, the device passes any reflected signals that it receiving circuit. This circuit amplifies the returning echoes, compares their frequency to that of the transmitted signal and converts any frequency differences into an audible tone.
Here's a summary of the acceptance criteria and study information for the VascuChek™ device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than explicitly listing acceptance criteria with numerical performance targets and reported values. Instead, it describes a series of non-clinical and in vivo tests performed. The "reported device performance" is essentially that the device passed these tests and was found to be "substantially equivalent" to the predicate.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Software/Firmware Performance | Functionality as designed, no critical errors. | Passed. Result demonstrated proper performance. |
| Mechanical Performance | Device maintains structural integrity and functions correctly under specified conditions. | Passed. Result demonstrated proper performance. |
| Integrity of Sterile Barrier | Sterility of the probe maintained. | Passed. Result demonstrated proper performance. |
| Biocompatibility | Materials are safe for patient contact. | Passed. Result demonstrated proper performance. |
| Pyrogenicity | Absence of pyrogenic substances. | Passed. Result demonstrated proper performance. |
| Shelf Life / Aging | Device functions as intended for its specified shelf life. | Passed. Result demonstrated proper performance. |
| Device Lifecycle | Device functions as intended throughout its expected operational life. | Passed. Result demonstrated proper performance. |
| Sterility Assurance | Sterilization process effectively renders the probe sterile. | Passed. Result demonstrated proper performance. |
| Reprocessing Manual Cleaning and Intermediate-Level Disinfection | Reusable components can be effectively cleaned and disinfected without degradation inhibiting performance. | Passed. Result demonstrated proper performance. |
| Distribution Simulation | Device integrity maintained during shipping and handling. | Passed. Result demonstrated proper performance. |
| Electrical Safety | Meets relevant electrical safety standards. | Passed. Result demonstrated proper performance. |
| EMC | Electromagnetic compatibility maintained, avoiding interference with other devices and proper function in an electromagnetic environment. | Passed. Result demonstrated proper performance. |
| Viral Permeability | Not explicitly stated what aspect was tested but implies testing related to fluid ingress or barrier integrity. | Passed. Result demonstrated proper performance. |
| Environmental Performance Testing | Device performs adequately under various environmental conditions (e.g., temperature, humidity). | Passed. Result demonstrated proper performance. |
| Simulated Use (In Vivo) | Audio quality in measuring blood flow velocity is comparable to the predicate device at different vessel depths/sizes. Subject device performs equivalently. | Performed using the subject device and predicate device. The performance data demonstrated substantial equivalence. This is the closest to a performance acceptance criteria, implying a qualitative or semi-quantitative comparison of audio quality and blood flow measurement capability. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test beyond "the subject device and predicate device" for the in vivo test. It implies a sufficient number of units or test scenarios were used to generate data for each performance test.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be non-clinical (laboratory/engineering) and in vivo (likely animal or simulated human models for the blood flow assessment, although this is not explicitly stated). The report does not mention human clinical trials. All studies are presumably prospective as they were conducted to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For the in vivo simulated use test comparing audio quality, it would typically involve trained personnel for evaluation, but their number and qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of the tests (engineering, biocompatibility, in vivo simulation), formal adjudication methods like 2+1 or 3+1 typically used in image interpretation studies are unlikely to be directly applicable. The test results would be assessed against pre-defined engineering or biological standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical testing was required." The in vivo test was a "simulated use" assessment comparing the subject device to the predicate in terms of audio quality for blood flow measurement, not a clinical study involving human readers/interpreters.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable in the context of the VascuChek™ device. This device is a cardiovascular blood flowmeter that produces an audible tone based on the Doppler effect. Its performance is evaluated on its ability to generate an accurate audible signal representing blood flow, which is inherently designed for human interpretation (listening to the audio). There is no "algorithm only" component that would operate without human input in its intended use.
7. The Type of Ground Truth Used
The ground truth for the various non-clinical tests would be established by:
- Engineering Standards/Specifications: For mechanical, electrical, EMC, and software performance.
- Regulatory Standards/Guidelines: For biocompatibility (e.g., ISO 10993), pyrogenicity, sterility, and reprocessing.
- Predicate Device Performance: For the in vivo simulated use test, the performance of the predicate device serves as the comparative "ground truth" or benchmark, implying that the subject device should produce similar (substantially equivalent) audio quality and blood flow detection capabilities.
8. The Sample Size for the Training Set
This information is not applicable as the VascuChek™ device, as described, does not appear to be an AI/machine learning device that requires a "training set." It is a hardware device based on the Doppler effect for real-time blood flow detection.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as point 8; there is no "training set" for this type of device.
§ 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).