(97 days)
The Remington Medical, Inc. VascuChek™ Clinical Device is intended for the non-invasive transcutaneous evaluation of blood flow in Peripheral Vasculature.
VascuChek™ is a cardiovascular blood flowmeter comprised of two components: a nonsterile, single-use VascuChek™ Clinical Probe which connects to the reusable, nonsterile VascuChek™ Transceiver.
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 receives to a 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.
The provided document is a 510(k) summary for the Remington Medical, Inc. VascuChek™ Clinical Device. The product is a cardiovascular blood flowmeter intended for non-invasive transcutaneous evaluation of blood flow in peripheral vasculature. The submission demonstrates substantial equivalence to the predicate device, Vascular Technology Incorporated (VTI) Surgical Doppler (K082870).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" for performance metrics in a quantitative manner (e.g., minimum sensitivity or specificity). Instead, the performance evaluation is based on demonstrating substantial equivalence to a predicate device through various non-clinical and an in vivo simulated use test. The criteria for acceptance are implied by the successful completion of these tests and a conclusion of substantial equivalence.
| Acceptance Criteria Category (Implied) | Reported Device Performance | Study Type |
|---|---|---|
| Software/Firmware Performance | Tests performed and met. | Non-clinical |
| Mechanical Performance | Tests performed and met. | Non-clinical |
| Biocompatibility | Tests performed and met. | Non-clinical |
| Device Lifecycle | Tests performed and met. | Non-clinical |
| Reprocessing (Cleaning and Low-Level Disinfection) | Tests performed and met. | Non-clinical |
| Distribution Simulation | Tests performed and met. | Non-clinical |
| Electrical Safety | Tests performed and met. | Non-clinical |
| EMC (Electromagnetic Compatibility) | Tests performed and met. | Non-clinical |
| Environmental Performance Testing | Tests performed and met. | Non-clinical |
| Audio Quality in Blood Flow Velocity Measurement | Assessed and compared performance of the new device to its predicate at different vessel depths/sizes. The results contributed to the conclusion of substantial equivalence. | In vivo Simulated Use |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions an "in vivo Simulated Use" test. However, it does not specify the sample size used for this test (e.g., number of subjects, number of measurements). It also does not provide details about the data provenance beyond stating it was an in vivo test. Therefore, information regarding country of origin of the data or whether it was retrospective or prospective is not available in the provided text.
3. Number of Experts Used to Establish the Ground Truth and Qualifications:
The document does not mention the use of experts to establish ground truth for any test set. The in vivo simulated use test focused on assessing audio quality and comparing performance to the predicate device, implying that the predicate's output or a direct measurement was used as a reference rather than expert consensus on a diagnostic outcome.
4. Adjudication Method for the Test Set:
Since the document does not describe the use of multiple experts or a diagnostic task requiring consensus, there is no mention of an adjudication method (e.g., 2+1, 3+1).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. The study focused on demonstrating substantial equivalence of the device's technical characteristics and performance to a predicate device, not on how human readers' performance might improve with or without AI assistance. The device itself is a blood flowmeter, not an AI-assisted diagnostic tool for interpretation by human readers in the traditional sense of an MRMC study.
6. Standalone Performance:
The primary focus of the performance data section is on the standalone performance of the VascuChek™ Clinical Device, both through non-clinical bench testing and the in vivo simulated use test. The purpose was to show that the device itself performs comparably to the predicate device.
7. Type of Ground Truth Used:
For the in vivo simulated use test, the ground truth appears to be established by comparison to the predicate device in terms of measuring the velocity of blood flow. The phrasing "compare performance of the new device to its predicate" suggests the predicate's output served as the reference for evaluating the subject device's audio quality in measuring blood flow velocity. There is no indication of pathology, outcomes data, or expert consensus being used as ground truth for this device's specific function.
8. Sample Size for the Training Set:
The document does not mention a training set because the VascuChek™ Clinical Device is a cardiovascular blood flowmeter, not a device that employs machine learning or artificial intelligence requiring a training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a training set, there is no information on how its ground truth might have been established.
§ 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).