(29 days)
The Quantix/ND device is intended for non-invasive, peripheral vessel examinations of blood flow measurements
Diagnostic Blood Flow Measurements
The Quantix/ND is a dual-beam, angle-independent, pulse-wave Doppler ultrasound system used for non-invasive (peripheral vessel) volume blood flow measurements, including blood flow velocity and volume blood flow. In addition to the conventional Doppler (blood flow velocity) measurements, the Quantix/ND technology utilizes special applications of ultrasound Doppler methods to obtain real-time measurements according to the definition of volume blood flow in target blood vessels. By definition, blood flow is the product of velocity and cross-sectional area. In other words, the volume blood flow is calculated by deriving flow velocity from the Doppler shift frequency using the basic standard formula and then multiplying the velocity by the cross-section area of the blood vessel.
It is impossible to provide the requested information based on the input text. The provided text is a 510(k) premarket notification for the Quantix/ND Device, which focuses on demonstrating substantial equivalence to a predicate device.
The document does not contain:
- Any specific acceptance criteria or performance metrics for the Quantix/ND device.
- Details of a study proving the device meets acceptance criteria.
- Information on sample sizes, data provenance, ground truth establishment, or expert qualifications for testing.
- Any mention of multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance studies.
The document primarily describes the device, its intended use, and its technological characteristics in comparison to a predicate device (FlowGuard, K013803) to assert substantial equivalence, which is the basis for 510(k) clearance. Clinical performance data or detailed validation studies with defined acceptance criteria are not typically part of the summary provided in a 510(k) notification unless specifically requested or if substantial equivalence cannot be established through other means.
§ 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).