(570 days)
The FloWire Doppler Guide Wires and the FloMap Ultrasound Instrument measure blood velocities in peripheral and coronary arteries. The FloWire/FloMap System are intended for use in conjunction with diagnostic procedures such as peripheral and coronary angiography and for interventional procedures such as balloon angioplasty, as well as other interventional procedures which utilize a guide wire in the peripheral and coronary vasculature. The SmartWire Doppler Guide Wire and SmartMap Ultrasound Instrument are intended for use in the cerebral vasculature to measure blood flow velocities during diagnostic angiography and/or any interventional procedures.
This 510(k) Notification is being submitted for modifications to the tip mounted transducer of Cardiometrics Doppler Guide Wires (both FloWire and SmartWire Doppler Guide Wires). The transducer modifications allow the beam width to increase from 28° to 35° and allow the Doppler Guide Wires to all function at 12 MHz. Previously, the .014" Doppler Guide Wire functioned at 15 MHz and the .018" Doppler Guide Wire functioned at 12 MHz. This modified transducer will be more efficient with a higher signal to noise ratio with the wider beam width will allow for easier signal acquisition by the user when positioning the Doppler Guide Wire in the vessel.
The currently marketed FloWire and SmartWire Doppler Guide Wires have the mechanical properties of other floppy steerable guide wires with the addition of a tip mounted ultrasound Doppler transducer. FloWire and SmartWire Doppler Guide Wires connect to a Rotary Connector Cable which is supplied with each guide wire. The Rotary Connector Cable in turn connects to the Patient Cable which connects to the Cardiometrics FloMap Ultrasound Instrument. The FloMap Instrument incorporates the electronics and software required to process the Doppler ultrasound signals in real time, displaying blood flow velocity measurements and spectral patterns on the instrument monitor. Blood flow velocity measurements are obtained using the FloWire and SmartWire Doppler Guide Wires to provide hemodynamic information in diagnostic and/or interventional procedures.
The provided text describes a 510(k) modification K951567 for Cardiometrics Doppler Guide Wires. This submission is for modifications to the tip-mounted transducer to increase beam width and standardize the operating frequency.
Here's an analysis of the provided information against your requested criteria:
1. A table of acceptance criteria and the reported device performance
Unfortunately, the provided text does not contain any explicit acceptance criteria or reported device performance metrics in the way you might expect for a typical diagnostic device study (e.g., sensitivity, specificity, or quantitative accuracy targets).
Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices after a modification. The "performance" described is largely qualitative, centering on the improvements due to the modification:
| Feature/Criterion (Inferred) | Reported Device Performance |
|---|---|
| Transducer Efficiency / Signal Quality | More efficient transducer with a higher signal-to-noise ratio. |
| Beam Width | Increased from 28° to 35°. |
| Ease of Signal Acquisition | Wider beam width will allow for easier signal acquisition by the user. |
| Operating Frequency | All Doppler Guide Wires function at 12 MHz (previously .014" was 15 MHz). |
| Measurement Accuracy (when signal is adequate) | Actual velocities provided by the existing transducer and the modified transducer when adequate signals are received will be identical. |
| Mechanical Properties | Substantially equivalent to other floppy steerable guide wires. |
| Biocompatibility | Tested and meets USP XXII Class IV and Tripartite Biocompatibility Guidance. |
| Intended Use | Remains identical to existing devices. |
| Method of Operation | Remains identical to existing devices. |
| Construction Methods and Materials | Either identical or substantially equivalent to existing devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a specific clinical "test set" or study involving patient data for the modified device's performance. The rationale for substantial equivalence is based on the technical modifications and their expected impact, rather than a new clinical trial comparing the old and new transducers head-to-head on a patient cohort.
Therefore, information regarding:
- Sample size for the test set: Not applicable / Not provided.
- Data provenance (country of origin, retrospective/prospective): Not applicable / Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since there is no described clinical "test set" requiring ground truth establishment, this information is not applicable and not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since there is no described clinical "test set," this information is not applicable and not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. This device is a medical instrument (Doppler Guide Wire) not an AI-powered diagnostic tool for image interpretation by "human readers." Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical medical instrument, not a standalone algorithm. Its function relies on being used by a clinician to acquire data which is then processed and displayed by the FloMap/SmartMap instrument for the clinician's interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Since there is no described clinical "test set" and a focus on substantial equivalence based on technical specifications and existing device performance, specific "ground truth" data of this nature (expert consensus, pathology, outcomes) is not applicable and not provided for this modification submission. The "ground truth" here is more akin to engineering specifications and equivalence to previously cleared devices.
8. The sample size for the training set
This section is not applicable. The device is a physical instrument, not a machine learning model, so there is no concept of a "training set" in the context of AI/ML development.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
Summary of the K951567 Submission Type:
This 510(k) submission is for a device modification, not an original device clearance or a de novo submission. The primary goal is to demonstrate substantial equivalence of the modified device to its own previously cleared version (predicate device). The evidence presented focuses on the technical changes (transducer design) and asserts that these changes improve efficiency and user experience without altering the fundamental intended use, safety, or core performance when a signal is acquired. It relies heavily on comparative analysis of specifications and existing biocompatibility data rather than new clinical outcome studies.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.