(570 days)
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No
The description focuses on hardware modifications (transducer) and real-time signal processing, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is used to measure blood velocities and provide hemodynamic information for diagnostic and interventional procedures, not to treat a medical condition.
Yes
The "Intended Use / Indications for Use" section states that the device is used to "measure blood velocities" and for "diagnostic procedures such as peripheral and coronary angiography." The "Device Description" also mentions that the device displays "blood flow velocity measurements and spectral patterns," providing "hemodynamic information in diagnostic and/or interventional procedures." These functionalities clearly indicate its use for diagnostic purposes.
No
The device description clearly details hardware components including Doppler Guide Wires with tip-mounted transducers, a Rotary Connector Cable, a Patient Cable, and the FloMap Ultrasound Instrument which incorporates electronics and software. The modifications described are to the physical transducer.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device measures blood velocities in vivo (within the body) in peripheral, coronary, and cerebral arteries. IVD devices are used to examine specimens derived from the human body in vitro (outside the body).
- Device Description: The description details a guide wire with a tip-mounted ultrasound transducer that is inserted into the vasculature. This is a direct interaction with the patient's body, not an analysis of a sample outside the body.
- Function: The device processes Doppler ultrasound signals in real time to display blood flow velocity measurements and spectral patterns. This is a physiological measurement taken directly from the patient.
The device is a diagnostic tool used during medical procedures, but it operates in vivo rather than in vitro.
N/A
Intended Use / Indications for Use
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.
Product codes
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Device Description
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.
This modified transducer allows for a more efficient transducer with a higher signal to noise ratio and wider beam width. The actual velocities provided by the existing transducer and the modified transducer when adequate signals are received will be identical. The basic overall design, methods of manufacturing, and materials used are substantially equivalent to existing Doppler Guide Wires.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Ultrasound
Anatomical Site
peripheral and coronary arteries, cerebral vasculature
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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| Summary of Safety and Effectiveness | |
|---|---|
| Cardiometrics Doppler Guide Wires | |
| Report of Device Modification | |
| OCT 25 1996 | 510(k) Modification K 951567 |
| Trade Name: | Cardiometrics FloWire Doppler Guide Wire and SmartWire |
| Doppler Guide Wire | |
| Generic Name: | Doppler Guide Wire |
| Manufacturer: | Cardiometrics, Inc. |
| 645 Clyde Avenue | |
| Mountain View, California 94043 | |
| Establishment Registration Number: 2938946 |
Classification:
In preparation of this PreMarket Notification, it was determined that devices of this generic type have been previously classified as Class II devices. No performance standards have yet been established for these products.
Product Description:
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.
013
1
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.
Intended Use:
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.
Rationale for Substantial Equivalence:
Cardiometrics Doppler Guide Wires (FloWire and SmartWire Doppler Guide Wires) are devices which were found to be substantially equivalent to predicate devices. Cardiometrics Doppler Guide Wires with the modified transducer are substantially equivalent to currently marketed Cardiometrics Doppler Guide Wires with regard to intended use, materials, and design.
2
This modified transducer allows for a more efficient transducer with a higher signal to noise ratio and wider beam width. The actual velocities provided by the existing transducer and the modified transducer when adequate signals are received will be identical. The basic overall design, methods of manufacturing, and materials used are substantially equivalent to existing Doppler Guide Wires.
Biocompatibility Evaluations:
Cardiometrics Doppler Guide Wires have been tested and meet the requirements of the USP XXII Class IV testing for plastics and the tests outlines in the Tripartite Biocompatibility Guidance for Medical Devices (September 1986). The biocompatibility test results provided support the safety of the subject device. No changes have been made which affect the biocompatibility testing.
Summary:
Based upon the transducer modification described in this summary, the Cardiometrics Doppler Guide Wires with modified transducers are substantially equivalent to those transducers utilized in existing Doppler Guide Wires. The intended use and method of operation remain identical. Also, the methods of construction and materials used are either identical or substantially equivalent to their existing Doppler Guide Wires.
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