(238 days)
The TCD-X is a transcranial Doppler device intended for recording non-invasively Doppler signals from intracranial vessels:
-For the display and measurement of cerebral artery blood flow velocities to determine the presence of hemodynanically significant deviations from normal values.
-For the detection of micro-embolic signals.
TCD-X has the ability to be used as Holter mode on ambulatory patients.
The robotic probe facilitates monitoring use by its ability to track Doppler signal all along recording time. The device is not intended to replace other means of evaluating vital patient physiological processes.
The TCD-X system is a unilateral, non-invasive Transcranial Portable or body-worn Ultrasound Diagnosis Doppler. It is designed to non-invasively measure and display major transcranial vessels blood flow velocities that supply the brain. The system can also provide potential embolic events count.
It is composed by a recorder module, a robotized probe, a hand held probe and associated components (three available sizes for spectacle frames, small carrying bag, SD card, battery charger, USB cable).
TCD-X module needs to be connected to an external computer for its display, processing, archiving records and printing.
All probes are reusable, non invasive and non sterile. TCD-X can be fitted by one probe at a time.
It is fitted with 2MHz PW robotized monitoring probe, and 2MHz PW hand held probe.
The robotized probe has the ability to adjust its angle automatically to search the Doppler signal. When the Doppler signal becomes weaker during its recording, the orientation of the robotized probe can be adjusted automatically to retrieve a good quality signal.
TCD-X can be used in two modes: Holter mode or Desktop TCD mode.
The Holter mode is used on ambulatory patient. During the recording of the transcranial Doppler signal, the TCD-X is placed on the patient in a shoulder bag. The transcranial Doppler signal is recorded on a SD card. The recorded Doppler signal display and processing are made after examination on the computer.
The desktop TCD mode is a common conventional mode used for all TCD ultrasound Doppler. This mode allows the user to display the transcranial Doppler signal in real time. During this mode, the TCD-X remains connected to the PC via an isolated USB, the patient is immobile and the recording is done directly on the PC hard disk. The Doppler signal processing and printing is also possible after the end of real time recording.
The provided documentation describes the TCD-X Transcranial Doppler Ultrasound System. The acceptance criteria and the study proving the device meets them are outlined as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Primary Functional Equivalence | Intended Use compatibility | Equivalent to predicate (EMS-9UA) (K122710) for: |
- Display and measurement of cerebral artery blood flow velocities.
- Detection of micro-embolic signals. |
| | Clinical Applications | Equivalent to predicate for Intracranial applications. |
| | Energy Delivered | Identical to predicate (Ultrasound energy). |
| | Frequency Modes / Transducers | 2MHz PW (covered by predicate's offerings). |
| | Mechanism of Action | Equivalent to predicate's modes (Unilateral, mono-gate, Monitoring). |
| | Desktop TCD functionality | Identical to predicate's desktop TCD operation. |
| | Transcranial monitoring probe | Equivalent, robotic mechanism identical to predicate. |
| | Transcranial handheld probe | Identical to predicate. |
| | Clinical Measurements | Identical to predicate (Peak/Mean/End diastolic velocity, Pulsatility Index, Resistance index, Systolic to diastolic ratio, Rise time, Heart rate, Emboli detection). |
| Safety Criteria | Acoustic Output Limits | Ispta.3 ≤ 720 mW/cm2, MI ≤ 1.9 (Global max MI and TIC
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.