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510(k) Data Aggregation
K Number
K182175Device Name
TCD-X
Manufacturer
Date Cleared
2019-04-05
(238 days)
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
Atys
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
Device Description
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.
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K Number
K012369Device Name
BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3
Manufacturer
Date Cleared
2001-08-10
(15 days)
Product Code
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
ATYS MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BASIC is a non-invasive diagnostic system to assist in the detection of peripheral vascular disease (arterial or venous).
The BASIC is not intended to be used for fetal monitoring nor for fetal applications. The BASIC is not intended for ophthalmic applications.
The BASIC is not intended for home use.
The BASIC is not intended for use on non-intact skin or eyes.
Photo-plethysmography module.
Pneumo-plethysmography module.
The pneumo-plethysmography module measures volume changes in limbs or digits. Relative limb volume increases with each heartbeat. The pneumo-plethysmography module measures this increase and depicts it as a waveform.
The pneumo-plethysmography is also used in conjunction with the Doppler module or the photo-plethysmography module to measure the systolic blood pressure in limbs or digits. In this case, the pneumo-plethysmography module is used to inflate a cuff to perform the occlusion.
The photo-plethysmography module: the amount of blood in the skin changes with each contraction of the heart. The Photo-plethysmography module measures this change and depicts it in a waveform.
The photo-plethysmography module is also used in conjunction with the pneumo-plethysmography module (blood pressure cuffs) to measure the systolic blood pressure. The photo-plethysmography module detects the return of the blood after the occlusion.
The pneumo-plethysmography module is not intended for neonatal applications.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular
Device Description
The diagnosis with the BASIC is performed via four separate modalities, each of which can be used to test either the arterial or venous system.
These four modalities are:
- 4 and 8 MHz continuous wave Doppler.
- Photoplethysmography,
- Air plethysmography,
- Systolic pressure examination.
The BASIC's principle of operation is based on:
- Doppler mode: the real time ultrasound measurement of blood velocity in the examined vessel is displayed as a waveform. The time overation of the velocity is made with a 4 or 8 MHz probe.
- Photoplethysmography: The photo plethysmography probe is placed on a digit or taped to the skin surface. The photo plethysmography probe contains an infrared light source and a sensitive photocell. The light source directs infrared light into the skin. The receiving photocell measures in real time the change of the amount of blood in the skin caused by the contraction of the heart. It depicts it in a waveform.
- Air plethysmography: the real time measure of the change of blood volume in a limb. An Air-filled pressure cuff is used to measure these changes. By wrapping a pressure cuff on a patient's leg, arm or digit, the blood flow at these locations can be quickly assessed. Relative limb volume increases with each heart beat. Air plethysmography measures this increase and depict it in a waveform.
- Systolic pressure examination requires a Doppler probe or an arterial photo-sensor and a pressure cuff to measure the patient's systolic pressure at different locations (legs, arms, digits).
The important data are not the absolute value of the pressures but the pressure differences or ratio.
The BASIC consists of the following components:
- The main console,
- The 4 and 8 MHz probes,
- The photo-plethysmography sensors,
- The cuffs (the cuffs are accessories not manufactured by Atys).
The main consoles provides various indicators and controls designed to lead the operator through the sequential procedures needed for the operation of the BASIC. It contains a LCD screen and a thermal printer to display the parameters and charts associated with the tests. The console also houses the electrical and electronical components, the cuff inflate pump, the pressure sensor (that measures the pressure in the cuff). The device operates from 220 V supply.
The 4 and 8 MHz probes are comprised of a sensor tip, a mechanical head, a cable and either two piezo electric transducers.
The transducer transforms the electrical energy into acoustical energy and vice versa.
The photo sensors are non focused sensors with two (arterial sensors) or four (vein sensors) emitters and a center receiver.
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