Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions automatic adjustment of the robotic probe to track the Doppler signal, but this appears to be a form of automated control based on signal strength, not necessarily AI/ML for complex pattern recognition or prediction. There is no mention of AI, ML, or related terms in the document.

Therapeutic

No

The device is intended for recording and displaying blood flow velocities and detecting micro-embolic signals, which are diagnostic functions, not therapeutic interventions.

Diagnostic

Yes

The device is intended for "determining the presence of hemodynamically significant deviations from normal values" and "detection of micro-embolic signals," which are diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is composed of hardware components including a recorder module, robotized probe, hand held probe, spectacle frames, carrying bag, SD card, battery charger, and USB cable. It is a physical ultrasound device with associated software for display, processing, archiving, and printing.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
TCD-X Function: The TCD-X is a transcranial Doppler device that uses ultrasound to non-invasively measure blood flow velocities within the intracranial vessels. It does not analyze specimens taken from the body.

The TCD-X is a medical device used for diagnostic purposes, but it falls under the category of in vivo diagnostic devices, as it interacts directly with the patient's body to obtain information.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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 hemodynamically 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.

Product codes

IYN, ITX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Intracranial vessels, cerebral artery

Indicated Patient Age Range

adult persons

Intended User / Care Setting

The TCD-X shall be used by or on the order of physician. The device should be used by trained physicians.
The TCD-X shall be used in hospital environment or in common examination room of a professional environment.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Clinical testing: A clinical trial involving 97 patients were conducted to support the use of spectacle frame as robotic probe holder compared to the robotic headband of the predicate device and this was found to be safe and effective.

Key Metrics

Not Found

Predicate Device(s)

K122710

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services seal. To the right of the seal is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a blue square.

April 5, 2019

Atys medical % Christine Turlat, Ph.D. Export Manager 17, Parc d'Arbora Soucieu En Jarrest, 69510 FRANCE

Re: K182175

Trade/Device Name: TCD-X Transcranial Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, ITX Dated: March 4, 2019 Received: March 11, 2019

Dear Dr. Turlat:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

1

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182175

Device Name

TCD-X Transcranial Doppler Ultrasound System

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Diagnostic Ultrasound Indications For Use Format

TCD-X System: Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
Fetal
Imaging
& Other	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic			N
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)
Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
Fetal
Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic			N
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)
Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
Fetal
Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic			N
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

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Diagnostic Ultrasound Indications For Use Format

TCD-X System: 2 MHz Handheld Probe Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under this appendix

Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

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Diagnostic Ultrasound Indications For Use Format

TCD-X System: 2 MHz Robotic Probe Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under this appendix

Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

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A.	Submitter information
●	Manufacturer	ATYS
17 parc d'Arbora, 69510 Soucieu-en-Jarrest, France
Phone: +33 4 78 05 69 69
Fax: +33 4 78 05 69 60
E-mail: atys@atysmedical.com
●	Official Correspondent	Christine TURLAT, Ph.D
Export manager
Tel: + 33 4 78 05 69 69
Email: atys@atysmedical.com
●	Date of the summary	27/07/2018
B.	Device identification
●	Trade name	TCD-X Transcranial Doppler Ultrasound System
●	Common Name	Transcranial Doppler (TCD) Ultrasound system with
robotized probe
Transcranial Doppler Holter with robotized probe
●	Federal Regulation Number	21 CFR 892.1550 System, Imaging, Pulsed Doppler
Ultrasonic
21 CFR 892.1570 Diagnostic Ultrasound Transduce
●	Model Number(s)	TCD-X system
18263 (Monitoring Robotized probe 2MHz)
22673 (Handheld probe 2MHz)
●	Class	Class II medical device
●	Product Code	IYN
●	Subsequent Product Code	ITY

C. ldentification of predicate device

Predicate devices EMS9UA (K122710) manufactured by Shenzhen . Delicate Electronics Co., Ltd. (Codes IYN, ITX and OQQ)

D. Performance Standards

There are no required performance standards under the Federal Food, Drug and Cosmetic Act. Voluntary standards to which we will conform include: IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 60601-2-37 and ISO 10993.

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ய் Indication for 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 hemodynamically 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 good Doppler signal all along recording time.

The device is not intended to replace other means of evaluating vital patient physiological processes.

. Intended patient population The TCD-X is intended to be applied on adult persons
. Intended operator The TCD-X shall be used by or on the order of physician. The device should be used by trained physicians.
Intended environment ● The TCD-X shall be used in hospital environment or in common examination room of a professional environment.
. Mode of operation 2 MHz probe (PW)
. Contraindications The TCD-X shall not be used on non-intact skin. The TCD-X probe is not for use on the eyes, fetal application and fetal monitoring.

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ட Description