TCD-X

K182175 · Atys · IYN · Apr 5, 2019 · Radiology

Device Facts

• Record ID: K182175
• Device Name: TCD-X
• Applicant: Atys
• Product Code: IYN · Radiology
• Decision Date: Apr 5, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2

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 Story

TCD-X is a portable/body-worn transcranial Doppler ultrasound system; measures blood flow velocities in intracranial vessels; detects micro-embolic signals. Components: recorder module, robotized probe, handheld probe, spectacle frame. Operation: Holter mode (ambulatory, SD card recording) or Desktop mode (real-time PC connection via isolated USB). Robotized probe automatically adjusts angle to maintain signal quality. Used in hospitals or professional examination rooms by trained physicians. Output: velocity spectra, hemodynamic indices (PI, RI, systolic/diastolic ratio), heart rate, emboli counts. Benefits: enables long-term monitoring of unpredictable phenomena in mobile patients; spectacle frame improves patient comfort and signal stability compared to traditional headbands.

Clinical Evidence

Clinical trial with 97 patients compared spectacle frame robotic probe holder to predicate's robotic headband. Results: spectacle frame provided better signal quality, required fewer manual adjustments, and was well-tolerated for 5-6 hour recordings without discomfort (unlike headband, which caused pressure-related headaches in 3/10 patients). No safety risks reported.

Technological Characteristics

Materials: biocompatible. Sensing: 2MHz Pulsed Wave (PW) Doppler. Energy: ultrasound. Form factor: portable recorder module with robotized/handheld probes and spectacle frame. Connectivity: isolated USB to PC, SD card for Holter. Power: internal Li-Ion battery (8h autonomy). Standards: IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 60601-2-37, ISO 10993.

Indications for Use

Indicated for adult patients for non-invasive recording of Doppler signals from intracranial vessels, measurement of cerebral artery blood flow velocities, and detection of micro-embolic signals. Contraindicated for use on non-intact skin, eyes, or for fetal applications/monitoring.

Regulatory Classification

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.

Predicate Devices

• EMS9UA (K122710)

Submission Summary (Full Text)

{0}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

## 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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

{3}------------------------------------------------

# 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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| Fetal<br>Imaging<br>& 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<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& 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<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& 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<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>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

{4}------------------------------------------------

# 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

{5}------------------------------------------------

# 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

{6}------------------------------------------------

| A. | Submitter information | |
|----|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| ● | Manufacturer | ATYS<br>17 parc d'Arbora, 69510 Soucieu-en-Jarrest, France<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| ● | Official Correspondent | Christine TURLAT, Ph.D<br>Export manager<br>Tel: + 33 4 78 05 69 69<br>Email: [e-mail] |
| ● | 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<br>robotized probe<br>Transcranial Doppler Holter with robotized probe |
| ● | Federal Regulation Number | 21 CFR 892.1550 System, Imaging, Pulsed Doppler<br>Ultrasonic<br>21 CFR 892.1570 Diagnostic Ultrasound Transduce |
| ● | Model Number(s) | TCD-X system<br>18263 (Monitoring Robotized probe 2MHz)<br>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.

{7}------------------------------------------------

#### 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.

{8}------------------------------------------------

#### ட 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.

{9}------------------------------------------------

| Specification | TCD-X | EMS-9UA | Differences<br>discussion |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | ATYS | Shenzhen Delicate Electronics Co. Ltd. | NA |
| 510(k) number | Proposed device | K122710 | NA |
| Product codes<br>Class | IYN, ITX<br>Class II | IYN, ITX, OQQ<br>Class II | Similar to predicate. |
| Intended use | The TCD-X is a transcranial Doppler<br>device intended for recording non-<br>invasively Doppler signals from<br>intracranial vessels:<br>- For the display and measurement of<br>cerebral artery blood flow velocities to<br>determine the presence of<br>hemodynamically significant deviations<br>from normal values.<br>-For the detection of micro-embolic<br>signals<br>TCD-X has the ability to be used as<br>Holter mode on ambulatory patients.<br>The Robotic probe facilitates<br>monitoring use by its ability to track<br>good Doppler signal all along recording<br>time.<br>The device is not intended to replace<br>other means of evaluating vital patient<br>physiological processes.<br>The TCD-X is intended to be applied<br>on adult persons.<br>The TCD-X shall be used by or on the<br>order of physician.<br>The device should be used by trained<br>physicians. | The EMS-9UA Transcranial Doppler<br>Ultrasound System is intended for use as<br>a diagnostic ultrasound fluid flow analysis<br>system:<br>1) For the measurement of cerebral artery<br>blood velocities to determine the presence<br>of hemodynamically significant deviations<br>from normal values<br>2) To assess arterial cerebral blood flow<br>for the occurrence of micro embolic<br>signals. Vessels intended for observation<br>include, but are not limited to the middle,<br>anterior and posterior cerebral arteries, via<br>the temporal windows, the vertebral mid<br>basilar arteries via the foramen magnum<br>and the ophthalmic artery and intracranial<br>internal carotid artery via the eye.<br>The Robo probe Headband facilitates<br>monitoring use by its ability to track the<br>Doppler signal.<br>The EMS9UA Transcranial Doppler is<br>intended for use during:<br>a) Diagnostic exams<br>b) Surgical interventions<br>The device is not intended to replace<br>other means of evaluating vital patient | Equivalent.<br>The predicate<br>device covers the<br>TCD-X:<br>Intended use, use<br>environment, target<br>users and patient<br>population. |
| | | | |
| | The TCD-X shall be used in hospital | physiological processes, is not intended to | |
| | environment or in common examination | be used in fetal applications, and is not | |
| | room of a professional environment. | intended to be used inside the sterile field. | |
| | TCD-X is fitted either 2 MHz probe | | |
| | (PW) | | |
| | The TCD-X shall not be used on non- | | |
| | intact skin. | | |
| | The TCD-X probe is not for use on the | | |
| | eyes, foetal application and foetal | | |
| | monitoring. | | |
| Clinical | Intracranial | Intracranial | Equivalent. |
| applications | | Extracranial | Predicate device |
| | | Peripheral | covers clinical |
| | | | applications of TCD- |
| | | | X. |
| Energy delivered | Ultrasound energy | Ultrasound energy | Identical to predicate |
| | |…