-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.

AI/ML Overview

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 < 1.0 designed). Complies with FDA guidance.
	Biocompatibility	Compatible patient surface contact materials, identical to predicate.
	Electrical Safety	Meets IEC 60601-1, IEC 60601-1-2.
	Software Life Cycle Processes	Meets IEC 62304.
	Risk Management Process	Meets ISO 10993-1.
	Thermal Safety (Cranial Thermal Index)	TIC designed to be <1.0 in all system configurations. Predicate may exceed 1 but informs user.
New Feature - Holter Mode Specific Criteria	Ability to be used as Holter mode (ambulatory)	Functionally proven, recording to SD card, post-processing on PC.
	Battery Safety	Rechargeable Li-Ion battery compliant with IEC 62133 and UL 1642.
	Robotic probe tracking in Holter mode	Robotized probe can track Doppler signal (same system as predicate).
New Feature - Spectacle Frame Specific Criteria	Comfort and Efficacy of Spectacle Frame vs. Headband	Clinical trial results showed better recording quality, fewer manual adjustments, and improved patient tolerance/comfort compared to standard headband.
	Biocompatibility of Spectacle Frame	Manufactured with biocompatible materials.

2. Sample size used for the test set and the data provenance:

Sample Size: 97 patients were involved in the clinical trial.
Data Provenance: The document does not explicitly state the country of origin, but the manufacturer is based in France. The study appears to be a prospective clinical trial comparing the new spectacle frame probe holder to the predicate's headband.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document mentions "Clinical trials have been conducted with a prototype of TCD-X and points out that: - Fixing the transducer in place with the spectacle frame resulted in recordings of better . quality, and fewer manual adjustments were required compared with fixation with the standard headband." and "No risk for the users or the patients was reported in this study."
However, the document does not specify the number of experts used to establish ground truth or their specific qualifications (e.g., number of years of experience, specialization), nor does it explicitly state how ground truth was established for the performance evaluation in this 97-patient study (e.g., a formal "ground truth" for a diagnosis, or expert evaluation of recording quality/patient comfort).

4. Adjudication method for the test set:

The document does not mention any specific adjudication method (e.g., 2+1, 3+1) for the clinical trial results. The findings are reported as observations from the trial.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This device is a Transcranial Doppler Ultrasound System, which is a diagnostic tool for measuring blood flow velocities and detecting micro-embolic signals. It does not appear to involve "human readers" interpreting images or AI assistance in a way that would fit a typical MRMC study aiming to improve human reader performance. The "robotic probe" automatically tracks the Doppler signal, which is a functional automation, not an AI interpretation aid for a human reader.
Therefore, an MRMC comparative effectiveness study was not performed in the context of human readers improving with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The document focuses on the hardware and its functional capabilities, including the robotic probe's ability to track the Doppler signal automatically and the Holter mode's ability to record signals for later processing. While these aspects imply automated functions, the evaluation is primarily on the device's ability to acquire good quality Doppler signals and provide measurements, not on a standalone algorithm making diagnostic decisions without human involvement. The indications for use state "The TCD-X is a transcranial Doppler device intended for recording non-invasively Doppler signals... For the display and measurement of cerebral artery blood flow velocities... For the detection of micro-embolic signals." This implies the human operator is still responsible for interpreting the data output by the system.
The study primarily validates the physical components (probe, frame) and operational modes (Holter).

7. The type of ground truth used:

The clinical study involving 97 patients primarily assessed the safety and effectiveness of the new spectacle frame probe holder compared to the predicate's headband, focusing on recording quality, need for manual adjustments, patient tolerance, and comfort.
For the core functional equivalence and performance, the ground truth is implicitly based on comparison to a legally marketed predicate device (EMS-9UA), which itself would have been cleared based on its ability to accurately measure blood flow velocities and detect emboli (likely established through phantom studies and/or correlation with other established diagnostic methods). The TCD-X ensures its measurements are equivalent to the predicate.

8. The sample size for the training set:

The document does not mention a "training set" in the context of machine learning or AI models. The TCD-X system is described as a medical electrical equipment (ultrasound device) with software (IEC 62304), but not explicitly as an AI/ML powered diagnostic tool that would require a distinct training set for an algorithm.

9. How the ground truth for the training set was established:

As no "training set" for an AI/ML algorithm is described, this question is not applicable.

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

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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.

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	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
FetalImaging& 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)
PeripheralVessel	Peripheral vessel
	Other (Specify)
Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
FetalImaging& 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)
PeripheralVessel	Peripheral vessel
	Other (Specify)
Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
FetalImaging& 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)
PeripheralVessel	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	ATYS17 parc d'Arbora, 69510 Soucieu-en-Jarrest, FrancePhone: +33 4 78 05 69 69Fax: +33 4 78 05 69 60E-mail: atys@atysmedical.com
●	Official Correspondent	Christine TURLAT, Ph.DExport managerTel: + 33 4 78 05 69 69Email: 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 withrobotized probeTranscranial Doppler Holter with robotized probe
●	Federal Regulation Number	21 CFR 892.1550 System, Imaging, Pulsed DopplerUltrasonic21 CFR 892.1570 Diagnostic Ultrasound Transduce
●	Model Number(s)	TCD-X system18263 (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

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.

TCD-X can be used in two modes: Holter mode or Desktop TCD mode.

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Specification	TCD-X	EMS-9UA	Differencesdiscussion
Manufacturer	ATYS	Shenzhen Delicate Electronics Co. Ltd.	NA
510(k) number	Proposed device	K122710	NA
Product codesClass	IYN, ITXClass II	IYN, ITX, OQQClass II	Similar to predicate.
Intended use	The TCD-X is a transcranial Dopplerdevice intended for recording non-invasively Doppler signals fromintracranial vessels:- For the display and measurement ofcerebral artery blood flow velocities todetermine the presence ofhemodynamically significant deviationsfrom normal values.-For the detection of micro-embolicsignalsTCD-X has the ability to be used asHolter mode on ambulatory patients.The Robotic probe facilitatesmonitoring use by its ability to trackgood Doppler signal all along recordingtime.The device is not intended to replaceother means of evaluating vital patientphysiological processes.The TCD-X is intended to be appliedon adult persons.The TCD-X shall be used by or on theorder of physician.The device should be used by trainedphysicians.	The EMS-9UA Transcranial DopplerUltrasound System is intended for use asa diagnostic ultrasound fluid flow analysissystem:1) For the measurement of cerebral arteryblood velocities to determine the presenceof hemodynamically significant deviationsfrom normal values2) To assess arterial cerebral blood flowfor the occurrence of micro embolicsignals. Vessels intended for observationinclude, but are not limited to the middle,anterior and posterior cerebral arteries, viathe temporal windows, the vertebral midbasilar arteries via the foramen magnumand the ophthalmic artery and intracranialinternal carotid artery via the eye.The Robo probe Headband facilitatesmonitoring use by its ability to track theDoppler signal.The EMS9UA Transcranial Doppler isintended for use during:a) Diagnostic examsb) Surgical interventionsThe device is not intended to replaceother means of evaluating vital patient	Equivalent.The predicatedevice covers theTCD-X:Intended use, useenvironment, targetusers and patientpopulation.

	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
			device.
Frequency modes /	2MHz PW	2MHz PW	Equivalent.
Transducers		4MHz PW/CW	Predicate device
(MHz)		8MHz PW/CW	covers frequency
			mode offered by
			TCD-X.
Mechanism of	Doppler Ultrasound, with the following	Doppler Ultrasound, with the following	Equivalent.
action	modes:	modes:	Predicate device
	Unilateral, mono-gate, Monitoring.	Unilateral, Bilateral, Multigates,	covers all
		Monitoring, M-Mode.	mechanism of action
			of TCD-X.
TCD-X used as	1-Device used next to bedside of	1-Device used next to bedside of patients	Identical to predicate
desktop TCD	patients	2-Small box connected to external PC	device.
	2-Small box connected to external PC	3-Real time Display, recording and
	3-Real time Display, recording and	processing of Doppler signal on PC
	processing of Doppler signal on PC	4-Post processing of Doppler signal.
	4-Post processing of Doppler signal.
TCD-X used as	1-TCD-X body worn on ambulatory	1-Device used next to bedside of patients	Equivalent
Holter	patients.	2-Small box connected to external PC	Set up and post

	2-Small box connected to PC for setuponly.3- Doppler signal recorded on SDCard.4-Doppler signal display andprocessing made after signal recording,downloading from SD card to PC.	during all examination.3-Doppler signal recorded on PC.4-Doppler signal display and processingduring examination and after examination.	processing Dopplersignal are similar topredicate device.Recording andmethod of usedifferences dot notimpact adverselysubstantialequivalence topredicate device.
Transcranialmonitoring probe.	2MHz PW reusable non sterile Roboticmonitoring probe.	2MHz PW reusable non sterile Roboticmonitoring probe.	EquivalentThe mechanism ofrobotized probe isidentical to EMS-9UA predicatedevice.
Transcranialhandheld probe	2MHz PW reusable non sterilehandheld probe	2MHz PW reusable non sterile handheldprobe	Identical to predicatedevice.
Monitoring probehandling	-Spectacle frame with unilateralmonitoring robotic probe	-Standard head frame with unilateral orbilateral monitoring robotic probes	EquivalentTCD-X method offixation of roboticmonitoring probe isequivalent to EMS-9UA predicatedevice.TCD-X method iseffective and do notimpact thesubstantialequivalence withpredicate device forunilateral mode.
Power supply	Internally powered device usingrechargeable Li-Ion battery	Mains	EquivalentThis is user
	(8 hours autonomy)		convenience featurethat does not impactthe operation orsafety of the patient.
Patient surfacecontact materials	Compatible	Compatible	IdenticalPatient surfacecontact probesmaterials areidentical to allpredicate devicesfrom the samematerial/assemblymanufacturer.
Performance	Sample volume adjustable	Sample Volume adjustable	Equivalent topredicate device.
	Depth adjustable	Depth adjustable	Equivalent topredicate device.
	Power: 0% to 100% where 100%represents Ispta.3 upper value thatkeeps the TIC (Cranial Thermal Index)in all configurations less than 1.Derated Ispta.3 is highly less than720mW/cm2 within FDA guidance.	Power% 0 to 100% where 100%represents Ispta.3 upper-tolerance limit720 mW/cm² within FDA guidance	Equivalent topredicate device.
Maximal acousticoutput Ispta.3(mW/cm2)	Below maximal FDA guideline limitsComply with FDA limits:Ispta.3 ≤ 720 mW/cm2MI ≤ 1.9 or the globalmaximum derated ISPPA ≤ 190 W/cm².TCD-X System global maximum MIand TIC (Cranial Thermal Index) areboth designed to be <1.0 in all systemconfigurations.	Below maximal FDA guideline limitsComply with FDA limits:Ispta.3 ≤ 720 mW/cm2MI ≤ 1.9or the global maximum derated ISPPA ≤190 W/cm².	Equivalent topredicate device.
Clinicalmeasurements	-Peak velocity,-Mean velocity-End diastolic velocity	-Peak velocity,-Mean velocity-End diastolic velocity	Identical to predicatedevice

	-Pulsatility Index,-Resistance index,-Systolic to diastolic ratio,-Rise time,-Heart rate,-Emboli detection	-Pulsatility Index,-Resistance index,-Systolic to diastolic ratio,-Rise time,-Heart rate,-Emboli detection
Velocity units	Cm/sec or kHz	Cm/sec or kHz	Identical to predicate device.
Display of thetrends of indices	Available	Available	Identical to predicate device.
Audiogram display	Available	Available	Identical to predicate device.
Signal and audioplayback	Available	Available	Identical to predicate device.
Configurableprotocols	Available	Available	Identical to predicate device.
Export of patientreports	Multiple formats	Multiple formats	Identical to predicate device
Labeling and/orpromotionalmaterials	LeafletUser manual	LeafletUser manual	Equivalent
StandardsCompliance	IEC 60601-1, 3.0 Ed.IEC 60601-1-2. 3.0 Ed.IEC 60601-2-37. 2.1 EdISO 10993 4.0 EdIEC 62304 1.1 Ed	IEC 60601-1, 3.0 Ed.IEC 60601-1-2. 3.0 Ed.IEC 60601-2-37. 2.1 EdISO 10993 4.0 Ed	TCD-X complieswith currentrecognizedstandards.
Box unit physicalcharacteristics	Size: 15 x 9,2 x 2,8 cmWeight: 0.35 kg (without accessories)	Size: 34.3 cm × 21.9 cm × 6.3 cmWeight: 1.30 kg (without accessories)	Equivalent topredicate device

G. Comparison of technological characteristics with the predicate device

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H. Substantial Equivalence Discussion

The TCD-X System is substantially equivalent to the EMS-9UA Transcranial Doppler Ultrasound System (K122710) based on indications for use and comparison of the functional capabilities. Both devices are intended to provide a diagnostic ultrasound fluid flow analysis. Features common to all systems include:

• Transcranial Doppler ultrasound systems used for fluid flow analysis

· Monitor the cerebral arteries via the temporal windows
· Utilize motorized probe and handheld probe for monitoring examinations
· Unilateral and Monoqate measurements possible
Use substantially equivalent operating modes
Measure equivalent hemodynamic indices
· Have equivalent monitoring functions
Display velocity spectrum

· Manufactured with materials that have been evaluated and found to be safe for the intended use of the device

Have patient contact surfaces are manufactured from the same materials
Manufactured to meet applicable physical, mechanical, and electrical safety

The TCD-X System is substantially equivalent to the EMS-9UA Transcranial Doppler Ultrasound System (K122710). This is based on the indications for use and comparison of the functional capabilities. Both devices are intended to provide a diagnostic ultrasound fluid flow analysis.

The minor differences (discussed below) between the TCD-X System and the EMS-9UA Transcranial Doppler Ultrasound System (K122710) do not raise new questions of safety or effectiveness. These differences are discussed as follows:

. TCD-X used as Holter

Contrary to the predicate device, the TCD-X can also be used as body-worn for ambulatory patients.

In this mode, the TCD-X is disconnected from the PC, put in its carrying bag, put on the patient and records the Doppler signal on the SD card.

The TCD-X is powered by a rechargeable Li-lon battery to allow ambulatory examinations.

Before starting the recording TCD-X displays to the maximum duration recording. The user can select this maximum duration setting or can set lower duration of record.

This duration depends on the battery level of charge, available capacity on the SD card and Doppler parameters set.

The rechargeable battery in the TCD-X System is compliant with the IEC 62133 (First and Second Edition Rechargeable Lithium-lon) and UL 1642 Standard for Lithium Batteries.

The robotized probe is used to track the Doppler signal during the monitoring. It is automated system that consists to change angles according to intensity level when monitoring. It is exactly the same system used with EMS-9UA and already cleared in (K122710).

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J. Acoustic Output

Below maximal FDA guideline limits Comply with FDA limits: Ispta.3 ≤ 720 mW/cm2 Ml ≤ 1.9 or the global maximum derated ISPPA ≤ 190 W/cm2.

TCD-X System global maximum MI and TIC (Cranial Thermal Index) are both designed to be <1.0 either in Desktop TCD or Holter mode.

EMS-9UA complies also with FDA limits Ispta.3 ≤ 720 mW/cm2. Cranial Thermal Index of EMS-9UA could exceed 1 but keeps always the user informed through the display.

K. Spectacle frame

The system that maintains the transcranial Doppler probe on the patient's head looks like a spectacle frame.

It can be used on awake or sedated patients.

For sedated patients (no movement, no complain about discomfort with wear), the spectacle type headframe allows the recording of a Doppler signal over several hours. It is equivalent to the headframe of the predicate device.

For awake patient, it is far more comfortable that the headframe of the predicate device. Indeed to prevent the probe from moving the headframe must be tight which is often painful after 20 min.

The spectacle type headframe has been designed to be comfortable.

The spectacle type headframe make possible longer recording or monitoring.

Clinical trials have been conducted with a prototype of TCD-X and points out that:

Fixing the transducer in place with the spectacle frame resulted in recordings of better . quality, and fewer manual adjustments were required compared with fixation with the standard headband.
. Patients tolerate recordings of 5 to 6 hours well
. There were no complaints of discomfort with the spectacle frame, whereas 3 of the 10 patients using the headband complained of a mild temporary headache due to pressure from the band.

No risk for the users or the patients was reported in this study.

The spectacle type headframe is manufactured by a manufacturer of spectacle frames. Biocompatible materials are used.

Summary of Non-Clinical Testing and Performance Standards ட்.

The TCD-X System is evaluated for acoustic output, biocompatibility, and accuracy, as well as thermal, electrical, electromagnetic, and mechanical safety. TCD-X meets the following standards and guidances:

IEC 60601-1:2005+A1:2012 Medical electrical equipment Part 1: General . requirements for basic safety and essential performance
. IEC 60601-1-2:2007 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 62304 Edition 1.1 2015-06 Medical device software - Software life cycle processes
Guidance for the Content of Premarket Submissions for Software Contained in Medical . Devices - Guidance for Industry and FDA Staff, May 2005

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ISO 10993-1:2009/Cor.1:2010 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
. IEC 60601-2-37: 2007(AMD1:2015) [Edition 2.1] - Medical Electrical Equipment -Part 2-37: Particular Requirements for The Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment
NEMA UD 2-2004 (R2009), Acoustic Output Measurement Standard For Diagnostic ● Ultrasound Equipment Revision 3
UD 3-2004 (R2009) Standard for Real-Time Display of Thermal and Mechanical . Acoustic Output Indices on Diagnostic Ultrasound Equipment. Revision 2.
. Guidance for Industry and FDA Staff Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: September 9, 2008
Use of International Standard ISO 10993-1, Biological evaluation of medical devices -. Part 1: Evaluation and testing within a risk management process. Guidance for Industry and Food and Drug Administration Staff, Issued on June 16, 2016.

M. Clinical testing

Review of literature pertaining to the safety of the TCD-X has been conducted and appropriate specifications have been incorporated in the design of the TCD-X.

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.

TCD-X has been subjected to extensive safety, performance testing and validation before release. All functional specifications, safety aspects following applicable standards, labeling requirements have been met and evaluated as safe and effective.

N. Conclusion

The increased mobility of TCD-X does not present any risk for the user or patient. With the TCD-X, it is not only possible to measure the blood velocities in seated, rested or anaesthetized patients but also in patients involved in different routine activities.

As the patient can move during the recording of the Doppler signal, he or she withstand better the recording and accept better long-term recording which is relevant to record unpredictable or random phenomena.

The documentation provided demonstrates that:

· The TCD-X System and transducers are substantially equivalent to the predicate device.
· There are no new questions of safety and effectiveness concerning the TCD-X System and transducers.

· The TCD-X System is designed to be at least as safe and effective as the predicate device.

· The TCD-X System is designed to perform as well as the predicate device.

Accordingly, the TCD-X System is believed to be substantially equivalent to a predicate device of the same type which is lawfully distributed in interstate commerce in the United States and that differences do not raise any further questions of the safety or effectiveness.

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008_510(k) Summary

Appendix G: Example Diagnostic Ultrasound Indications For Use Format

System: __TCD-X ____________________________________________________________________________________________________________________________________________________________

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	ColorDoppler	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	Peripheral vessel
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

Transducers that are marked by N for TCD-X system are already cleared by predicate device

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008_510(k) Summary

Appendix G: Example Diagnostic Ultrasound Indications For Use Format

System: __TCD-X Transducer: __2 MHz Robotic Probe: reference _______________________________________

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	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &	Fetal
Other	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	Peripheral vessel
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

Transducers that are marked by N for TCD-X system are already cleared by predicate device

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008_510(k) Summary

Appendix G: Example Diagnostic Ultrasound Indications For Use Format

System: __TCD-X Transducer: __2 MHz Handheld probe: reference _________________________________________

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	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &	Fetal
Other	Abdominal
	Intra-operative(Specify)
	Intra-operative(Neuro)
	Laparoscopic
	Pediatric
	Small Organ(Specify)
	Neonatal
	Cephalic
	Adult Cephalic			N
	Trans-rectal
	Trans-vaginalTrans-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	Peripheral vessel
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 ImagingTransducers that are marked by N for TCD-X system are already cleared by predicate device

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.