For the measurement of cerebral artery blood velocities to determine the presence of hemo-dynamically significant deviations from normal values;
To assess arterial cerebral blood flow for the occurrence of micro embolic signals. Vessels intended for observation include, but are not limited to the middle, anterior cerebral arteries, via the temporal windows, the vertebral mid basilar arteries via the foramen magnum and the ophthalmic artery and internal carotid artery via the eye. The robotic probe headband facilitates monitoring use by its ability to track the Doppler signal.
While the Transcranial Doppler Ultrasound System to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The system provides a noninyasive characterization of the arterial circulation and its beat-to-beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals. The noninvasive blood pressure waveform is measured on the subject's finger.
Using the blood pressure calibration module, the system can additionally provide an upper arm non-invasive blood pressure measurement to determine the blood pressure value for calibration.
The system is intended for use during:
Diagnostic exams;
Surgical interventions.
The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.
The EMS-9D EXP and EMS-9D PRO is intended to be used for subjects above 18 years of age. The MS-9D EXP and EMS-9D PRO is intended for use in hospitals, clinics and research centers.

Device Description

EMS-9D PRO and EMS-9D EXP are Transcranial Doppler (TCD) ultrasound system, which is developed based on the EMS-9D, it inherits all the EMS-9D's hardware and mechanical structure design. EMS-9D PRO and EMS-9D EXP are not only a Transcranial Doppler ultrasound system which used non-invasive technique to obtain the information of blood flow velocities throughout the body, but also a blood pressure monitor. This method of measurement is particularly useful for examining the major arteries supplying blood to the brain, and continuously measuring blood pressure.
TCD is useful for evaluation of numerous neurological vascular diseases such as vasospasm and intracranial stenosis. TCD is also extremely valuable for intraoperative monitoring to help detect sudden changes in blood flow.
The EMS-9D PRO and EMS-9D EXP integrate main unit, TCD probes, Nano Core module, upper arm blood pressure module and analog output module (EMS-9D EXP only), dedicated software, remote control, headframe, upper arm cuff, finger cuff and optional probes.
EMS-9D EXP/EMS-9D PRO should be used in hospitals or healthcare facilities by doctors or trained healthcare professionals.

AI/ML Overview

The provided text describes a Transcranial Doppler Ultrasound System (EMS-9D EXP/PRO) and references several non-clinical tests to assert its substantial equivalence to predicate devices, particularly regarding its Transcranial Doppler Ultrasound part, Nano Core part (Finger Arterial Blood Pressure), and Upper Arm Cuff Measurement part.

However, the document is a 510(k) Summary for regulatory submission, not a detailed clinical study report. It focuses on demonstrating equivalence to previously cleared devices rather than presenting novel clinical efficacy data with defined acceptance criteria and study results in the typical sense of a diagnostic performance study.

Therefore, many of the requested details about acceptance criteria, specific study design (e.g., sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance), and ground truth establishment for new clinical performance evaluation are not explicitly present or applicable in this regulatory summary. The document primarily relies on engineering performance specifications and comparison to predicate device specifications.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly substantial equivalence to the predicate devices and adherence to relevant safety and performance standards. The "reported device performance" refers to the specifications of the proposed device, which are shown to be equivalent to the predicate.

Characteristic	Acceptance Criteria (Predicate Device K173801)	Reported Device Performance (Proposed Device)	Comparison
Transcranial Doppler Ultrasound Part
Product Code	IYN, ITX, OQQ	IYN, ITX, OQQ	No difference
Regulation No.	21 CFR 892.1550, 21 CFR 892.1570	21 CFR 892.1550, 21 CFR 892.1570	No difference
Class	II	II	No difference
Intended Use	As described for K173801 (long text)	As described for proposed device (long text)	No difference
Configuration	EMS-9D: Main Unit + Transducer	EMS-9D EXP/PRO: Main Unit + Transducer + NIBP Module	Yes, added NIBP module (see Analysis 1)
Input Power	80VA	120VA	Yes, higher (see Analysis 2)
1.6MHz PW Probe
Depth	not less than 150 mm	not less than 150 mm	No difference
Speed range	10cm/s~300cm/s	10cm/s~300cm/s	No difference
Maximum Error	±15%	±15%	No difference
2MHz PW Probe
Depth	not less than 150 mm	not less than 150 mm	No difference
Speed range	10cm/s~300cm/s	10cm/s~300cm/s	No difference
Maximum Error	±15%	±15%	No difference
4MHz CW Probe
Depth	not less than 85 mm	not less than 85 mm	No difference
Speed range	10cm/s~300cm/s	10cm/s~300cm/s	No difference
Maximum Error	±15%	±15%	No difference
8MHz CW Probe
Depth	not less than 35 mm	not less than 35 mm	No difference
Speed range	10cm/s~200cm/s	10cm/s~200cm/s	No difference
Maximum Error	±15%	±15%	No difference
16MHz PW Probe
Depth	not less than 8 mm	not less than 8 mm	No difference
Speed range	10cm/s~120cm/s	10cm/s~120cm/s	No difference
Maximum Error	±15%	±15%	No difference
Nano Core Module (Finger Arterial Blood Pressure)
Product Code	DXQ (K173916 Finapres NOVA)	DXQ	No difference
Regulation No.	21 CFR 870.1130	21 CFR 870.1130	No difference
Classification	Class II	Class II	No difference
Upper Arm Cuff Measurement Part
Regulation No.	21CRF 870.1120 (K182433)	21CRF 870.1120	No difference
Classification	Class II	Class II	No difference
Product Code	DXQ	DXQ	No difference
Intended Use	Reusable blood pressure cuff for NIBP systems	Reusable blood pressure cuff for NIBP systems	No difference
Patient Populations	Adult	Adult	No difference
Circumference	25-35cm	25-35cm	No difference
Pressure Range	0-300 mmHg	0-300 mmHg	No difference
Sterility	Non-sterile	Non-sterile	No difference
Max. Leakage	< 4mm Hg/min.	< 4mm Hg/min.	No difference
Material	Cuff (Patient contacted): PU	Cuff (Patient contacted): PU	No difference
Biocompatibility	Comply with ISO 10993-5; ISO 10993-10	Comply with ISO 10993-5; ISO 10993-10	No difference

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

Transcranial Doppler Ultrasound System: This document does not specify a sample size for a clinical test set or details on data provenance (e.g., country of origin, retrospective/prospective). The performance data cited are technical specifications compared to a predicate device.
Nano Core Module & Upper Arm Cuff: Similarly, no specific sample sizes for clinical test sets or data provenance are mentioned for these components, as they are being compared to cleared predicate devices.

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

Not applicable/Not provided. This document demonstrates technical equivalence and adherence to standards rather than a clinical performance study requiring expert ground truth establishment for a diagnostic output.

4. Adjudication method for the test set

Not applicable/Not provided, as this is not a study focused on diagnostic accuracy requiring adjudication.

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

Not applicable. The described device is a Transcranial Doppler Ultrasound System, not an AI-assisted diagnostic tool for image interpretation that would typically be evaluated with MRMC studies.

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

Not applicable, as this device is not an algorithm for standalone diagnostic interpretation. It is a diagnostic ultrasound system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the technical specifications, the "ground truth" is derived from engineering measurements, adherence to recognized standards (e.g., IEC 60601 series, NEMA UD 2-2004), and comparison against the specifications of the predicate devices. Clinical ground truth like pathology or outcomes data is not mentioned in this summary.

8. The sample size for the training set

Not applicable. This document does not describe a machine learning or AI algorithm that requires a training set.

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

Not applicable, as there is no mention of a training set for an AI algorithm.

Summary of Study Type:

The document describes a 510(k) premarket notification, which is a process to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. The "study" referenced in the document is primarily non-clinical testing to ensure safety, electrical performance, acoustic output, and electromagnetic compatibility according to recognized international and national standards (IEC 60601-1, IEC 60601-2-37, IEC 80601-2-30, IEC 60601-1-2, NEMA UD 2-2004). The clinical performance is inferred through the substantial equivalence claim based on identical intended use and equivalent technical specifications to predicate devices. The modifications (addition of NIBP module, higher input power) are addressed by stating they do not impact safety and effectiveness or by referencing compliance with additional relevant standards for those components.

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Shenzhen Delica Medical Equipment Co., Ltd. Yolanda Lan RA Engineer 6F, Block 10, The Second Industrial Zone Guanlong, Nanshan District Shenzhen, Guangdong 51855 China

October 18, 2021

Re: K190228

Trade/Device Name: 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, OQQ, DXN, DXQ

Dear Yolanda Lan:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 13, 2019. Specifically, FDA is updating this SE Letter as an administrative correction to include the correct contact name for the submission.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jessica Lamb, OHT7: Office of In Vitro Diagnostics and Radiological Health, 301-796-6167, jessica.lamb(@fda.hhs.gov.

Sincerely.

Jessica Lamb

Jessica Lamb, Ph.D. Assistant Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.

Shenzhen Delica Medical Equipment Co., Ltd.

June 13, 2019

% Ms. Yolanda Lan Regulatory Affairs Engineer 6F, Block 10, The Second Industrial Zone, Nanshan District Shenzhen, Guangdong 51855 CHINA

Re: K190228

Dear Diana Hong:

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 mav, 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

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K190228

Device Name

Transcranial Doppler Ultrasound System

Indications for Use (Describe)

While the Transcranial Doppler Ultrasound System is intended for use as a diagnostic ultrasound fluid flow analysis system, it can be:

For the measurement of cerebral artery blood velocities to determine the presence of hemo-dynamically significant deviations from normal values;
To assess arterial cerebral blood flow for the occurrence of micro embolic signals. Vessels intended for observation include, but are not limited to the middle, anterior cerebral arteries, via the temporal windows, the vertebral mid basilar arteries via the foramen magnum and the ophthalmic artery and internal carotid artery via the eye. The robotic probe headband facilitates monitoring use by its ability to track the Doppler signal.

While the Transcranial Doppler Ultrasound System to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The system provides a noninyasive characterization of the arterial circulation and its beat-to-beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals. The noninvasive blood pressure waveform is measured on the subject's finger.

Using the blood pressure calibration module, the system can additionally provide an upper arm non-invasive blood pressure measurement to determine the blood pressure value for calibration.

The system is intended for use during:

Diagnostic exams;
Surgical interventions.

The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.

The EMS-9D EXP and EMS-9D PRO is intended to be used for subjects above 18 years of age. The MS-9D EXP and EMS-9D PRO is intended for use in hospitals, clinics and research centers.

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

ال Prescription Use (Part 21 CFR 801 Subpart D)

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

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System: Transcranial Doppler Ultrasound System EMS-9D EXP/EMS-9D PRO

Transducer: 1.6MHz PW Probe (02.0001.0170.01)