Transcranial Doppler Ultrasound System is intended for use as a diagnostic ultrasound fluid flow analysis system: 1) For the measurement of cerebral artery blood velocities to determine the presence of hemo dynamically significant deviations from normal values; 2) 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 and posterior cerebral arteries, via the temporal windows, the vertebral mid basilar arteries via the foramen magnum and the ophthalmic artery and intracranial internal carotid artery via the eye. The Roboprobe Headband facilitates monitoring use by its ability to track the Doppler signal. Transcranial Doppler is intended for use during: 1) Diagnostic exams; 2) 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. This device is intended for use by qualified and appropriately trained healthcare professionals. It can be used in hospitals or medical clinics. Mode of Operation is Pulsed Wave (PW) Doppler mode

Device Description

The EMS-9M1 and EMS-9M2 Transcranial Doppler Ultrasound System is a Transcranial Doppler (TCD) system using non-invasive technique to obtain the information of blood flow velocities throughout the body. This method of measurement is particularly useful for examining the major arteries supplying blood to the brain. 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. Both the EMS-9Ml and EMS-9M2 are Track 1 devices. EMS-9M1 and EMS-9M2 should be used in hospitals or healthcare facilities by doctors or trained healthcare professionals.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a Transcranial Doppler Ultrasound System (models EMS-9M1/EMS-9M2). It focuses on demonstrating substantial equivalence to a predicate device (K173801).

Crucially, the document explicitly states "No clinical study is included in this submission" (Page 5, Section 7). This means that the information requested about acceptance criteria and a study proving the device meets them (clinical performance) is not provided in this document. The submission relies solely on non-clinical tests to show that the proposed device meets design specifications and is substantially equivalent to the predicate device.

Therefore, I cannot provide details about:

A table of acceptance criteria and reported device performance based on clinical data.
Sample size used for a clinical test set or its provenance (retrospective/prospective, country).
Number of experts, their qualifications, or adjudication methods for clinical ground truth.
Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
Stand-alone (algorithm-only) performance studies.
Type of ground truth used for clinical validation.
Sample size for a training set or how ground truth was established for it, as no clinical studies were performed.

However, based on the document, I can infer the "acceptance criteria" and "proof" in the context of this 510(k) submission as follows:

Acceptance Criteria (as implied by a 510(k) submission aiming for Substantial Equivalence):

The primary acceptance criteria for a 510(k) cleared device, particularly when no clinical studies are performed, are that the device:

Has the same intended use as the predicate device.
Has the same technological characteristics as the predicate device, or if there are differences, these differences do not raise new questions of safety or effectiveness.
Meets recognized consensus standards for safety and performance.

The Study Proving the Device Meets These Acceptance Criteria (Non-Clinical):

The "study" proving the device meets these criteria is the non-clinical testing performed by the manufacturer, as detailed in Section 6 and 8 of the document.

1. Table of Acceptance Criteria (Implied for Non-Clinical Equivalence) and Reported Device Performance:

Since no clinical study was performed, the "performance" is largely demonstrated by meeting and adhering to established safety and performance standards.

Acceptance Criterion (for Substantial Equivalence based on Non-Clinical Data)	Reported Device Performance (from Non-Clinical Tests)
Same Intended Use (21 CFR 892.1550/1570)	Met: Proposed device's indications for use are identical to the predicate device, K173801. (Page 4, "Indication for use" table)
Same Technological Characteristics, or differences do not raise new safety/effectiveness questions. (Key physical & functional parameters)	Met: Most core technological characteristics (e.g., product code, regulation number, class, intended use, probe type, depth measurement, speed range, maximum error) are identical to the predicate. Minor differences (Connection modes, power supply mode, nominal voltage, internal power supply) were tested and deemed not to affect safety or effectiveness. (Pages 6-8, "Summary of Technological characteristics" tables and "Difference" explanations)
Compliance with Recognized Consensus Standards (Electrical safety, EMC, Acoustic Output, Basic Safety & Essential Performance)	Met: Non-clinical tests verified compliance with: - IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012 (General medical electrical equipment safety) - IEC 60601-2-37:2015 (Specific to ultrasonic medical diagnostic equipment) - IEC 60601-1-2: 2014 (EMC) - NEMA UD 2-2004 (R2009) Revision 3 (Acoustic Output) (Page 5, Section 6)

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable for clinical data: As stated, "No clinical study is included in this submission."
For non-clinical testing: The "test set" would refer to the physical devices and testing environments (e.g., test setups for electrical safety, EMC, acoustic measurements). The document implies that these tests were performed on the proposed device models (EMS-9M1/EMS-9M2). Data provenance would be from internal lab testing by the manufacturer (Shenzhen Delica Medical Equipment Co., Ltd., China). This is standard for pre-market submissions based on non-clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not applicable for clinical data: No clinical study was performed.
For non-clinical testing: The "ground truth" for non-clinical testing is established by recognized standards and their accompanying test methodologies. The "experts" would be the engineers and technicians involved in performing these tests, following the procedures outlined in the standards. Their qualifications would be expertise in medical device testing, particularly in electrical safety, EMC, and ultrasound performance measurements according to the cited IEC and NEMA standards.

4. Adjudication Method for the Test Set:

Not applicable for clinical data: No clinical study was performed.
For non-clinical testing: Adjudication is not typically performed in the same way as in clinical studies. Test results from the non-clinical studies are compared directly against predefined acceptance limits specified by the recognized consensus standards. Any deviations would lead to failure and require re-design or re-testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable: The device is a Transcranial Doppler Ultrasound System, not an AI-powered image analysis tool for human readers. No MRMC study was conducted as no clinical study was included.

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

Not applicable: This is a hardware diagnostic device that measures blood flow velocities; it is not an algorithm for standalone diagnostic interpretation.

7. The type of ground truth used:

Not applicable for clinical data: No clinical study was performed to establish a clinical ground truth (e.g., expert consensus, pathology, or outcomes data).
For non-clinical testing: The "ground truth" is based on the specifications and limits defined within recognized national and international consensus standards (IEC 60601 series, NEMA UD 2). For example, the accuracy of velocity measurement (±15%) is compared against physical phantoms or established reference measurements rather than clinical patient outcomes.

8. The sample size for the training set:

Not applicable: No clinical study was performed, and the device does not involve machine learning algorithms that would require a "training set" in the traditional sense of AI/ML development.

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

Not applicable: See #8.

In summary, the document details a 510(k) submission based purely on substantial equivalence through non-clinical performance data and adherence to recognized standards, not on a clinical study demonstrating efficacy or specific performance metrics in a patient population.

Summary

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Image /page/0/Picture/0 description: The image shows 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 acronym and name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.

July 8, 2022

Shenzhen Delica Medical Equipment Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, 200120 CHINA

Re: K213009

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 Dated: May 30, 2022 Received: June 8, 2022

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 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

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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,

For

Michael D. O'Hara, Ph.D. Deputy Director DHT 8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Device Name

Transcranial Doppler Ultrasound System

Indications for Use (Describe)

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 and posterior cerebral arteries, via the temporal windows, the vertebral mid basilar arteries via the foramen magnum and the ophthalmic artery and intracranial internal carotid artery via the eye.

The Roboprobe Headband facilitates monitoring use by its ability to track the Doppler signal.

Transcranial Doppler 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.

This device is intended for use by qualified and appropriately trained healthcare professionals. It can be used in hospitals or medical clinics. Mode of Operation is Pulsed Wave (PW) Doppler mode

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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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92(a)(2).

The assigned 510(k) Number: K213009

1. Date of Preparation: 7/7/2022
1. Sponsor Identification

Shenzhen Delica Medical Equipment Co., Ltd.

18F, Building B, High-tech park, Guangqiao Road, Tianliao Community, Yutang Street, Guangming District, Shenzhen, 518107, P.R. China

Establishment Registration Number: 3006441164

Contact Person: Zhenhua Xiao Position: Management Representative Tel: +86-755-86210116 Fax: +86-755-86210002 Email: overseas(@delicasz.com

3. Designated Submission Correspondent

Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)

Mid-Link Consulting Co., Ltd.

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: Transcranial Doppler Ultrasound System Common Name: Transcranial Doppler Models: EMS-9M1/EMS-9M2

Regulatory Information Classification: II Classification name: Ultrasonic pulsed doppler imaging system Product Code: IYN: Regulation Number: 21 CFR 892.1550; Review Panel: Radiology;

Classification: II Classification name: Diagnostic ultrasonic transducer Product Code: ITX, OQQ; Regulation Number: 21 CFR 892.1570; Review Panel: Radiology;

Indication for use:

Transcranial Doppler Ultrasound System is intended for use as a diagnostic ultrasound fluid flow analysis system:

For the measurement of cerebral artery blood velocities to determine the presence of hemo 1) 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 and posterior cerebral arteries, via the temporal windows, the vertebral mid basilar arteries via the foramen magnum and the ophthalmic artery and intracranial internal carotid artery via the eye.

The Roboprobe Headband facilitates monitoring use by its ability to track the Doppler signal. Transcranial Doppler is intended for use during:

1. Diagnostic exams;
1. Surgical interventions.

This device is intended for use by qualified and appropriately trained healthcare professionals. It can be used in hospitals or medical clinics. Mode of Operation is Pulsed Wave (PW) Doppler mode.

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Device Description:

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.

Both the EMS-9Ml and EMS-9M2 are Track 1 devices.

EMS-9M1 and EMS-9M2 should be used in hospitals or healthcare facilities by doctors or trained healthcare professionals.

ડ. Identification of Predicate Device
510(k) Number: K173801 Product Name: Transcranial Doppler Ultrasound System
1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012, Medical electrical equipment - Part 1: General requirements for basic safety, and essential performance.
IEC 60601-2-37:2015, Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
IEC 60601-1-2: 2014, Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and teats.
NEMA UD 2-2004 (R2009), Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3.
1. Clinical Test Conclusion

No clinical study is included in this submission.

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8. Summary of Technological characteristics

ITEM	Proposed Device	Predicate Device, K173801	Remark
	Table 1 General Comparison
Model	EMS-9M1 / EMS-9M2	EMS-9F	/
Product Code	IYN, ITX and OQQ	IYN, ITX and OQQ	Same
RegulationNo.	21 CFR 892.1570	21 CFR 892.1570	Same
Class	II	II	Same
Indication forUse	Transcranial Doppler UltrasoundSystem is intended for use as adiagnostic ultrasound fluid flowanalysis system:1) For the measurement ofcerebral artery blood velocities todetermine the presence of hemodynamically significant deviationsfrom normal values;2) To assess arterial cerebral bloodflow for the occurrence of microembolic signals. Vessels intendedfor observation include, but arenot limited to the middle, anteriorand posterior cerebral arteries, viathe temporal windows, thevertebral mid basilar arteries viathe foramen magnum and theophthalmic artery and intracranialinternal carotid artery via the eye.The Roboprobe Headbandfacilitates monitoring use by itsability to track the Doppler signal.Transcranial Doppler is intendedfor use during:1) Diagnostic exams;2) Surgical interventions.The device is not intended toreplace other means of evaluatingvital patient physiologicalprocesses is not intended to be	Transcranial Doppler UltrasoundSystem is intended for use as adiagnostic ultrasound fluid flowanalysis system:1) For the measurement of cerebralartery blood velocities to determinethe presence of hemo dynamicallysignificant deviations from normalvalues;2) To assess arterial cerebral bloodflow for the occurrence of microembolic signals. Vessels intended forobservation include, but are notlimited to the middle, anterior andposterior cerebral arteries, via thetemporal windows, the vertebral midbasilar arteries via the foramenmagnum and the ophthalmic arteryand intracranial internal carotidartery via the eye.The Roboprobe Headband facilitatesmonitoring use by its ability to trackthe Doppler signal.Transcranial Doppler is intended foruse during:1) Diagnostic exams;2) Surgical interventions.The device is not intended to replaceother means of evaluating vitalpatient physiological processes, is notintended to be used in fetal	Same
	used in fetal applications, and isnot intended to be used inside thesterile field.	applications, and is not intended to beused inside the sterile field.
	This device is intended for use byqualified and appropriately trainedhealthcare professionals. It can beused in hospitals or medicalclinics. Mode of Operation isPulsed Wave (PW) Doppler mode.
Configuration	EMS-9M1: Main Unit+PC/Laptop/Surface+ TransducerEMS-9M2:Main Unit+PC/Laptop/Surface+ Transducer	Main Unit+ PC/Laptop+ Transducer	Same
Connectionmodes	EMS-9M1: USB/LAN/WIFIEMS-9M2: USB/LAN/WIFI	USB	Difference

ты e ﺍﻟﻤﻌﺎﺭﺿﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ 1

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Difference-Connection mode

Compared with the predicate device, the connection mode of EMS-9M1 and EMS-9M2 has additional LAN and WIFI, which makes the proposed device more convenient to use. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

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ITEM	Proposed Device		Predicate Device,K173801	Remark
	EMS-9M1	EMS-9M2	EMS-9F
Screen	NO	NO	No	Same
Power supply mode	AC Power supply /Internal Power supply	AC Power supply /Internal Power supply	AC power supply	Difference
External NominalVoltage	AC 100V-240V	AC 100V-240V	DC +12V, -12V,+6V	Difference
Nominal Frequency	50Hz/60Hz	50Hz/60Hz	/	Same
Internal power supply	14.4V 3000mAH	14.4V 3000mAH	/	Difference
Probe	2 MHz PW probe/	2 MHz PW probe/	2 MHz PW probe4 MHz CW probe	Same
2MHzPW	Depth	not less 150 mm	not less 150 mm	not less 150 mm	Same
	Speed range	10cm/s~300cm/s	10cm/s~300cm/s	10cm/s~300cm/s	Same
	MaximumError	±15%	±15%	±15%	Same

Table 2 Specifications Comparison
-----------------------------------

Difference - Power supply mode

Compared with the predicate device, the proposed devices have one more power supply mode, powered by the built-in battery. The electrical safety testing of proposed device with built-in battery was conducted according to IEC 60601-1, and the test results of electrical safety testing demonstrate that the power supply of built-in battery is acceptable. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

Difference - Nominal Voltage

Although the external nominal voltage of proposed device are different with that of predicate device. The electrical safety testing of proposed device was conducted according to IEC 60601-1, and the test results of electrical safety testing demonstrate that the external nominal voltage of proposed device is acceptable. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

Difference - Internal power supply

Compared with the predicate device, the predicate device has no internal power supply, and the proposed device has an internal power supply. And the internal power supply provides battery test report and battery specification, this difference will not affect the safety and effectiveness of the proposed device.

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9. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the proposed devices are as safe, as effective, and perform as well as or better than the legally marketed predicate device K173801.

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.