Transcranial Doppler Ultrasound System

{0}------------------------------------------------ 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. 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You must comply with all the Act's {1}------------------------------------------------ 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 {2}------------------------------------------------ ## Indications for Use ### Device Name Transcranial Doppler Ultrasound System Indications for Use (Describe) 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 | Type of Use ( <i>Select one or both, as applicable</i> ) | | |----------------------------------------------------------|-----------------------------------------------| | ☑ 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. {3}------------------------------------------------ # 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 - 2. 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 {4}------------------------------------------------ #### 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; 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. {5}------------------------------------------------ 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. - ડ. Identification of Predicate Device 510(k) Number: K173801 Product Name: Transcranial Doppler Ultrasound System - 6. 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. - 7. Clinical Test Conclusion No clinical study is included in this submission. {6}------------------------------------------------ ### 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 | | Regulation<br>No. | 21 CFR 892.1570 | 21 CFR 892.1570 | Same | | Class | II | II | Same | | Indication for<br>Use | Transcranial Doppler Ultrasound<br>System is intended for use as a<br>diagnostic ultrasound fluid flow<br>analysis system:<br>1) For the measurement of<br>cerebral artery blood velocities to<br>determine the presence of hemo<br>dynamically significant deviations<br>from normal values;<br>2) To assess arterial cerebral blood<br>flow for the occurrence of micro<br>embolic signals. Vessels intended<br>for observation include, but are<br>not limited to the middle, anterior<br>and posterior cerebral arteries, via<br>the temporal windows, the<br>vertebral mid basilar arteries via<br>the foramen magnum and the<br>ophthalmic artery and intracranial<br>internal carotid artery via the eye.<br>The Roboprobe Headband<br>facilitates monitoring use by its<br>ability to track the Doppler signal.<br>Transcranial Doppler is intended<br>for use during:<br>1) Diagnostic exams;<br>2) Surgical interventions.<br>The device is not intended to<br>replace other means of evaluating<br>vital patient physiological<br>processes is not intended to be | Transcranial Doppler Ultrasound<br>System is intended for use as a<br>diagnostic ultrasound fluid flow<br>analysis system:<br>1) For the measurement of cerebral<br>artery blood velocities to determine<br>the presence of hemo dynamically<br>significant deviations from normal<br>values;<br>2) To assess arterial cerebral blood<br>flow for the occurrence of micro<br>embolic signals. Vessels intended for<br>observation include, but are not<br>limited to the middle, anterior and<br>posterior cerebral arteries, via the<br>temporal windows, the vertebral mid<br>basilar arteries via the foramen<br>magnum and the ophthalmic artery<br>and intracranial internal carotid<br>artery via the eye.<br>The Roboprobe Headband facilitates<br>monitoring use by its ability to track<br>the Doppler signal.<br>Transcranial Doppler is intended for<br>use during:<br>1) Diagnostic exams;<br>2) Surgical interventions.<br>The device is not intended to replace<br>other means of evaluating vital<br>patient physiological processes, is not<br>intended to be used in fetal | Same | | | used in fetal applications, and is<br>not intended to be used inside the<br>sterile field. | applications, and is not intended to be<br>used inside the sterile field. | | | | This device is intended for use by<br>qualified and appropriately trained<br>healthcare professionals. It can be<br>used in hospitals or medical<br>clinics. Mode of Operation is<br>Pulsed Wave (PW) Doppler mode. | | | | Configuration | EMS-9M1: Main Unit+<br>PC/Laptop/Surface+ Transducer<br>EMS-9M2:Main Unit+<br>PC/Laptop/Surface+ Transducer | Main Unit+ PC/Laptop+ Transducer | Same | | Connection<br>modes | EMS-9M1: USB/LAN/WIFI<br>EMS-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 {7}------------------------------------------------ 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. {8}------------------------------------------------ | ITEM | Proposed Device | | Predicate Device,<br>K173801 | Remark | | |-----------------------------|--------------------------------------------|--------------------------------------------|----------------------------------|-----------------|------| | | EMS-9M1 | EMS-9M2 | EMS-9F | | | | Screen | NO | NO | No | Same | | | Power supply mode | AC Power supply /<br>Internal Power supply | AC Power supply /<br>Internal Power supply | AC power supply | Difference | | | External Nominal<br>Voltage | AC 100V-240V | AC 100V-240V | DC +12V, -12V,<br>+6V | Difference | | | Nominal Frequency | 50Hz/60Hz | 50Hz/60Hz | / | Same | | | Internal power supply | 14.4V 3000mAH | 14.4V 3000mAH | / | Difference | | | Probe | 2 MHz PW probe<br>/ | 2 MHz PW probe<br>/ | 2 MHz PW probe<br>4 MHz CW probe | Same | | | 2MHz<br>PW | 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 | | | Maximum<br>Error | ±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. {9}------------------------------------------------ #### 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.