(291 days)
Not Found
No
The document does not mention AI, ML, deep learning, neural networks, or any related terms. The description focuses on standard Doppler ultrasound technology and its application.
No
The Intended Use section clearly states that the device is "intended for use as a diagnostic ultrasound fluid flow analysis system" and describes its purpose for measuring and assessing blood velocities and micro embolic signals, which are diagnostic functions. It does not mention any therapeutic capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system "is intended for use as a diagnostic ultrasound fluid flow analysis system" and lists diagnostic exams as an intended use.
No
The device description explicitly states it is a "Transcranial Doppler Ultrasound System" and mentions using a "non-invasive technique to obtain the information of blood flow velocities". This indicates the use of hardware components (ultrasound transducer, system for generating and receiving ultrasound waves) to acquire the data, not just software processing of pre-existing data. The mention of standards like IEC 60601-1 and IEC 60601-2-37 further supports the presence of hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states that this is a Transcranial Doppler Ultrasound System. It uses ultrasound to measure blood flow velocities within the body (specifically, in cerebral arteries). This is an in vivo (within the living body) diagnostic method, not an in vitro method.
- Intended Use: The intended use describes measuring blood velocities and assessing blood flow directly in the cerebral arteries. This is a non-invasive technique applied to the patient's body.
Therefore, based on the provided information, this device falls under the category of medical devices used for in vivo diagnosis, not in vitro diagnosis.
N/A
Intended Use / Indications for Use
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;
- 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
Product codes (comma separated list FDA assigned to the subject device)
IYN, ITX, OQQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Pulsed Wave (PW) Doppler mode
Anatomical Site
Cerebral artery, middle cerebral artery, anterior cerebral artery, posterior cerebral artery, vertebral mid basilar arteries, ophthalmic artery, intracranial internal carotid artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified and appropriately trained healthcare professionals. It can be used in hospitals or medical clinics.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
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;
- 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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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
-
- Date of Preparation: 7/7/2022
-
- 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:
-
- 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.
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 -
- 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:
- Non-Clinical Test Conclusion
-
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.
-
- 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 | |||
| No. | 21 CFR 892.1570 | 21 CFR 892.1570 | Same |
| Class | II | II | Same |
| 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
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: - Diagnostic exams;
- Surgical interventions.
The device is not intended to
replace other means of evaluating
vital patient physiological
processes is not intended to be | 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 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: - 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 | Same |
| | used in fetal applications, and is
not intended to be used inside the
sterile field. | 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. | | |
| Configuration | EMS-9M1: Main Unit+
PC/Laptop/Surface+ Transducer
EMS-9M2:Main Unit+
PC/Laptop/Surface+ Transducer | Main Unit+ PC/Laptop+ Transducer | Same |
| Connection
modes | EMS-9M1: USB/LAN/WIFI
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.
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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 Nominal
Voltage | 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 probe
4 MHz CW probe | Same | |
| 2MHz
PW | Depth | not less 150 mm | not less 150 mm | not less 150 mm | Same |
| | Speed range | 10cm/s300cm/s | 10cm/s300cm/s | 10cm/s~300cm/s | Same |
| | Maximum
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.
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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.