(209 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the description focuses on standard ultrasound technology and signal processing.
No
The device is described as a "diagnostic ultrasound fluid flow analysis system" intended for "measurement of cerebral artery blood velocities" and to "assess arterial cerebral blood flow," which points to a diagnostic function rather than a therapeutic one. The "Intended Use" explicitly states it's "not intended to replace other means of evaluating vital patient physiological processes."
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "Transcranial Doppler Ultrasound System is intended for use as a diagnostic ultrasound fluid flow analysis system." Additionally, the "Device Description" mentions its usefulness for "evaluation of numerous neurological vascular diseases" and "intraoperative monitoring to help detect sudden changes in blood flow," all of which point to a diagnostic function.
No
The device description explicitly states it is a "Transcranial Doppler Ultrasound System" and mentions a "Roboprobe Headband," indicating the presence of hardware components for ultrasound signal acquisition and tracking.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body. The intended use and device description clearly state that this system uses non-invasive ultrasound to measure blood flow velocities within the cerebral arteries. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The device interacts directly with the patient. It uses ultrasound transducers placed on the patient's head to obtain data. IVDs typically involve laboratory analysis of samples.
The device is a diagnostic ultrasound system used for in vivo (within the living body) measurements.
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; 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 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.
Product codes (comma separated list FDA assigned to the subject device)
IYN, ITX, OQQ
Device Description
The EMS-9D/EMS-9F 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. EMS-9D/EMS-9F should be used in hospitals or healthcare facilities by doctors or trained healthcare professionals.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
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
doctors or trained healthcare professionals / hospitals or healthcare facilities
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 60601-2-37:2007, 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: 2007, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Depth, Speed range, Maximum Error
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA acronym and the agency's name are in blue.
Shenzhen Delica Medical Equipment Co., Ltd. % Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai. 200120 CHINA
Re: K173801
Trade/Device Name: Transcranial Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, ITX, OQQ Dated: June 12, 2018 Received: June 22, 2018
Dear Ms. 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. 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.
July 11th, 2018
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Ms. Diana Hong
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,
Jeff Rodger
for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173801
Device Name
Transcranial Doppler Ultrasound System
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 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
System: Transcranial Doppler Ultrasound System EMS-9D
Transducer: 1.6MHz PW Probe (02.0001.0170.01)
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 | |||||||
| (Track 1&3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | P | ||||||
| Fetal | ||||||||
| Imaging & | ||||||||
| Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative(Specify) | ||||||||
| Intra-operative(Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ(Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P | |||||||
| 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 | ||||||||
| Vessel | Peripheral vessel | P | ||||||
| Other (Specify) |
4
System: Transcranial Doppler Ultrasound System EMS-9D
Transducer: 1.6MHz PW Probe (AP99-0815-PW1.60)
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 | ||||||||
| (Track 1&3) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (Specify) | Other* | ||||||||
| (Specify) | |||||||||
| Ophthalmic | Ophthalmic | P | |||||||
| Fetal | |||||||||
| Imaging & | |||||||||
| Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative(Specify) | |||||||||
| Intra-operative(Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ(Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | P | ||||||||
| 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 | |||||||||
| Vessel | Peripheral vessel | P | |||||||
| Other (Specify) |
5
System: Transcranial Doppler Ultrasound System EMS-9D
Transducer: 1.6MHz PW Probe (02.0001.1613.02)
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 | ||||||||
| (Track 1&3) | B | M | PWD | CWD | Color | ||||
| Doppler | 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 | P | ||||||||
| 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 | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (Specify) | |||||||||
| Clinical Application | Mode of Operation | ||||||||
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Track 1&3) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (Specify) | Other* | ||||||||
| (Specify) | |||||||||
| Ophthalmic | Ophthalmic | P | |||||||
| Fetal | |||||||||
| Imaging & | |||||||||
| Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative(Specify) | |||||||||
| Intra-operative(Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ(Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | P | ||||||||
| 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 | |||||||||
| Vessel | Peripheral vessel | P | |||||||
| Other (Specify) | |||||||||
| Clinical Application | Mode of Operation | ||||||||
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Track 1&3) | B | M | PWD | CWD | Color | ||||
| Doppler | 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 | |||||||||
| 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 | |||||||||
| Vessel | Peripheral vessel | P | |||||||
| Other (Specify) |
6
System: Transcranial Doppler Ultrasound System EMS-9D
Transducer: 2MHz PW Probe (02.0001.0214.01)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
7
System: Transcranial Doppler Ultrasound System EMS-9D
Transducer: 4MHz CW Probe (02.0001.0408.01)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
8
System: Transcranial Doppler Ultrasound System EMS-9D
Transducer: 8MHz CW Probe (02.0001.0805.01)
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 | |||||||
| (Track 1&3) | B | M | PWD | CWD | Color | |||
| Doppler | 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 | ||||||||
| 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 | ||||||||
| Vessel | Peripheral vessel | P | ||||||
| Other (Specify) |
9
System: Transcranial Doppler Ultrasound System EMS-9D
Transducer: 16MHz PW Probe (02.0128.1601.01)
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 | |||||||
| (Track 1&3) | B | M | PWD | CWD | Color | |||
| Doppler | 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 | ||||||||
| 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 | ||||||||
| Vessel | Peripheral vessel | P | ||||||
| Other (Specify) |
10
System: Transcranial Doppler Ultrasound System EMS-9F
Transducer: 2MHz PW Probe (02.0001.0214.01)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | Other*
(Specify) |
|---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|--|---------------------|
| General
(Track 1 Only) | Specific
(Track 1&3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | | |
| Ophthalmic | Ophthalmic | | | P | | | | | |
| Fetal | Fetal | | | | | | | | |
| Imaging &
Other | Abdominal | | | | | | | | |
| | Intra-operative(Specify) | | | | | | | | |
| | Intra-operative(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ(Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | P | | | | | |
| | 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
Vessel | Peripheral vessel | | | P | | | | | |
| | Other (Specify) | | | | | | | | |
11
System: Transcranial Doppler Ultrasound System EMS-9F
Transducer: 2MHz PW Probe (AP99-0607-PW2.0)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | Other*
(Specify) |
|-----------------------------|------------------------------------|-------------------|---|-----|-----|---------------|-----------------------|---------------------|
| | | B | M | PWD | CWD | Color Doppler | Combined
(Specify) | |
| General
(Track 1 Only) | Specific
(Track 1&3) | | | | | | | |
| Ophthalmic | Ophthalmic | | | P | | | | |
| Fetal
Imaging &
Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative(Specify) | | | | | | | |
| | Intra-operative(Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ(Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | P | | | | |
| | 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
Vessel | Peripheral vessel | | | P | | | | |
| | Other (Specify) | | | | | | | |
12
System: Transcranial Doppler Ultrasound System EMS-9F
Transducer: 2MHz PW Probe (02.0001.0213.01)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | Other*
(Specify) | |
|---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|--|
| General
(Track 1 Only) | Specific
(Track 1&3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal | Fetal | | | | | | | | |
| Imaging &
Other | Abdominal | | | | | | | | |
| | Intra-operative(Specify) | | | | | | | | |
| | Intra-operative(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ(Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | P | | | | | |
| | 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
Vessel | Peripheral vessel | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | | |
| General | Specific | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | Other*
(Specify) | |
| (Track 1 Only) | (Track 1&3) | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal | Fetal | | | | | | | | |
| Imaging &
Other | Abdominal | | | | | | | | |
| | Intra-operative(Specify) | | | | | | | | |
| | Intra-operative(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ(Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | 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
Vessel | Peripheral vessel | | | P | | | | | |
| | | Other (Specify) | | | | | | | |
13
System: Transcranial Doppler Ultrasound System EMS-9F
Transducer: 4MHz CW Probe (02.0001.0408.01)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
14
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K173801
-
- Date of Preparation: 6/12/2018
-
- Sponsor Identification
Shenzhen Delica Medical Equipment Co., Ltd. 6C, Block 10, The Second Industrial Zone, Guanlong, Nanshan District, Shenzhen 518055, China
Establishment Registration Number: 3006441164
Contact Person: Zhenhua Xiao Position: Management Representative Tel: +86-0755-26413482 Fax: +86-0755-86210002 Email: quality@delicasz.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China Tel: +86(0)21 2281-5850 Fax: +1(0)360 925-3199 Email: info@mid-link.net
15
4. Identification of Proposed Device
Trade Name: Transcranial Doppler Ultrasound System; Common Name: Transcranial Doppler; Models: EMS-9D and EMS-9F
Regulatory Information Classification: II Product Code: IYN, ITX and OQQ; Regulation Number: 21 CFR 892.1550 and 21 CFR 892.1570; Review Panel: Radiology:
Indications 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 used in fetal applications, and is not intended to be used inside the sterile field.
Device Description:
The EMS-9D/EMS-9F 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.
EMS-9D/EMS-9F should be used in hospitals or healthcare facilities by doctors or trained healthcare professionals.
16
-
- Identification of Predicate Device
510k Number: K122710
- Identification of Predicate Device
Product Name: Transcranial Doppler with Robotic Probe Headband; Manufacturer: Shenzhen Delicate Electronics Co., Ltd.
-
- 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 60601-2-37:2007, 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: 2007, 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.
-
- Substantially Equivalent
| ITEM | Proposed Device | Predicate Device, K122710 |
|---|---|---|
| Product Code | IYN, ITX and OQQ | IYN, ITX and OQQ |
| Regulation No. | 21 CFR 892.1550 and 21 CFR 892.1570 | 21 CFR 892.1550 and 21 CFR 892.1570 |
| Class | II | II |
Table 1 Substantially Equivalent Comparison
17
| | | 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 applications, and
is not intended to be used inside the sterile field. | | 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 applications, and
is not intended to be used inside the sterile field. | |
|-------------------|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Intended Use | | | | | |
| Configuration | | EMS-9F: Main Unit+PC/Laptop+Transducer
EMS-9D: Main Unit+Transducer | | EMS-9UA: Main Unit+PC/Laptop+Transducer
EMS-9PB: Main Unit+Transducer | |
| Model | | EMS-9D | EMS-9F | EMS-9PB | EMS-9UA |
| Screen | | 15" LCD Display | No | 15" LCD Display | No |
| Nominal Voltage | | AC 100V-240V | DC +12V, -12V, +5V | AC 100V-240V | DC +12V, -12V, +6V |
| Nominal Frequency | | 50Hz/60Hz | / | 50Hz/60Hz | / |
| Input Power | | 80VA | 60VA | 275VA | 30VA |
| Probe | | 1.6/2/1.6MHz PW probe
and 4/8MHz CW probe | 2MHz PW probe and
4/8MHz CW probe | 1.6MHz PW probe and
4/8MHz CW probe | 2MHz PW probe and
4/8MHz CW probe |
| Performance | | | | | |
| 1.6MHz
PW | Depth | not less 150 mm | / | not less 134 mm | / |
| | Speed
range | 10cm/s300cm/s | / | 20cm/s200cm/s | / |
| | Maximum | $\pm$ 15% | / | $\pm$ 20% | / |
| 2MHz
PW | Depth | not less 150 mm | not less 150 mm | not less 134 mm | not less 134 mm |
| | Speed
range | 10cm/s300cm/s | 10cm/s300cm/s | 20cm/s200cm/s | 20cm/s200cm/s |
| | Maximum
Error | ±15% | ±15% | ±20% | ±20% |
| | 4MHz
CW | Depth | not less 85 mm | not less 85 mm | not less 50 mm |
| | | Speed
range | 10cm/s300cm/s | 10cm/s300cm/s | 10cm/s100cm/s |200cm/s | / | 10cm/s
| Maximum
Error | | ±15% | ±15% | ±20% | ±20% |
| 8MHz
CW | | Depth | not less 35 mm | / | not less 20 mm |
| | | Speed
range | 10cm/s50cm/s |120cm/s | / | / |
| | Maximum
Error | ±15% | / | ±20% | ±20% |
| | 16MHz
PW | Depth | not less 8 mm | / | / |
| | | Speed
range | 10cm/s
| Maximum
Error | | ±15% | / | / | / |
18
The main differences between proposed device and predicate device include nominal voltage, input power, probe and performance. Both proposed device and predicate device comply with IEC 60601-1, IEC 60601-2 and IEC 60601-2-37, they are identical in electrical safety and EMC. Compared with the predicate device, 16MHz PW probe are added in EMS-9D and 8MHz CW is removed in EMS-9F. Referring to the comparison table, the performance of proposed device is fully better than that of predicate device - the proposed device has longer measurement depth, larger speed range and less error. The acoustic output test has demonstrated that all the probes comply with Track 3 Acoustic Output Limit. Therefore, these items do not impact the safety and effectiveness.
The proposed device, Transcranial Doppler Ultrasound System, is determined to be Substantially Equivalent (SE) to the predicate device, Transcranial Doppler with Robotic Probe Headband, K122710, in respect of safety and effectiveness.