Transcranial Doppler Ultrasound System
Device Facts
| Record ID | K190228 |
|---|---|
| Device Name | Transcranial Doppler Ultrasound System |
| Applicant | Shenzhen Delica Medical Equipment Co., Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Jun 13, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
Indications for Use
While the Transcranial Doppler Ultrasound System is intended for use as a diagnostic ultrasound fluid flow analysis system, it can be: 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 internal carotid artery via the eye. The robotic probe headband facilitates monitoring use by its ability to track the Doppler signal. While the Transcranial Doppler Ultrasound System to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The system provides a noninyasive characterization of the arterial circulation and its beat-to-beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals. The noninvasive blood pressure waveform is measured on the subject's finger. Using the blood pressure calibration module, the system can additionally provide an upper arm non-invasive blood pressure measurement to determine the blood pressure value for calibration. The system is intended for use during: 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. The EMS-9D EXP and EMS-9D PRO is intended to be used for subjects above 18 years of age. The MS-9D EXP and EMS-9D PRO is intended for use in hospitals, clinics and research centers.
Device Story
System (EMS-9D EXP/PRO) integrates Transcranial Doppler (TCD) ultrasound, finger arterial blood pressure (NIBP) monitoring, and upper arm blood pressure calibration. TCD component uses probes (1.6MHz–16MHz) to measure cerebral blood flow velocities and detect micro-embolic signals; robotic headband tracks Doppler signals. NIBP module provides continuous beat-to-beat hemodynamic characterization. Used in hospitals, clinics, and research centers by physicians or trained professionals for diagnostic exams and surgical interventions. Output includes blood flow velocity data, pressure waveforms, and hemodynamic parameters. Benefits include noninvasive evaluation of neurological vascular diseases (e.g., vasospasm, intracranial stenosis) and intraoperative blood flow monitoring.
Clinical Evidence
Bench testing only. Compliance verified against IEC 60601-1 (safety), IEC 60601-2-37 (ultrasound), IEC 80601-2-30 (sphygmomanometers), IEC 60601-1-2 (EMC), and NEMA UD 2 (acoustic output).
Technological Characteristics
System includes main unit, TCD probes (1.6MHz-16MHz PW/CW), Nano Core NIBP module, and upper arm cuff. Materials: PU (cuff). Connectivity: USB. Standards: IEC 60601-1, IEC 60601-2-37, IEC 80601-2-30, IEC 60601-1-2, NEMA UD 2. Biocompatibility: ISO 10993-5, ISO 10993-10.
Indications for Use
Indicated for adult patients (>18 years) requiring diagnostic ultrasound fluid flow analysis of cerebral arteries (middle, anterior, vertebral, basilar, ophthalmic, internal carotid) or noninvasive hemodynamic/blood pressure monitoring. Contraindicated for fetal applications and use inside the sterile field.
Regulatory Classification
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.
Predicate Devices
- Transcranial Doppler Ultrasound System (K173801)
- Noninvasive Blood Pressure Monitor (K173916)
- Blood Pressure Cuff (K182433)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Shenzhen Delica Medical Equipment Co., Ltd. Yolanda Lan RA Engineer 6F, Block 10, The Second Industrial Zone Guanlong, Nanshan District Shenzhen, Guangdong 51855 China
October 18, 2021
Re: K190228
Trade/Device Name: Transcranial Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, ITX, OQQ, DXN, DXQ
Dear Yolanda Lan:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 13, 2019. Specifically, FDA is updating this SE Letter as an administrative correction to include the correct contact name for the submission.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jessica Lamb, OHT7: Office of In Vitro Diagnostics and Radiological Health, 301-796-6167, jessica.lamb(@fda.hhs.gov.
Sincerely.
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
Shenzhen Delica Medical Equipment Co., Ltd.
June 13, 2019
% Ms. Yolanda Lan Regulatory Affairs Engineer 6F, Block 10, The Second Industrial Zone, Nanshan District Shenzhen, Guangdong 51855 CHINA
Re: K190228
Trade/Device Name: Transcranial Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, ITX, OQQ, DXN, DXO Dated: March 25, 2019 Received: April 30, 2019
Dear Diana Hong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
#### Indications for Use
510(k) Number (if known) K190228
#### Device Name
Transcranial Doppler Ultrasound System
#### Indications for Use (Describe)
While the Transcranial Doppler Ultrasound System is intended for use as a diagnostic ultrasound fluid flow analysis system, it can be:
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 internal carotid artery via the eye. The robotic probe headband facilitates monitoring use by its ability to track the Doppler signal.
While the Transcranial Doppler Ultrasound System to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The system provides a noninyasive characterization of the arterial circulation and its beat-to-beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals. The noninvasive blood pressure waveform is measured on the subject's finger.
Using the blood pressure calibration module, the system can additionally provide an upper arm non-invasive blood pressure measurement to determine the blood pressure value for calibration.
The system is intended for use during:
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.
The EMS-9D EXP and EMS-9D PRO is intended to be used for subjects above 18 years of age. The MS-9D EXP and EMS-9D PRO is intended for use in hospitals, clinics and research centers.
Type of Use (Select one or both, as applicable)
ال Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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System: Transcranial Doppler Ultrasound System EMS-9D EXP/EMS-9D PRO
Transducer: 1.6MHz PW Probe (02.0001.0170.01)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | |
|-----------------------------|------------------------------------|-------------------|-------------------|-----|-----|------------------|-----------------------|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Track 1&3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging &<br>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<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | P | | | | |
| | Other (Specify) | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
| General<br>(Track 1 Only) | Specific<br>(Track 1&3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging &<br>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<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | P | | | | |
| | Other (Specify) | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
| General<br>(Track 1 Only) | Specific<br>(Track 1&3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging &<br>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<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |
| Clinical Application | | | Mode of Operation | | | | | |
| General<br>(Track 1 Only) | Specific<br>(Track 1&3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging &<br>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<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | P | | | | |
| | Other (Specify) | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
| General<br>(Track 1 Only) | Specific<br>(Track 1&3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging &<br>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<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | P | | | |
| | Other (Specify) | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
| General<br>(Track 1 Only) | Specific<br>(Track 1&3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging &<br>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<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | P | | | |
| | Other (Specify) | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | Combined<br>(Specify) | Other*<br>(Specify) |
| General<br>(Track 1 Only) | Specific<br>(Track 1&3) | B | M | PWD | CWD | Color Doppler | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging &<br>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<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | P | | | | |
| | Other (Specify) | | | | | | | |
{5}------------------------------------------------
System: Transcranial Doppler Ultrasound System EMS-9D EXP/EMS-9D PRO
Transducer: 1.6MHz PW Probe (AP99-0815-PW1.60)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
{6}------------------------------------------------
System: Transcranial Doppler Ultrasound System EMS-9DEXP /EMS-9D PRO
Transducer: 1.6MHz PW Probe (02.0001.1613.02)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
{7}------------------------------------------------
System: Transcranial Doppler Ultrasound System EMS-9D EXP/EMS-9D PRO
Transducer: 2MHz PW Probe (02.0001.0214.01)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
{8}------------------------------------------------
System: Transcranial Doppler Ultrasound System EMS-9D EXP/EMS-9D PRO
Transducer: 4MHz CW Probe (02.0001.0408.01)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
{9}------------------------------------------------
System: Transcranial Doppler Ultrasound System EMS-9D EXP/EMS-9D PRO
Transducer: 8MHz CW Probe (02.0001.0805.01)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
{10}------------------------------------------------
System: Transcranial Doppler Ultrasound System EMS-9D EXP/EMS-9D PRO
Transducer: 16MHz PW Probe (02.0128.1601.01)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
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# Section 6 510(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: K190228
- 1. Date of Preparation: 03/30/2019
- 2. Sponsor Identification
#### Shenzhen Delica Medical Equipment Co.,Ltd.
6F, Block 10, The Second Industrial Zone, Guanlong, Nanshan District, Shenzhen 518055, China
Establishment Registration Number: 3006441164
Contact Person: Yolanda Lan Position: Regulatory Affair Engineer Tel: +86-0755-26413482-115 Fax: +86-0755-86210002 Email: lanxy(@delicasz.com
- 3. Identification of Proposed Device
Trade Name: Transcranial Doppler Ultrasound System; Common Name: Transcranial Doppler; Models: EMS-9D EXP and EMS-9D PRO
#### Regulatory Information
Classification: II
Product Code: IYN, ITX and OQQ, DXN, DXQ
Regulation Number: 21 CFR 892.1550 and 21 CFR 892.1570; 21 CFR 870.1130; 21 CFR 870.1120 Review Panel: Radiology;
Indications for Use:
While the Transcranial Doppler Ultrasound System is intended for use as a diagnostic ultrasound fluid flow analysis system, it can be:
1) 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 robotic probe headband facilitates monitoring use by its ability to track the Doppler signal.
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While the Transcranial Doppler Ultrasound System to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The system provides a noninvasive characterization of the arterial circulation and its beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals. The noninvasive blood pressure waveform is measured on the subject's finger.
Using the blood pressure calibration module, the system can additionally provide an upper arm noninvasive blood pressure measurement to determine the blood pressure value for calibration.
The system 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.
The EMS-9D EXP and EMS-9D PRO is intended to be used for subjects above 18 years of age. The EMS-9D EXP and EMS-9D PRO is intended for use in hospitals, clinics and research centers.
Device Description:
EMS-9D PRO and EMS-9D EXP are Transcranial Doppler (TCD) ultrasound system, which is developed based on the EMS-9D, it inherits all the EMS-9D's hardware and mechanical structure design. EMS-9D PRO and EMS-9D EXP are not only a Transcranial Doppler ultrasound system which used non-invasive technique to obtain the information of blood flow velocities throughout the body, but also a blood pressure monitor. This method of measurement is particularly useful for examining the major arteries supplying blood to the brain, and continuously measuring blood pressure.
TCD is useful for evaluation of numerous neurological vascular diseases such as vasospasm and intracranial stenosis. TCD is also extremely valuable for intraoperative monitoring to help detect sudden changes in blood flow.
The EMS-9D PRO and EMS-9D EXP integrate main unit, TCD probes, Nano Core module, upper arm blood pressure module and analog output module (EMS-9D EXP only), dedicated software, remote control, headframe, upper arm cuff, finger cuff and optional probes.
EMS-9D EXP/EMS-9D PRO should be used in hospitals or healthcare facilities by doctors or trained healthcare professionals.
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- Identification of Predicate Device
Transcranial Doppler Ultrasound part: 510k Number: K173801 Product Name: Transcranial Doppler Ultrasound System Manufacturer: Shenzhen Delica Medical Equipment Co., Ltd.
Nano Core Part: (Finger Arterial Blood Pressure) 510k Number: K173916 Product Name: Noninvasive Blood Pressure Monitor Manufacturer: Finapres Medical Systems B.V.
Upper Arm Cuff Measurement Part: 510k Number: K182433 Product Name: Blood Pressure Cuff Manufacturer: Shenzhen Caremed Medical Technology Co.,Ltd
#### 5. 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 predicated 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 80601-2-30:2009+A1:2013 Medical electrical equipment -- Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers
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.
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- Substantially Equivalent Discussio 9
ble 1 Substantially Equivalent Comparison of Transcranial Doppler Ultrasound pa
| ITEM | Proposed Device | Predicate Device, K173801 | Difference? |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Product Code | IYN, ITX and OQQ | IYN, ITX and OQQ | no |
| Regulation No. | 21 CFR 892.1550, 21 CFR 892.1570 | 21 CFR 892.1550, 21 CFR 892.1570 | no |
| Class | II | II | no |
| Intended Use | Transcranial Doppler Ultrasound System is intended<br>for use as a diagnostic ultrasound fluid flow analysis<br>system:<br>1) Measurement of cerebral artery blood velocities to<br>determine the presence of hemo-dynamically<br>significant deviations from normal values;<br>2) To assess arterial cerebral blood flow for the<br>occurrence of micro embolic signals. Vessels intended<br>for observation include, but are not limited to the<br>middle, anterior and posterior cerebral arteries, via the<br>temporal windows, the vertebral mid basilar arteries<br>via the foramen<br>magnum and the ophthalmic artery and intracranial<br>internal carotid artery via the eye.<br><br>Transcranial Doppler is intended for use during:<br>1)Diagnostic exams;<br>2)Surgical interventions.<br><br>The device is not intended to replace other means of<br>evaluating vital patient physiological processes, is not<br>intended to be used in fetal applications, and is not<br>intended to be used inside the sterile field. | Transcranial Doppler Ultrasound System is<br>intended for use as a diagnostic ultrasound fluid<br>flow analysis system:<br>1) Measurement of cerebral artery blood velocities<br>to determine the presence of hemo-dynamically<br>significant deviations from normal values;<br>2) To assess arterial cerebral blood flow for the<br>occurrence of micro embolic signals. Vessels<br>intended for observation include, but are not<br>limited to the middle, anterior and posterior<br>cerebral arteries, via the temporal windows, the<br>vertebral mid basilar arteries via the foramen<br>magnum and the ophthalmic artery and intracranial<br>internal carotid artery via the eye.<br><br>Transcranial Doppler is intended for use during:<br>1) Diagnostic exams;<br>2) Surgical interventions.<br><br>The device is not intended to replace other means<br>of evaluating vital patient physiological processes,<br>is not intended to be used in fetal applications, and<br>is not intended to be used inside the sterile field. | no |
| Configuration | EMS-9D EXP: Main Unit + Transducer + NIBP<br>Module<br>EMS-9D PRO: Main Unit + Transducer + NIBP<br>Module | EMS-9D: Main Unit +Transducer | Yes, see analysis 1<br>below the tables |
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| ITEM | Model | EMS-9D EXP | EMS-9D PRO | Predicate Device, K173801<br>EMS-9D | Difference? |
|-----------|--------------------------------------|----------------------------------------------|----------------------------------------------|----------------------------------------------|-----------------------------------------|
| | Component Family | Image: [Component Family] | | | / |
| | Screen<br>Nominal Voltage<br>Nominal | 15" LCD Display<br>AC 100V-240V<br>50Hz/60Hz | 15" LCD Display<br>AC 100V-240V<br>50Hz/60Hz | 15" LCD Display<br>AC 100V-240V<br>50Hz/60Hz | Yes, see analysis 1<br>below the tables |
| | Input Power | 120VA | 120VA | 80VA | no |
| | Transducer | 1.6/2/16MHz PW probe<br>and 4/8MHz CW probe | 1.6/2/16MHz PW probe<br>and 4/8MHz CW probe | 1.6/2/16MHz PW probe and 4/8MHz CW probe | no |
| | Performance | | | | |
| | Depth | not less than 150 mm | not less than 150 mm | not less than 150 mm | no |
| 1.6MHz PW | Speed range | 10cm/s~300cm/s | 10cm/s~300cm/s | 10cm/s~300cm/s | no |
| | Maximum Error | ±15% | ±15% | ±15% | no |
| | Depth | not less than 150 mm | not less than 150 mm | not less than 150 mm | no |
| 2MHz PW | Speed range | 10cm/s~300cm/s | 10cm/s~300cm/s | 10cm/s~300cm/s | no |
| | Maximum Error | ±15% | ±15% | ±15% | no |
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Image /page/16/Picture/0 description: The image contains the logo for the company "elica". The logo consists of the word "elica" written vertically in a sans-serif font, with the letters stacked on top of each other. To the left of the word is a blue graphic design that resembles a stylized wing or a series of angled lines converging towards a point.
| ITEM | Proposed Device | Predicate Device, K173801 | Difference? |
|----------------------|---------------------|---------------------------|-------------|
| Depth<br>4MHz | not less than 85 mm | not less than 85 mm | no |
| Speed range<br>CW | 10cm/s~300cm/s | 10cm/s~300cm/s | no |
| Maximum Error | ±15% | ±15% | no |
| Depth<br>8MHz | not less than 35 mm | not less than 35 mm | no |
| Speed range<br>CW | 10cm/s~200cm/s | 10cm/s~200cm/s | no |
| Maximum Error | ±15% | ±15% | no |
| Depth<br>16MHz<br>PW | not less than 8 mm | not less 8 mm | no |
| Speed range | 10cm/s~120cm/s | 10cm/s~120cm/s | no |
| Maximum Error | ±15% | ±15% | no |
able 2 Substantially Equivalent Comparison of Nano Core
| ITEM | Proposed Device | Predicate Device, K173916 | Difference |
|------------------------|-----------------|--------------------------------------------------|------------|
| Nano<br>Core<br>Module | | Finapres NOVA Noninvasive<br>Hemodynamic Monitor | / |
| | EMS-9D EXP | | no |
| Product Code | DXQ | DXQ | no |
| Regulation No. | 21 CFR 870.1130 | 21 CFR 870.1130 | no |
| Classification | Class II | Class II | no |
| | EMS-9D PRO | | |
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Image /page/17/Picture/0 description: The image shows the logo for "Elica". The logo consists of a stylized blue graphic element resembling a fan or a series of angled lines, positioned to the left of the text "elica" written in a simple, sans-serif font. The text is oriented vertically, with the letters stacked on top of each other.
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Image /page/18/Picture/0 description: The image contains the word "elica" in a vertical orientation. The word is written in a simple, sans-serif font and is black. To the left of the word is a blue graphic design that resembles a stylized fan or a series of angled lines converging towards a point.
able 3 Substantially Equivalent Comparison of Upper Arm Cuff Measurement part
| ITEM | Proposed Device | Predicate Device, K182433 | Difference? | |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|
| | EMS-9D EXP<br>(Upper Arm Cuff Model: NIA-PS) | EMS-9D PRO<br>(Upper Arm Cuff Model: NIA-PS) | Caremed Reusable Blood Pressure Cuff | |
| Regulation No. | 21CRF 870.1120 | 21CRF 870.1120 | 21CRF 870.1120 | no |
| Classification | Class II | Class II | Class II | no |
| Product Code | DXQ | DXQ | DXQ | no |
| Intended use | The reusable blood pressure cuff is an accessory used in conjunct…
