Transcranial Doppler Ultrasound System

K173801 · Shenzhen Delica Medical Equipment Co., Ltd. · IYN · Jul 11, 2018 · Radiology

Device Facts

• Record ID: K173801
• Device Name: Transcranial Doppler Ultrasound System
• Applicant: Shenzhen Delica Medical Equipment Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Jul 11, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1550
• Device Class: Class 2

Intended 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 and posterior cerebral arteries, via the temporal windows, the vertebral mid basilar arteries via the foramen magnum and the ophthalmic artery and intracranial internal carotid artery via the eye. The Roboprobe Headband facilitates monitoring use by its ability to track the Doppler signal. Transcranial Doppler is intended for use during: 1) Diagnostic exams; 2) Surgical interventions. The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.

Device Story

System uses non-invasive pulsed-wave (PW) and continuous-wave (CW) Doppler ultrasound to measure blood flow velocities in major cerebral arteries; detects vasospasm, intracranial stenosis, and micro-embolic signals. Input: Doppler ultrasound signals from transducers (1.6MHz, 2MHz, 4MHz, 8MHz, 16MHz). Operation: Transducer emits ultrasound; reflected signals processed to calculate velocity and flow characteristics. Output: Real-time blood flow velocity data displayed on monitor. Used in hospitals/healthcare facilities by physicians or trained professionals; Roboprobe Headband enables signal tracking during monitoring. Output assists clinicians in evaluating neurological vascular diseases and intraoperative blood flow changes; aids in clinical decision-making regarding patient vascular health.

Clinical Evidence

Bench testing only. Performance verified against design specifications and international standards (IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2, NEMA UD 2-2004). Acoustic output testing confirmed compliance with Track 3 limits. No clinical data provided.

Technological Characteristics

Diagnostic ultrasound fluid flow analysis system. Models EMS-9D/EMS-9F. Probes: 1.6MHz, 2MHz, 4MHz, 8MHz, 16MHz (PW/CW). Connectivity: Main unit with PC/laptop integration. Power: AC 100V-240V or DC. Safety: Complies with IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2. Acoustic output: NEMA UD 2-2004 (Track 3).

Indications for Use

Indicated for patients requiring diagnostic ultrasound fluid flow analysis of cerebral arteries (middle, anterior, posterior, vertebral, mid-basilar, ophthalmic, intracranial internal carotid) to detect hemodynamically significant deviations or micro-embolic signals. Used during diagnostic exams and surgical interventions. Not for fetal applications.

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 with Robotic Probe Headband (K122710)

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 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);

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#### 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 ([e-mail]) or phone [phone] 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

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#### 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;

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.

| 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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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<br>(Track 1 Only) | Specific<br>(Track 1&3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | P | | | | |
| 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) | | | | | | | |

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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<br>(Track 1 Only) | Specific<br>(Track 1&3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | P | | | | | |
| 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) | | | | | | | | |

{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<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 | | | P | | | | | |
| 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) | | | | | | | | |

{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<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) | | | | | | | |

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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<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) | | | | | | | |

{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*<br>(Specify) |
|---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|--|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Track 1&3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | | |
| Ophthalmic | Ophthalmic | | | P | | | | | |
| Fetal | Fetal | | | | | | | | |
| Imaging &<br>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<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) | | | | | | | | |

{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*<br>(Specify) |
|-----------------------------|------------------------------------|-------------------|---|-----|-----|---------------|-----------------------|---------------------|
| | | B | M | PWD | CWD | Color Doppler | Combined<br>(Specify) | |
| General<br>(Track 1 Only) | Specific<br>(Track 1&3) | | | | | | | |
| Ophthalmic | Ophthalmic | | | P | | | | |
| 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) | | | | | | | |

{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*<br>(Specify) | |
|---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|--|
| General<br>(Track 1 Only) | Specific<br>(Track 1&3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal | Fetal | | | | | | | | |
| Imaging &<br>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<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 | Specific | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) | |
| (Track 1 Only) | (Track 1&3) | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal | Fetal | | | | | | | | |
| Imaging &<br>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<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) | | | | | | | |

{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

- 1. Date of Preparation: 6/12/2018
- 2. 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: [phone] Fax: [phone] Email: [e-mail]

- 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: [phone] Fax: [phone] Email: [e-mail]

{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:

- 1) For the measurement of cerebral artery blood velocities to determine the presence of hemo dynamically significant deviations from normal values;
- 2) To assess arterial cerebral blood flow for the occurrence of micro embolic signals. Vessels intended for observation include, but are not limited to the middle, anterior and posterior cerebral arteries, via the temporal windows, the vertebral mid basilar arteries via the foramen magnum and the ophthalmic artery and intracranial internal carotid artery via the eye.

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

- 1) Diagnostic exams;
- 2) Surgical interventions.

The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.

#### 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}------------------------------------------------

- 5. Identification of Predicate Device
510k Number: K122710

Product Name: Transcranial Doppler with Robotic Probe Headband; Manufacturer: Shenzhen Delicate Electronics Co., Ltd.

- 6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012, Medical electrical equipment – Part 1: General requirements for basic safety, and essential performance.

IEC 60601-2-37:2007, 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.

- 7. 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<br>intended for use as a diagnostic ultrasound fluid<br>flow analysis system:<br>1) For the measurement of cerebral artery blood<br>velocities to determine the presence of hemo<br>dynamically significant deviations from normal<br>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>The Roboprobe Headband facilitates monitoring<br>use by its ability to track the Doppler signal.<br>Transcranial Doppler is intended for use during:<br>1) Diagnostic exams;<br>2) Surgical interventions.<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. | | Transcranial Doppler Ultrasound System is<br>intended for use as a diagnostic ultrasound fluid<br>flow analysis system:<br>1) For the measurement of cerebral artery blood<br>velocities to determine the presence of hemo<br>dynamically significant deviations from normal<br>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>The Roboprobe Headband facilitates monitoring<br>use by its ability to track the Doppler signal.<br>Transcranial Doppler is intended for use during:<br>1) Diagnostic exams;<br>2) Surgical interventions.<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. | |
|-------------------|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Intended Use | | | | | |
| Configuration | | EMS-9F: Main Unit+PC/Laptop+Transducer<br>EMS-9D: Main Unit+Transducer | | EMS-9UA: Main Unit+PC/Laptop+Transducer<br>EMS-9PB: Main Unit+Transducer | |
| Model | | EMS-9D…