TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA

K092164 · Shenzhen Delicate Electronics Co., Ltd. · OQQ · May 13, 2010 · Radiology

Device Facts

• Record ID: K092164
• Device Name: TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA
• Applicant: Shenzhen Delicate Electronics Co., Ltd.
• Product Code: OQQ · Radiology
• Decision Date: May 13, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

The EMS9UA 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 hemodynamically 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. The EMS9UA Transcranial Doppler is intended for use during: a) Diagnostic exams b) 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

EMS9UA is a transcranial Doppler ultrasound system with a robotic probe headband for long-term monitoring. It inputs ultrasound Doppler return signals; a servo motor controller and added software track the signal to maintain probe position, preventing signal loss during patient movement. The system outputs blood flow waveforms and velocity measurements. Used in clinics, hospitals, and physician offices by trained medical personnel for diagnostic exams and surgical interventions. The healthcare provider monitors the output to identify hemodynamically significant deviations or micro-embolic signals, aiding clinical decision-making regarding cerebral blood flow. The robotic headband improves monitoring stability compared to manual probes.

Clinical Evidence

Clinical trial involving 100 patients compared the EMS9UA with the Spencer Technologies Marc 600 predicate headband. The study concluded the device is safe and effective for its intended use.

Technological Characteristics

Diagnostic ultrasound system; 2, 4, and 8 MHz transducers; PWD and CWD modes. Features a robotic probe headband with servo motor control for automated probe positioning. Complies with UL 2601-1, IEC 60601-1-2, IEC 60601-2-37, and AIUM/NEMA UD 2/3 standards. Software-controlled tracking mechanism.

Indications for Use

Indicated for diagnostic ultrasound fluid flow analysis in adult patients. Used for measuring cerebral artery blood velocities and assessing micro-embolic signals in cerebral and ophthalmic arteries. Not for fetal use.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

• EMS9U Transcranial Doppler (K060112)
• SPENCER TCD 100M MARC 600 (K002533)

Submission Summary (Full Text)

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Shenzhen Delicate Electronics Co. Ltd

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## SUMMARY

MAY 1 3 2010

This summary of 510k safety and effectiveness information is being submitted in accordance with 21CFR part 807.92

Submitters name, address, phone number, contact person and 1. preparation date:

Name:

Shenzhen Delicate Electronics Co. Ltd. 6C, Block 8, Tian-an Ind. Area 518054 Nanshan District Shenzhen People's Republic of China Phone: [phone] Fax: [phone] Responsible person: Frank Qui

Official Correspondent:

William Stern Multigon Industries, Inc. 1 Odell Plaza Yonkers, N.Y. 10701 Phone: [phone] X27 Fax: . [phone]

Date of Preparation:

April 7, 2009

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2. Device:

Proprietary Name: EMS9UA Transcranial Doppler with Robotic Probe Headband

> Common Name: Transcranial and Vascular Doppler Diagnostic Ultrasound Transducer Classification Name: 21 CFR892.1550 System,Imaging,Pulsed Doppler, Ultrasonic 21 CFR892.1570 Diagnostic Ultrasound Transducer

Classification Number: 90IYN 90ITX

Manufactured By:

Shenzhen Delicate Electronics Co. Ltd. 6C, Block 8, Tian-an Ind. Area 518054 Nanshan District Shenzhen People's Republic of China Phone: [phone] Fax: [phone]

3. Substantially Equivalency

Device Description:

Shenzhen Delicate believes that the Model EMS-9UA is substantially equivalent to its EMS OU Transcranial Doppler which was cleared on May 5, 2006 510kH K060112. The EMS-9UA has the same device description except that the head frame used for longer term monitoring has the ability to track the Doppler signal and therefore not lose the signal with patient movement and time. The tracking is accomplished by adding to the EMS9U an additional circuit which detects the ultrasound Doppler return and positions the face of the probe in the headband to maximize the detected ultrasound return. The headband electronics does not change or interfere with the transmitted ultrasound. Except for the servo motor controller added to the circuitry of the EMS9U range and the software added to control it, and the modifications to the INNSO Tange and the servo motor controlled probe, the EMS9U range and the EMS- 9UA are identical internally and functionally. The probes are identical to those cleared in K060112.

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Hence the EMS-9UA is substantially equivalent to the EMS9U range of Trans Cranial Dopplers.

Product Comparison Chart

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| Parameters | EMS9U range | EMS-9UA | SPENCER TCD 100M MARC 600 |
|----------------------------------------------------|---------------------------------------------------|-----------------------------------------------------------|---------------------------------------|
| 510k Number | K060112 | K092164 | K002533 |
| Transducer Frequency | 2,4, and 8 mHz | 2,4, and 8 mHz | 2 mHz |
| Frequency Spectrum | FFT256/512 dots | FFT256/512 dots | FFT256/512 dots |
| Frequency Ranges | 1 to 16 mHz | 1 to 16 mHz | 2 mHz |
| Depth Measurement | 5 to 136 mm | 5 to 136 mm | 5 to 140 mm |
| Gain | 0 to 40 dB | 0 to 40 dB | 0 to 40 dB |
| Clinical Application<br>For 2 mHz | | | |
| PWD | Opthalmic, Adult Cephalic<br>& Peipheral Vascular | Opthalmic, Adult Cephalic<br>& Peipheral Vascular | Opthalmic, Adult Cephalic |
| CWD | Opthalmic & Peripheral<br>Vascular | Opthalmic & Peripheral<br>Vascular | |
| Clinical Application<br>For 4 mHz and 8 mHz<br>CWD | Peripheral Vascular | Peripheral Vascular | |
| Head Frame | Bilateral Probes Adjusted<br>Manually | Bilateral Probes Adjusted<br>Manually and/or<br>matically | Bilateral Probes Adjusted<br>Manually |

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#### 4. PERFORMANCE STANDARDS

No performance standards have been established for the EMS9UA Transcranial Doppler under section 514 of the Federal Food and Drug Act. However the EMS9UA Transcranial Doppler has been designed to meet the following standards:

UL 2601-1 Safety Requirements for Medical Equipment AIUM/NEMA UD 2 Standard for Real Time Display of Thermal and Mechanical Output Indices on Diagnostic Ultrasound Equipment AIUM/NEMA UD 3 Standard for Real Time Display of Thermal and Mechanical Output Indices on Diagnostic Ultrasound Equipment IEC 1157 Declaration of Acoustic Power IEC60601-1-2 IEC60601-2-37

#### 5. INDICATIONS FOR USE

Indications for Use:

The EMS9UA Transcranial Doppler Ultrasound System is intended for use as a diagnostic ultrasound fluid flow analysis system:

I ) For the measurement of cerebral artery blood velocities to determine the presence of hemodynamically 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.

The EMS9UA Transcranial Doppler is intended for use during:

a) Diagnostic exams

b) 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.

## 6. CONTRA-INDICATIONS

None known at this time.

## 7. COMPARISON TO PREDICATE DEVICES

The EMS9UA Transcranial Doppler has the same device characteristics as the approved predicate device listed above with the commonality of ultrasound transducers, priprively of operation, and display of blood flow waveforms.

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## 8. TEST DATA

The EMS9UA Transcranial Doppler with Robotic Probe Headband has been subjected to extensive safety, performance testing, and validation before release. Final testing of the EMS9UA included various performance tests designed to ensure that the device met all of its functional specifications. Safety tests have been performed to ensure the device complies with applicable industry and safety standards.

A clinical trial involving 100 patients was conducted comparing the EMS9UA Transcranial Doppler with Robotic Headband with the Spencer Technologies Marc 600 predicate headband and was found to be safe and effective.

The Model EMS9UA Transcranial Doppler device labeling includes instructions for safe and effective use, warnings, cautions and guidance for use. It has therefore shown to be safe and effective.

#### 9. LITERATURE REVIEW

A review of the literature pertaining to the safety of the EMS9UA Transcranial Doppler has been conducted and appropriate safeguards have been incorporated in the design of the EMS9UA Transcranial Doppler.

#### 10. CONCLUSIONS

The conclusion drawn from these tests is that the EMS9UA Transcranial Vascular Doppler with Robotic Probe Headband and it's transducers is substantially equivalent in safety and efficacy to the predicate devices listed in the comparison table above

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

# MAY 1 3 2010

Shenzhen Delicate Electronics Co., Ltd. % Mr. William Stern Official Correspondent Multigon Industries, Inc. 1 Odell Plaza YONKERS NY 10701

Re: K092164

Trade/Device Name: EMS9UA Transcranial Doppler Robotic Probe Headband Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: OQQ, IYN and ITX Dated: April 19, 2010 Received: April 21, 2010

Dear Mr. Stern:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the EMS9UA Transcranial Doppler Robotic Probe Headband, as described in your premarket notification:

## Transducer Model Number

| 2 MHz |
|-------|
| 4 MHz |
| 8 MHz |

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Brendan O'Leary at [phone].

Sincerely yours

Donald Trump

Donald St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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## Indications for Use

## 510(k) Number (if known): K092164

Device Name: EMS9UA Transcranial Doppler with Robotic Probe Headband

Indications for Use:

The EMS9UA 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 hemodynamically 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, The EMS9UA Transcranial Doppler is intended for use during:

a) Diagnostic exams

b) 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.

It is to be used by trained medical personnel in hospitals, clinics and physicians offices by prescription or doctor's orders. --

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) .

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robattzeckey
K092164

(División Sign-om)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

K092164

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#### APPENDIX G: Diagnostic Ultrasound Indications for use for whole

# SYSTEM: EMS9UA TRANSCRANIAL DOPPLER K092164

# INTENDED USE: diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| TRANSDUCER | CLINICAL APPLICATION | MODE OF OPERATION | PREVIOUSLY |
|------------|----------------------|-------------------|------------|
| FREQUENCY | | | CLEARED |
| 2 MHZ | OPTHALMIC | PWD | K060112 |
| 2 MHZ | ADULT CEPHALIC | PWD | K060112 |
| 2 MHZ | PERIPHERAL VESSEL | PWD | K060112 |
| 4 MHZ | PERIPHERAL VESSEL | CWD | K060112 |
| 8 MHZ | PERIPHERAL VESSEL | CWD | K060112 |

## PWD= PULSED WAVE DOPPLER

CWD=CONTINUOUS WAVE DOPPLER

(Division Sign-Off Division of Radiological Devices ice Evaluation and Safety Office of In Vitro

510K Kag2164

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## Contains Nonbinding Recommendations Appendix G

# Appendix G: Example Diagnostic Ultrasound Indications For Use Format

System: EMS9UA_Transcranial_Doppler

Transducer: 2 mHz

Previously cleared under K060112 May 5 2006

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>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | P | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | 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 Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | P | | | | |
| | Other (Specify) | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix

* Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging Haymonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

(Division Sign-Off)

510K

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation an

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Contains Nonbinding Recommendations Appendix G

# Appendix G: Example Diagnostic Ultrasound Indications For Use Format

System: Transducer:

EMSQUA 4-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Intended blagnostics intrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 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 | | | | | | | |
| | Other (Specify) | | | | P | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix * Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

510K

(Division Sign-Off) Division of Radiological Devic Office of In Vitro Diagnostic Device Evaluation

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## Contains Nonbinding Recommendations Appendix G

# Appendix G: Example Diagnostic Ultrasound Indications For Use Format

EMS9UA System:

Transducer:

-8_mHz

Previously_Cleared under k060112 May 5 2006

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General | Specific | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| (Track 1 Only) | (Tracks 1 & 3) | | | | | | | |
| 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) | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix

* Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging,

(Division Sign-Off)

510K

Division of Radiological Dev Office of In Vitro Division of Hadlollogical Devices
Office of In Vitro Diagnostic Device Evaluation

K092164
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