SONOTRAX SERIES ULTRASONIC POCKET DOPPLER

K101960 · Edan Instruments, Inc. · HEP · Aug 10, 2010 · Obstetrics/Gynecology

Device Facts

• Record ID: K101960
• Device Name: SONOTRAX SERIES ULTRASONIC POCKET DOPPLER
• Applicant: Edan Instruments, Inc.
• Product Code: HEP · Obstetrics/Gynecology
• Decision Date: Aug 10, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.2660
• Device Class: Class 2

Indications for Use

The Sonotrax series of Ultrasonic Pocket Doppler are intended for use by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physicians assistants, in hospitals, clinics and private offices. The 2 MHz and/ or 3 MHz obstetrical probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being. They can also be used to verify fetal heart viability following patient trauma. The 4 MHz, 5 MHz and/or 8 MHz vascular probes are indicated for the detection of blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.

Device Story

Hand-held ultrasonic Doppler device; utilizes ultrasound probe to transmit acoustic waves into patient body; reflected waves from moving blood/tissues received by probe; converted to electric signals; processed by CPU; audio output provided; fetal heart rate/vascular flow velocity displayed on LCD. Used by healthcare professionals in clinics/hospitals. Provides real-time auditory and visual feedback to assist clinicians in assessing fetal status or peripheral vascular flow; aids in clinical decision-making regarding fetal viability or vascular disease detection.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including software, hardware, safety, and environmental testing, and risk analysis.

Technological Characteristics

Hand-held ultrasonic Doppler; 2MHz, 3MHz, 4MHz, 5MHz, and 8MHz probes; Doppler shift principle; LCD display; CPU-based digital signal processing; battery-powered; non-invasive; intended for clinical use.

Indications for Use

Indicated for healthcare professionals (nurses, midwives, technicians, PAs) in clinical settings. 2/3 MHz probes: fetal heart rate detection from early gestation to delivery, fetal well-being assessment, and post-trauma viability verification. 4/5/8 MHz probes: detection of venous/arterial blood flow to assist in peripheral vascular disease diagnosis. Contraindicated for ICU, OR, or home use.

Regulatory Classification

Identification

A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.

Predicate Devices

• SONOTRAX ULTRASONIC POCKET DOPPLER (K080087)

Submission Summary (Full Text)

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Section 1

K101960

Sonotrax Series Ultrasonic Pocket Doppler SPECIAL 510(K) DEVICE MODIFICATION

# 510(k) Summary of Safety and Effectiveness

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

| Submitter: | Edan Instruments, Inc<br>3/F - B, Nanshan Medical<br>Equipments Park, Nanhai Rd 1019#,<br>shekou, Nanshan Shenzhen,<br>518067 P.R. China<br>Tel: [phone]<br>Fax:[phone]<br>Contact person: Yue Qiuhong | | | AUG 10 2010 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|--|-------------|
| Official correspondent: | William Stern<br>Multigon Industries,Inc.<br>1 Odell Plaza<br>Yonkers, N.Y. 10701<br>Phone: [phone] X27<br>Fax: [phone] | | | |
| Date of Preparation: | 2010-6-21 | | | |
| Proprietary Name: | Sonotrax Series Ultrasonic Pocket Doppler<br>(Models:Sonotrax Lite, Sonotrax Basic, Sonotrax BasicA, Sonotrax<br>Pro, Sonotrax II, Sonotrax II Pro, Sonotrax Vascular) | | | |
| Classification Name: | 21 CFR 884.2660 Fetal ultrasonic monitor and accessories<br>21 CFR 884.2660 Ultrasonic Blood Flow Monitor | | | |
| Product code: | KNG<br>HEP | | | |
| Predicate Devices: | | | | |
| | Predicate devices | SONOTRAX ULTRASONIC POCKET<br>DOPPLER | | |
| | Manufacturer | Edan Instruments, Inc | | |

Device Description:

---- .

The Sonotrax series Ultrasonic Pocket Doppler is a hand-held device The Sonotrax Schoolino and display of fetal heart rate and for non-invasive incasurement and inciple of Doppler shift of an ultrasound. The ultrasound is transmitted from the probe to patient

K080087

K #

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Dody (maternal abdominal wall), and moves through biophysical objects. The acoustic ultrasound is reflected by blood and moving objects. The acoustic articles The reflected ultrasound is received by the probe and is converted into electric signals.

The waveform data are applied to the CPU for all the digital The waveronm 'data- are 'upperation keys. The audio signal is taken processing on LCD Diopia), episer to generate the analogue signals before digital processing.

The following probes are supplied with the Ultrasonic Pocket Doppler:

1. 2MHz for fetal heart rate.

2. 3MHz for fetal heart rate

2. SIMIZ for fetal neart face taxe
3. 4MHz for detections of arterial and venous blood flow velocity.

5. 4MHz for detections of arterial and venous blood flow velocity.

4. 3MHz for detections of arterial and venous blood flow velocity.

## Comparison with predicate device

The Sonotrax Series Ultrasonic Pocket Doppler models in item The Sonotrax Sches Chrassine Sonotrax Basic, Sonotrax BasicA, 2.above incruding Donotrax II, Sonotrax II Pro, Sonotrax Vascular, Sollowax 110, Bollowarnaracteristics as all the predicate approved devices in item 3. above. All of these above models use the same technology and circuitry as the already approved Sonotrax Doppler technology and choultry as the anodification application, we have added a 5MHz vascular probe for vascular use. Hence the Sonotrax added a Jiviliz Vascular probo ici vascular above are substantially equivalent to the predicate devices cited.

Intended Use:

The Sonotrax series of Ultrasonic Pocket Doppler are intended for use The Sollottax series of Officialing registered nurses, practical by health call professionals metading rogend to physicians assistants, by
nurses, midwives, ultrasound technicians, and physicians assistants, by nurses, Intuwives, untrasound volimes. In hospitals, clinics and private offices.

The 2 MHz and/ or 3 MHz obstetrical probes are indicated for the I he 2 MHz and/ of 5 NHTZ 000021007 100 early gestation thru delivery and as a detection of fetal neart fate from carry gestiated
general indication of fetal well being. They can also be used to verify fetal heart viability following patient trauma.

The 4 MHz, 5 MHz and/or 8 MHz vascular probes are indicated for The 4 MHz, 3 MHz and/or of MIL-1ascand provins and arteries for assisting in the detection of peripheral vascular disease.

Contraindications:

It is not intended for use in intensive care units, operating rooms or

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Sonotrax Series Ultrasonic Pocket Doppler SPECIAL 510(K) DEVICE MODIFICATION

#### Section 1

#### Test Summary:

The following quality assurance measures were applied to the The Tonowing "quality" assureries of Ultrasonic Pocket Doppler

- · Software testing
for home use.

- · Hardware testing
- · Safety testing
- · Environment test
- Risk analysis
- Final validation

#### Conclusion:

Verification and validation testing was done on the Sonotrax series of Ultrasonic Pocket Doppler. This premarket notification Submission Onfasonic I ocker Doppier. This of Ultrasonic Pocket Doppler is substantially equivalent to the predicate device.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in a stylized, minimalist design.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

AUG 1 0 2010

Mr. Yue Qiuhong (Tracy) Certification Engineer Edan Instruments, Inc. 3/F-B, Nanshan Medical Equipments Park, Nanhai Dr 1019# Shenzhen, Guangdong, 518067 CHINA

Re: K101960

Trade/Device Name: Sonotrax Series Pocket Doppler Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: KNG and HEP Dated: July 8, 2010 Received: July 12, 2010

#### Dear Mr. Yue Oiuhong:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) 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 the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to parery aket 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll me [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Donald J. Trump

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

## Enclosure

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Sonotrax Series Ultrasonic Pocket Doppler SPECIAL 510(K) DEVICE MODIFICATION 101960

Section 1

# Indication for Use

## AUG 1 0 2010

510(k) Number (if known):

Device Name: Sonotrax Series Ultrasonic Pocket Doppler Device Name: Sonotrax Series Onlasome PosicA, Sonotrax Pro, Sonotrax II , Sonotrax II , Sonotrax II Pro, Sonotrax Vascular)

The Sonotrax Series Ultrasonic Pocket Doppler is intended to be used by health care The Sonotrax Series Ultrasonic Focker Doppier is midwives, ultrasound technicians, and professionals including registered harses, practical nations, on hospitals, clinics and private offices.

The 2 MHz and/or 3 MHz.probes are indicated for the detection of fetal heart rion early The 2 MHz andor > MHz probos are manufaction of fetal well being. They can also be used to verify fetal heart viability following patient trauma.

The 4 MHz, 5 MHz and/or 8 MHz vascular probes are indicated for the detection of blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.

× Prescription Use (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE) ○ДИО

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Sa

510K K101.960