SONOTRAX ULTRASONIC POCKET DOPPLER

K040480 · Edan Instruments, Inc. · KNG · May 25, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K040480
• Device Name: SONOTRAX ULTRASONIC POCKET DOPPLER
• Applicant: Edan Instruments, Inc.
• Product Code: KNG · Obstetrics/Gynecology
• Decision Date: May 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2660
• Device Class: Class 2

Intended Use

Detection of fetal heartbeat from early gestation thru delivery. Verify fetal heart viability after patient trauma. Display of fetal heart rate. Prescription Device: Federal Law (US) restricts this device to sale by or on order of a physician. Under the direction of a physician it may be used by other health care professionals including Registered Nurses, Practical Nurses , Midwives, and Ultrasound Technicians

Device Story

Sonotrax Ultrasonic Pocket Doppler uses Doppler shift principle to detect fetal heart and artery blood flow. Device utilizes split D piezoelectric transducer; high-frequency oscillator transmits ultrasound acoustic waves into body via coupling medium. Reflected ultrasound from fetal heart/blood is received by transducer, converted to electronic signal, amplified, and filtered. Resulting baseband audio Doppler signal output via loudspeaker; fetal heart rate calculated and shown on LCD. Used in clinical settings by physicians, nurses, midwives, or ultrasound technicians to assess fetal well-being and viability. Provides real-time auditory and visual feedback to assist clinical decision-making regarding fetal status.

Clinical Evidence

Bench testing only. Device subjected to extensive safety, performance, and validation testing to ensure compliance with functional requirements and industry safety standards.

Technological Characteristics

Handheld ultrasonic fetal monitor. Uses split D piezoelectric transducer for transmission/reception. Operates via Doppler shift principle. Includes LCD for heart rate display and loudspeaker for audio output. Requires water-based coupling medium.

Indications for Use

Indicated for detection of fetal life and heart rate from early gestation through delivery, and verification of fetal heart viability following patient trauma.

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

• Baby Dopplex 3000MK 2 (K010889)
• Cadence Doppler Ultrasound System (K991441)
• Imexdop CT+ (K942441)
• Sonicaid One Fetal Heart Detector (K023618)

Submission Summary (Full Text)

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510k Submission , SONOTRAX Ultrasonic Fetal Pocket Doppler Edan Instruments, Inc.

MAY 2 5 2004

## SUMMARY

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

- 1. Submitters name, address, phone number, contact person and preparation date:
Name: Edan Instruments, Inc 4/F, New Energy Building 2009 Nanyou Road Nanshan, Shenzhen Guangdong 518054 China Phone: [phone] 755 26062022 Fax; Responsible person: Xie Xicheng

Official Correspondent:

William Stern Multigon Industries, Inc. 1 Odell Plaza Yonkers, N.Y. 10701 Phone: [phone] x27 Fax: [phone]

Date of Preparation: 2/19/04

- 2. Device:

| Proprietary Name: | Sontotrax Ultrasonic Pocket Doppler |
|----------------------|------------------------------------------|
| Common Name: | Ultrasonic Fetal Monitor |
| Classification Name: | Fetal Ultrasonic Monitor and Accessories |
| Product Code: | KNG |
| Manufactured By: | Edan Instruments, Inc., China |

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- 3. Predicate Devices:
K010889, Baby Dopplex 3000MK 2, Huntleigh Healthcare Inc. UK. K991441, Cadence Doppler Ultrasound System, Medasonics, Inc. K942441, Imexdop CT+, Imex Medical Systems, Inc. Golden, CO. K023618, Sonicaid One Fetal Heart Detector, UK

- 4. Classification Names :
Class II as per 21CFR 884-2660, Fetal Ultrasonic Monitor and accessories.

- న. Description:
The Sonotrax fetal Doppler uses the tried and true principle of Doppler shift Of an ultrasound signal to deect the blod flow within the fetal heart and arteries.

The Sonotrax Fetal Doppler uses a split D piezoelectric transducer. A high frequency oscillator supplies a continuous high frequency voltage to one half of the split D transmitter transducer. The high frequency voltage is converted to an ultrasound acoustic wave by the transducer and is transmitted to biophysical objects thru an applied coupling water based medium and moves thru biophysical objects. The acoustic ultrasound is reflected by blodd , and moving objects such as the fetal heart. The reflected ultrasound is received by the second split D receiver transducer and is converted via the piezoelectric effect into a high frequency electronic signal. The received electronic signal is amplified and detected. The result is a base band audio Doppler shifted signal which is filtered , and converted to audio via a loud speaker. At the same time the fetal heart rate is applied to and displayed on a liquid crystal counter display.

- 6. Indications for use:
Detection of fetal life .from early gestation thru delivery and as a general indication of fetal well being. It can also be used to verify fetal heart viability following patient trauma.

- 7. Contra-indications:
None known at this time.

- 8. Comparison to Predicate Devices:

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The Sonotrax Basic fetal Doppler has the same device characteristics as all the predicate approved devices in item 3 above.

- ರ. Test Data:
The Sonotrax Basic Fetal Doppler device has been subjected to extensive safety, performance testing and validations before release. Final testing of the Sonotrax basic fetal Doppler includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety tests have further been performed to ensure the device complies with applicable industry and safety stanmdards.

The Sonotrax Basic Fetal Doppler device labeling includes instructions for safe and effective use, warnings cautions and guidance for use.

- 10. Literature Review:
A review of the literature pertaining to the safety of Doppler Blood flowmeter Has been conducted and appropriate safeguards have been incorporated in the design of the Sonotrax Basic fetal Doppler.

- 10. Conclusions:
The conclusion drawn from these tests is that the Sonotrax Basic fetal Doppler device is equivalent in safety and efficacy to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and contains the department's name around the perimeter. In the center of the logo is an image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 2 5 2004

Edan Instruments, Inc. % Mr. William Stern Official Correspondent Multigon Industries, Inc. l Odell Plaza YONKERS NY 10701

Re: K040480 Trade/Device Name: Sonotrax Ultrasonic Pocket Doppler Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: 85 KNG Dated: February 23, 2004 Received: February 25, 2004

Dear Mr. Stern:

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. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act), 21 CFR 1000-1050

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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Boyden

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): k040480

SONOTRAX Ultrasonic Pocket Doppler Device Name:

Indications For Use:

Detection of fetal heartbeat from early gestation thru delivery. Verify fetal heart viability after patient trauma. Display of fetal heart rate.

Prescription Device:

Federal Law (US) restricts this device to sale by or on order of a physician. Under the direction of a physician it may be used by other health care professionals including Registered Nurses, Practical Nurses , Midwives, and Ultrasound Technicians

Prescription Use YES (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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. bivadon

ive, Abdominal, Division of Reproduct and Radiological D 510(k) Number

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