Detection of fetal heart rate, detection of multiple pregnancies. Verify fetal heart viability following patient trauma. Display of fetal heart rate, monitor fetal heart rate during labor.

Device Description

The Echo Sounder ES-102EX Fetal Doppler system utilizes the well understood principle of Doppler shift of an ultrasound signal to detect the flow of blood within the fetal heart wall motion and arteries. The unit amplifies the high frequency oscillation output and then supplies this to the transmitter transducer. The high frequency voltage is converted to ultrasound by the transducer and is transmitted to external objects. The ultrasound transmitted by the transducer movers straight through biophysical object(s), and is reflected by the moving object (fetal heartbeat etc.). The reflected ultrasound is received by the receiving transducer and is converted into electronic signals again. The converted electronic signals are amplified and then are detected. After removing unnecessary noise signals and improving S/N ratio at the filter circuit, the Doppler shift signals are amplified and are converted to audible sound pressure through a speaker or a headset. Simultaneously the signals are applied to the heart rate LCD display.

AI/ML Overview

The provided 510(k) submission for the Echo Sounder ES-102EX Fetal Doppler does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically found in submissions for AI/ML-based diagnostic devices.

The Koven Technology Echo Sounder ES-102EX Fetal Doppler is a non-AI/ML medical device. It operates on the well-understood principle of Doppler shift to detect fetal heart activity. Its submission focuses on demonstrating substantial equivalence to predicate devices through technical specifications, safety testing (not performance-based on clinical outcomes), and compliance with industry standards, rather than clinical performance metrics that would require acceptance criteria.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: This type of detail is not presented for this device.
Sample size used for the test set and the data provenance: No clinical test set is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such test set is described.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable as this is not an AI-assisted diagnostic device.
If a standalone performance study was done: Not applicable in the context of AI/ML algorithm-only performance. The performance deemed sufficient is its equivalence to predicate devices based on its technical operation.
The type of ground truth used: Not applicable for this type of device. Its "ground truth" would be the actual physical Doppler shift it detects, not a diagnosis or clinical outcome requiring expert consensus.
The sample size for the training set: Not applicable as this device does not use machine learning.
How the ground truth for the training set was established: Not applicable.

Summary of the document's content regarding device performance and acceptance:

The document states that the Echo Sounder ES-102EX Fetal Doppler has been "subjected to extensive safety, performance, and validations prior to release." It also mentions "various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications." However, these are general statements and do not specify particular acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) or detail the studies performed to meet them.

The primary conclusion for clearance is based on substantial equivalence to predicate devices (K942441, K991441, K010889) in terms of safety and efficacy, implying that its performance is considered acceptable because it functions similarly to devices already on the market. The FDA letter confirms this, stating the device is "substantially equivalent...to legally marketed predicate devices."

The only specific testing mentioned is the requirement for a "postclearance special report" containing "acoustic output measurements based on production line devices," to ensure compliance with approved acoustic output levels. This relates to device safety, not clinical diagnostic performance in the way an AI/ML device would be evaluated.

Summary

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510(k) Submission, Echo Sounder ES-102EX Koven Technology. Inc.

Summary

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92

1. Company making the submission:

Name:Address:	Company making submission:	Correspondent (contract):
	Koven Technology, Inc.12125 Woodcrest Executive Dr.Suite 220	Delphi Consulting Group11874 South Evelyn Circle
	St. Louis, MO 63141	Houston, Texas 770713404
Telephone:	1-314-542-2101	1-713-723-4080
Fax:	1-314-542-6020	1-775-429-9524
Contact:	Paul G. Koven	J. Harvey Knauss
	President	Consultant
E-mail:	Koven@koven.com	harvey@delphiconsulting.com

2. Device:

Proprietary Name: Common Name: Classification Name: Manufactured by:

Echo Sounder ES-102EX Fetal Doppler Ultrasonic Fetal Monitor Fetal ultrasonic monitor and accessories Hadeco, Hayashi Denki Co., Ltd., Japan

3. Predicate Device(s):

K942441, IMEXDOP CT+, IMEX Medical Systems, Inc., Golden, CO 80403. K991441. Cadence Doppler Ultrasound System, Medasonics, Inc. K010889. Baby Dopplex 3000 MK 2, Huntleigh Healthcare, Inc., UK

Classifications Names & Citations: 4.

Class II per 21 CFR 2660, Fetal ultrasonic monitor and accessories.

5. Description:

The unit amplifies the high frequency oscillation output and then supplies this to the transmitter transducer. The high frequency voltage is converted to ultrasound by the transducer and is transmitted to external objects. The ultrasound transmitted by the transducer movers straight through biophysical object(s), and is reflected by the moving object (fetal heartbeat etc.). The reflected ultrasound is received by the receiving transducer and is converted into electronic signals again.

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The converted electronic signals are amplified and then are detected. After removing unnecessary noise signals and improving S/N ratio at the filter circuit, the Doppler shift signals are amplified and are converted to audible sound pressure through a speaker or a headset. Simultaneously the signals are applied to the heart rate LCD display.

6. Indications for use:

Detection of fetal life, detection of multiple pregnancies, fetal screens from early gestation through delivery and general indication of fetal well being. Verify fetal heart viability following patient trauma.

7. Contra-indications:

None known at this time.

8. Comparison:

The Echo Sounder ES-102EX Fetal Doppler has the same device characteristics as the predicate device.

9. Test Data:

The Echo Sounder ES-102EX Fetal Doppler device has been subjected to extensive safety, performance, and validations prior to release. Final testing for the system 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 standards.

The Echo Sounder ES-102EX Fetal Doppler device labeling includes instructions for safe and effective use. It includes Warning, Cautions, and guidance for use.

10. Literature Review:

A review of literature pertaining to the safety of Doppler Blood Flowmeters has been conducted. Appropriate safeguards have been incorporated in the design of the Echo Sounder ES-102EX Fetal Doppler.

11. Conclusions:

The conclusion drawn from these tests is that the Echo Sounder ES-102EX Fetal Doppler device is equivalent in safety and efficacy to its predicated device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

DEC 1 9 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Koven Technology, Inc. % Mr. J. Harvey Knauss Consultant Delphi Consulting Group 11874 South Evelyn Circle HOUSTON TX 77071

Re: K023143

Trade Name: Echo Sounder, Model ES-102EX Fetal Doppler Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: 85 KNG Dated: September 19, 2002 Received: September 20, 2002

Dear Mr. Knauss:

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 Echo Sounder, Model ES-102EX, as described in your premarket notification:

Transducer Model Number

2 MHz CW Doppler Transducer, Model T2M20N8A

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Knauss

This determination of substantial equivalence is granted on the condition that prior to shipping the first . device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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 contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (800) 638-041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Mr. Colin Pollard, at (301) 594-1180.

Sincerely yours,

David C. Ingram

for N
D

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

Enclosures

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510(k) Number K_023143

Echo Sounder ES-102EX Fetal Doppler Device Name:

Indications for use:

Detection of fetal heart rate, detection of multiple pregnancies. Verify fetal heart viability following patient trauma. Display of fetal heart rate, monitor fetal heart rate during labor.

Prescription Device.

: :

Federal Law (US) restricts this device to sale by or on the order of a physician.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use YES

Over-The-Counter Use

(Per 21 CFR 801.109)

Daniel C. Lynn

(Optional Format 1-2-96)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

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Regulation Number and Section

§ 884.2660 Fetal ultrasonic monitor and accessories.

(a)
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.(b)
Classification. Class II (performance standards).