(90 days)
Detection of fetal heartbeat from early gestation thru delivery. Verify fetal heart viability after patient trauma. Display of fetal heart rate.
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.
The provided text is a 510(k) submission for the SONOTRAX Ultrasonic Pocket Doppler. It describes the device, its intended use, and its equivalence to predicate devices, but it does not include a study or specific acceptance criteria with reported device performance results in the format requested.
Here's an analysis of the provided information relative to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as quantifiable performance metrics with thresholds in the provided text. The submission broadly states the device "meets all of its functional requirements and performance specifications" and "complies with applicable industry and safety standards."
- Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy for fetal heart tone detection) are reported. The submission indicates "various performance tests" were done but doesn't detail their outcomes.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable, as there's no mention of a test set with ground truth established by experts.
- Qualifications: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable, as no test set with ground truth is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No, there is no mention of a MRMC comparative effectiveness study.
- Effect Size of Human Readers Improvement: Not applicable, as no such study was conducted or reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The device itself is a standalone ultrasonic fetal doppler. However, the submission does not report specific standalone algorithm performance metrics in the context of AI, as this device predates widespread AI application in medical devices. The "performance tests" mentioned relate to the device's functional operation.
7. The Type of Ground Truth Used:
- Ground Truth: Not explicitly defined or used in the context of a performance study demonstrating accuracy against a established truth (like pathology or clinical outcomes). The "Test Data" section refers to "safety, performance testing and validations," implying internal testing against design specifications and industry standards, not against a clinical ground truth for diagnostic accuracy.
8. The Sample Size for the Training Set:
- Sample Size: Not applicable. This device is a hardware device based on the Doppler principle, not an AI/machine learning algorithm requiring a "training set."
9. How the Ground Truth for the Training Set was Established:
- Ground Truth Establishment: Not applicable, as there is no training set for this type of device.
In summary:
The 510(k) submission for the SONOTRAX Ultrasonic Pocket Doppler focused on demonstrating substantial equivalence to predicate devices based on similar device characteristics, indications for use, and a review of safety and performance testing. It does not provide the detailed performance study information with quantifiable acceptance criteria, sample sizes, expert ground truth establishment, or AI-related metrics that you requested. Such detailed performance studies, particularly in a structured, quantitative manner, became more common and expected in later regulatory submissions, especially for software as a medical device (SaMD) and AI-powered devices.
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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
-
- 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: 86 755 26062059 86 755 26062022 Fax; Responsible person: Xie Xicheng
- Submitters name, address, phone number, contact person and preparation date:
Official Correspondent:
William Stern Multigon Industries, Inc. 1 Odell Plaza Yonkers, N.Y. 10701 Phone: 914 376 5200 x27 Fax: 914 376 5565
Date of Preparation: 2/19/04
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- 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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- Classification Names :
Class II as per 21CFR 884-2660, Fetal Ultrasonic Monitor and accessories.
- Classification Names :
-
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.
-
- 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.
- Indications for use:
-
- Contra-indications:
None known at this time.
- Contra-indications:
-
- 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.
-
- 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.
- Literature Review:
-
- 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.
- Conclusions:
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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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (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 (800) 638-2041 or (301) 443-6597 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)
، ،
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. bivadon
ive, Abdominal, Division of Reproduct and Radiological D 510(k) Number
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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).