(90 days)
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.
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.
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.
§ 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).