(202 days)
HeraBEAT™ US is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound. HeraBEAT™ US is indicated for use by medical professionals in clinical or home care settings for singleton pregnancies from 12 weeks gestation.
HeraBEAT™ US is a hand-held, battery powered audio Doppler device integrated with 2MHz probe, used for detecting and displaying the fetal heart rate (FHR) and FHR sound. The device uses an optical sensor to distinguish between the FHR and the maternal heart rate (MHR) to eliminate "crosstalk" in the FHR display.
HeraBEAT™ US includes the following components:
- The handheld HeraBEAT™ US device that incorporates an ultrasound transducer, rechargeable battery, and internal microcontroller and Bluetooth Low Energy (BLE) chip for wireless data transfer from the HeraBEAT™ US device to the user's smartphone.
- The HeraBEAT™ application, which is downloaded from an app store to the user's smartphone. The HeraBEAT™ application is used to communicate with the HeraBEAT™ US device using wireless BLE. It controls the operation of the device and receives the FHR values for numerical display to the user. It plays the FHR sound and stores the FHR values in a history log.
HeraBEAT™US is supplied with a battery charger (power supply), two tubes of commercially available Aquasonic 100 Ultrasound Transmission Gel (cleared under K802146), carry case and User Manual.
The HeraBEAT™ US fetal ultrasonic monitor is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound. It is indicated for use by medical professionals in clinical or home care settings for singleton pregnancies from 12 weeks gestation.
Here's an analysis of its acceptance criteria and the supporting study information:
1. Acceptance Criteria and Reported Device Performance
The document implicitly defines acceptance criteria through its comparison to the predicate device, MD800. The key performance metric is Fetal Heart Rate (FHR) measurement accuracy.
| Acceptance Criteria (Based on Predicate Device) | Reported Device Performance (HeraBEAT™ US) |
|---|---|
| FHR measuring range: 50-240 bpm (Predicate: 50-210 bpm) | FHR measuring range: 50-240 bpm |
| Accuracy: +/- 2bpm | Accuracy: +/- 2bpm |
| Resolution: 1 bpm | Resolution: 1 bpm |
| Ultrasound nominal frequency: 2 MHz | Ultrasound nominal frequency: 2 MHz |
Note: The HeraBEAT™ US has a wider FHR measuring range (240 bpm) compared to the predicate (210 bpm), which suggests an improvement or at least equivalent capability. The accuracy and resolution are identical to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for a clinical test set for FHR measurement accuracy. It mentions "Bench Performance Testing" where "Clinical measurement accuracy was conducted per the acoustic output measurement methodology as recommended in the FDA guidance document." This suggests the accuracy was validated using simulated signals or known standards in a lab environment, not necessarily a study with a test set of actual patients.
Therefore, details on data provenance (country of origin, retrospective/prospective) and the type of ground truth are not applicable as there is no described clinical test set for FHR accuracy.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document as there is no described clinical test set with human-established ground truth for FHR measurement. The accuracy was assessed against acoustic output measurement methodologies, not expert interpretation of fetal heart sounds/rates from patients.
4. Adjudication Method
This information is not provided in the document. As there is no described clinical test set involving human interpretation and ground truth establishment, adjudication methods are not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of an MRMC comparative effectiveness study in the provided document. The submission focuses on substantial equivalence based on technical characteristics and bench testing.
6. Standalone Performance Study
The document describes "Bench Performance Testing" where "Clinical measurement accuracy was conducted per the acoustic output measurement methodology as recommended in the FDA guidance document 'Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers,' dated September 9, 2008." This indicates that the device's accuracy in measuring FHR was assessed using a controlled, standalone method, likely with calibrated equipment or simulated signals, to verify its technical specifications. However, this is distinct from a clinical standalone study involving human patients.
7. Type of Ground Truth Used
For the "Bench Performance Testing" of FHR measurement accuracy, the ground truth was established by:
- Acoustic output measurement methodology per FDA guidance: This implies the use of validated standards and equipment to measure the acoustic output and resulting FHR determination, rather than expert consensus, pathology, or outcomes data from patients.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set for the HeraBEAT™ US device. Given that it's a fixed-function fetal doppler, it's unlikely to rely on typical machine learning training sets in the same way an AI-powered diagnostic image analysis tool would. Its performance is based on established signal processing and measurement principles inherent in the hardware and software design.
9. How Ground Truth for the Training Set Was Established
This information is not applicable as no training set is mentioned for the device.
§ 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).