(15 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal (Mode of Operation: CWD)
Not Found
This document is a 510(k) clearance letter for the BabyBeat Cordless fetal ultrasonic monitor and accessories, issued by the FDA in 2006. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter acknowledges that the device is substantially equivalent to legally marketed predicate devices and therefore can be marketed, subject to general controls provisions of the Act and additional controls for Class II devices.
The only specific requirement mentioned that relates to performance is a postclearance special report that must 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." The letter states that if this report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply.
However, this is a post-market requirement for production units, not a pre-market study designed to define or meet specific acceptance criteria for performance metrics. The document does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication method for test set.
- MRMC comparative effectiveness study.
- Standalone performance study results.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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).