(90 days)
The Ultrasonic TableTop Doppler is intended to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices.
The 2 MHz and/or 3 MHz probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being. They can also be used to verify fetal heart viability following patient trauma.
The 4 MHz, 5 MHz and/or 8 MHz vascular probes are indicated for the detection of blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.
Ultrasonic TableTop Doppler provides the following primary features:
- Basic parameters: FHR, blood flow
- 240 seconds fetal heart sound record and playback
- Infrared communication(for SD6 only)
- Ni-MH battery for 20 hours continuous working of main unit
- Li-ion battery for 2.5 hours continuous working of SD6 probe
The provided text is a 510(k) summary for the Edan Instruments, Inc. Ultrasonic TableTop Doppler (Models SD5 and SD6). It lists device information, predicate devices, and indications for use, but does not contain information about acceptance criteria or a study proving the device meets those criteria.
The document primarily focuses on establishing substantial equivalence to previously cleared devices. It includes forms for "Diagnostic Ultrasound indications for Use" for various probes (5MHz, 4MHz, 8MHz vascular probes, and 5MHz, 4MHz, 8MHz CW wireless vascular probes), indicating their intended use for blood flow detection in peripheral vascular applications. However, these forms do not detail performance metrics, acceptance criteria, or study results.
Therefore, I cannot provide the requested information from the given text.
The following information is NOT present in the provided text:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance.
- If a standalone (algorithm only without human-in-the-loop performance) study was done.
- The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- The sample size for the training set.
- How the ground truth for the training set was established.
The document is a regulatory submission focused on establishing substantial equivalence for an ultrasonic doppler device, not a performance study report with detailed acceptance criteria and results.
§ 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).