(15 days)
The HDI 5000 system and transducers are intended for diagnostic ultrasound imaging and fluid flow analysis of the human body.
The HDI 5000 system and transducer(s) function in a manner identical to all diagnostic ultrasound systems and transducers. The system circuitry generates an electronic voltage pulse which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The Doppler functions of this system process the Doppler shift frequencies from the echoes of moving targets (such as blood), to detect and graphically display the Doppler shifts of these tissues as flow. The HDI 5000 system gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis.
The provided document is a 510(k) Summary for the Philips HDI 5000 Diagnostic Ultrasound System. It details the device's technical characteristics and its substantial equivalence to predicate devices. However, this document does not contain acceptance criteria or a study proving the device meets specific performance criteria in the format requested.
The document focuses on:
- Substantial Equivalence: It asserts that the HDI 5000 system is substantially equivalent in safety and effectiveness to previously cleared ultrasound systems. This means it functions in a similar manner and uses comparable technologies, rather than demonstrating performance against specific clinical metrics.
- Intended Use: It lists the various clinical applications for which the device and its transducers (3D6-2 Trans-Abdominal Broadband Curved Array and C8-4v/8.0-4.0 MHz/11mm Curved Array) are intended, along with the supported modes of operation.
- Technical Information: It briefly describes how the ultrasound system works (generating electronic pulses, converting to ultrasonic waves, processing Doppler shifts).
- Compliance: It states that the systems have acoustic output levels below FDA limits and are manufactured with safe materials, designed to applicable electrical and physical safety standards.
Therefore, I cannot extract the requested information regarding acceptance criteria and performance study details from this document. The information typically associated with such a request (like specific performance metrics, sample sizes, ground truth establishment, expert qualifications, or MRMC studies) is not present in this 510(k) summary, which instead focuses on demonstrating equivalence to predicate devices.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.