(88 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows.
Clinical Applications: Opthalmic, Fetal, Abdominal, Adult Cephalic, Cardiac Adult.
Mode of Operation: B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (B+M, B+M+Color (CVI), B+PW), Harmonic Imaging of tissue, Harmonic Imaging of contrast agents.
Functionality: No change. Design cleared with K964309 has the ability to perform harmonic imaging of tissue.
Scientific Concepts: Use of harmonic imaging reduces clutter in the image. Clutter exists in images of difficult to image patients. It therefore follows that reducing clutter if it exists will improve 2D/ B-mode image quality.
Significant Characteristics of the Modification: This submittal is being done solely for the purpose of allowing FDA to review claims of effectiveness.
Significant Safety Concerns: None. Harmonic Imaging of tissue is being done today with several systems already the market.
The provided text is a 510(k) summary for the HP Sonos 5500 Ultrasound Imaging System with a Harmonic Tissue Imaging Option. It focuses on demonstrating substantial equivalence to predicate devices and describes the intended use and scientific concepts behind the harmonic imaging feature. However, it does not contain any information about acceptance criteria, specific device performance metrics, study designs (sample sizes, data provenance, expert qualifications, adjudication methods), or ground truth establishment.
Therefore, I cannot fulfill your request for the detailed table and study information because the necessary data is not present in the provided document.
The document only states:
- Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body, with Harmonic Imaging of tissue being a "new indication" (N) with this submittal.
- Scientific Concept: "Use of harmonic imaging reduces clutter in the image. Clutter exists in images of difficult to image patients. It therefore follows that reducing clutter if it exists will improve 2D/ B-mode image quality."
- Study Type: "This submittal is being done solely for the purpose of allowing FDA to review claims of effectiveness." However, it does not detail how effectiveness was "proven" with specific performance metrics or studies. It relies on the substantial equivalence to predicate devices that already perform harmonic imaging.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.