(15 days)
The CX50 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical -mode), Pulse Wave Doppler, continuous Wave Doppler, color Doppler, tissue Doppler Imaging and Harmonics (Tissue and contrast) modes. The device is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic, Intracardiac echo, Intraoperative, Laparoscopic, Fetal, Abdominal, Pediatric, Small Organ, Adult Cephalic, Neonatal Cephalic, Trans-vaginal, Musculoskeletal, Gynecological, Cardiac Adult, Cardiac pediatric, Trans-Esophogeal. (Cardiac), Peripheral Vessel, Other (Carotid).
The CX50 Diagnostic Ultrasound System is a compact, AC or battery powered, 128 -channel, cardiac ultrasound imaging system. It uses custom digital electronic and fabrication technologies to provide diagnostic ultrasound information and is housed in a portable, laptop-style chassis. The subject of this submission is the addition of new indications to Philips CX50 ultrasound system and the transducers that employ the new indications. The new indications include: ICE (intracardiac echo), Intraoperative, and Laparoscopic.
The provided 510(k) summary for the Philips CX50 Diagnostic Ultrasound System with additional indications (K123784) states that no new clinical tests were conducted for this submission. The device's safety and effectiveness are supported by non-clinical performance data and its substantial equivalence to predicate devices (Philips Healthcare HD11 Diagnostic Ultrasound System, K062247, and Philips iU22, K030455).
Therefore, there is no information in the provided text regarding acceptance criteria for a study proving the device meets those criteria, as no such study was performed or submitted as part of this 510(k) notification.
The document explicitly states:
"This release of CX50 introduces no new indications for use, modes, features, or technologies relative to the predicate devices (HD11, K062247, and iU22, K030455) that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices."
Since no new clinical tests were performed, the remaining sections of your request (sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and ground truth establishment for training set) are not applicable to the information provided in this 510(k) summary.
§ 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.