(16 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal - OB/GYN, Abdominal, Intra-operative (Abdominal organs and vascular), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (breast, thyroid, testicles.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Musculo-skel. (Conventional), Musculo-skel. (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel.
Typical examinations performed using the SonoSite High-Resolution Ultrasound System (C3 Series) are: Abdominal Imaging Applications, Cardiac Imaging Applications, Gynecology and Infertility Imaging Applications, Interventional and Intraoperative Imaging Applications, Obstetrical Imaging Applications, Pediatric and Neonatal Imaging Applications, Prostate Imaging Applications, Superficial Imaging Applications, Vascular Imaging Applications.
The system includes the ability to measure the intima-media thickness (IMT) of the carotid artery using digital ultrasound images. The IMT measurement of the carotid artery may be used adjunctively with other medical data obtained by a physician to help assess the cardiovascular health of a patient.
The SonoSite High-Resolution Ultrasound System (C3 Series) is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display highresolution, real-time ultrasound data in 2D, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, and Velocity Color Doppler or in a combination of these modes.
The System has an electrocardiography (ECG) display feature and supports a 3-lead ECG cable assembly to collect data for M-mode and Doppler measurements. The System provides measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The System has a PW and CW Doppler audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities.
The system includes the ability to measure the intima-media thickness (IMT) of the carotid artery using digital ultrasound images. The IMT measurement of the carotid artery may be used adjunctively with other medical data obtained by a physician to help assess the cardiovascular health of a patient.
The system includes Digital Imaging and Communications (DICOM) capabilities as well as general computer communication capabilities to provide the acceptance, transfer, display, storage, and digital processing of ultrasound images and loops. Security support is also provided to facilitate HIPAA compliance.
The SonoSite High-Resolution Ultrasound System (C3 Series) is designed to accept curved or linear transducers of the types and frequency listed in the table below. All actions affecting the performance of the transducer are activated from the main system control panel.
The provided text describes the SonoSite High-Resolution Ultrasound System (C3 Series) and its transducers. However, it does not include information about specific acceptance criteria or a study that proves the device meets acceptance criteria in the manner requested (e.g., performance metrics, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness study details).
Instead, the document focuses on:
- 510(K) Summary of Safety and Effectiveness: This section aims to demonstrate substantial equivalence to legally marketed predicate devices, not necessarily to provide detailed performance metrics against specific acceptance criteria.
- Device Description: Outlines the functionalities and features of the ultrasound system.
- Intended Use: Lists the clinical applications for which the system is designed.
- Technological Characteristics: Describes the device's operating principles and acoustic output limits, which conform to standards rather than setting specific acceptance criteria for diagnostic accuracy or performance.
- Transducer Model Numbers and Indications for Use: Provides tables detailing which transducers are cleared for specific clinical applications and modes of operation.
Therefore, based solely on the provided text, I cannot complete the requested information regarding acceptance criteria and a study proving the device meets them because such details are not present in this 510(k) summary.
The document states that the device conforms to certain standards and that its acoustic output limits are the same as predicate Track 3 devices (e.g., ISPTA, TI, MI limits). However, these are technical specifications and compliance statements, not performance acceptance criteria linked to a validation study.
To answer your request, a different type of document, such as a detailed clinical validation study report or a more comprehensive performance specification document, would be needed.
§ 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.