(530 days)
The Explorer CVS device is intended to be used to produce images of peripheral and intracranial vasculature to be analysed by trained medical personnel for assessment and diagnosis of vascular status and disorders.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Neonatal Cephalic (PWD); Peripheral Vascular (PWD, CWD)
Adult Cephalic (B, M)
Intravascular (PWD, CWD); Peripheral Vascular (PWD, CWD)
Intravascular (CWD); Peripheral Vascular (PWD, CWD)
The Explorer CVS device is a diagnostic ultrasonic Doppler. The Explorer CVS Doppler device utilizes multiple frequencies of transducers to provide high resolution images.
The provided text is a 510(k) summary for the Explorer CVS Transcranial and Peripheral Vascular Doppler device. It does not contain information about acceptance criteria or specific study results demonstrating the device meets those criteria.
Instead, the document details:
- Manufacturer and contact information
- Device classification and proprietary name
- Substantial equivalence to predicate devices
- Device description and intended use
- Technological characteristics
- FDA's letter of clearance, including a condition for submitting a post-clearance special report on acoustic output measurements
- Indications for use forms for different transducers (2 MHz PW-Doppler, 4 MHz CW/PW-Doppler, and 8 MHz CW/PW-Doppler)
Based on the provided text, I cannot complete the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert ground truth establishment, or MRMC studies. The document only specifies the intended use and modes of operation for various clinical applications, indicating what the device is cleared to do, not how its performance was measured against quantitative criteria.
§ 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.