(15 days)
The TERASON™ ECHO/t3000 Ultrasound System with Stress Echo is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use a tabulated in Section 4.3 of this submission.
The TERASON™ ECHO/t3000 Ultrasound System with Stress Echo comprises two versions of the TERATECH Model 2000 Imaging System introduced under K051334.
The provided text is a 510(k) summary for the TERASON™ Ultrasound System with Continuous Wave (CW) Doppler. It describes the device, its intended use, and the basis for substantial equivalence to predicate devices, but does not contain information about specific performance acceptance criteria or a study proving the device meets those criteria.
Instead, the document primarily focuses on:
- Device Description: Comparing the TERASON™ Echo/t3000 to the TERATECH 2000, highlighting features like CW Doppler, ECG Trigger, Tissue Doppler, LV Dyssynchrony Assessment, and Stress Echo.
- Intended Use: A detailed table outlining clinical applications and modes of operation for various transducers (AcuNav 8F & 10F, 4V2, UST-534, V5Ms).
- Substantial Equivalence: Stating that the Stress Echo function is substantially equivalent to the Acuson Cypress Ultrasound, and that the device will be marketed with previously cleared transducers from Acuson and Aloka.
- FDA Clearance Letter: Confirming the FDA's review and determination of substantial equivalence.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment as it is not present in the provided text. The document is an FDA 510(k) summary, which typically focuses on demonstrating equivalence to legally marketed predicate devices rather than detailing independent performance studies against specific acceptance criteria.
§ 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.