(57 days)
The SONOLINE 7XX ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal. Superficial Musculoskeletal, and Peripheral Vascular applications. The addition of THI Imaging will not add new indications for use to the 7XX.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
The SONOLINE 7XX is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire ultrasound data and display it in B-Mode, M-Mode, Color Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, or in a combination of modes, on a CRT display.
The provided text describes a 510(k) premarket notification for the addition of Tissue Harmonic Imaging (THI) to the Siemens SONOLINE 7XX Diagnostic Ultrasound System. However, it does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance.
Instead, the document focuses on:
- Establishing substantial equivalence: The primary goal of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This is achieved by comparing the new device's technological characteristics and intended uses to those of existing cleared devices.
- Listing intended uses: The document details the clinical applications for which the SONOLINE 7XX system (with and without THI) is intended.
- Safety standards: It lists various product safety standards that the SONOLINE 7XX has been designed to meet.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance because that data is not present in the provided text.
The tables within the document relate to the Indications for Use for different transducers with the SONOLINE Versa Family (including the 7XX) and explicitly state whether Tissue Harmonic Imaging (THI) is a "new indication" (N), "previously cleared" (P), or "added under Appendix E" (E) for each clinical application. This is about regulatory clearance for specific uses, not performance metrics or clinical study results demonstrating performance against 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.