FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The gel cap is intended for use as an ultrasound coupling medium for use with the Site-Rite Prevue® Ultrasound System. The device is intended for use with pediatrics and adults.

The needle guides are intended to provide guidance for a needle to intersect an ultrasound beam at a fixed distance below the skin to assist the medical practitioner in placing the tip of a needle in a specific structure. This device is intended for use with pediatrics and adults.

Device Description

The Site~Rite Prevue® Ultrasound System is a portable device that features real-time 2D ultrasound imaging. Additional features include compact size, simple user interface, and various calculations. The system may incorporate various accessories, including an upright stand, A/C adapter, needle guide/gel cap kits, etc. The system includes USB support for storage devices with no external power connections (eg., USB flash drive).

The Site~Rite Prevue® Ultrasound System is a portable device that features real-time 2D ultrasound imaging. Additional features include compact size, and simple user interface. The system may incorporate various accessories, including an upright stand, A/C adapter, needle guide, etc. The system includes USB support for storage devices with no external power connections (e.g., USB flash drive).

The Site~Rite Prevue+® Ultrasound System is a portable device that features real-time 2D ultrasound imaging. Additional features include compact size and a simple user interface. The system may incorporate various accessories, including an upright stand, A/C adapter, needle guide, etc. The system includes USB support for storage devices with no external power connections (eq., USB flash drive).

AI/ML Overview

The provided text is a 510(k) Summary for the Site-Rite Prevue® Ultrasound System and the Site-Rite Prevue+® Ultrasound System. It details aspects of the device's design, indications for use, and a comparison to a predicate device.

However, the document does not contain the specific information required to answer your request about acceptance criteria and a study proving the device meets the acceptance criteria. This type of detailed study information, including specific performance metrics, sample sizes for test/training sets, expert information, and adjudication methods, is typically found in the full 510(k) submission, not in the summary document. The summary only broadly states that "Verification and validation activities were designed and performed to demonstrate that the subject Site~~Rite Prevue® Ultrasound System and the Site~~Rite Prevue+® Ultrasound System met predetermined performance specifications" and "The subject devices met all pre-determined acceptance criteria."

Therefore, I cannot provide the requested table and detailed study information based on the provided text. The document refers to compliance with various medical device standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, NEMA UD 2-2004), which outline general requirements for safety and performance, but it does not specify device-specific acceptance criteria or the study results that demonstrate these criteria were met.

Summary

Regulation Number and Section

§ 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.