(149 days)
BR-FHUS Navigation 1.0 is intended as a standalone software device installed on a standalone windows-based computer to assist physicians with tools for electromagnetic tracking of instruments in respect of breast ultrasound images generated from FDA cleared handheld ultrasound devices. The device is not intended to be used in the environment of strong magnetic or electromagnetic fields, such as in Magnetic Resonance Imaging (MRI) room. BR-FHUS Navigation 1.0 is indicated for use as an adjunct to handheld breast ultrasound to assist the physicians in their scanning process. The scanning paths are displayed on a route map and provide quality control of scanning to provide an overall observation of scanning process.
BR-FHUS Navigation 1.0 is a standalone software device installed on a standalone windows-based computer. It requires an off-the-shelf PC computer, computer user interface (keyboard, mouse, display), off-the-shelf image capture device (PCI frame grabber card or USB frame grabber device), and an off-the-shelf 3D electromagnetic tracking system (Ascension Technologies). The system includes software for Position Sensor Monitoring, Image presentation and recording, and user interface, and hardware including a Position Sensor Clip (electromagnetic), Sensor Transmitter, and Control Computer.
The provided text describes the BR-FHUS Navigation 1.0 device and its substantial equivalence to a predicate device, the Tractus TissueMapper Image Recording System. However, the document does not contain detailed acceptance criteria or a specific study proving the device meets quantitative acceptance criteria beyond a general statement of "in specification."
Here's a breakdown of the information that can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria: The document does not explicitly state specific quantitative acceptance criteria for performance metrics. It only generally states that "all functional requirements have been met" and "core functions execute as expected."
Reported Device Performance: The document does not provide numerical results for device performance. It only states: "The result of these tests demonstrates that BR-FHUS Navigation 1.0 validation is with in specification. As such, BR-FHUS Navigation 1.0 is as safe and effective as the predicate devices and is substantially equivalent to existing products on the market today." And "In all instances, BR-FHUS Navigation 1.0 functioned as intended and the operation observed was as expected."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in quantitative terms (e.g., accuracy +/- X mm, error rate |
§ 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.