(98 days)
The General Purpose ATL Needle Guide Kit consists of accessories for the Model ATL C3 Scanhead which are used for guiding a needle or catheter during a diagnostic ultrasound procedure in order to perform a biopsy or precise needle placement. The subject device is to be used only for those indications which have been FDA-cleared for the Model ATL C3 Scanhead (consult transducer manual).
General Purpose ATL Needle Guide Kit for use with ATL Ultrasound Transducers
The provided document is a 510(k) clearance letter from the FDA for a General Purpose Needle Guide Kit. It is a regulatory document and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot extract the requested information from this document.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.