(83 days)
GTK Disposable Needle Guides when used in conjunction with ultasound system transducer where configuration is suitable (e.g. Aloka, Alpinion, BK, Esaote, GE, Hitachi, Mindray, Philips, Toshiba, Siemens, and Shimadzu ultrasound systems) and attached to the ultrasound system's transducers, is to facilitate proper needle placement to access anatomical structures.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a device called "GTK Disposable Needle Guides." It outlines the FDA's determination of substantial equivalence to a predicate device and details regulatory requirements.
However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The letter primarily focuses on:
- The FDA's decision on market clearance based on substantial equivalence.
- Regulatory requirements for the manufacturer (registration, labeling, adverse event reporting, quality systems, etc.).
- Contact information for various FDA divisions.
- The Indications for Use statement for the device.
Therefore, I cannot provide the requested information based on the content of 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.