Search Results

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.

Ask a specific question about this device