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THIS DEVICE IS USED IN CONJUNCTION WITH A HEMO-DIALISIS MACHINE FOR BLOOD PHERESIS. THIS DEVICE IS A STERILE, SINCLE USE DEVICE.

EXEL SINGLE NEEDLE AVF

I am sorry, but the provided text, which appears to be an FDA 510(k) clearance letter for the "Excel AVF Single Needle for Blood Pheresis" device, does not contain the information required to answer your request.

The document is a regulatory communication establishing substantial equivalence for the device. It focuses on:

• Device Name: Excel AVF Single Needle for Blood Pheresis
• Manufacturer: Exel International, Inc.
• Regulatory Class: II (21 CFR 876.5540)
• Indications for Use: "THIS DEVICE IS USED IN CONJUNCTION WITH A HEMO-DIALYSIS MACHINE FOR BLOOD PHERESIS. THIS DEVICE IS A STERILE, SINGLE USE DEVICE."
• Date of Clearance: May 5, 1998

This type of document does not typically include detailed information about acceptance criteria, specific device performance studies, sample sizes, expert qualifications, adjudication methods, or AI-related aspects (like MRMC studies, standalone algorithm performance, or training set details). These details would usually be found in the manufacturer's 510(k) submission itself, not in the FDA's clearance letter.

Therefore, I cannot populate the table or answer the specific questions you've posed based on the provided text.

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