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K Number
K963658
Device Name
EXEL AVF SINGLE NEEDLE
Manufacturer
EXEL INTL.
Date Cleared
1998-05-05

(609 days)

Product Code
FMI
Regulation Number
880.5570
Type
Traditional
Panel
General Hospital
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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

Device Description

EXEL SINGLE NEEDLE AVF

AI/ML Overview

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.

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).