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K Number
K980768
Device Name
VACUETTE HOLDEX
Manufacturer
GREINER MEDITECH, INC.
Date Cleared
1998-04-09

(41 days)

Product Code
FMI
Regulation Number
880.5570
Type
Traditional
Panel
HO
Reference & Predicate Devices
K921520
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

To be used in routine venipuncture procedures using butterfly needles and/or hypodermic luer needles.

Device Description

The VACUETTE® Holdex® Holder is a single-use disposable plastic device to be used in routine venipuncture procedures using butterfly needles or luer needles. Sterile and non-sterile versions are available. The sterile version of VACUETTE® Holdex® is manufactured from polystyrene plastic and is sterilized by electronic beam. The non-sterile version is autoclavable and is manufactured from polycarbonate plastic.

AI/ML Overview

The provided text is a 510(k) summary for the Greiner VACUETTE® Holder and the FDA's response letter. It does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device (Becton Dickinson's VACUTAINER® Brand holder). This means it's a regulatory submission to show the new device is as safe and effective as a device already legally marketed, rather than a report on specific performance testing against pre-defined acceptance criteria.

Therefore, I cannot provide the requested information based on the input text. The text does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for a test set or data provenance.
  3. Number of experts or their qualifications for establishing ground truth.
  4. Adjudication method.
  5. Information on a multi-reader, multi-case comparative effectiveness study.
  6. Information on standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 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).