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K Number
K990371
Device Name
DIABETIC NEEDLE DISPOSAL, MODEL # PMSM - 950
Manufacturer
POST MEDICAL, INC.
Date Cleared
1999-04-21

(72 days)

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

The Diabetic Needle Syringe Disposal (D.N.D.) is to be used by the diabetic patient at home for the collection of contaminated disposable sharps at the point of use.

Device Description

Diabetic Needle Syringe Disposal (D.N.D)

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for a "Diabetic Needle Syringe Disposal (D.N.D.)" device, stating that it is substantially equivalent to a legally marketed predicate device.

It details:

  • The device name and model number (PMSM - 950)
  • Regulatory class (II) and product code (FMI)
  • Indications for Use: "to be used by the diabetic patient at home for the collection of contaminated disposable sharps at the point of use."
  • The date of clearance (April 21, 1999)

However, it does not include:

  1. A table of acceptance criteria or reported device performance.
  2. Details about sample sizes, data provenance, or study types (retrospective/prospective).
  3. Information on experts, ground truth establishment, or adjudication methods.
  4. Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
  5. Sample sizes for training sets or how ground truth for training sets was established.

This document is a regulatory approval notice, not a detailed study report.

§ 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).