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K Number
K013293
Device Name
NIPRO HYPODERMIC NEEDLE
Manufacturer
NIPRO MEDICAL CORP.
Date Cleared
2001-12-14

(73 days)

Product Code
FMI
Regulation Number
880.5570
Type
Traditional
Panel
HO
Reference & Predicate Devices
K944355
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Nipro® Hypodermic Needle is intended to be used to inject fluids into or withdraw fluids from parts of the body below the surface of the skin.

Device Description

The devices that we intend to market are hypodermic needles as described in 21 CFR 880.5570. Two types of hypodermic needles will be available: types L (long) and S (short). Type L hypodermic needles are 11/2 to 11/2 inches long and Type S needles 74 to 1 inch long.

AI/ML Overview

I am sorry but the provided text does not contain detailed information about acceptance criteria, study methodologies, or performance results for the Nipro Hypodermic Needle. The documents provided relate to its 510(k) premarket notification and substantial equivalence to a predicate device, which focuses on regulatory approval rather than a detailed performance study as you described.

Therefore, I cannot fulfill your request for:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes for test sets or their data provenance.
  • Number and qualifications of experts for ground truth.
  • Adjudication methods.
  • MRMC comparative effectiveness study results.
  • Standalone performance details.
  • Ground truth type.
  • Training set sample size or ground truth establishment for the training set.

The document primarily states that the Nipro Hypodermic Needle is "similar in design, technical, performance, and biological characteristics" to a legally marketed predicate device (K944355) and is intended for injecting or withdrawing fluids under the skin. It does not provide the specific study details you are asking for.

§ 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).