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K Number
K955772
Device Name
CLINICARE STERILE DISPOSABLE SYRINGE/NEEDLES
Manufacturer
TTK BIOMED, LTD.
Date Cleared
1996-07-08

(200 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

The Clinicare Sterile Disposable Syringes and Needles are intended to be used for general purpose injections.

Device Description

The Clinicare Needles and Syringes comply with: ISO 7886, Sterile Hypodermic Syringes for Single Use; ISO 7864. Sterile Hypodermic Needles for Single Use; ISO 594, Conical Fitting with a 6% (Luer) Paper for Syringes, Needles and Certain Other Equipment; ISO 9626 Stainless Steel Needle Tubing for Manufacture of Medical Devices; and, ISO 6009, Hypodermic Needles for Single Use. The sterile disposable syringes are made with prolypropylene. The needles are made from thin walled SS304 capillary tubes. The rubber gaskets are made from natural rubber. The barrels are lubricated with Polydimethyl Silicone.

AI/ML Overview

This 510(k) summary describes a submission for Clinicare Sterile Disposable Syringes, Sterile Disposable Syringes With Needles, and Sterile Disposable Needles. It does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The document is a regulatory submission intended to demonstrate substantial equivalence to predicate devices, not a study report detailing performance against specific acceptance criteria. It focuses on:

  • General Information: Submitter and device names, classification.
  • Predicate Devices: Lists Becton, Dickinson & Company products.
  • Description of Device: States compliance with relevant ISO standards (ISO 7886, ISO 7864, ISO 594, ISO 9626, ISO 6009) and material composition (polypropylene, SS304 capillary tubes, natural rubber, polydimethyl silicone lubricant).
  • Intended Use: General purpose injections.
  • Technological Characteristics & Tests for Substantial Equivalence: States "None," implying the device is substantially equivalent to predicates without requiring new technological characteristics or specific performance tests for this particular submission type.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study design, sample sizes, expert involvement, or ground truth, as this information is not present in 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).