LogoFDA 510(k) Search
K Number
K983430
Device Name
LITE-TOUCH SYRINGE
Manufacturer
MEDICORE, INC.
Date Cleared
1999-02-09

(133 days)

Product Code
FMF
Regulation Number
880.5860
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For use in hospitals, clinics, home use for the delivery of insulin to diabetics.

Device Description

Lite Touch Syringes

AI/ML Overview

The provided text is a clearance letter from the FDA for a device called "Lite-Touch Syringe." It does not contain information about the acceptance criteria, study details, or performance data of the device. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements for marketing it.

Therefore, I cannot provide the requested information based on the given input. The document does not describe:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes for test sets, data provenance, or the number/qualifications of experts for ground truth.
  • Adjudication methods.
  • MRMC comparative effectiveness studies or standalone algorithm performance.
  • Types of ground truth used.
  • Sample size for the training set or how its ground truth was established.

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).