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K Number
K982018
Device Name
LIGHT SABER ASPIRATION NEEDLE
Manufacturer
MINRAD, INC.
Date Cleared
1998-08-07

(60 days)

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

Single use disposable aspiration needle to attach to a syringe to inject fluids into, or retract fluids from the body

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device called "Light Saber™ Aspiration Needle." It primarily states that the device has been found substantially equivalent to a predicate device and can therefore be marketed.

The letter does not contain details about:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes used for any test set or data provenance.
  • The number or qualifications of experts used to establish ground truth.
  • Any adjudication methods.
  • Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
  • Whether standalone (algorithm only) performance was done.
  • The type of ground truth used.
  • The sample size for the training set.
  • How the ground truth for the training set was established.

Therefore, I cannot fulfill your request with the given input.

§ 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).