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K Number
K990831
Device Name
SUPERGUARD SAFETY SYRINGE
Manufacturer
U.S. SAFETY SYRINGES CO., INC.
Date Cleared
2000-03-08

(362 days)

Product Code
MEG
Regulation Number
880.5860
Type
Traditional
Panel
HO
Reference & Predicate Devices
K920321,K924072
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SuperGuard™ Safety Syringe is intended as a sterile, single use, disposable syringe, employing an antistick device, for use in the administration of intramuscular and subcutaneous injections.

Device Description

The SuperGuard ™ Safety Syringe is a piston syringe combined with a sharps Injury Prevention mechanism that shields the hypodermic needle from exposure and reuse after an initial use.

AI/ML Overview

This document is a 510(k) summary for a medical device called the SuperGuard™ Safety Syringe. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets those criteria.

Therefore, I cannot extract the requested information. The document focuses on establishing substantial equivalence based on technological characteristics and materials similarities to existing devices, rather than presenting performance data against specific acceptance criteria.

Here's a breakdown of why each requested point cannot be answered from the provided text:

  1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on comparing material and technological characteristics to predicate devices, not performance against specific criteria.
  2. Sample size used for the test set and the data provenance: Not present. No performance testing data is provided.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No ground truth establishment is described as there's no performance study detailed.
  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present. No performance study detailed.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not present. This device is a syringe, not an AI-assisted diagnostic tool, so an MRMC study is not applicable.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. Again, this is a physical device, not an algorithm.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present. No performance study detailed.
  8. The sample size for the training set: Not present. No machine learning training described.
  9. How the ground truth for the training set was established: Not present. No machine learning training described.

§ 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).