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K Number
K972536
Device Name
SYRINGE NEEDLE REMOVER (S.N.R.)
Manufacturer
POST MEDICAL, INC.
Date Cleared
1997-08-15

(68 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

For the disposal of medical sharps in health care facilities and home use.

Device Description

Not Found

AI/ML Overview

This looks like a 510k clearance letter for a medical device (Syringe Needle Remover (S.N.R.)) from 1997. The document primarily focuses on the regulatory approval and does not contain details about acceptance criteria or a study proving device performance in the way modern AI/ML device submissions do. Such detailed performance studies were not typically required or documented in this format for 510(k) submissions in 1997 for this type of device.

Therefore, most of the requested information cannot be found in the provided text.

Here's what can be extracted and a clear indication of what's missing:

  1. A table of acceptance criteria and the reported device performance:

    • Acceptance Criteria: Not specified in this document. For a Syringe Needle Remover, acceptance criteria would typically relate to its effectiveness in removing needles, preventing accidental sticks, and safe containment.
    • Reported Device Performance: Not reported in this document.

  2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

    • Not applicable/Not provided. This document is a regulatory clearance letter, not a study report.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

    • Not applicable/Not provided. This document does not describe a study involving expert-established ground truth.

  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    • Not applicable/Not provided.

  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 applicable. This is a mechanical device, not an AI/ML diagnostic tool.

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • Not applicable. This is a mechanical device, not an AI/ML algorithm.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    • Not applicable/Not provided.

  8. The sample size for the training set:

    • Not applicable. This is a mechanical device, not an AI/ML model that undergoes training.

  9. How the ground truth for the training set was established:

    • Not applicable.

Summary based on the provided document:

The provided document is a 510(k) clearance letter from the FDA for a non-AI/ML medical device, the "Syringe Needle Remover (S.N.R.)". The letter confirms that the device is "substantially equivalent" to predicate devices already on the market. It does not contain information about specific performance acceptance criteria or detailed study results that would typically be associated with modern AI/ML device submissions. The "study that proves the device meets the acceptance criteria" is not described in this regulatory clearance letter.

§ 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).