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K Number
K970997
Device Name
NEO-CARE LUMBER PUNCTURE KIT
Manufacturer
KLEIN-BAKER MEDICAL, INC.
Date Cleared
1997-05-22

(64 days)

Product Code
MIA
Regulation Number
868.5150
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

A single use, disposable, lumbar puncture kit for collection and sampling of spinal fluid from Neonatal patients.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for the Neo-Care Lumbar Puncture Kit. It is not a study report or a summary of a study that establishes acceptance criteria and reports device performance against those criteria. Therefore, most of the requested information cannot be extracted from this document.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the device's clearance is based on substantial equivalence to a predicate device, rather than a standalone study demonstrating performance against predefined acceptance criteria. The FDA reviews the provided information to ensure the new device is as safe and effective as a legally marketed predicate device.

Therefore, the following information cannot be provided based on the given text:

  • A table of acceptance criteria and the reported device performance
  • Sample sizes used for the test set and the data provenance
  • Number of experts used to establish the ground truth for the test set and their qualifications
  • Adjudication method for the test set
  • Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size
  • Whether a standalone (algorithm only) performance study 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

The only piece of relevant information provided is the Indications for Use:

Indications for Use: A single use, disposable, lumbar puncture kit for collection and sampling of spinal fluid from Neonatal patients.

§ 868.5150 Anesthesia conduction needle.

(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).