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K Number
K110194
Device Name
MEDLINE EPIDURAL AND SPINAL NEEDLES
Manufacturer
MEDLINE, INDUSTRIES, INC.
Date Cleared
2011-06-17

(144 days)

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

This anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification approval letter for the Medline Epidural and Spinal Needles. It does not present any clinical study data or acceptance criteria for device performance.

Therefore, I cannot provide the requested information, such as:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes for test sets or training sets.
  • Data provenance or details about experts.
  • Adjudication methods.
  • MRMC study information.
  • Standalone performance.
  • Types of ground truth.

This letter solely indicates that the FDA has reviewed the device and determined it to be substantially equivalent to legally marketed predicate devices, allowing it to be marketed subject to general controls. It does not contain the detailed study results and performance metrics typically found in a clinical study report or a summary of safety and effectiveness data.

§ 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).