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K Number
K041869
Device Name
SELF RETAINING BICANALICULUS INTUBATION SET
Manufacturer
FCI OPHTHALMICS, INC.
Date Cleared
2004-11-18

(132 days)

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

Bicanalicular intubation is indicated in treatments of epiphora in adults (not to be used in infants), particularly in cases of:

  • Meatic pathologies (meatic atresia)
  • Canalicular pathologies (canalicular stricture)
Device Description

Self-Retaining Bicanaliculus Intubation Set

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device (Self-Retaining Bicanaliculus Intubation Set). It confirms "substantial equivalence" to a legally marketed predicate device, allowing it to be marketed.

However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The document is purely a regulatory letter stating that the device has been cleared for market based on substantial equivalence. It does not include the technical details of any performance testing or clinical studies that might have been submitted to support that equivalence.

Therefore, I cannot fulfill your request for the specific information about acceptance criteria and study details based on the provided text.

N/A