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K Number
K992664
Device Name
TFX MEDICAL STYLET CATHETER
Manufacturer
TFX MEDICAL GROUP
Date Cleared
2000-04-13

(248 days)

Product Code
DRB
Regulation Number
870.1380
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This product is intended for use in conjunction with catheters or other devices, which require the aid of a stylet to render it stiff for placement.

Device Description

The TFX Medical Hydrophilic Coated or Uncoated Stylet consists of a hub which is bonded to the flexible stainless steel shaft.

AI/ML Overview

This 510(k) submission (K992664) for the TFX Medical Coated Catheter Stylet focuses on demonstrating substantial equivalence to a predicate device rather than providing a study with acceptance criteria and measured performance.

Therefore, this document does not contain the requested information regarding acceptance criteria and a study that proves the device meets those criteria.

The submission is for a Class II medical device, and the FDA's clearance is based on the finding of "substantial equivalence" to a legally marketed predicate device (Lake Region Stylet), meaning the basic features, designs, and intended uses are the same, and the differences raise no new issues of safety and effectiveness.

To directly answer your request based on the provided text, the following information is NOT available:

  1. A table of acceptance criteria and the reported device performance: Not present.
  2. Sample size used for the test set and the data provenance: No test set is described.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No test set or ground truth described.
  4. Adjudication method: Not applicable as no test set is described.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not performed or reported.
  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
  7. The type of ground truth used: Not applicable as no study data is presented.
  8. The sample size for the training set: Not applicable as no study data is presented.
  9. How the ground truth for the training set was established: Not applicable as no study data is presented.

§ 870.1380 Catheter stylet.

(a)
Identification. A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.(b)
Classification. Class II (performance standards).