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K Number
K180253
Device Name
Sheridan Endobronchial Tubes
Manufacturer
Teleflex Medical
Date Cleared
2018-11-02

(276 days)

Product Code
CBI
Regulation Number
868.5740
Type
Traditional
Panel
AN
Reference & Predicate Devices
K141888
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SHERIDAN® Endobronchial Tube is intenced for use in thoracic surgery, bronchospirometry, administration of Endobronchial anesthesia and other uses commonly requiring Endobronchial intubation. The SHERIDAN® Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.

Device Description

The Sheridan Endobronchial Tube is a sterile, single patient use PVC Double-Lumen Endobronchial Tube (also referred to as a DLT) that is inserted into the trachea via the mouth in order to selectively ventilate one lung.

AI/ML Overview

I am sorry, but based on the provided text, I cannot provide the requested information. The text describes a 510(k) premarket notification for a medical device (Sheridan Endobronchial Tubes) and focuses on demonstrating substantial equivalence to a predicate device.

The document does not contain information about:

  1. A table of acceptance criteria and reported device performance for a study. Instead, it lists general tests performed (e.g., 15mm machine end Connector separation strength, Cuff resting diameter, Cuff herniation, Cuff Burst Evaluation, Cuff Bond Strength, Side arm bonding strength) and their principles, but no specific acceptance criteria or quantitative performance results are provided.
  2. Sample size used for a test set.
  3. Data provenance (country of origin, retrospective/prospective).
  4. Number of experts or their qualifications for establishing ground truth.
  5. Adjudication method.
  6. Multi-reader multi-case (MRMC) comparative effectiveness study.
  7. Standalone (algorithm-only) performance. The device described is a physical medical device, not an AI algorithm.
  8. Type of ground truth used.
  9. Sample size for a training set. Once again, this is a physical device, and the concept of a "training set" for an AI algorithm does not apply.
  10. How the ground truth for the training set was established.

The document primarily focuses on comparing the proposed device's features, intended use, technology, and materials to a predicate device to establish substantial equivalence under the FDA's 510(k) pathway. It mentions "Non-clinical Comparative Performance Testing" but only lists types of tests, not the results or acceptance criteria that would allow for the detailed answers requested.

§ 868.5740 Tracheal/bronchial differential ventilation tube.

(a)
Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.(b)
Classification. Class II (performance standards).