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K Number
K102127
Device Name
ENDOTRACHEAL TUBE CHANGERS
Manufacturer
INSTRUMENTATION INDUSTRIES, INC.
Date Cleared
2010-08-27

(29 days)

Product Code
LNZ
Regulation Number
868.5730
Type
Special
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. This device is intended for sale by or on the order of a physician.

Device Description

The JEM Series Endotracheal Tube Changer consists of an extruded open lumen, imprinted with graduated markings. The graduated markings are used as a guide for the successful replacement of a tracheal tube.

AI/ML Overview

The provided text is a 510(k) Summary for JEM Endotracheal Tube Changers. It describes the device, its intended use, and the purpose of the 510(k) submission, which is to add ethylene oxide as an alternate sterilization method and to expand the user instructions.

However, the provided document does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.

The document is a Special 510(k) submission, which means it addresses minor changes to a previously cleared device. In such a submission, the focus is typically on demonstrating that the changes do not alter the substantial equivalence of the device, rather than conducting new performance studies against acceptance criteria for the core functionality. The original PMS submission (Premarket Approval of the JEM 400 in 1981) would have contained such data, but it is not included in this document.

Therefore, I cannot provide the requested information from the given text.

Specifically, the document does not contain:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set or data provenance.
  3. Number of experts or their qualifications for ground truth establishment.
  4. Adjudication method.
  5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
  6. Information about a standalone algorithm performance study.
  7. The type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 868.5730 Tracheal tube.

(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).