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K Number
K142467
Device Name
IntelAir Nasal Airway Support System
Manufacturer
ABEON MEDICAL CORPORATION
Date Cleared
2014-11-24

(82 days)

Product Code
CCK
Regulation Number
868.1400
Type
Special
Panel
AN
Reference & Predicate Devices
K131506
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The device is indicated for use in patients requiring supplemental oxygenation, patients requiring capnographic monitoring, and patients requiring non-definitive airway support. To be used in one or any combination of the preceding circumstances.

Device Description

The subject device is a non-sterile, single-use airway support system that is intended to support airway patency, aid in supplemental oxygen delivery and assist in respiratory gas sample collection for capnogrpahy. The device consists of an airway tube, accessory tubes, and in some versions a magnetic securement system.

AI/ML Overview

The provided text does not contain information about acceptance criteria for device performance or a study demonstrating that the device meets such criteria. The document is a 510(k) premarket notification approval letter for the IntelAir Nasal Airway Support System, indicating that the device is substantially equivalent to a predicate device. While it mentions performance data related to biocompatibility and mechanical testing, it does not describe specific acceptance criteria (e.g., in terms of sensitivity, specificity, accuracy, or other performance metrics) against which the device's functional performance was measured.

The "Performance Data" section briefly lists the types of tests performed (biocompatibility and mechanical testing) but does not provide results, acceptance thresholds, or details about how these tests "prove" the device meets specific performance criteria relevant to its intended function (supplemental oxygenation, capnographic monitoring, airway support).

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size, data provenance, number/qualifications of experts, or adjudication method for a test set.
  3. Information on MRMC comparative effectiveness studies or standalone performance.
  4. Details about the type, sample size, or establishment of ground truth for training data.

§ 868.1400 Carbon dioxide gas analyzer.

(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).