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K Number
K051226
Device Name
AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER
Manufacturer
Cardinal Health
Date Cleared
2005-11-17

(189 days)

Product Code
BZD
Regulation Number
868.5905
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The AirLife™ Nasal Continuous Positive Airway Pressure (nCPAP) System Driver is intended to provide CPAP for use in hospitals to treat newborns and infants with RDS or are recovering from RDS.

Device Description

The AirLife™ nCPAP System Driver (hardware) delivers a mixture of air and oxygen to provide the prescribed level of CPAP through a circuit and generator. Either a prong or mask is attached to the generator as a patient interface. The generator is held to the infant's nose by a fixation device.

AI/ML Overview

The provided text is a 510(k) summary for the AirLife™ Nasal Continuous Positive Airway Pressure (nCPAP) System Driver. This document describes a medical device and its regulatory submission, not a study that proves a device meets acceptance criteria.

Therefore, I cannot extract the requested information as the document does not contain:

  • A table of acceptance criteria and reported device performance.
  • Details on sample size, data provenance, ground truth establishment for test or training sets, expert qualifications, or adjudication methods.
  • Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

The document states that "All materials used in the fabrication of the AirLife™ Infant Nasal Continuous Positive Airway Pressure (nCPAP) Driver were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 'Biological Evaluation of Medical Devices'. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use." This is a general statement about material testing and safety compliance, not a detailed study report with specific acceptance criteria and performance data for the device's functional aspects.

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).