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K Number
K072885
Device Name
CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110
Manufacturer
DRAEGER MEDICAL AG & CO. KG
Date Cleared
2008-04-07

(181 days)

Product Code
CBK
Regulation Number
868.5895
Type
Traditional
Panel
AN
Reference & Predicate Devices
K984056,K060705,K982454
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Carina is a long-term ventilator-dependent patients or ventilator-assisted patients. The device is intended for treatment of sub-acute care patients in hospital or medical rooms. The device is intended for invasive ventilation or non-invasive ventilation. The device is intended for patients with a tidal volume of at least 100 mL. The device is intended for use by qualified medical personnel.

Device Description

The Carina. is a mechanical ventilator for use inside a hospital (sub-acute care). It offers the following ventilation modes:

  • · VC-SIMV (Volume controlled synchronized intermittent mandatory ventilation)
  • · PC-AC (Pressure controlled assisted control)
  • · PC-SIMV (Pressure controlled synchronized intermittent mandatory ventilation)
  • · SPN-PS (VG) (Pressure Support + (volume guarantee))
  • · SPN-CPAP (Continuous Positive Airway Pressure)
  • · Apnoea ventilation in SPN group mode (for spontaneously breathing patients)
    The device can be used for invasive and non invasive ventilation (e.g. trachea tube and mask ventilation). The device offers both high pressure oxygen inlet and oxygen via a low pressure oxygen inlet (max. 500 hPa/10L/min).
    The device monitors the following ventilation parameters:
  • · Airway pressure (PIP, Pmean, PEEP)
  • · Inspiratory Tidal volume (VTi)
  • · Breath rate (f)
  • · Minutes volume (MV , MV leak)
  • The device has the following user-settable alarms:
  • · Airway pressure high
  • · Minute volume high / low
  • · Rapid shallow breathing (high frequency alarm)
  • · Apnea alarm
  • · Disconnection alarm
    Flow and pressure curves are displayed on the display. Spontaneous breathing (Triggered breath) of a patient is indicated on the screen by an asterisk (*).
    Airway pressure high as a dotted line is displayed on the screen.
AI/ML Overview

The provided text contains a 510(k) summary for the Dräger Medical AG & Co. KG Carina Continuous Ventilator. However, it does not include information about specific acceptance criteria or a study proving the device meets those criteria. The document focuses on establishing substantial equivalence to predicate devices, describing the device, its intended use, and the regulatory process.

Therefore, I cannot provide the requested information based on the given text.

The document does not contain:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes, data provenance, number of experts for ground truth, or adjudication methods for a test set.
  3. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or an effect size.
  4. Details of a standalone algorithm performance study.
  5. The type of ground truth used.
  6. The sample size for the training set or how its ground truth was established.

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).