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K Number
K051469
Device Name
CAREVENT ATV+ AND CAREVENT MRI
Manufacturer
O-TWO MEDICAL TECHNOLOGIES, INC.
Date Cleared
2005-09-28

(117 days)

Product Code
BTL
Regulation Number
868.5925
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The CAREvent ATV+ and CAREvent MRI are pneumatically powered, time cycled, intermittent, positive pressure automatic transport ventilator used to provide resuscitation and/or ventilatory support to a wide range of patients (from above 5 kg (11 lbs.) and higher) during transport.

They are designed to be used by suitably trained medical personnel in the prehospital, Intra-hospital, inter-hospital and air ambulance settings.

In addition CAREvent MRI is suitable for use in 1.5 - 3.0 Tesla MRI medical imaging suite environments, where ventilatory support may also be required during an MRI imaging procedure.

The ventilator is suitable for use in:

  • · Pulmonary resuscitation during respiratory and/or cardiac arrest.
  • · Short term ventilatory support in the pre-hospital, Intra-hospital, inter-hospital and air ambulance transport of non-breathing patients.
  • · In addition CAREvent MRI only is suitable for use in 1.5 3.0 Tesla MRI medical imaging suite environments, where ventilatory support may also be required during an MRI imaging procedure.
Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding the CAREvent ATV+ and CAREvent MRI ventilators. It confirms substantial equivalence to predicate devices and outlines general regulatory requirements. However, it does not contain any information regarding acceptance criteria, device performance metrics, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), or standalone algorithm performance, or how ground truth was established for training or test sets.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or other study details based solely on the provided text. The document is primarily an approval letter, not a detailed study report.

§ 868.5925 Powered emergency ventilator.

(a)
Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).