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K Number
K992608
Device Name
ATC OPTION FOR EVITA 2 DURA AND EVITA 4
Manufacturer
DRAGER, INC.
Date Cleared
1999-08-24

(20 days)

Product Code
CBK
Regulation Number
868.5895
Type
Special
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Evita 2 dura and the Evita 4 are time cycled , constant volume, long term, intensive care ventilators for adults and children with a body weight of at least 3 kg.

Intended environment for use of the device

  • user facilities ..
  • inner clinical transport -
Device Description

The Evita 4 or the Evita 2 dura are time cycled microprocessor-controlled intensive care ventilators. Both devices can be equipped with the ATC option. ATC means automatic tube compensation. This ventilation mode extension provides a compensation of an endotracheal or tracheostomy tube. It calculates and displays the tracheal pressure from a mathematical model on the basis of selected type of tube and tube internal diameter.

AI/ML Overview

The provided document is a 510(k) summary for the Dräger ATC option for Evita 2 dura and Evita 4 ventilators. This type of document is used to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a standalone study with performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication method, MRMC studies, standalone performance), or ground truth establishment.

Instead, the document focuses on comparing the new device to predicate devices based on:

  • Intended Use: Identical to predicate devices.
  • Patient Range: Identical to predicate devices.
  • Intended Environment for Use: Identical to predicate devices.
  • Technology, Performance Specifications, Materials, Dimensions, Operating Parameters: Deemed substantially equivalent to predicate devices.

The FDA's letter (K992608) confirms the finding of "substantial equivalence" based on this comparison. It does not refer to a specific performance study against defined acceptance criteria.

§ 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).