FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Evita 4 / 2 Dura with NeoFlow Option is a long-term ventilator to be used for intensive care and inner clinical transport of adults, children, infants and neonates with a minimum body weight of 0.5 kg.

The device is microprocessor controlled and provides the following ventilation modes:

CMV/assist Controlled Mandatory Ventilation Controlled and assisted volume constant ventilation, with the options: - CPPV Continuous Positive Pressure Ventilation - PLV Pressure Limited Ventilation - AutoFlow For automatic regulation of inspiratory flow - IRV Inversed Ratio Ventilation
SIMV Synchronised Intermittent Mandatory Ventilation Procedure for weaning patients off the ventilator after they have started spontaneous breathing. With the options: - PLV - AutoFlow
MMV Mandatory Minute Volume Ventilation Spontaneous breathing with automatic adjustment of mandatory ventilation to the patients minute volume requirement. With the options: - PLV - AutoFlow
SB Spontaneous Breathing Spontaneous breathing at ambient pressure
CPAP Continuos Positive Airway Pressure Spontaneous breathing with positive airway pressure
ASB/PSV Assisted Spontaneous Breathing / Pressure Support Ventilation Pressure supported spontaneous breathing
PCV+ Pressure controlled ventilation, combined with free spontaneous breathing during the complete breathing cycle, and adjustable pressure increase to CPAP level
APRV Airway Pressure Release Ventilation Spontaneous breathing on two pressure levels with long time ranges - independently adjustable.
Apnea Ventilation For switching over automatically to volume controlled ventilation if breathing stops.
ILV Independent Lung Ventilation Separate, differentiated synchronised ventilation with one Evita 4 / 2 Dura for each lung.

Device Description

The Evita 4 NeoFlow option extends the patient range of the Evita 4 ventilator to neonates with a minimum weight of 0,5 kg.

The Evita 4 equipped with the NeoFlow option provides the following ventilation modes.

CMV/assist Controlled Mandatory Ventilation Controlled and assisted volume contant ventilation with the options: - CPV Continuous Positive Pressure Ventilation - PLV Pressure Limited Ventilation - AutoFlow For automatic regulation of inspiratory flow - IRV Inversed Ratio Ventilation
SIMV Synchronized Intermittent Mandatory Ventilation Procedure for weaning patients off the ventilator after they have started spontaneous breathing. With the options: - PLV - AutoFlow
MMV Mandatory Minute Volume Ventilation Spontaneous breathing with automatic adjustment of mandatory ventilation to the patients minute volume requirement. With the options: - PLV - AutoFlow
SB Spontaneous Breathing Spontaneous breathing at ambient pressure
CPAP Continuous Positive Airway Pressure Spontaneous breathing with positive airway pressure
ASB/PSV Assisted Spontaneous Breathing / Pressure Support Ventilation Pressure supported spontaneous breathing
PCV+ Pressure Controlled Ventilation Pressure controlled ventilation combined with free spontaneous breathing during the complete breathing cycle, and adjustable pressure increase to CPAP level
APRV Airway Pressure Release Ventilation Spontaneous breathing on two pressure levels with long time ranges - independently adjustable
Apnea Ventilation For switching over automatically to volume controlled mandatory ventilation if breathing stops
ILV Independent Lung Ventilation Separate, differentiated, synchronized ventilation with one Evita 4 for each lung.

AI/ML Overview

Here's an analysis of the provided text regarding the Dräger Evita 4 NeoFlow Ventilator, focusing on acceptance criteria and study information.

Based on the provided document, there is no information about specific acceptance criteria or a study designed to prove the device meets those criteria.

The document is a 510(k) summary for the Dräger Evita 4 NeoFlow Ventilator, and its primary purpose is to demonstrate substantial equivalence to previously marketed devices, not to present performance data against specific acceptance criteria.

Therefore, many of the requested fields cannot be answered using the provided text.

However, I can extract and state what information is present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not specified in the provided document.
Reported Device Performance: Not detailed in the provided document in the context of specific performance metrics or acceptance criteria. The document describes the functionality of the device's NeoFlow option, which extends the patient range of the Evita 4 ventilator to neonates with a minimum weight of 0.5 kg and lists available ventilation modes.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not mentioned. No specific test set or study data is presented.
Data Provenance: Not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. No ground truth establishment for a test set is discussed.

4. Adjudication Method for the Test Set

Not applicable. No test set or adjudication method is discussed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No mention of an MRMC study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a ventilator, not an AI algorithm.

7. Type of Ground Truth Used

Not applicable. No study involving ground truth for performance evaluation is described.

8. Sample Size for the Training Set

Not applicable. This document is a 510(k) for a medical device (ventilator), not an AI/ML device that typically involves training sets.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, no training set is relevant to this type of device submission as described.

Summary of Information from the Document:

The document describes the Dräger Evita 4 NeoFlow Ventilator, an option that extends the Evita 4 ventilator to neonates with a minimum weight of 0.5 kg. It lists the various ventilation modes the device offers. The 510(k) submission (K983219) was cleared by the FDA on December 7, 1998, based on substantial equivalence to predicate devices like the Evita 4, Babylog 8000 plus (both Dräger), and Servo 300 (Siemens). The FDA letter confirms the device is classified as Class II and is subject to general controls.

Key takeaway: This 510(k) summary focuses on the technical description and the claim of substantial equivalence for a hardware medical device (ventilator), not on a performance study against specific acceptance criteria using a test set which is more common for software or AI/ML components.

Summary

Regulation Number and Section

§ 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).