(222 days)
Evita 2 dura is a long-term ventilator for the intensive care ventilation of patients with a body weight of at least 3 kg up to 200 Kg.
The device is microprocessor-controlled and provides the following ventilation modes :
- CMV - Intermittent Positive Pressure Ventilation Controlled and assisted volume-constant ventilation
- SIMV Synchronized Intermittent Mandatory Ventilation Procedure for weaning patients off the ventilator after they have started spontaneous breathing
- MMV Mandatory Minute Volume Ventilation Spontaneous breathing with automatic adjustment of mandatory ventilation to the patient's minute volume requirement.
- CPAP Continuous Positive Airway Pressure Spontaneous breathing with positive airway pressure and adjustable pressure support.
- PCV+ Pressure Controlled Ventilation Pressure-controlled ventilation combined with free spontaneous breathing during the complete breathing cycle, and adjustable pressure support from CPAP level.
- APRV Airway Pressure Release Ventilation Spontaneous breathing on two pressure levels with long time ranges - independently adjustable.
Furthermore Evita 2 dura offers the following special ventilation modes : - Apnea ventilation For switching over automatically to volume-controlled ventilation if breathing stops.
- ILV Independent Lung Ventilation, optional Separate, differentiated, synchronised ventilation with one Evita 3 unit for each lung.
Application range - Intensive care units
- Inner-clinical transport
The Evita 2 dura is a time cycled, constant volume ventilator for long term use in intensive care and inner clinical transport. The device is microprocessor controlled and 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 2 dura for each lung
The provided text is a 510(k) Summary for the Dräger Evita 2 dura ventilator, which claims substantial equivalence to predicate devices (Evita 4, Evita, and Servo 300). This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed device, rather than providing independent clinical studies with acceptance criteria in the way a novel therapeutic device might. Therefore, the document does not describe traditional acceptance criteria and a study proving the device meets them in the sense of performance metrics against a clinical ground truth.
Instead, the "acceptance criteria" here are implied by the comparison to predicate devices, showing that the Evita 2 dura operates within similar parameters and provides similar functionality. The "study" is this comparative analysis itself.
Here's an analysis based on the information provided, framed to address your questions as best as possible within the context of a 510(k) submission for substantial equivalence:
1. Table of "Acceptance Criteria" and Reported Device Performance
Since this is a 510(k) for substantial equivalence, formal "acceptance criteria" with numerical targets are not explicitly stated in the document as they would be for a de novo device. The "acceptance criteria" are implicitly met if the device's characteristics are deemed substantially equivalent to the predicate devices. The performance is reported as a detailed comparison to these predicates.
Below is a summary table based on the provided comparison, highlighting key functional and technical specifications. The "Acceptance Criteria" column reflects what the device needs to match or be similar to in the predicate devices, and "Reported Device Performance" is the Evita 2 dura's characteristic.
| Feature | Implicit Acceptance Criteria (based on predicate Evita 4) | Evita 2 dura Reported Performance |
|---|---|---|
| Working Principle | Time cycled, volume constant, pressure controlled | Like Evita 4 (Time cycled, volume constant, pressure controlled) |
| Software Controlled | Yes | Yes |
| Gas delivery system | Fast "High Pressure Servo Valve", microprocessor controlled | Like Evita 4 |
| Ventilation Modes | CMV, SIMV, CPAP, ASB, Assist Control, MMV, PCV+ (BIPAP), APRV, CMV/Assist Control/SIMV/MMV with AutoFlow, ILV | All listed modes as Evita 4 |
| Rate (bpm) | 0.5 to 100 bpm | Like Evita 4 |
| Vt (Adult Mode) | 0.1 to 2.0 L | Like Evita 4 |
| O2-Conc. | 21 to 100 Vol.% | Like Evita 4 |
| Display Type | TFT-LC-Display (Color) | LC-Display (monochrom) or TFT (Color) |
| Alarm Condition Indicator | Red LED and TFT-LC-Display | Red LED and TFT or LC-Display |
| Audible Alarm | Yes, adjustable sound level | Yes, adjustable sound level |
| Power Supply (AC) | 100V to 240 V, 50/60 Hz | Like Evita 4 |
| CO2 / SpO2 Monitoring | Option for Evita 4 (built-in monitoring of expiration) | Option for Evita 2 dura (Evita 4 has this built-in) |
| DC Power Supply | Option, range 12 or 24V DC | Like Evita 4 |
2. Sample Size for the Test Set and Data Provenance
This document does not describe a "test set" in the context of a clinical performance study with patient data. The "test" for substantial equivalence is primarily a comparison of technical specifications and functional features against legally marketed predicate devices.
- Sample Size: N/A (no clinical test set of patients or samples is described).
- Data Provenance: The data is a comparison of the technical specifications and features of the Dräger Evita 2 dura against three predicate devices: Dräger Evita 4, Dräger Evita, and Siemens Servo 300. This information would typically come from technical documentation, design specifications, and marketing materials of these established devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable to a 510(k) submission based on substantial equivalence through technical comparison. There is no "ground truth" derived from expert consensus on a test set of medical data described in this document. The "ground truth" for a 510(k) is the established safety and effectiveness of the predicate device(s).
4. Adjudication Method for the Test Set
- Not applicable, as there is no human adjudication of a clinical test set described. The "adjudication" is essentially the FDA's regulatory review of the substantial equivalence claim.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study is not mentioned or implied in this 510(k) summary. This type of study is typically for diagnostic imaging devices or other tools where human readers interpret results, and would not be relevant for a ventilator's functional equivalency claim.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. The device is a ventilator, which is a medical device directly interacting with a patient's respiratory system, not an algorithm providing a standalone diagnostic output. Therefore, an "algorithm-only" performance study as might be conducted for AI-based diagnostic software is not relevant here. The performance is assessed through hardware and software functionality and how it controls ventilation parameters.
7. Type of Ground Truth Used
- The "ground truth" in this context is the established safety and effectiveness of the predicate devices (Evita 4, Evita, and Servo 300), as demonstrated by their prior marketing clearance and use. The Evita 2 dura is deemed "substantially equivalent" if it shares similar technological characteristics and has the same intended use as these predicates, without raising new questions of safety or effectiveness.
8. Sample Size for the Training Set
- Not applicable. This document pertains to the market clearance of a medical device (ventilator) based on substantial equivalence, not the development or validation of a machine learning algorithm that requires a distinct training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for a machine learning algorithm described.
In summary: The provided document is a 510(k) summary demonstrating substantial equivalence for a medical ventilator. The "acceptance criteria" and "study" are interpreted in the context of regulatory comparison to predicate devices, rather than a clinical trial with specific performance metrics and a patient-derived ground truth. The primary mechanism for clearance is showing that the new device is functionally and technologically similar to existing, legally marketed devices.
§ 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).