(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.
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Datei: Summary.RTF Date: 19.12.1996 Author: Frank Clanzett
510(k) SUMMARY Summary of Safety and Effectiveness
APPLICANTS NAME AND ADDRESS:
Drager Inc. Critical Care Systems 4101-100 Pleasant Valley Road Chantilly, VA 20151
AUG 26 1997
APPLICANTS TELEPHONE NUMBER: (703)-817-0100
APPLICANTS FACSIMILE NUMBER: (703)-817-0101
APPLICANTS CONTACT PERSON: Harald Kneuer Regulatory Affairs Manager
DATE THE SUMMARY WAS PREPARED:
November 11, 1996
DEVICE NAME:
Trade Name: Common Name: Classification Name: Evita 2 dura Evita 2 dura Ventilator, Continuous (per 21 CFR 868.5895)
LEGALLY MARKETED DEVICE TO WHICH DRAGER INC. IS CLAIMING SUBSTANTIAL EQUIVALENCE:
Evita 4 - Manufactured by Dragerwerk AG, Lubeck, Germany and sold in the United States by Drager Inc.
Evita - Manufactured by Dragerwerk AG, Lubeck, Germany and sold in the United States by Drager Inc.
Servo 300 - Sold in the United States by Siemens
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Intensive Care Ventilator Data Comparison Sheet
| Device | Evita 4 | Evita 2 dura | Evita | Servo 300 |
|---|---|---|---|---|
| 510 (K) number | K 961687 | K 961687 | K 924930 | K902859 |
| Manufacturer | Dräger | Dräger | Dräger | Siemens |
| Classification | Intensive CareVentilator | Intensive CareVentilator | Intensive CareVentilator | Intensive CareVentilator |
| Working Principle | time cycled, volumeconstant, pressurecontrolled. | like Evita 4like Evita 4 | time cycled, volumeconstant, pressurecontrolled. | time cycled, volumeconstant, pressurecontrolled. |
| Software controlled | Yes | Yes | Yes | Yes |
| Gas delivery system | Fast "High PressureServo Valve",microprocessorcontrolled | like Evita 4 | Fast "High PressureServo Valve",microprocessorcontrolled | Fast "High PressureServo Valve",microprocessorcontrolled |
| Voltage for gas delivery system | 12 V DC | like Evita 4 | 12 V DC | - |
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| Device | Evita 4 | Evita 2 dura | Evita | Servo 300 |
|---|---|---|---|---|
| Pneumatic Unit | Partnumber84 12 360 | like Evita 4 | ||
| Software forPneumatic Unit | Partnumber84 11 742 | like Evita 4 | ||
| Electronic Unit | Partnumber84 12 835 | like Evita 4 | ||
| Software forElectronic Unit | Partnumber84 11 741 | like Evita 4 | ||
| Modes of Ventilation: | ||||
| CMV | Yes | Yes | Yes | Yes |
| SIMV | Yes | Yes | Yes | Yes |
| CPAP | Yes | Yes | Yes | Yes |
| ASB | Yes | Yes | Yes | Yes |
| Assist Control | Yes | Yes | Yes | Yes |
| MMV | Yes | Yes | Yes | No |
| PCV+ (BIPAP) | Yes*1 | Yes*1 | Yes | Yes |
| APRV | Yes | Yes | Yes | No |
| CMV, Assist Control, | Yes*2 | Yes*2 | No | Yes |
| SIMV and MMV with | ||||
| AutoFlow | ||||
| ILV | Yes | Yes | Yes | Yes |
| Device | Evita 4 | Evita 2 dura | Evita | Servo 300 |
| Ventilator Settings | ||||
| Rate | 0.5 to 100 bpm | like Evita 4 | 5 to 60 bpm for CMV0.5 to 20 bpm forSIMV | 5 to 150 bpm for CMV0.5 to 40 bpm forSIMV |
| Vt | 0.02 to 0.3 L (PediatricMode)*3 | like Evita 4 | 0.1 to 2.0 L | 0.002 to 4.0 L |
| TinspI:E-Ratio | 0.1 to 2.0 L (Adult Mode)30.1 ... 10 snot directly adjustable4 | like Evita 4like Evita 4 | not directly adjustable4:1 to 1:5 | 10 to 80 % (stepless)not directly adjustable |
| Flow | 6 to 30 lpm (PaediatricMode)*36 to 120 lpm (Adult Mode)*3 | like Evita 4 | 6 to 120 lpm | not directly adjustable |
| PmaxPEEP02-Conc. | 0 to 100 cmH2O0 to 35 cmH2O21 to 100 Vol.% | like Evita 4like Evita 4like Evita 4 | 0 to 100 cmH2O0 to 35 cmH2O21 to 100 Vol.% | 10 to 120 cmH2O0 to 50 cmH2O21 to 100 Vol.% |
| Flow Trigger Sensivity | ||||
| for CMV assist | 0.3 to 15 lpm*5 | like Evita 4 | 0.5 to 5.0 cmH2O | 0 to 17 cmH2O P.trigger |
| for SIMV | 0.3 to 15 lpm*5 | like Evita 4 | 0.7 cmH2O fixedtrigger | 0 to 17 cmH2O P.trigger |
| for ASB (pressuresupport) | 0.3 to 15 lpm | like Evita 4 | 1 to 15 lpm | 0 to 17 cmH2O P.trigger |
| for CPAP | 0.2 cmH2O fixed trigger | like Evita 4 | 0.2 cmH2O fixedtrigger | |
| Pinsp | 0 to 80 cmH2O | like Evita 4 | 10 to 100 cmH2O | 0 to 100 cmH2O |
| Rise timePressure Support | 0 to 2 s0 to 80 cmH2O | like Evita 4like Evita 4 | 0 to 2 s0 to 80 cmH2O | 0 to 10 %0 to 100 cmH2O |
| Device | Evita 4 | Evita 2 dura | Evita | Servo 300 |
| Parameter settingMain ventilation settings | with 10.4" Color TFT-LC-display, Touch screenand central | With keys, 7-Seg.Display rotary knob andcentral rotary dial knobfor selecting andconfirming*6 | rotary knob for everyparameter | rotary knob for everyparameter |
| further settings | With 10.4" Color TFT-LC-Display, Touch screenand central rotary knob | Via menu | menu via hardkeys | |
| Monitors/IndicatorsPower ON | TFT-LC-Display (Color) | LC-Display (monochrom)or TFT (Color) | LC-Display | LED |
| Dimension of Display | 21.1cm x 15.8cm640 x 480 dots | 12.5cm x 9.5cm640 x 480 dots | 9.8cm x 7.9cm128 x 240 dots | |
| Alarm Condition | red LED andTFT- LC-Display | red LED andTFT or LC-Display | red LED andLC Display | red LED andLED Display |
| Warnings | yellow LED andTFT-LC-Display | yellow LED andLC or TFT | yellow LED andLC-Display | |
| Messages | TFT-LC-Display | LCD-or TFT-Display | LC-Display | LED-Display |
| Curves | TFT-LC-Display | LCD-or TFT-Display | LC-Display | no |
| Device | Evita 4 | Evita 2 dura | Evita | Servo 300 |
| Measured values | TFT-LC-Display | LC-or TFT Display | LC-Display and 7-Segment-Display | several LED-Displays |
| Adjusted values | TFT-LC-Display | 7-Segment Display andLC- or TFT- Display | Scale of potentiometerand LC-Display | Scale of potentiometerand LED-Display |
| Audible Alarm | Yes | Yes | Yes | Yes |
| Alarm sound level | adjustable | adjustable | fixed | adustable |
| Pressure Limitation | ||||
| adjustable Pmax | 0 to 100 cmH2O | like Evita 4 | 0 to 100 cmH2O | 10 to 100 cmH2O |
| Safety Valve | 100 cmH20 | like Evita 4 | 100 cmH2O | 120 cmH20 |
| Inspiratory relief valve | Yes | like Evita 4 | Yes | Yes |
| Device | Evita 4 | Evita 2 dura | Servo 300 | |
| Alarms | ||||
| Airway Pressure High /Low | Yes | Yes | Yes | |
| Minute volume High / Low | Yes | Yes | Yes | |
| Apnea | Yes | Yes | Yes | |
| Gas Supply Failure | Yes | Yes | Yes | |
| Power failure | Yes | Yes | Yes | |
| Alarm Silence / Reset | Yes | Yes | Yes | |
| Ventilator Inoperative | Yes | Yes | Yes | |
| Breathing frequency High | Yes | Yes | No | |
| Oxygen concentration High /Low | Yes | Yes | Yes | |
| Breathing gas temperatur High | Yes | Yes | No | |
| Endexpiratory CO2- | ||||
| concentrationetCO2 High / Low | Yes | Yes*8 (option) | No | |
| O2 saturation SpO2 High / Low | Yes (option)*9 | Yes*9 | No | |
| Pulse High / Low | Yes (option) *9 | Yes*9 | No | |
| Device | Evita | Evita 2 dura | Evita | Servo 300 |
| Displayed Valuesmax. airway pressure Ppeak | 0 to 99 cmH2O | like Evita 4 | 0 to 99 cmH2O | Yes |
| Plateau pressure | 0 to 99 cmH2O | like Evita 4 | 0 to 99 cmH2O | Yes |
| PEEP | 0 to 99 cmH2O | like Evita 4 | 0 to 99 cmH2O | Yes |
| mean airway pressure | 0 to 99 cmH2O | like Evita 4 | 0 to 99 cmH2O | Yes |
| min. airway pressure | 0 to 99 cmH2O | like Evita 4 | 0 to 99 cmH2O | No |
| insp. oxygen concentration | 15 to 100 Vol.-% | like Evita 4 | 5 to 99 Vol.-% | Yes |
| Minute volume MV | 0 to 99 Ipm | like Evita 4 | 0 to 99 Ipm | Yes |
| spont. breath. volume MVspon | 0 to 99 Ipm | like Evita 4 | 0 to 99 Ipm | No |
| Tidal volume VT | 0 to 3999 ml | like Evita 4 | 0 to 3999 ml | Yes |
| spont. tidal volume VTspon | 0 to 3999 ml | like Evita 4 | 0 to 3999 ml | No |
| breathing frequency f | 0 to 150 bpm | like Evita 4 | 0 to 80 bpm | Yes |
| spont. breathing frequency fspon | 0 to 150 bpm | like Evita 4 | 0 to 80 bpm | No |
| breathing gas temperatur | 18 to 51°C | like Evita 4 | 18 to 51°C | No |
| endexp. CO2-concentration etCO2 | 0 to 13.3 Vol.% | like Evita 4 *8 | - | No |
| Device | Evita 4 | Evita 2 dura | Evita | Servo 300 |
| CO2-production | 0 to 999 ml/min | like Evita 4*8 | - | No |
| Seriel dead space Vds | 0 to 999 ml | like Evita 4*8 | - | No |
| Dead Space Ventilation Vds/VT | 0 to 999 ml | like Evita 4*8 | - | |
| etCO2 | 0 to 13.3 Vol% | like Evita 4*8 | - | |
| Compliance C (calculated value) | 0 to 250 ml/cmH2O | like Evita 4 | 0 to 250 ml/cmH2O | No |
| Resistance R (calculated value) | 0 to 99 cmH2O/I/s | like Evita 4 | 0 to 99 cmH2O/I/s | No |
| Pulse Rate | 20 to 250 bpm (option*9) | like Evita 4*9 | - | No |
| SpO2 | 0 - 100 %*9 | like Evita 4*9 | - | |
| Displayed curves | ||||
| Airway pressure Paw (t) | Yes | like Evita 4 | Yes | No |
| Flow (t) | Yes | like Evita 4 | Yes | No |
| Exsp. C02-concentration FCO2 | Yes | like Evita 4*8 | - | No |
| Plethmogram | Yes*9 | like Evita 4 | ||
| Device | Evita 4 | Evita 2 dura | Evita | Servo 300 |
| Special Functions | ||||
| Intermittend PEEP | Yes | like Evita 4 | Yes | No |
| Inspiration Hold | Yes | like Evita 4 | Yes | Yes |
| Apnea Ventilation | Yes | like Evita 4 | Yes | Yes |
| Nebulization | Yes | like Evita 4 | Yes | Yes |
| Suction Help Mode | Yes | like Evita 4 | Yes | No |
| Switch over function | Yes | like Evita 4 | Yes | Yes |
| Physical Characteristics | ||||
| Dimensions WxHxD | 530 x 290 x 450 mm | 530 x 290 x 420 mm | 530 x 270 x 420 mm | 242 x 360 240 mm(pneumatics) 427 x 110 x 321 mm (front panel) |
| Weight | 27 kg | like Evita 4 | 27 kg | 23.2 kg |
| Operation Temperature | 10 to 40°C | like Evita 4 | 15 to 40°C | |
| Storage Temperature | -20 to 60°C | like Evita 4 | -20 to 60°C |
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- see explanation of differences
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e explanation of difference
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(
- see explanation of differences
ﺭﻳﺴﻴﺴﻴ
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.
| Device | Evita 4 | Evita 2 dura | Evita | Servo 300 |
|---|---|---|---|---|
| Power Supply | ||||
| AC-Power connection range | 100V to 240 V, 50/60 Hz | like Evita 4 | 100V to 127 V, 220 Vto 240 V, 50/60 Hz | 100, 120, 220 and 240V AC, 50/60 Hz |
| Power consumption | approximately 125 W | like Evita 4 | approximately 125 W | 40 W |
| DC-connection | Option, range 12 or 24VDC*10 | like Evita 4 | No | 24 V DC |
| Internal battery | Option *10 | like Evita 4 | No | Yes |
| Operating time with battery | > 10 min *10 | like Evita 4 | No | Approx. 30 min |
| Typ of internal batterie | lead, free of maintenance | like Evita 4 | - | lead, free ofmaintenance |
| Recharge time | < 1.5 hours | like Evita 4 | - | 10 hours |
(
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Explanation of Differences
- Fyita 2 dura and Evita 4 uses the name BIPAP for the name BIPAP for the same ventilation mode. This pressure 1 controlled ventilation mode is combined with free spontaneous breathing during the complete breathing cycle.
- Evita 2 dura and Evita 4 uses extra setting AutoFlow for all volume controlled ventilation modes (CMV, SIMV, and MMV) വ instead of a seperate mode (Pressure regulated volume controlled of the serve 300).
- Evita 2 dura and Evita 4 distinguishes between an Adult and a Pediatric Mode, which can be selected by the user after 3 switching on.
- Evita 2 dura and Evita 4 uses instead of an I:E-adjustment of the Inspiratory Time Tinsp ব
- Evita 2 dura and Evita 4 uses the Flow Trigger for the adustment of the trigger sensivity in all ventilation modes 5
- Evita 2 dura uses a different operating concept: റ 11 ventilation parameter, for example VT is adjusted as follows: By pressing a key the parameter the adjusted parameter is selected. After that the yellow LED on the key is activated. Turn the central rotary knob = adjust the value Press the central rotary knob = confirm the value The yelow LED is switched off. The value is displayed by a 7-Segement-Display.
- In Evita 2 dura for adjusting of the parameters are no potentiometer used. The adjusted by 7 7-Segment-displays (each 11 parameters have an own 7-segment-display).
- Evita 2 dura can be equipped with an built-in monitoring for the expiration. The basic version of Evita 4 8 is equipped with this feature.
- Evita 2 dura and Evita 4 can be equipped optional with an oxygen saturation measurement த
- Evita 2 dura and Evita 4 can be equipped with a DC power supply 10
- see explanation of differences
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Dräger
DESCRIPTION OF THE DEVICE:
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 theoptions: | |
| - 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 havestarted spontaneous breathing. With the options: | |
| - PLV | |
| - AutoFlow | |
| - MMV | Mandatory Minute Volume Ventilation |
| Spontaneous breathing with automatic adjustment of mandatoryventilation to the patients minute volume requirement. With theoptions: | |
| - PLV | |
| - AutoFlow | |
| - SB | Spontaneous BreathingSpontaneous breathing at ambient pressure |
| - CPAP | Continuous Positive Airway PressureSpontaneous breathing with positive airway pressure |
| - ASB/PSV | Assisted Spontaneous Breathing / Pressure Support VentilationPressure supported spontaneous breathing |
| - PCV+ | Pressure Controlled VentilationPressure controlled ventilation combined with free spontaneousbreathing during the complete breathing cycle, and adjustablepressure increase to CPAP level |
| - APRV | Airway Pressure Release VentilationSpontaneous breathing on two pressure levels with long timeranges - independently adjustable |
| - ApneaVentilation | For switching over automatically to volume controlledmandatory ventilation if breathing stops |
| - ILV | Independent Lung VentilationSeparate, differentiated, synchronized ventilation with one Evita2 dura for each lung |
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Dräge
INTENDED USE OF THE DEVICE:
The Evita 2 dura is a long term ventilator for the intensive care 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 | Controlled Mandatory Ventilation |
|---|---|
| - SIMV | Synchronized Intermittent Mandatory Ventilation |
| - MMV | Mandatory Minute Volume Ventilation |
| - CPAP | Continuous Positive Airway Pressure |
| - PCV+ | Pressure Controlled Ventilation, combined with freespontaneous breathing during the complete breathing cycle andadjustable pressure support from CPAP level. |
| - APRV | Airway Pressure Release VentilationSpontaneous breathing on two pressure levels with long timeranges - independently adjustable. |
| - Apneaventilation | For switching over automatically to volume controlledventilation if breathing stops. |
| - ILV | Independent Lung VentilationSeparate, differentiated, synchronised ventilation with one Evita2 dura unit for each lung. |
| Application range | - Intensive Care units- Inner clinical transport |
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Dräger
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES:
The ventilator functions of the Evita 2 dura are substantially equivalent to the Evita 4, the Evita and the Servo 300 ventilators. The Evita 2 dura integrates the optional functions for CO2 and SpO2 that are presently performed by the Evita 4.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Frank Clanzett Regulatory Affairs Specialist
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Harald Kneuer Drager, Inc................................ Critical Care Systems 4101 Pleasant Valley Road, Suite 100 Chantilly, Virginia 20151
AUG 26 1997
K970165 Re: Evita 2 Dura Regulatory Class: II (two) Product Code: 73 CBK May 27, 1997 Dated: May 28, 1997 Received:
Dear Mr. Kneuer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such Existing major regulations affecting your device additional controls. can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requiation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (EDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Intended use of the product
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 VentilationControlled and assisted volume-constant ventilation |
|---|---|
| - SIMV | Synchronized Intermittent Mandatory VentilationProcedure for weaning patients off the ventilator after they havestarted spontaneous breathing |
| - MMV | Mandatory Minute Volume VentilationSpontaneous breathing with automatic adjustment of mandatoryventilation to the patient's minute volume requirement. |
| - CPAP | Continuous Positive Airway PressureSpontaneous breathing with positive airway pressure and adjustablepressure support. |
| - PCV+ | Pressure Controlled VentilationPressure-controlled ventilation combined with free spontaneousbreathing during the complete breathing cycle, and adjustablepressure support from CPAP level. |
| - APRV | Airway Pressure Release VentilationSpontaneous breathing on two pressure levels with long timeranges - 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.
Independent Lung Ventilation, optional Separate, differentiated, synchronised ventilation with one Evita 3 unit for each lung.
Application range
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ILV
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Intensive care units
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Inner-clinical transport
Kein
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Prescription Use
Beier (Project Manager)
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Division of Cardiovascular, R. Division of Cardiovae .
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OTC
§ 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).