(309 days)
The Evita intensive care ventilator (Evita V800 / Evita V600) is intended for the ventilation of adults, pediatric patients and neonates weighing a minimum of 0.4 kg (0.88 lb). The device is indicated for patients who require temporary or longer-term breathing support for different medical reasons. The device is intended for stationary use in hospitals and medical rooms or for intrahospital patient transport. The device is intended to be used by qualified and trained medical personnel. The device is indicated to provide critical care specific therapy. The device provides ventilation monitoring and modes for volume controlled, pressure controlled and spontaneous breathing.
The intensive care ventilators Evita V800 and Evita V600 were developed and are manufactured by Dräger in Lübeck, Germany. Evita V800 and Evita V600 are specified for the ventilation of adults, pediatric patients and neonates. These devices provide mandatory ventilation modes and ventilation modes for supporting spontaneous breathing as well as ventilation monitoring. Evita V800 and Evita V600 are available in different device variants and can additionally be upgraded by software and hardware options as well as attachable accessories. Evita V800 and Evita V600 are available with a basic device configuration that comprises the following: Trolley with four castors and brakes, Display unit (graphical user interface), Ventilation unit. The changes have been made in the device design including functional integration of the Infinity series C cockpit into the device by changing "PC based Cockpit technology" to an "Embedded Control Display (ECD) technology" including a visually updated (color) in the graphical user interface. The hardware complexity has been reduced. In addition, a Gas supply Unit has been added as well as the Power supply Unit as an option. The device software and firmware have been redesigned. The functionality and features of Babylog VN800 / VN600 are identical to the predicate device.
The provided text is a 510(k) Premarket Notification Summary for the Dräger Evita V800 and Evita V600 ventilators. It details the device's characteristics and its substantial equivalence to predicate devices. However, the document does not contain information regarding an acceptance criteria table, device performance report, details of a study with sample sizes, data provenance, expert ground truth, adjudication methods, MRMC comparative effectiveness study, standalone algorithm performance, or training set details.
The document focuses on demonstrating substantial equivalence to predicate devices (Infinity Acute Care System Workstation Critical Care K093633 and Puritan Bennett™ 980 Series Ventilator System K193056) through comparison of intended use, technological characteristics, and non-clinical testing.
The "Discussion of Non-clinical Testing" section lists various tests performed, such as sterilization, biocompatibility, software, electrical safety, EMC, alarm systems, respiratory gas monitors, waveforms, technical system requirements, accessories compatibility, and human factors engineering. It states that results were summarized in "Test Summary tables" and "evidence included in this submission," but these summaries and evidence are not present in the provided text.
Therefore, I cannot fulfill the request for information on acceptance criteria, device performance, or study details as this information is not included in the provided 510(k) summary.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
May 16, 2023
Draegerwerk AG & Co. KGaA Holger Nadler Senior Regulatory Affairs Manager 53/55 Moislinger Allee Luebeck, Schleswig-Holstein 23542 Germany
Re: K222024
Trade/Device Name: Evita V800, Evita V600 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK Dated: April 17, 2023 Received: April 17, 2023
Dear Holger Nadler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ting Song -S
For James J. Lee, Ph.D. Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222024
Device Name Evita V800 Evita V600
Indications for Use (Describe)
The Evita intensive care ventilator (Evita V600) is intended for the ventilation of adults, pediatric patients and neonates weighing a minimum of 0.4 kg (0.88 lb). The device is indicated for patients who require temporary or longer-term breathing support for different medical reasons. The device is intended for stationary use in hospitals and medical rooms or for intrahospital patient transport. The device is intended to be used by qualified and trained medical personnel. The device is indicated to provide critical care specific therapy. The device provides ventilation monitoring and modes for volume controlled, pressure controlled and spontaneous breathing.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
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510(k) Summary
Image /page/3/Picture/2 description: The image shows the word "Dräger" in a stylized blue font, with two dots above the "a". Below the word "Dräger" is the alphanumeric code "K222024" in black font. The background of the image is white. The text is centered.
510(k) Premarket Notification Summary
| Submitter: | Drägerwerk AG & Co. KGaAMoislinger Allee 53-5523542 Lübeck, GermanyEstablishment's registration number: 9611500 |
|---|---|
| Official Correspondent: | Dr. Bettina MoebiusHead of Regulatory Affairs CentralE-Mail: bettina.moebius@draeger.comTelephone: +49 451 882 4100 |
| US Agent: | Darlene ThibodeauHead of Quality Assurance and ComplianceE-mail: darlene.thibodeau@draeger.comTelephone: (978) 773-1060 |
| Date prepared: | 16 May 2023 |
| Device Name: | Common name: VentilatorTrade Name: Evita V800 / Evita V600Classification Continuous, Facility Use868.5895Product Code: CBK Class: II |
Predicate Device: Infinity Acute Care System Workstation Critical Care, K093633
Referenced Device: Puritan Bennett™ 980 Series Ventilator System, K193056 was used as a reference device for extension of flow range for the patient category "adult" in O2 therapy up to 801/min. The predicate device only supports a flow rate up to 60//min.
Drägerwerk AG & Co. KGaA is submitting a traditional 510(k) premarket notification for a new device, Evita V800 / Evita V600.
Device Description
The intensive care ventilators Evita V800 and Evita V600 were developed and are manufactured by Dräger in Lübeck, Germany.
Evita V800 and Evita V600 are specified for the ventilation of adults, pediatric patients and neonates. These devices provide mandatory ventilation modes and ventilation modes for supporting spontaneous breathing as well as ventilation monitoring.
Evita V800 and Evita V600 are available in different device variants and can additionally be upgraded by software and hardware options as well as attachable accessories.
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Traditional 510(k)
Image /page/4/Picture/3 description: The image shows the word "Dräger" in a bold, blue font. Below the word "Dräger" is the alphanumeric code "K222024" in a smaller, black font. The logo is simple and clear, with the company name prominently displayed.
Evita V800 and Evita V600 are available with a basic device configuration that comprises the following:
- Trolley with four castors and brakes
- Display unit (graphical user interface)
- Ventilation unit
The changes have been made in the device design including functional integration of the Infinity series C cockpit into the device by changing "PC based Cockpit technology" to an "Embedded Control Display (ECD) technology" including a visually updated (color) in the graphical user interface. The hardware complexity has been reduced. In addition, a Gas supply Unit has been added as well as the Power supply Unit as an option. The device software and firmware have been redesigned. The functionality and features of Babylog VN800 / VN600 are identical to the predicate device.
Intended Use / Indications for Use
The Evita intensive care ventilator (Evita V800 / Evita V600) is intended for the ventilation of adults, pediatric patients and neonates weighing a minimum of 0.4 kg (0.88 lb).
The device is indicated for patients who require temporary or longer-term breathing support for different medical reasons. The device is intended for stationary use in hospitals and medical rooms or for intrahospital patient transport. The device is intended to be used by qualified and trained medical personnel. The device is indicated to provide critical care specific therapy. The device provides ventilation monitoring and modes for volume controlled, pressure controlled and spontaneous breathing.
| Standard Number and Version | Title |
|---|---|
| ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 andA2:2010/(R)2012 | Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance |
| IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION | Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral Standard: Electromagneticdisturbances - Requirements and tests |
| IEC 60601-1-6 Edition 3.1 2013-10 | Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essentialperformance - Collateral standard: Usability |
| Standard Number and Version | Title |
| IEC 60601-1-8 Edition 2.1 2012-11 | Medical electrical equipment - Part 1-8: Generalrequirements for basic safety and essentialperformance - Collateral Standard: Generalrequirements, tests and guidance for alarmsystems in medical electrical equipment andmedical electrical systems |
| ISO 80601-2-12 First edition2011-04-15 | Medical electrical equipment - Part 2-12: Particularrequirements for the safety of lung ventilators -Critical care ventilators [Including: TechnicalCorrigendum 1 (2011)] |
| ISO 80601-2-55 Second edition2018-02 | Medical electrical equipment - Part 2-55: Particularrequirements for the basic safety and essentialperformance of respiratory gas monitors |
| IEC 60601-1-10 Edition 1.12013-11 | Medical electrical equipment - Part 1-10: Generalrequirements for basic safety and essentialperformance - Collateral Standard: Requirementsfor the development of physiologic closed-loopcontrollers |
| ISO 14971 Third Edition 2019-12 | Medical devices - Application of risk managementto medical devices |
| IEC 62304 Edition 1.1 2015-06CONSOLIDATED VERSION | Medical device software - Software life cycleprocesses |
| IEC 62366-1 Edition 1.0 2015-02 | Medical devices - Part 1: Application of usabilityengineering to medical devices |
| ISO 10993-1 Fifth edition 2018-08 | Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk managementprocess |
| ISO 18562-1 First edition 2017-03 | Biocompatibility evaluation of breathing gaspathways in healthcare applications - Part 1:Evaluation and testing within a risk managementprocess |
| IEC 62133-2 Edition1.0 2017-02 | Secondary cells and batteries containing alkaline orother non-acid electrolytes - Safety requirementsfor portable sealed secondary cells, and forbatteries made from them, for use in portableapplications - Part 2: Lithium systems |
| IEC 62133-1 Edition1.0 2017-02 | Secondary cells and batteries containing alkaline orother non-acid electrolytes - Safety requirementsfor portable sealed secondary cells, and forbatteries made from them, for use in portableapplications - Part 1: Nickel systems |
| TR 60601-4-2 Edition 1.0 2016-05 | Medical electrical equipment - Part 4-2: Guidanceand interpretation - Electromagnetic immunity:performance of medical electrical equipment andmedical electrical systems |
List of Consensus Standards
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Image /page/5/Picture/3 description: The image shows the Dräger logo in blue, with the text "K222024" printed below it. The Dräger logo is a stylized wordmark with two dots above the "a". The text "K222024" is in black and appears to be a product or identification code.
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Traditional 510(k) 510(k) Summary
Image /page/6/Picture/2 description: The image shows the Dräger logo in blue, with the word "Dräger" in a stylized font. Below the logo, the text "K222024" is printed in black. The logo and text are centered.
Determination of Substantial Equivalence:
The EVITA V800, EVTA V600 ventilators are substantially equivalent to the predicate Infinity Acute Care (K093633) and the reference device, Puritan Bennett™ 980 Series Ventilator System, (K1930569), as described in the following table:
| Topic | Proposed deviceEVITA V800, EVITA V600 | Predicate deviceInfinity Acute Care System Workstation CriticalCare | Comments |
|---|---|---|---|
| Device TradeName | EVITA V800EVITA V600 | Infinity Acute Care System Workstation Critical Care | - |
| Manufacturer | Drägerwerk AG & Co. KGaA | Drägerwerk AG & Co. KGaA | same as predicatedevice |
| 510(k) number | K093633 | - | |
| Regulationnumber -Classificationdescription | 868.5895 - Continuous Ventilator | 868.5895 - Continuous Ventilator | same |
| Regulatoryclass | Class II | Class II | same |
| Product code | CBK | CBK | same |
| Patientpopulation | • Adult• Pediatric• Neonate | • Adult• Pediatric• Neonate | same |
| Topic | Proposed deviceEVITA V800, EVITA V600 | Predicate deviceInfinity Acute Care System Workstation CriticalCare | Comments |
| Intended UseIndicationsfor Use | The Evita intensive care ventilator (Evita V800 / Evita V600)is intended for the ventilation of adults, pediatric patientsand neonates weighing a minimum of 0.4 kg (0.88 lb).The device is indicated for patients who require temporaryor longer-term breathing support for different medicalreasons. The device is intended for stationary use inhospitals and medical rooms or for intrahospital patienttransport. The device is intended to be used by qualifiedand trained medical personnel. The device is indicated toprovide critical care specific therapy. The device providesventilation monitoring and modes for volume-controlled andpressure-controlled ventilation and spontaneous breathing. | The Infinity Acute Care System Workstations CriticalCare consist of monitoring and control displays andadditional therapy units. They are intended to be usedas integrated, networked, and configurableworkstations to provide critical care specific therapy.The Infinity Acute Care System Workstations CriticalCare are intended to be used by qualified and trainedmedical personnel.The Infinity C Series Medical Cockpits, consisting ofthe C500 and the C700, are monitoring and controldisplays for the Infinity Acute Care System (IACS).Medical Cockpits are intended to be used to monitorwaveforms, parameter information, and alarms as wellas to control settings. The Infinity Series MedicalCockpits are intended to be used in environmentswhere patient care is provided by trained healthcareprofessionals.The Evita V500 ventilation unit of the Infinity AcuteCare System is intended for the ventilation ofadult, pediatric and neonatal patients. Evita V500offers mandatory ventilation modes and ventilationmodes for spontaneous breathing support andairway monitoring.The Evita V500 ventilation unit is used with Infinity CSeries Dräger Medical Cockpits. The Evita V500ventilation unit is intended for use in different medicalcare areas.Evita V500 is intended for stationary use inhospitals and medical rooms or for patienttransportation within the hospital. | Similar |
| Topic | Proposed deviceEVITA V800, EVITA V600 | Predicate deviceInfinity Acute Care System Workstation CriticalCare | Comments |
| Intended user | The operating organization must ensure the following:– Every user group has the required qualifications (e.g.,has undergone specialist training or acquiredspecialist knowledge through experience).– Every user group has been trained to perform the task.Clinical usersThis user group operates the product in accordance withthe intended use.Users have medical specialist knowledge in the field ofventilation. Users have knowledge of device monitoring andventilation care. | The Infinity Acute Care System Workstations CriticalCare are intended to be used by qualified and trainedmedical personnel.The Infinity Series Medical Cockpits are intended to beused in environments where patient care is providedby trained healthcare professionals. | Similar |
| Environmentof use | The device is intended for stationary use in hospitals andmedical rooms or for intrahospital patient transport.Do not use the device in the following environments of use:- Hyperbaric chambers- Magnetic resonance imaging– Together with flammable gases or flammable solutionsthat can mix with air, oxygen, or nitrous oxide- Areas with danger of explosion- Areas with combustible and highly flammable substances- Rooms with insufficient ventilationDo not operate the device with helium or helium mixtures. | Intended for stationary use in hospitals and medicalrooms or for patient transportation within the hospital.Not intended for use in:- In hyperbaric chambers- For magnetic resonance imaging (MRT, NMR, NMI)- With flammable gases or anesthetic agents- In areas of explosion hazard- In areas with combustible or explosive substancesIn rooms without adequate ventilation | Similar |
| Gas supply | Central gas supply | Central gas supply | Same |
| Gas cylinders• Transport supply unit (optional)• Gas cylinder holder (optional) | Gas cylinders• Transport supply cart (optional)• Gas bottle holder (optional) | Same | |
| Gas supply unit GS500 (optional) | Gas supply unit GS500 (optional) | Same | |
| Gas dosage,mixing anddelivery | Dosage of Air/O2 in mixing chamber | Dosage of Air/O2 in mixing chamber | Same |
| Inspiratory valve | Inspiratory valve | Same | |
| Expiratory valve | Expiratory valve | Same | |
| Topic | Proposed deviceEVITA V800, EVITA V600 | Predicate deviceInfinity Acute Care System Workstation CriticalCare | Comments |
| Pneumatic nebulizer (optional, part of "Nebulizer" option) | Pneumatic nebulizer (optional, part of "Medication nebulization" option) | Same | |
| Pressure andvolumemonitoring | Inspiratory and expiratory pressure | Inspiratory and expiratory pressure | Same |
| Inspiratory and expiratory flow/volume | Inspiratory and expiratory flow/volume | Same | |
| Proximal flow/volume (optional, part of "Neonatal ventilation" option) | Proximal flow/volume (optional, part of "Neonatal ventilation" option) | Same | |
| 2 ambient pressure sensors | 1 ambient pressure sensor and user setting altitude | Similar | |
| Oxygenmonitoring | Paramagnetic side-stream sensor | Paramagnetic side-stream sensor | Same |
| Flow balancing of Air and O2 | Flow balancing of Air and O2 | Same | |
| Carbondioxidemonitoring | Main-stream sensor using infrared absorption spectroscopy(optional, part of "CO2 monitoring" option)• part no. 6871950 MCable - Mainstream CO2• part no. 6873570 CO2 mainstream sensor | Main-stream sensor using infrared absorptionspectroscopy (optional, part of "CO2 monitoring"option)• part no.6871950 MCable - Mainstream CO2 | Different |
| Power supply | Internal battery (NiMH) | Internal battery (NiMH) | Same |
| Power supply unit PS500 (optional)• part no. 8418950 lead-acid• part no. 8422900 lithium iron phosphate (LFP) | Different | ||
| Battery monitoring | Battery monitoring | Same | |
| Main switch | Toggle switch | Same | |
| User interface | TFT LCD capacitive touchscreen display | TFT LCD resistive touchscreen display | Different |
| Evita V800: 18.5 in display | IACS Medical cockpit C500: 17 in display | Different | |
| Evita V600: 15.6 in display | IACS Medical cockpit C500: 17 in display | Different | |
| Rotary knob for selecting, adjusting and confirming | Rotary knob for selecting, adjusting and confirming | Same | |
| Power supply indicators | Power supply indicators | Similar | |
| On/off key | On/off key | Same | |
| Topic | Proposed deviceEVITA V800, EVITA V600 | Predicate deviceInfinity Acute Care System Workstation CriticalCare | Comments |
| User interface,screen displays | Operation display | Operation display | Similar |
| Graphical user interface including structured screen designand characteristic color scheme | Graphical user interface including structured screen designand characteristic color scheme | Different | |
| Bed coupling (optional) | - | Different | |
| Waveforms | Curves | Same | |
| Graphical trends | Graphical trends | ||
| Tabular trends | Numeric trends | ||
| Loops | Loops | ||
| Alarm logbook | Alarm history | ||
| Logbook | Logbook | ||
| Numeric parameters | Numeric parameters | ||
| Lists of measured values and set values | Preconfigured lists of measured values and set values | ||
| User-specific list for measured values and set values | Customized lists for measured values and set values | ||
| Smart Pulmonary View (optional) | Smart Pulmonary View (optional) | ||
| Generalmonitoring,alarmprinciples | Optical and acoustical alarm indication | Optical and acoustical alarm indication | Same |
| Alarm silence key | Alarm silence key | Same | |
| High, medium and low alarm priorities | High, medium and low alarm priorities | Same | |
| Downgrading and resetting of defined alarms | Downgrading and resetting of defined alarms | Same | |
| Alarm logbook | Alarm history | Same | |
| Nurse call (optional) | Nurse call (optional) | Same | |
| Generalmonitoring,specific alarms | Alarm, cause, and remedy texts | Alarm, cause, and remedy texts | Different |
| Alarm grade and priority score | Alarm grade and priority score | Different | |
| Set criteria | Set criteria | Different | |
| User-initiated system test | User-initiated system test | Same | |
| Topic | Proposed deviceEVITA V800, EVITA V600 | Predicate deviceInfinity Acute Care System Workstation CriticalCare | Comments |
| Devicemonitoring | Gas supply | Gas supply | Same |
| Power supply | Power supply | Similar | |
| Device temperature | Device temperature | Same | |
| Mutual Processor Monitoring | Mutual Processor Monitoring | Same | |
| Connection to display unit | Connection to display unit | Different | |
| Communication protocols | MEDIBUS | MEDIBUS | Same |
| MEDIBUS.X | not available | Different | |
| MED.X.Comp | not available | Different | |
| Type of patientinterface | Invasive ventilation (Tube):- Endotracheal tube (for adults, pediatric patients andneonates) | Invasive ventilation (Tube):- Endotracheal tube (for adults, pediatric patientsand neonates) | Same |
| Tracheostomy cannula (for adults and pediatric patients) | Tracheostomy cannula (for adults and pediatricpatients) | ||
| Non-invasive ventilation (NIV) (optional):- NIV mask (for adults, pediatric patients and neonates)Prongs (for pediatric patients and neonates) | Non-invasive ventilation (NIV) (optional):- NIV mask (for adults, pediatric patients andneonates)Prongs (for pediatric patients and neonates) | Same | |
| O2 Therapy:- Nasal cannula (for adults, pediatric patients andneonates) | O2 Therapy:- Nasal cannula (for adults, pediatric patients andneonates)Oxygen mask (for adults, pediatric patients andneonates) | Same | |
| Therapy types | Invasive ventilation (Tube) | Invasive ventilation (Tube) | Same |
| Non-invasive ventilation (NIV) (optional) | Non-invasive ventilation (NIV) (optional) | Same | |
| O2 Therapy | O2 Therapy | Same | |
| Topic | Proposed deviceEVITA V800, EVITA V600 | Predicate deviceInfinity Acute Care System Workstation CriticalCare | Comments |
| Ventilationmodes | Volume Control - Synchronized Intermittent MandatoryVentilation,VC-SIMV (for neonates only available in combination withAutoFlow) | Volume Control - Synchronized Intermittent MandatoryVentilation,VC-SIMV (for neonates only available in combinationwith AutoFlow) | Same |
| Volume Control - Assist Control,VC-AC (for neonates only available in combination withAutoFlow) | Volume Control - Assist Control,VC-AC (for neonates only available in combination withAutoFlow) | Same | |
| Volume Control - Controlled Mandatory Ventilation,VC-CMV (for neonates only available in combination withAutoFlow) | Volume Control - Continuous Mandatory Ventilation,VC-CMV (for neonates only available in combinationwith AutoFlow) | Same | |
| Volume Control - Mandatory Minute Ventilation,VC-MMV (optional for Evita V600, for neonates onlyavailable in combination with AutoFlow) | Volume Control - Mandatory Minute Ventilation,VC-MMV (optional, for neonates only available incombination with AutoFlow) | Same | |
| Pressure Control - Synchronized Intermittent MandatoryVentilation,PC-SIMV | Pressure Control - Synchronized IntermittentMandatory Ventilation,PC-SIMV | Same | |
| Pressure Control - Synchronized Intermittent MandatoryVentilation plus,PC-SIMV+ | Pressure Control - Biphasic positive airway pressure,PC-SIMV+ | Same | |
| Pressure Control - Assist Control,PC-AC | Pressure Control - Assist Control,PC-AC | Same | |
| Pressure Control - Controlled Mandatory Ventilation,PC-CMV (mode available in NIV for neonates) | Pressure Control - Continuous Mandatory Ventilation,PC-CMV (mode available in NIV for neonates) | Same | |
| Pressure Control - Airway Pressure Release Ventilation,PC-APRV (optional for Evita V600) | Pressure Control - Airway Pressure ReleaseVentilation,PC-APRV (optional) | Same | |
| Topic | Proposed deviceEVITA V800, EVITA V600 | Predicate deviceInfinity Acute Care System Workstation CriticalCare | Comments |
| Pressure Control - Pressure Support Ventilation,PC-PSV (optional) | Pressure Control - Pressure Support Ventilation,PC-PSV (optional) | Same | |
| Spontaneous - Continuous Positive Airway Pressure,Pressure Support,SPN-CPAP/PS | Spontaneous - Continuous Positive Airway Pressure,Pressure Support,SPN-CPAP/PS | Same | |
| Spontaneous - Continuous Positive Airway Pressure,Volume Support,SPN-CPAP/VS | Spontaneous - Continuous Positive Airway Pressure,Volume Support,SPN-CPAP/VS | Same | |
| Spontaneous - Continuous Positive Airway Pressure,SPN-CPAP (optional, mode only available in NIV forneonates) | Spontaneous - Continuous Positive Airway Pressure,SPN-CPAP (optional, mode only available in NIV forneonates) | Same | |
| Spontaneous - Proportional Pressure Support,SPN-PPS (optional) | Spontaneous - Proportional Pressure Support,SPN-PPS (optional) | Same | |
| Additionalsettings forventilation | Apnea ventilation | Apnea ventilation | Same |
| Trigger | Flow trigger | Same | |
| Sigh | Sigh | Same | |
| AutoFlow (optional for Evita V600) | AutoFlow (optional) | Same | |
| Volume guarantee | Volume Guarantee | Same | |
| ATC (optional for Evita V600) | ATC (optional) | Same | |
| AutoRelease | AutoRelease | Same | |
| Variable PS (optional) | Variable PS (optional) | Same | |
| Anti-air shower | Reduced flow after detected disconnection until detectedreconnection | Reduced flow after detected disconnection untildetected reconnection | Same |
| Maneuvers | Manual insp./inspiration hold | Manual inspiration/hold | Same |
| Expiration hold | Exp. Hold (Expiratory hold) | Same | |
| O2/suctioning | Suction maneuver | Same | |
| Topic | Proposed deviceEVITA V800, EVITA V600 | Predicate deviceInfinity Acute Care System Workstation CriticalCare | Comments |
| Manual disconnection | Manual disconnection | Same | |
| Nebulization (optional) | Medication nebulization (optional) | Same | |
| Measurement maneuver Low-flow PV loop (optional) | Low Flow PV Loop (optional) | Same | |
| Diagnostics - measurement maneuver● Measurement of intrinsic PEEP (PEEPi)● Measurement of occlusion pressure (P0.1)● Measurement of maximum inspiratory effort of thepatient (NIF) | Diagnostic functions:● Intrinsic PEEP measurement● Occlusion pressure measurement● NIF measurement | Same | |
| Softwareoption forweaningprocess | SmartCare/PS:knowledge-based system for the automated control ofpressure support in SPN-CPAP/PS (optional) | SmartCare/PS:knowledge-based system for the automated control ofpressure support in SPN-CPAP/PS (optional) | Same |
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Traditional 510(k)
Image /page/7/Picture/3 description: The image shows the word "Dräger" in a bold, blue font. Above the "a" in Dräger are two dots. Below the word Dräger is the alphanumeric string "K222024".
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Traditional 510(k)
Image /page/8/Picture/3 description: The image shows the Dräger logo in blue, with the text "K222024" below it. The Dräger logo is a stylized wordmark with two dots above the "a". The text "K222024" is in a simple sans-serif font and appears to be a product or part number.
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Dräger
K222024
Traditional 510(k)
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Traditional 510(k)
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Dräger
Traditional 510(k)
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Traditional 510(k)
Image /page/12/Picture/3 description: The image shows the logo for Dräger, a German company that manufactures medical and safety technology products. The logo consists of the word "Dräger" in a bold, sans-serif font, with two dots above the "ä". Below the logo is the alphanumeric string "K222024".
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Traditional 510(k)
Image /page/13/Picture/3 description: The image shows the word "Dräger" in a stylized blue font, with two dots above the "ä". Below the word "Dräger" is the alphanumeric code "K222024" in black font. The logo is simple and clean, with the company name prominently displayed.
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Traditional 510(k)
Image /page/14/Picture/3 description: The image shows the Dräger logo in blue, with the word "Dräger" in a bold, sans-serif font. Below the logo, the text "K222024" is displayed in a smaller, sans-serif font. The logo and text are centered and presented against a white background.
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Traditional 510(k)
Image /page/15/Picture/2 description: The image shows the logo for Dräger, a German company that manufactures medical and safety technology products. The logo is in blue and features the company's name in a stylized font. Below the logo is the text "K222024" in black. The logo is simple and recognizable, and it is often used on Dräger's products and marketing materials.
| Substantial Equivalence to the reference device, Puritan Bennett ™ 980 | |||
|---|---|---|---|
| Specification | Reference Device | Proposed device | Discussion of Differences |
| Puritan Bennett™ 980 Series Ventilator SystemK193056 | EVITA V800, EVITA V600K222024 | ||
| O2 Therapy | O2 therapy (High Flow Oxygen Therapy) delivers heated and humidified gas at a set FiO2 and flow rate through an unsealed heated patient interface. | O2 therapy (High Flow Oxygen Therapy) delivers heated and humidified gas at a set FiO2 and flow rate through an unsealed heated patient interface. Configurable start values per patient categoryLimitation of maximum pressure can be set | Substantially equivalent – O2 therapy (High Flow Oxygen Therapy) is substantially equivalent to the reference device Puritan Bennett PB980. The technology for the delivery of High Flow Oxygen Therapy, which is delivery of a set oxygen concentration (FiO2) at a fixed flow rate, is not novel or new to the ventilator. The intended patient for High Flow Oxygen Therapy on both products is a spontaneously breathing patient. A humidifier is required for the delivery of High Flow Oxygen Therapy from both ventilators. The O2 Therapy function on the subject as well as on the reference device is available for adult, pediatric and neonatal patients. |
| High Flow Oxygen Therapy Flow Rate | Adult: 1 to 80 liters/minute | Adult: 2 to 80 liters/minute | Equivalent to the Puritan Bennett PB980The flow range was narrowed slightly (lower end of the flow rate is 2LPM instead of 1 LPM in the Puritan Bennett PB980). This does not affect the safety or performance of this feature. Testing has been completed as documented in the 510(k) to |
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Traditional 510(k)
Image /page/16/Picture/3 description: The image shows the Dräger logo in blue, with the text "K222024" below it. The Dräger logo consists of the word "Dräger" in a bold, sans-serif font, with two dots above the "ä". The text "K222024" is in a smaller, sans-serif font and is centered below the logo.
Discussion of Non-clinical Testing
The Evita V800 / Evita V600 ventilator is a new device and has undergone extensive testing to qualify it with e.g., national and international consensus standards, technical system requirements and other requirements. The following verification and validation activities were deemed necessary to establish substantial equivalence to the predicate device and were carried out under well-established methods, their results summarized in Test Summary tables and the evidence included in this submission.
- Sterilization
- Biocompatibility
- Software, including cybersecurity ●
- . Electrical safety
- Electromagnetic compatibility (EMC)
- Alarm Systems in medical electrical equipment ●
- Respiratory gas monitors
- Waveforms, including comparisons to the predicate device and performance
- Technical System Requirements, covering:
- o Risk control measures
- o Technical data
- Essential safety and performance
- . Accessories compatibility
- . Human factors enqineering, usability
Conclusion
The conclusions drawn from non-clinical tests and the comparison of intended use and technological characteristics with its predicate demonstrate that the new product Evita V800 / Evita V600 is substantially equivalent to the predicate device Infinity Acute Care System Workstation Critical Care K093633 and raises no differences of safety or effectiveness.
- END -
§ 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).