(309 days)
No
The summary does not mention any AI or ML capabilities, and the description focuses on hardware and software redesign for basic ventilation functions.
Yes
The intended use states, "The device is indicated to provide critical care specific therapy."
No
Explanation: The device is described as an "intensive care ventilator" intended for "breathing support" and "ventilation monitoring." Its primary function is therapeutic (providing critical care specific therapy and breathing support), not diagnostic. While it performs "ventilation monitoring," this is part of delivering and adjusting therapy, not diagnosing a medical condition.
No
The device description explicitly mentions hardware components such as a trolley, display unit, ventilation unit, gas supply unit, and power supply unit. It also discusses changes to the device design and hardware complexity.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a ventilator for providing breathing support to patients. It focuses on delivering air and controlling respiration, not on examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility.
- Device Description: The description details the hardware and software components related to ventilation, such as the display unit, ventilation unit, gas supply unit, and power supply unit. These are all components of a life support system, not an in vitro diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
In summary, the Evita intensive care ventilator is a medical device used for respiratory support, which falls under a different regulatory category than in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
CBK
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults, pediatric patients, and neonates weighing a minimum of 0.4 kg (0.88 lb).
Intended User / Care Setting
Intended User: Qualified and trained medical personnel.
Care Setting: Stationary use in hospitals and medical rooms or for intrahospital patient transport.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was conducted, including:
- 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: Risk control measures, Technical data, Essential safety and performance
- Accessories compatibility
- Human factors engineering, usability
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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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3
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. KGaA
Moislinger Allee 53-55
23542 Lübeck, Germany
Establishment's registration number: 9611500 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Dr. Bettina Moebius
Head of Regulatory Affairs Central
E-Mail: bettina.moebius@draeger.com
Telephone: +49 451 882 4100 |
| US Agent: | Darlene Thibodeau
Head of Quality Assurance and Compliance
E-mail: darlene.thibodeau@draeger.com
Telephone: (978) 773-1060 |
| Date prepared: | 16 May 2023 |
| Device Name: | Common name: Ventilator
Trade Name: Evita V800 / Evita V600
Classification Continuous, Facility Use
868.5895
Product 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.
4
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 and | |
| A2:2010/(R)2012 | Medical electrical equipment - Part 1: General |
| requirements for basic safety and essential | |
| performance | |
| IEC 60601-1-2 Edition 4.1 2020- | |
| 09 CONSOLIDATED VERSION | Medical electrical equipment - Part 1-2: General |
| requirements for basic safety and essential | |
| performance - Collateral Standard: Electromagnetic | |
| disturbances - Requirements and tests | |
| IEC 60601-1-6 Edition 3.1 2013- | |
| 10 | Medical electrical equipment - Part 1-6: General |
| requirements for basic safety and essential | |
| performance - Collateral standard: Usability | |
| Standard Number and Version | Title |
| IEC 60601-1-8 Edition 2.1 2012- | |
| 11 | Medical electrical equipment - Part 1-8: General |
| requirements for basic safety and essential | |
| performance - Collateral Standard: General | |
| requirements, tests and guidance for alarm | |
| systems in medical electrical equipment and | |
| medical electrical systems | |
| ISO 80601-2-12 First edition | |
| 2011-04-15 | Medical electrical equipment - Part 2-12: Particular |
| requirements for the safety of lung ventilators - | |
| Critical care ventilators [Including: Technical | |
| Corrigendum 1 (2011)] | |
| ISO 80601-2-55 Second edition | |
| 2018-02 | Medical electrical equipment - Part 2-55: Particular |
| requirements for the basic safety and essential | |
| performance of respiratory gas monitors | |
| IEC 60601-1-10 Edition 1.1 | |
| 2013-11 | Medical electrical equipment - Part 1-10: General |
| requirements for basic safety and essential | |
| performance - Collateral Standard: Requirements | |
| for the development of physiologic closed-loop | |
| controllers | |
| ISO 14971 Third Edition 2019- | |
| 12 | Medical devices - Application of risk management |
| to medical devices | |
| IEC 62304 Edition 1.1 2015-06 | |
| CONSOLIDATED VERSION | Medical device software - Software life cycle |
| processes | |
| IEC 62366-1 Edition 1.0 2015- | |
| 02 | Medical devices - Part 1: Application of usability |
| engineering to medical devices | |
| ISO 10993-1 Fifth edition 2018- | |
| 08 | Biological evaluation of medical devices - Part 1: |
| Evaluation and testing within a risk management | |
| process | |
| ISO 18562-1 First edition 2017- | |
| 03 | Biocompatibility evaluation of breathing gas |
| pathways in healthcare applications - Part 1: | |
| Evaluation and testing within a risk management | |
| process | |
| IEC 62133-2 Edition1.0 2017-02 | Secondary cells and batteries containing alkaline or |
| other non-acid electrolytes - Safety requirements | |
| for portable sealed secondary cells, and for | |
| batteries made from them, for use in portable | |
| applications - Part 2: Lithium systems | |
| IEC 62133-1 Edition1.0 2017-02 | Secondary cells and batteries containing alkaline or |
| other non-acid electrolytes - Safety requirements | |
| for portable sealed secondary cells, and for | |
| batteries made from them, for use in portable | |
| applications - Part 1: Nickel systems | |
| TR 60601-4-2 Edition 1.0 2016- | |
| 05 | Medical electrical equipment - Part 4-2: Guidance |
| and interpretation - Electromagnetic immunity: | |
| performance of medical electrical equipment and | |
| medical electrical systems |
List of Consensus Standards
5
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.
6
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 device
EVITA V800, EVITA V600 | Predicate device
Infinity Acute Care System Workstation Critical
Care | Comments |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Device Trade
Name | EVITA V800
EVITA V600 | Infinity Acute Care System Workstation Critical Care | - |
| Manufacturer | Drägerwerk AG & Co. KGaA | Drägerwerk AG & Co. KGaA | same as predicate
device |
| 510(k) number | | K093633 | - |
| Regulation
number -
Classification
description | 868.5895 - Continuous Ventilator | 868.5895 - Continuous Ventilator | same |
| Regulatory
class | Class II | Class II | same |
| Product code | CBK | CBK | same |
| Patient
population | • Adult
• Pediatric
• Neonate | • Adult
• Pediatric
• Neonate | same |
| Topic | Proposed device
EVITA V800, EVITA V600 | Predicate device
Infinity Acute Care System Workstation Critical
Care | Comments |
| 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 and
pressure-controlled ventilation and spontaneous breathing. | The Infinity Acute Care System Workstations Critical
Care consist of monitoring and control displays and
additional therapy units. They are intended to be used
as integrated, networked, and configurable
workstations to provide critical care specific therapy.
The Infinity Acute Care System Workstations Critical
Care are intended to be used by qualified and trained
medical personnel.
The Infinity C Series Medical Cockpits, consisting of
the C500 and the C700, are monitoring and control
displays for the Infinity Acute Care System (IACS).
Medical Cockpits are intended to be used to monitor
waveforms, parameter information, and alarms as well
as to control settings. The Infinity Series Medical
Cockpits are intended to be used in environments
where patient care is provided by trained healthcare
professionals.
The Evita V500 ventilation unit of the Infinity Acute
Care System is intended for the ventilation of
adult, pediatric and neonatal patients. Evita V500
offers mandatory ventilation modes and ventilation
modes for spontaneous breathing support and
airway monitoring.
The Evita V500 ventilation unit is used with Infinity C
Series Dräger Medical Cockpits. The Evita V500
ventilation unit is intended for use in different medical
care areas.Evita V500 is intended for stationary use in
hospitals and medical rooms or for patient
transportation within the hospital. | Similar |
| Topic | Proposed device
EVITA V800, EVITA V600 | Predicate device
Infinity Acute Care System Workstation Critical
Care | Comments |
| Intended user | The operating organization must ensure the following:
– Every user group has the required qualifications (e.g.,
has undergone specialist training or acquired
specialist knowledge through experience).
– Every user group has been trained to perform the task.
Clinical users
This user group operates the product in accordance with
the intended use.
Users have medical specialist knowledge in the field of
ventilation. Users have knowledge of device monitoring and
ventilation care. | The Infinity Acute Care System Workstations Critical
Care are intended to be used by qualified and trained
medical personnel.
The Infinity Series Medical Cockpits are intended to be
used in environments where patient care is provided
by trained healthcare professionals. | Similar |
| Environment
of use | The device is intended for stationary use in hospitals and
medical 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 solutions
that can mix with air, oxygen, or nitrous oxide - Areas with danger of explosion
- Areas with combustible and highly flammable substances
- Rooms with insufficient ventilation
Do not operate the device with helium or helium mixtures. | Intended for stationary use in hospitals and medical
rooms 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 substances
In 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 and
delivery | 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 device
EVITA V800, EVITA V600 | Predicate device
Infinity Acute Care System Workstation Critical
Care | Comments |
| | Pneumatic nebulizer (optional, part of "Nebulizer" option) | Pneumatic nebulizer (optional, part of "Medication nebulization" option) | Same |
| Pressure and
volume
monitoring | 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 |
| Oxygen
monitoring | Paramagnetic side-stream sensor | Paramagnetic side-stream sensor | Same |
| | Flow balancing of Air and O2 | Flow balancing of Air and O2 | Same |
| Carbon
dioxide
monitoring | 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 absorption
spectroscopy (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 device
EVITA V800, EVITA V600 | Predicate device
Infinity Acute Care System Workstation Critical
Care | Comments |
| User interface,
screen displays | Operation display | Operation display | Similar |
| | Graphical user interface including structured screen design
and characteristic color scheme | Graphical user interface including structured screen design
and 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) | |
| General
monitoring,
alarm
principles | 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 |
| General
monitoring,
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 device
EVITA V800, EVITA V600 | Predicate device
Infinity Acute Care System Workstation Critical
Care | Comments |
| Device
monitoring | 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 |
| Communicatio
n protocols | MEDIBUS | MEDIBUS | Same |
| | MEDIBUS.X | not available | Different |
| | MED.X.Comp | not available | Different |
| Type of patient
interface | Invasive ventilation (Tube): - Endotracheal tube (for adults, pediatric patients and
neonates) | Invasive ventilation (Tube): - Endotracheal tube (for adults, pediatric patients
and neonates) | Same |
| | Tracheostomy cannula (for adults and pediatric patients) | Tracheostomy cannula (for adults and pediatric
patients) | |
| | 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 and
neonates)
Prongs (for pediatric patients and neonates) | Same |
| | O2 Therapy: - Nasal cannula (for adults, pediatric patients and
neonates) | O2 Therapy: - Nasal cannula (for adults, pediatric patients and
neonates)
Oxygen mask (for adults, pediatric patients and
neonates) | 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 device
EVITA V800, EVITA V600 | Predicate device
Infinity Acute Care System Workstation Critical
Care | Comments |
| Ventilation
modes | Volume Control - Synchronized Intermittent Mandatory
Ventilation,
VC-SIMV (for neonates only available in combination with
AutoFlow) | Volume Control - Synchronized Intermittent Mandatory
Ventilation,
VC-SIMV (for neonates only available in combination
with AutoFlow) | Same |
| | Volume Control - Assist Control,
VC-AC (for neonates only available in combination with
AutoFlow) | Volume Control - Assist Control,
VC-AC (for neonates only available in combination with
AutoFlow) | Same |
| | Volume Control - Controlled Mandatory Ventilation,
VC-CMV (for neonates only available in combination with
AutoFlow) | Volume Control - Continuous Mandatory Ventilation,
VC-CMV (for neonates only available in combination
with AutoFlow) | Same |
| | Volume Control - Mandatory Minute Ventilation,
VC-MMV (optional for Evita V600, for neonates only
available in combination with AutoFlow) | Volume Control - Mandatory Minute Ventilation,
VC-MMV (optional, for neonates only available in
combination with AutoFlow) | Same |
| | Pressure Control - Synchronized Intermittent Mandatory
Ventilation,
PC-SIMV | Pressure Control - Synchronized Intermittent
Mandatory Ventilation,
PC-SIMV | Same |
| | Pressure Control - Synchronized Intermittent Mandatory
Ventilation 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 Release
Ventilation,
PC-APRV (optional) | Same |
| Topic | Proposed device
EVITA V800, EVITA V600 | Predicate device
Infinity Acute Care System Workstation Critical
Care | 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 for
neonates) | Spontaneous - Continuous Positive Airway Pressure,
SPN-CPAP (optional, mode only available in NIV for
neonates) | Same |
| | Spontaneous - Proportional Pressure Support,
SPN-PPS (optional) | Spontaneous - Proportional Pressure Support,
SPN-PPS (optional) | Same |
| Additional
settings for
ventilation | 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 detected
reconnection | Reduced flow after detected disconnection until
detected 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 device
EVITA V800, EVITA V600 | Predicate device
Infinity Acute Care System Workstation Critical
Care | 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 the
patient (NIF) | Diagnostic functions:
● Intrinsic PEEP measurement
● Occlusion pressure measurement
● NIF measurement | Same |
| Software
option for
weaning
process | SmartCare/PS:
knowledge-based system for the automated control of
pressure support in SPN-CPAP/PS (optional) | SmartCare/PS:
knowledge-based system for the automated control of
pressure support in SPN-CPAP/PS (optional) | Same |
7
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".
8
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.
9
Dräger
K222024
Traditional 510(k)
10
Dräger
Traditional 510(k)
11
Dräger
Traditional 510(k)
12
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".
13
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.
14
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.
15
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 System | |||
| K193056 | EVITA V800, EVITA V600 | ||
| K222024 | |||
| 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 PB980 |
| The 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 |
16
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.
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