Evita V800, Evita V600

K222024 · Draegerwerk AG & CO Kgaa · CBK · May 16, 2023 · Anesthesiology

Device Facts

• Record ID: K222024
• Device Name: Evita V800, Evita V600
• Applicant: Draegerwerk AG & CO Kgaa
• Product Code: CBK · Anesthesiology
• Decision Date: May 16, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Evita V800/V600 are intensive care ventilators for adult, pediatric, and neonatal patients; provide mandatory and spontaneous ventilation modes; monitor airway pressure, flow, and volume. Inputs include central gas supply or cylinders; gas mixing (Air/O2) via internal chamber; controlled by embedded display unit (ECD) with capacitive touchscreen and rotary knob. Used in hospitals/intrahospital transport by trained clinicians. Output includes delivered ventilation therapy and real-time patient monitoring data (waveforms, trends, loops, alarms). Healthcare providers use output to adjust ventilation settings and weaning protocols (e.g., SmartCare/PS). Benefits include respiratory support for patients requiring critical care. Features include optional CO2 monitoring, nebulization, and battery-powered operation.

Clinical Evidence

Bench testing only. Verification and validation activities included sterilization, biocompatibility, software/cybersecurity, electrical safety, EMC, alarm systems, respiratory gas monitoring, waveform performance, technical system requirements, accessory compatibility, and human factors/usability engineering.

Technological Characteristics

Materials: Biocompatible breathing gas pathways. Sensing: Paramagnetic O2 sensor, infrared absorption spectroscopy for CO2, pressure/flow sensors. Energy: AC power, internal NiMH battery, optional PS500 (lead-acid or LFP). Form factor: Trolley-mounted with 15.6" (V600) or 18.5" (V800) capacitive touchscreen. Connectivity: MEDIBUS, MEDIBUS.X, MED.X.Comp. Software: Embedded Control Display (ECD) technology. Sterilization: Compatible with hospital cleaning/disinfection protocols.

Indications for Use

Indicated for adults, pediatric patients, and neonates (min 0.4 kg) requiring temporary or long-term breathing support. Used in hospitals/medical rooms or for intrahospital transport by qualified medical personnel. Provides critical care therapy, ventilation monitoring, and volume/pressure/spontaneous breathing modes.

Regulatory Classification

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.

Predicate Devices

• Infinity Acute Care System Workstation Critical Care (K093633)

Reference Devices

• Puritan Bennett™ 980 Series Ventilator System (K193056)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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. KGaA<br>Moislinger Allee 53-55<br>23542 Lübeck, Germany<br>Establishment's registration number: 9611500 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Dr. Bettina Moebius<br>Head of Regulatory Affairs Central<br>E-Mail: [e-mail]<br>Telephone: [phone] |
| US Agent: | Darlene Thibodeau<br>Head of Quality Assurance and Compliance<br>E-mail: [e-mail]<br>Telephone: [phone] |
| Date prepared: | 16 May 2023 |
| Device Name: | Common name: Ventilator<br>Trade Name: Evita V800 / Evita V600<br>Classification Continuous, Facility Use<br>868.5895<br>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.

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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-<br>1:2005/(R)2012 and A1:2012,<br>C1:2009/(R)2012 and<br>A2:2010/(R)2012 | Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential<br>performance |
| IEC 60601-1-2 Edition 4.1 2020-<br>09 CONSOLIDATED VERSION | Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential<br>performance - Collateral Standard: Electromagnetic<br>disturbances - Requirements and tests |
| IEC 60601-1-6 Edition 3.1 2013-<br>10 | Medical electrical equipment - Part 1-6: General<br>requirements for basic safety and essential<br>performance - Collateral standard: Usability |
| Standard Number and Version | Title |
| IEC 60601-1-8 Edition 2.1 2012-<br>11 | Medical electrical equipment - Part 1-8: General<br>requirements for basic safety and essential<br>performance - Collateral Standard: General<br>requirements, tests and guidance for alarm<br>systems in medical electrical equipment and<br>medical electrical systems |
| ISO 80601-2-12 First edition<br>2011-04-15 | Medical electrical equipment - Part 2-12: Particular<br>requirements for the safety of lung ventilators -<br>Critical care ventilators [Including: Technical<br>Corrigendum 1 (2011)] |
| ISO 80601-2-55 Second edition<br>2018-02 | Medical electrical equipment - Part 2-55: Particular<br>requirements for the basic safety and essential<br>performance of respiratory gas monitors |
| IEC 60601-1-10 Edition 1.1<br>2013-11 | Medical electrical equipment - Part 1-10: General<br>requirements for basic safety and essential<br>performance - Collateral Standard: Requirements<br>for the development of physiologic closed-loop<br>controllers |
| ISO 14971 Third Edition 2019-<br>12 | Medical devices - Application of risk management<br>to medical devices |
| IEC 62304 Edition 1.1 2015-06<br>CONSOLIDATED VERSION | Medical device software - Software life cycle<br>processes |
| IEC 62366-1 Edition 1.0 2015-<br>02 | Medical devices - Part 1: Application of usability<br>engineering to medical devices |
| ISO 10993-1 Fifth edition 2018-<br>08 | Biological evaluation of medical devices - Part 1:<br>Evaluation and testing within a risk management<br>process |
| ISO 18562-1 First edition 2017-<br>03 | Biocompatibility evaluation of breathing gas<br>pathways in healthcare applications - Part 1:<br>Evaluation and testing within a risk management<br>process |
| IEC 62133-2 Edition1.0 2017-02 | Secondary cells and batteries containing alkaline or<br>other non-acid electrolytes - Safety requirements<br>for portable sealed secondary cells, and for<br>batteries made from them, for use in portable<br>applications - Part 2: Lithium systems |
| IEC 62133-1 Edition1.0 2017-02 | Secondary cells and batteries containing alkaline or<br>other non-acid electrolytes - Safety requirements<br>for portable sealed secondary cells, and for<br>batteries made from them, for use in portable<br>applications - Part 1: Nickel systems |
| TR 60601-4-2 Edition 1.0 2016-<br>05 | Medical electrical equipment - Part 4-2: Guidance<br>and interpretation - Electromagnetic immunity:<br>performance of medical electrical equipment and<br>medical 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 device<br>EVITA V800, EVITA V600 | Predicate device<br>Infinity Acute Care System Workstation Critical<br>Care | Comments |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Device Trade<br>Name | EVITA V800<br>EVITA V600 | Infinity Acute Care System Workstation Critical Care | - |
| Manufacturer | Drägerwerk AG & Co. KGaA | Drägerwerk AG & Co. KGaA | same as predicate<br>device |
| 510(k) number | | K093633 | - |
| Regulation<br>number -<br>Classification<br>description | 868.5895 - Continuous Ventilator | 868.5895 - Continuous Ventilator | same |
| Regulatory<br>class | Class II | Class II | same |
| Product code | CBK | CBK | same |
| Patient<br>population | • Adult<br>• Pediatric<br>• Neonate | • Adult<br>• Pediatric<br>• Neonate | same |
| Topic | Proposed device<br>EVITA V800, EVITA V600 | Predicate device<br>Infinity Acute Care System Workstation Critical<br>Care | Comments |
| Intended Use<br>Indications<br>for Use | The Evita intensive care ventilator (Evita V800 / Evita V600)<br>is intended for the ventilation of adults, pediatric patients<br>and neonates weighing a minimum of 0.4 kg (0.88 lb).<br>The device is indicated for patients who require temporary<br>or longer-term breathing support for different medical<br>reasons. The device is intended for stationary use in<br>hospitals and medical rooms or for intrahospital patient<br>transport. The device is intended to be used by qualified<br>and trained medical personnel. The device is indicated to<br>provide critical care specific therapy. The device provides<br>ventilation monitoring and modes for volume-controlled and<br>pressure-controlled ventilation and spontaneous breathing. | The Infinity Acute Care System Workstations Critical<br>Care consist of monitoring and control displays and<br>additional therapy units. They are intended to be used<br>as integrated, networked, and configurable<br>workstations to provide critical care specific therapy.<br>The Infinity Acute Care System Workstations Critical<br>Care are intended to be used by qualified and trained<br>medical personnel.<br>The Infinity C Series Medical Cockpits, consisting of<br>the C500 and the C700, are monitoring and control<br>displays for the Infinity Acute Care System (IACS).<br>Medical Cockpits are intended to be used to monitor<br>waveforms, parameter information, and alarms as well<br>as to control settings. The Infinity Series Medical<br>Cockpits are intended to be used in environments<br>where patient care is provided by trained healthcare<br>professionals.<br>The Evita V500 ventilation unit of the Infinity Acute<br>Care System is intended for the ventilation of<br>adult, pediatric and neonatal patients. Evita V500<br>offers mandatory ventilation modes and ventilation<br>modes for spontaneous breathing support and<br>airway monitoring.<br>The Evita V500 ventilation unit is used with Infinity C<br>Series Dräger Medical Cockpits. The Evita V500<br>ventilation unit is intended for use in different medical<br>care areas.Evita V500 is intended for stationary use in<br>hospitals and medical rooms or for patient<br>transportation within the hospital. | Similar |
| Topic | Proposed device<br>EVITA V800, EVITA V600 | Predicate device<br>Infinity Acute Care System Workstation Critical<br>Care | Comments |
| Intended user | The operating organization must ensure the following:<br>– Every user group has the required qualifications (e.g.,<br>has undergone specialist training or acquired<br>specialist knowledge through experience).<br>– Every user group has been trained to perform the task.<br><br>Clinical users<br>This user group operates the product in accordance with<br>the intended use.<br>Users have medical specialist knowledge in the field of<br>ventilation. Users have knowledge of device monitoring and<br>ventilation care. | The Infinity Acute Care System Workstations Critical<br>Care are intended to be used by qualified and trained<br>medical personnel.<br>The Infinity Series Medical Cockpits are intended to be<br>used in environments where patient care is provided<br>by trained healthcare professionals. | Similar |
| Environment<br>of use | The device is intended for stationary use in hospitals and<br>medical rooms or for intrahospital patient transport.<br>Do not use the device in the following environments of use:<br>- Hyperbaric chambers<br>- Magnetic resonance imaging<br>– Together with flammable gases or flammable solutions<br>that can mix with air, oxygen, or nitrous oxide<br>- Areas with danger of explosion<br>- Areas with combustible and highly flammable substances<br>- Rooms with insufficient ventilation<br>Do not operate the device with helium or helium mixtures. | Intended for stationary use in hospitals and medical<br>rooms or for patient transportation within the hospital.<br>Not intended for use in:<br>- In hyperbaric chambers<br>- For magnetic resonance imaging (MRT, NMR, NMI)<br>- With flammable gases or anesthetic agents<br>- In areas of explosion hazard<br>- In areas with combustible or explosive substances<br>In rooms without adequate ventilation | Similar |
| Gas supply | Central gas supply | Central gas supply | Same |
| | Gas cylinders<br>• Transport supply unit (optional)<br>• Gas cylinder holder (optional) | Gas cylinders<br>• Transport supply cart (optional)<br>• Gas bottle holder (optional) | Same |
| | Gas supply unit GS500 (optional) | Gas supply unit GS500 (optional) | Same |
| Gas dosage,<br>mixing and<br>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<br>EVITA V800, EVITA V600 | Predicate device<br>Infinity Acute Care System Workstation Critical<br>Care | Comments |
| | Pneumatic nebulizer (optional, part of "Nebulizer" option) | Pneumatic nebulizer (optional, part of "Medication nebulization" option) | Same |
| Pressure and<br>volume<br>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<br>monitoring | Paramagnetic side-stream sensor | Paramagnetic side-stream sensor…