Evita (V800); Evita (V600)

K253647 · Draegerwerk AG & CO Kgaa · CBK · May 7, 2026 · Anesthesiology

Device Facts

• Record ID: K253647
• Device Name: Evita (V800); Evita (V600)
• Applicant: Draegerwerk AG & CO Kgaa
• Product Code: CBK · Anesthesiology
• Decision Date: May 7, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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.

Device Story

Evita V800/V600 are intensive care ventilators providing mandatory and spontaneous breathing support; inputs include central gas supply or cylinders, monitored via flow/pressure sensors and optional CO2/O2 sensors. Device transforms inputs into controlled ventilation via inspiratory/expiratory valves; features include volume/pressure-controlled modes and optional SmartCare/PS weaning. Operated by trained clinicians in hospitals/transport; output displayed on touchscreen GUI with waveforms, trends, and alarm logs. Enhancements include automated driving-pressure calculation, selectable minute-volume alarm sources, and NTP synchronization. Benefits include precise respiratory support and monitoring for critical care patients. Software updates now support server-triggered delivery. Clinical decision-making supported by real-time monitoring and automated weaning logic.

Clinical Evidence

No clinical data required. Substantial equivalence supported by bench testing, including electrical safety, EMC, alarm system performance, biocompatibility (ISO 10993-1, ISO 18562), and software verification/validation. Summative usability testing per IEC 62366-1 confirmed no new use-related risks.

Technological Characteristics

Continuous ventilator; gas mixing chamber; inspiratory/expiratory valves. Materials: FKM V80G1, Ultradur B4521 PRO. Sensing: Paramagnetic O2, infrared CO2, flow/pressure sensors. Power: Internal NiMH battery, PS500 (lead-acid or LFP). Connectivity: MEDIBUS, MEDIBUS.X, NTP. Software: MATLAB/Simulink (SmartCare/PS). Standards: IEC 60601-1, ISO 80601-2-12, ISO 14971.

Indications for Use

Indicated for adults, pediatric patients, and neonates (min 0.4 kg) requiring temporary or long-term breathing support. Used in hospitals or for intrahospital transport by trained medical personnel. Contraindicated for hyperbaric chambers, MRI, flammable gas environments, and use with helium/helium mixtures.

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

• Evita V800, Evita V600 (K222024)

Reference Devices

• Getinge Maquet Servo-U (K180098)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

May 7, 2026

Draegerwerk AG & CO Kgaa
Holger Nadler
Regulatory Affairs Manager
Moislinger Allee 53-55
Luebeck, 23
Germany

Re: K253647
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: November 17, 2025
Received: November 20, 2025

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K253647 - Holger Nadler
Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

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K253647 - Holger Nadler
Page 3

Sincerely,

John S. Bender -S

for Ethan Nyberg, Ph.D.
Assistant Director
DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K253647 | |
| Device Name Evita (V800); Evita (V600) | |
| Indications for Use (Describe) 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. | |
| 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) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

{4}

Evita V800 / Evita V600

Dräger

Traditional 510(k)

510(k) Summary

# 510(k) Premarket Notification Summary

**Submitter:** Drägerwerk AG & Co. KGaA
Moislinger Allee 53-55
23542 Lübeck, Germany
Establishment’s registration number: 9611500

**Contact Person:** Holger Nadler
Regulatory Affairs Manager
E-Mail: [e-mail]
Telephone: [phone]

**Date prepared:** April 9, 2026

This 510(k) Summary is being submitted in accordance with 21 CFR 807.92.

**Device Name:**
Common name: Ventilator
Trade Name: Evita V800 / Evita V600
Classification name: Continuous ventilator
Regulation Number: 21 CFR §868.5895
Product Code: CBK (Ventilator, Continuous, Facility Use)
Class: II

**Predicate Device:** Evita V800, Evita V600, K222024

**Reference device:** Getinge Maquet Servo-U K180098

**Device Description**

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 with a basic device configuration that comprises

the following:

- Display unit (graphical user interface)
- Ventilation unit with Software

**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

Page 1 of 16

{5}

Evita V800 / Evita V600

Dräger

Traditional 510(k)

510(k) Summary

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 intended use is unchanged compared to the predicate device (K222024)

# Technological Characteristics and Differences vs Predicate

## Ventilation/Functions

Decelerating-flow setting in VC modes (setting only; no new mode; comparable to SERVO-U/n 2.1, K180098). Additionally, the subject device introduces: selectable minute-volume alarm source (inspiratory/expiratory/leakage-corrected; default expiratory); simultaneous adjustment of alarm limits for MV/RR/VT ("Autoset"); an automated driving-pressure procedure (calculates Pplat, Pdrive, Cstat; display/decision-support only); and a PEEP/FiO2 view (display-only, no therapy control).

Comparable to SERVO-U/n 2.1 (K180098: 'Volume Control improvements including decelerating flow')

## User interface and usability

GUI harmonization with unchanged "Touch-Turn-Confirm" operating principle; summative usability validation per IEC 62366-1 confirms no new use-related risks

## Infrastructure/Maintenance

O2-sensor calibration additionally possible via GS500 (same algorithm as predicate); server-triggered software update available in addition to local service-PC; NTP time synchronization added (no therapy impact)

## Alarms

Tidal-volume alarms: derived limits applied under defined criteria; alarm texts consolidated/clarified; configurable priorities within controlled bounds; underlying detection logic, thresholds, and timing unchanged

## Software implementation (no functional change)

SmartCare/PS migrated from Java to MATLAB/Simulink; algorithm behavior, alarms, thresholds, and IFU remain unchanged; equivalence verified by software V&V

## Hardware/Labeling/Accessories

Supplier-driven material updates (e.g., sealing ring 8416067, flow-sensor cable plug handle) with biocompatibility confirmed; air-inlet labeling updated ("Do not obstruct" +

Page 2 of 16

{6}

Evita V800 / Evita V600
Dräger
Traditional 510(k)
510(k) Summary

warning symbol); accessories list cleaned; PS500 LFP battery replacement interval extended from 4 to 6 years based on test data; no new risks introduced

Page 3 of 16

{7}

Evita V800 / Evita V600

Dräger

Traditional 510(k)

510(k) Summary

List of Consensus Standards

| Standard Number and Version | Title |
| --- | --- |
| IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION | 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 3.2 2020-07 CONSOLIDATED VERSION | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION | 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 |
| IEC 60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION | 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 80601-2-12 Third edition 2023-11 | Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators |
| ISO 80601-2-55 Second edition 2018-02 [Including AMD1:2023] | Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitor [Including Amendment 1 (2023)]. |
| ISO 80601-2-90 First edition 2021-08 | Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment |
| 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 1.1 2020-06 CONSOLIDATED VERSION | 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 |

Page 4 of 16

{8}

Evita V800 / Evita V600

Dräger

Traditional 510(k)

510(k) Summary

| Standard Number and Version | Title |
| --- | --- |
| 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 |
| ISO 18562-1 Second edition 2024-03 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process |
| ISO 18562-2 Second edition 2024-03 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter |
| ISO 18562-3 First edition 2017-03 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds |
| ISO 18562-3 Second Edition 2024-03 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds |
| 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 |
| ISO 17664-1 First edition 2021-07 | Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices |
| ISO 17664-2 First edition 2021-02 | Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices. |

Page 5 of 16

{9}

Evita V800 / Evita V600

Dräger

Traditional 510(k)

510(k) Summary

Comparison to Predicate

| Topic | Proposed device EVITA V800, EVITA V600 | Predicate device EVITA V800, EVITA V600 | Comments |
| --- | --- | --- | --- |
| Device Trade Name | EVITA V800 EVITA V600 | EVITA V800 EVITA V600 | - |
| Manufacturer | Drägerwerk AG & Co. KGaA | Drägerwerk AG & Co. KGaA | Same |
| 510(k) number | | K222024 | - |
| 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 |

{10}

Evita V800 / Evita V600

Dräger

Traditional 510(k)

510(k) Summary

| Topic | Proposed device EVITA V800, EVITA V600 | Predicate device EVITA V800, EVITA V600 | Comments |
| --- | --- | --- | --- |
| 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. | 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 indicated to provide critical care specific therapy. The device provides ventilation monitoring and modes for volume controlled, pressure controlled and spontaneous breathing. | Intended Use unchanged |
| 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 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. | Same |

Page 7 of 16

{11}

Evita V800 / Evita V600

Dräger

Traditional 510(k)

510(k) Summary

| Topic | Proposed device EVITA V800, EVITA V600 | Predicate device EVITA V800, EVITA V600 | Comments |
| --- | --- | --- | --- |
| 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 – In vehicles, airplanes, helicopters, and on ships Do not operate the device with helium or helium mixtures. | 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. | Same |
| Gas supply | Central gas supply | Central gas supply | Same |
| | Gas cylinders • Transport supply unit (optional) • Gas cylinder holder (optional) | Gas cylinders • Transport supply unit (optional) • Gas cylinder holder (optional) | Same |
| | Gas supply unit GS500 | Gas supply unit GS500 | 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 |
| | Pneumatic nebulizer (optional, part of “Nebulizer” option) | Pneumatic nebulizer (optional, part of “Nebulizer” option) | Same |
| | Inspiratory and expiratory pressure | Inspiratory and expiratory pressure | Same |

Page 8 of 16

{12}

Evita V800 / Evita V600

Dräger

Traditional 510(k)
510(k) Summary

| Topic | Proposed device EVITA V800, EVITA V600 | Predicate device EVITA V800, EVITA V600 | Comments |
| --- | --- | --- | --- |
| Pressure and volume monitoring | 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 | 2 ambient pressure sensors | Same |
| Oxygen monitoring | Paramagnetic side-stream sensor | Paramagnetic side-stream sensor | Same |
| | Flow balancing of Air and O₂ | Flow balancing of Air and O₂ | Same |
| PEEP/FiO₂ view (display-only) | Added | Not available | Different; no therapy control |
| 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 • part no. 6873570 CO2 mainstream sensor | Same |
| Power supply | Internal battery (NiMH) | Internal battery (NiMH) | Same |
| | Power supply unit PS500 • part no. 8418950 lead-acid • part no. 8422900 lithium iron phosphate (LFP) | Power supply unit PS500 • part no. 8418950 lead-acid • part no. 8422900 lithium iron phosphate (LFP) | Same |
| | Battery monitoring | Battery monitoring | Same |
| | Main switch | Main switch | Same |
| Battery maintenance interval (LFP) | 6 years | 4 years | Different; supported by test reports; hardware unchanged |

Page 9 of 16

{13}

Evita V800 / Evita V600

Dräger

Traditional 510(k)
510(k) Summary

| Topic | Proposed device EVITA V800, EVITA V600 | Predicate device EVITA V800, EVITA V600 | Comments |
| --- | --- | --- | --- |
| User interface | TFT LCD capacitive touchscreen display • Evita V800: 18.5 in • Evita V600: 15.6 in | TFT LCD capacitive touchscreen display • Evita V800: 18.5 in • Evita V600: 15.6 in | Same |
| Rotary knob for selecting, adjusting and confirming | Rotary knob for selecting, adjusting and confirming | Same |
| Power supply indicators | Power supply indicators | Same |
| On/off key | On/off key | Same |
| Operation display | Operation display | Same |
| Graphical user interface including structured screen design and characteristic color scheme | Graphical user interface including structured screen design and characteristic color scheme | Same |
| GUI harmonization | Updated layout | Previous layout | Different; summative HFE per IEC 62366-1 |
| User interface, screen displays | Waveforms | Waveforms | Same |
| Graphical trends | Graphical trends |
| Tabular trends | Tabular trends |
| Loops | Loops |
| Alarm logbook | Alarm logbook |
| Logbook | Logbook |
| Numeric parameters | Numeric parameters |
| Lists of measured values and set values | Lists of measured values and set values |
| User-specific list for measured values and set values | User-specific list for measured values and set values |
| Smart Pulmonary View | Smart Pulmonary View |
| | Optical and acoustical alarm indication | Optical and acoustical alarm indication | Same |

Page 10 of 16

{14}

Evita V800 / Evita V600

Dräger

Traditional 510(k)
510(k) Summary

| Topic | Proposed device EVITA V800, EVITA V600 | Predicate device EVITA V800, EVITA V600 | Comments |
| --- | --- | --- | --- |
| General monitoring, alarm principles | 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 | Same |
| | Alarm grade and priority score | Alarm grade and priority score | |
| | Set criteria | Set criteria | |
| Minute-volume alarm source | Selectable (default exp.) | Expiratory only | Different; underlying detection/thresholds unchanged |
| Autoset (MV/RR/VT limits) | Available | Not available | Different; ranges unchanged; UI confirmation; validated |
| Tidal-volume alarms: derived limits/texts/priorities | Derived limits under criteria; texts consolidated; priorities configurable within bounds | Legacy texts; fixed priorities | Different; detection logic/timing unchanged |
| Device monitoring | User-initiated system test | User-initiated system test | Same |
| | Gas supply | Gas supply | Same |
| | Power supply | Power supply | Same |
| | Device temperature | Device temperature | Same |
| | Mutual Processor Monitoring | Mutual Processor Monitoring | Same |
| | Connection to display unit | Connection to display unit | Same |
| Communication protocols | MEDIBUS | MEDIBUS | Same |
| | MEDIBUS.X | MEDIBUS.X | |
| | MED.X.Comp | MED.X.Comp | |

Page 11 of 16

{15}

Evita V800 / Evita V600

Dräger

Traditional 510(k)
510(k) Summary

| Topic | Proposed device EVITA V800, EVITA V600 | Predicate device EVITA V800, EVITA V600 | Comments |
| --- | --- | --- | --- |
| NTP time synchronization | Added (no therapy impact) | Not available | Different; cybersecurity assessed |
| Maintenance / Software update | | | |
| Server-triggered software update | Available in addition to service-PC | Service-PC only | Different; authenticated/integrity-protected |
| Therapy types | Invasive ventilation (Tube) | Invasive ventilation (Tube) | Same |
| | Non-invasive ventilation (NIV) | Non-invasive ventilation (NIV) | Same |
| | O2 Therapy | O2 Therapy | Same |
| Ventilation modes | Volume Control - Synchronized Intermittent Mandatory Ventilation, VC-SIMV | Volume Control - Synchronized Intermittent Mandatory Ventilation, VC-SIMV | Same |
| | Volume Control - Assist Control, VC-AC | Volume Control - Assist Control, VC-AC | Same |
| | Volume Control - Controlled Mandatory Ventilation, VC-CMV | Volume Control - Controlled Mandatory Ventilation, VC-CMV | Same |
| | Volume Control - Mandatory Minute Ventilation, VC-MMV | Volume Control - Mandatory Minute Ventilation, VC-MMV | 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 - Synchronized Intermittent Mandatory Ventilation plus, PC-SIMV+ | Same |

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{16}

Evita V800 / Evita V600

Dräger

Traditional 510(k)

510(k) Summary

| Topic | Proposed device EVITA V800, EVITA V600 | Predicate device EVITA V800, EVITA V600 | Comments |
| --- | --- | --- | --- |
| | Pressure Control - Assist Control, PC-AC | Pressure Control - Assist Control, PC-AC | Same |
| | Pressure Control - Controlled Mandatory Ventilation, PC-CMV | Pressure Control - Controlled Mandatory Ventilation, PC-CMV | Same |
| | Pressure Control - Airway Pressure Release Ventilation, PC-APRV | Pressure Control - Airway Pressure Release Ventilation, PC-APRV | Same |
| | Pressure Control - Pressure Support Ventilation, PC-PSV | Pressure Control - Pressure Support Ventilation, PC-PSV | 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, SPN-CPAP | Spontaneous - Continuous Positive Airway Pressure, SPN-CPAP | Same |
| | Spontaneous - Continuous Positive Airway Pressure, Volume Support, SPN-CPAP/VS | Spontaneous - Continuous Positive Airway Pressure, Volume Support, SPN-CPAP/VS | 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 for Evita V600) | Same |

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{17}

Evita V800 / Evita V600

Dräger

Traditional 510(k)

510(k) Summary

| Topic | Proposed device EVITA V800, EVITA V600 | Predicate device EVITA V800, EVITA V600 | Comments |
| --- | --- | --- | --- |
| | Volume guarantee | Volume Guarantee | Same |
| | ATC (optional for Evita V600) | ATC (optional for Evita V600) | Same |
| | AutoRelease | AutoRelease | Same |
| | Variable PS (optional) | Variable PS (optional) | Same |
| Decelerating-flow (VC modes) | Available (setting only) | Not available as manual setting | Different; comparable to Servo-U (K180098); bench, waveform met acceptance |
| 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 insp./inspiration hold | Same |
| | Expiration hold | Expiration hold | Same |
| | O2/suctioning | O2/suctioning | Same |
| | Manual disconnection | Manual disconnection | Same |
| | Nebulization | Nebulization | Same |
| | Measurement maneuver Low-flow PV loop (optional) | Measurement maneuver 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) | Diagnostics - measurement maneuver • Measurement of intrinsic PEEP (PEEPi) • Measurement of occlusion pressure (P0.1) • Measurement of maximum inspiratory effort of the patient (NIF) | Same |
| Driving pressure | Automated | Manual evaluation only | Different; automates existing maneuver; verified/validated |

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{18}

Evita V800 / Evita V600

Dräger

Traditional 510(k)
510(k) Summary

| Topic | Proposed device EVITA V800, EVITA V600 | Predicate device EVITA V800, EVITA V600 | Comments |
| --- | --- | --- | --- |
| 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 |
| Implementation language | MATLAB/Simulink | Java | Different (implementation only); algorithm/alarms unchanged; V&V equivalence |
| Gas pathway | | | |
| Gas inlet sealing ring material | Material FKM V80G1 | Material FKM V80G2 | Different; biocompatibility confirmed |
| Air-inlet filter assembly | New supplier; strap & silicone seal | Previous supplier | Different; verification/biocompatibility passed |
| Accessories/Materials/ Labeling | | | |
| Flow-sensor cable plug handle material | Ultradur B4521 PRO | Ultradur B4520 PRO | Different; biocompatibility confirmed |
| Air-intake labeling | Do not obstruct' plus prohibition symbol; location unchanged; labeling only | EMERGENCY – AIR INTAKE | Different; compliance with ISO 80601-2-12; no functional change |
| Accessories list | Removed flex hoses | Listed hoses | Different; misuse risk mitigated; labeling updated |

{19}

Evita V800 / Evita V600

Dräger

Traditional 510(k)

510(k) Summary

# Discussion of Non-clinical Testing

The Evita V800 / Evita V600 ventilator is a modified 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
- Critical care ventilators standard
- Respiratory gas monitors
- Technical System Requirements, covering:
- Risk control measures
- Technical data
- Essential safety and performance
- Accessories compatibility
- Human factors engineering, usability

Clinical Performance Data

Clinical performance data: None required to support substantial equivalence.

# Conclusion

Based on the intended use, technological characteristics, and non-clinical performance testing, the Evita V800/V600 subject device is as safe and effective as the predicate device (K222024) and is substantially equivalent. Identification of Servo-U (K180098) as a reference device supports the decelerating-flow setting comparison.

- END -

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