The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. The NKV-550 offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The NKV-550 is intended for use in hospitals and hospital-type facilities, as well as, for in-hospital transportation.

Device Description

The Nihon Kohden NKV-550 Series Ventilator System consists of a graphic user interface (GUI) and a breath delivery unit (BDU). The GUI allows clinicians to set ventilator control parameters such as tidal volume and inspiratory pressure, to set alarm limits such as high inspiratory pressure alarm, to view monitored numeric values, to view waveform and loops, and to operate various features through the apps.

The BDU contains a microprocessor that receives inputs from the electronic system and controls the pneumatic system for breath delivery to the patient. It also provides various alarms, a safety valve, and other design features.

AI/ML Overview

The Nihon Kohden NKV-550 Series Ventilator System's acceptance criteria and the study proving it meets these criteria are described below.

1. Table of Acceptance Criteria and Reported Device Performance

Technical Characteristic	Acceptance Criteria (Predicate Device: Draeger Evita Infinity V500, K093633)	Reported Device Performance (Nihon Kohden NKV-550 Series Ventilator System)	Comparison
Indication for Use	Intended for the ventilation of adult, pediatric and neonatal patients. Offers mandatory ventilation modes and ventilation modes for spontaneous breathing support and airway monitoring. Intended for use in different medical care areas (hospitals, medical rooms) or for patient transportation within the hospital.	Intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. Offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. Intended for use in hospitals and hospital-type facilities, as well as for in-hospital transportation.	Same
Environment of Use	Hospitals, hospital-type facilities and in-hospital transportation for patients who need ventilation therapy	Hospitals, hospital-type facilities and in-hospital transportation for patients who need ventilation therapy	Same
Anatomical Site	Patient airways	Patient airways	Same
Target Population	Adult, pediatric and neonatal patients	Adult, pediatric and neonatal patients	Same
Performance	Met ISO 80601-2-12 requirements on essential performance of critical care ventilator	Met ISO 80601-2-12 requirements on essential performance of critical care ventilator	Same
Waveform Comparison	Comparable waveform test result	Comparable waveform test result	Substantially equivalent
Design	Consists of a graphic user interface to set and monitor ventilation, breath delivery unit, breathing circuit; Controls air and oxygen deliveries by proportional valves through microprocessors	Consists of a graphic user interface to set and monitor ventilation, breath delivery unit, breathing circuit; Controls air and oxygen deliveries by proportional valves through microprocessors	Substantially equivalent
Chemicals Delivered to Patient	Medical Air and Oxygen	Medical Air and Oxygen	Same
Delivery method to Patient	Positive pressure	Positive pressure	Same
Energy Used for Device	AC Power and DC Power (battery)	AC Power and DC Power (battery)	Same
Control principle	Time-cycled, volume-constant, pressure-controlled	Time-cycled, volume-constant, pressure-controlled	Same
Therapy Types	Intubated, Non-invasive, O2 Therapy	Invasive, Non-invasive, O2 Therapy	Same

2. Sample size used for the test set and the data provenance:

The document does not explicitly state a "test set" in the context of clinical data for performance evaluation. Instead, the performance was demonstrated through non-clinical testing against various standards and comparisons to a predicate device. Therefore, a specific sample size for a test set of patient data is not applicable here as clinical performance data was not required for substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as clinical performance data was not required, and thus, no ground truth established by experts on patient data was utilized for the device's clearance. The "ground truth" for the non-clinical testing was established by the requirements and thresholds set by the relevant international standards (e.g., ISO 80601-2-12, ANSI AAMI ES60601-1, etc.).

4. Adjudication method for the test set:

Not applicable, as clinical performance data and expert-established ground truth were not used for the device's clearance.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a ventilator system, not an AI-assisted diagnostic or interpretation tool that would involve human readers or MRMC studies.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The device's performance was evaluated in a standalone manner by testing against established international standards. The listed "Summary of Non-Clinical Performance Data" includes:

Software Verification
Electrical Safety & EMC Testing
Agency Testing to Applicable Standards
Device Functionality Testing
Performance of Therapy Types and Ventilation Modes
Product Endurance
Power Performance
Environmental
Cleaning & Disinfection
Gas Path Biocompatibility
Human Factors/Usability Testing
Risk Management
Waveform Comparison with Predicate
Accessory Compatibility

These tests assess the device's intrinsic functions and compliance with safety and performance requirements, which can be considered standalone performance.

7. The type of ground truth used:

For the non-clinical performance evaluation, the "ground truth" was derived from:

International Standards: e.g., ISO 80601-2-12 (essential performance of critical care ventilators), ANSI AAMI ES60601-1 (general requirements for basic safety and essential performance), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-1-6 (usability), IEC 60601-1-8 (alarm systems), IEC 62133 (batteries), ISO 80601-2-55 (respiratory gas monitor), ISO 10993-1 (biological evaluation), ISO 18562-1 to 3 (biocompatibility of breathing gas pathways).
Predicate Device Characteristics: The Nihon Kohden NKV-550 Series Ventilator System was compared to the predicate device (Draeger Evita Infinity V500) based on its documented technical characteristics and performance, aiming for substantial equivalence.

8. The sample size for the training set:

Not applicable, as this device does not appear to involve machine learning or AI models that would require a training set of data. Its performance is based on engineering design and meeting pre-defined physical and functional specifications.

9. How the ground truth for the training set was established:

Not applicable, as there is no mention of a training set or machine learning components in the provided documentation.

Summary

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December 7, 2018

Nihon Kohden OrangeMed, Inc. Sheryl Higgins Director of RA/OA 1800 E. Wilshire Ave. Santa Ana, California 92705

Re: K181695

Trade/Device Name: Nihon Kohden NKV-550 Series Ventilator System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK Dated: November 6, 2018 Received: November 7, 2018

Dear Sheryl Higgins:

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 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

James J. Lee -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

Nihon Kohden NKV-550 Series Ventilator System

Indications for Use (Describe)

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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Section 5 - 510(k) Summary

Date

December 07, 2018

Submitter / Manufacturing Location

Nihon Kohden OrangeMed, Inc. 1800 E. Wilshire Avenue Santa Ana, CA 92705 USA

Company Contact

Sheryl Higgins - Director of Regulatory Affairs and Quality Assurance Email: shiggins@orange-med.com Phone: (949) 502-6448 x7012 Fax: (949) 748-8867

Common Name of Device

Critical Care Ventilator

Trade Name

Nihon Kohden NKV-550 Series Ventilator System

Classification Name

Product Code: CBK - Ventilator, Continuous, Facility Use Regulation Number: 21 CFR 868:5895 Device Class: II Review Panel: Anesthesiology

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Predicate Device

Product:	Evita Infinity® V500
510k #:	K093633
Manufacturer:	Draegerwerk AG & Co. KGaA
Establishment Reg. #:	9611500

Device Description

Indication For Use

Product Intended Function

The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation using medical oxygen and external sources of compressed medical air to deliver oxygen concentrations of 21% to 100%. Ventilatory support is intended to be delivered invasively or noninvasively to patients who require Assisted/Control Mandatory Ventilation (A/CMV), Synchronized Intermittent Mandatory Ventilation (SIMV) or Spontaneous Ventilation (SPONT).

Summary of Technical Characteristics

The Nihon Kohden NKV-550 Series Ventilator System technological characteristics are substantially equivalent as compared to the predicate device and are summarized in the table below.

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TechnicalCharacteristic	Nihon Kohden NKV-550 SeriesVentilator System	Draeger Evita V500 Ventilation Unit*(Predicate Device - K093633)	Comparison
Indication forUse	The Nihon Kohden NKV-550Series Ventilator System isintended to provide continuousventilation for adult, pediatric andneonatal patients who requireinvasive or noninvasive respiratorysupport. The NKV-550 offersmandatory and spontaneousventilation modes as well asrespiratory monitoring. The NKV-550 is intended for use in hospitalsand hospital-type facilities, as wellas for in-hospital transportation.	The Evita V500 ventilation unit of theInfinity Acute Care System is intendedfor the ventilation of adult, pediatric andneonatal patients. Evita V500 offersmandatory ventilation modes andventilation modes for spontaneous breathing support and airwaymonitoring. The Evita V500 ventilationunit is used with Infinity C SeriesDraeger Medical Cockpits. The EvitaV500 ventilation unit is intended for usein different medical care areas. EvitaV500 is intended for stationary use inhospitals and medical rooms or forpatient transportation within the hospital.	Same
Environment ofUse	Hospitals, hospital-type facilitiesand in-hospital transportation forpatients who need ventilationtherapy	Hospitals, hospital-type facilities and in-hospital transportation for patients whoneed ventilation therapy	Same
Anatomical Site	Patient airways	Patient airways	Same
TargetPopulation	Adult, pediatric and neonatalpatients	Adult, pediatric and neonatal patients	Same
Performance	Met ISO 80601-2-12 requirementson essential performance of criticalcare ventilator	Met ISO 80601-2-12 requirements onessential performance of critical careventilator	Same
WaveformComparison	Comparable waveform test result	Comparable waveform test result	Substantiallyequivalent
Design	Consists of a graphic user interfaceto set and monitor ventilation,breath delivery unit, breathingcircuit;Controls air and oxygen deliveriesby proportional valves throughmicroprocessors	Consists of a graphic user interface to setand monitor ventilation, breath deliveryunit, breathing circuit;Controls air and oxygen deliveries byproportional valves throughmicroprocessors	Substantiallyequivalent
ChemicalsDelivered toPatient	Medical Air and Oxygen	Medical Air and Oxygen	Same
Delivery methodto Patient	Positive pressure	Positive pressure	Same
Energy Used forDevice	AC Power and DC Power (battery)	AC Power and DC Power (battery)	Same
Control principle	Time-cycled, volume-constant,pressure-controlled	Time-cycled, volume-constant, pressure-controlled	Same
TechnicalCharacteristic	Nihon Kohden NKV-550 SeriesVentilator System	Draeger Evita V500 Ventilation Unit*(Predicate Device – K093633)	Comparison
Therapy Types	Invasive, Non-invasive, O2Therapy	Intubated, Non-invasive, O2 Therapy	Same

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*Information from manufacturer's "Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.1" (Ed: 3 - 2010-08)

Summary of Non-Clinical Performance Data

Performance of the Nihon Kohden NKV-550 Series Ventilator System was demonstrated by the following:

Software Verification
Electrical Safety & EMC Testing
Agency Testing to Applicable Standards
Device Functionality Testing ●
Performance of Therapy Types and ● Ventilation Modes
Product Endurance
Power Performance .
Environmental ●
Cleaning & Disinfection ●
Gas Path Biocompatibility ●
Human Factors/Usability Testing
. Risk Management
. Waveform Comparison with Predicate
Accessory Compatibility

Where applicable, the Nihon Kohden NKV-550 Series Ventilator System has been tested in compliance with the following standards:

Standard	Testing
ISO 80601-2-122011/04/15 Ed: 1;CORR 1: 2011/10/15	Medical Electrical Equipment - Part 2-12: Particular Requirements for BasicSafety and Essential Performance of Critical Care Ventilators
ANSI AAMI ES60601-12005+AC1;A2 (R2012)	Medical Electrical Equipment - Part 1: General Requirements for Basic Safetyand Essential Performance
IEC 60601-1-22014/02/25 Ed: 4	Medical Electrical Equipment - Part 1-2: General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
IEC 60601-1-62013/10/28 Ed: 3.1	Medical electrical equipment - Part 1-6: General requirements for safety -Collateral Standard: Usability
IEC 60601-1-82012/11/28 Ed: 2.1	Medical Elec. Equip. - Part 1-8: General Req. for Basic Safety & EssentialPerf. - Collateral Standard: General Req., Tests & Guidance for AlarmSystems in Medical Elec. Equip. & Medical Elec. Systems
IEC 621332012/12/06 Ed: 2.0	Secondary cells and batteries containing alkaline or other non-acid electrolytes- Safety requirements for portable sealed secondary lithium cells, and forbatteries made from them, for use in portable applications - Part 2: Lithiumsystems
ISO 80601-2-552011/12/15 Ed: 1	Medical Electrical Equipment - Part 2-55: Particular Requirements for TheBasic Safety and Essential Performance of Respiratory Gas Monitor
ISO 10993-12009/10/15 Ed: 4; TC 1 2010	Biological Evaluation of Medical Devices - Part 1: Evaluation and Testingwithin a Risk Management Process
ISO 18562-1 to 32017/03 Ed: 1	Biocompatibility Evaluation of Breathing Gas Pathways inHealthcare Applications

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Summary of Clinical Performance Data

Not Applicable - Clinical performance data was not required to demonstrate substantial equivalence.

Conclusion

The evaluation and testing performed demonstrates that the Nihon Kohden NKV-550 Series Ventilator System is as safe and as effective as the predicate device.

Regulation Number and Section

§ 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).