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 to maximize patient safety.

AI/ML Overview

This document, K192307, is a 510(k) premarket notification for a medical device (Nihon Kohden NKV-550 Series Ventilator System). It asserts substantial equivalence to a predicate device. As such, the FDA does not require a clinical study with human patients to demonstrate device performance against specific acceptance criteria for a new AI/ML algorithm. Instead, the focus is on demonstrating that the revised device meets the same performance and safety standards as the predicate device.

Therefore, the requested information about "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML algorithm (including sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) is not applicable to this submission. This submission is for a ventilator, not an AI/ML diagnostic or therapeutic device.

The document discusses non-clinical performance data and states that clinical performance data was not required to demonstrate substantial equivalence.

Here's a breakdown of why the specific questions about an AI/ML study can't be answered from this document:

1. A table of acceptance criteria and the reported device performance: The document does not provide a table of performance acceptance criteria in the context of an AI/ML algorithm's output. It mentions "Met ISO 80601-2-12 requirements on essential performance of critical care ventilator," which refers to international safety and performance standards for ventilators, not an AI's diagnostic accuracy.
2. Sample sizes used for the test set and the data provenance: Not applicable. There is no AI/ML test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. There is no AI/ML ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable. There is no AI/ML training set.
9. How the ground truth for the training set was established: Not applicable.

What the document does provide regarding device performance:

The document states that the performance of the Nihon Kohden NKV-550 Series Ventilator System was demonstrated by various non-clinical tests performed in compliance with Design Controls:

Software Verification
Electrical Safety & EMC Testing
Device Functionality Testing
Performance of Therapy Types and Ventilation Modes
Environmental Testing
Cleaning & Disinfection
Risk Management
Accessory Compatibility
Regression Testing

The key "performance" criterion mentioned is meeting ISO 80601-2-12 requirements on essential performance of critical care ventilators. This is a general safety and effectiveness standard for the device's physical and functional operation, not related to an AI's analytical accuracy.

In summary, this 510(k) submission is for a conventional medical device (a ventilator) with minor modifications, and as such, the detailed clinical study and AI/ML-specific acceptance criteria information requested is not part of this type of regulatory submission.

Summary

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January 10, 2020

Nihon Kohden OrangeMed, Inc. Sheryl Higgins V.P. of RA/QA 1800 E. Wilshire Avenue Santa Ana, California 92705

Re: K192307

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: December 9, 2019 Received: December 12, 2019

Dear Ms. 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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

James J. Lee Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices 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) K192307

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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Image /page/3/Picture/0 description: The image shows the logo for NIHON KOHDEN. The logo consists of a blue abstract symbol on the left, resembling waves or a stylized letter 'N'. To the right of the symbol, the text "NIHON KOHDEN" is written in a bold, sans-serif font, also in blue. The overall design is clean and corporate, suggesting a company in the technology or medical field.

510(k) Summary

Submission Date

January 09, 2020

Submitter / Manufacturing Location

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

Company Contact

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

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

Predicate Device

Product:	Nihon Kohden NKV-550 Series Ventilator System
510k #:	K181695
Manufacturer:	Nihon Kohden OrangeMed, Inc.
Establishment Reg. #:	3014631252

Reference Device

Drager Medical AG & Co KG - Evita Infinity V500 (K093633) Maquet Critical Care AB - Servo U (K151814) Puritan Bennett 980 Ventilator System (K162738)

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Image /page/4/Picture/0 description: The image contains the logo for Nihon Kohden OrangeMed, Inc. The logo consists of the text "NIHON KOHDEN" in blue, with a blue graphic to the left of the text. Below the blue text is the text "Nihon Kohden OrangeMed, Inc." in orange.

Device Description

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 to maximize patient safety.

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 with the Predicate Device

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.

Table 7-1Characteristic	Nihon Kohden NKV-550 SeriesVentilator System(Proposed Device)	Nihon Kohden NKV-550 SeriesVentilator System(Predicate Device – K181695)	Comparison
Indication forUse	The Nihon Kohden NKV-550 SeriesVentilator System is intended toprovide continuous ventilation foradult, pediatric and neonatal patientswho require invasive or noninvasiverespiratory support. The NKV-550offers mandatory 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 Nihon Kohden NKV-550 SeriesVentilator System is intended toprovide continuous ventilation foradult, pediatric and neonatal patientswho require invasive or noninvasiverespiratory support. The NKV-550offers mandatory 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.	Same

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Image /page/5/Picture/0 description: The image features the logo of NIHON KOHDEN. The logo consists of a stylized blue graphic on the left, resembling a square with curved lines inside. To the right of the graphic, the text "NIHON KOHDEN" is written in a bold, sans-serif blue font. The overall design is clean and corporate, suggesting a professional and established organization.

Table 7-1Characteristic	Nihon Kohden NKV-550 SeriesVentilator System(Proposed Device)	Nihon Kohden NKV-550 SeriesVentilator System(Predicate Device – K181695)	Comparison
Environment ofUse	Hospitals, hospital-type facilitiesand in-hospital transportation forpatients who need ventilationtherapy	Hospitals, hospital-type facilitiesand in-hospital transportation forpatients who need ventilationtherapy	Same
Anatomical Site	Patient airways	Patient airways	Same
TargetPopulation	Adult, pediatric and neonatalpatients	Adult, pediatric and neonatalpatients	Same
Performance	Met ISO 80601-2-12 requirementson essential performance of criticalcare ventilator	Met ISO 80601-2-12 requirementson essential performance of criticalcare ventilator	Same
Design	Consists of a graphic user interfaceto set and monitor ventilation,breath delivery unit, breathingcircuit;Controls air and oxygen deliveriesby proportional valves through	Consists of a graphic user interfaceto set and monitor ventilation,breath delivery unit, breathingcircuit;Controls air and oxygen deliveriesby proportional valves through	Same
	microprocessors	microprocessors
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
Therapy Types	Invasive, Non-invasive, O2 Therapy	Invasive, Non-invasive, O2 Therapy	Same

The differences between the modified Nihon Kohden NKV-550 Ventilator System and the predicate device (K181695) are as follows:

1. Update.
1. Device/manufacturing improvements such as (a) More efficient cooling of the electronics module, (b) Revised sealing method between Monitor Arm (MNT5513P) and Top Housing (HSG5504M), (c) Improved IO board bracket, and (d) Additional EEPROM for secondary storage location for data.
1. Replace the Exhalation Flow Sensor (SEN5505P) any time the sensor fails calibration or after 5 cycles of cleaning and disinfection, whichever occurs first.
1. Compatible accessories.

Device modifications were made in compliance Design Control procedures.

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Image /page/6/Picture/0 description: The image shows the logo for NIHON KOHDEN. The logo consists of a blue abstract shape on the left, followed by the company name in blue, sans-serif font. The abstract shape appears to be a stylized representation of a wave or a pulse, possibly alluding to the company's focus on medical equipment. The text is in all caps and is easily readable.

Nihon Kohden OrangeMed, Inc.

Summary of Technical Characteristics with the Reference Device

The Drager V500 and Servo U are used as reference devices for the proposed Nihon Kohden NKV-550 Series Ventilator System as both the reference devices and the proposed device are critical care ventilators.

Table 7-2	Nihon Kohden NKV-550	Draeger Medical AG & Co.	Maquet Critical Care AB -	Puritan Bennett 980 Series
Characteristic	Series Ventilator System	KG - Drager V500	Servo U	Ventilator System	Comparison
	(Proposed Device)	(Reference Device K093633)	(Reference Device K151814)	(Reference Device K162738)
Indication forUse	The Nihon Kohden NKV-550Series Ventilator System isintended to provide continuousventilation for adult, pediatricand neonatal patients whorequire invasive or noninvasiverespiratory support. The NKV-550 offers mandatory andspontaneous ventilation modesas well as respiratorymonitoring. The NKV-550 isintended for use in hospitalsand hospital-type facilities, aswell as for in-hospitaltransportation.	The Evita V500 ventilation unitof the Infinity Acute CareSystem is intended for theventilation of adult, pediatricand neonatal patients. EvitaV500 offers mandatoryventilation modes andventilation modes forspontaneous breathing supportand airway monitoring. TheEvita V500 ventilation unit isused with Infinity C SeriesDraeger Medical Cockpits. TheEvita V500 ventilation unit isintended for use in differentmedical care areas. Evita V500is intended for stationary use inhospitals and medical rooms orfor patient transportation withinthe hospital.	The SERVO-U ventilatorsystem is:intended for respiratorysupport, monitoring andtreatment of neonatal,pediatric and adult patientsto be used only byhealthcare providers*to be used only inprofessional healthcarefacilities and for transportwithin these facilities	The Puritan Bennett 980 SeriesVentilator System is designed foruse on patient population sizesfrom Neonatal (NICU) throughAdult who require respiratorysupport or mechanical ventilationand weigh a minimum of 0.3kg(0.66lb). It is suitable for servicein hospital (institutions) and intra-hospital transport to providecontinuous positive pressureventilatory support using medicaloxygen and compressed medicalair from either an internal aircompressor or external air sourcesto deliver oxygen concentrationsof 21% to 100%. Ventilatorysupport can be deliveredinvasively or non-invasively topatients who require the followingtypes of ventilator support- Positive Pressure Ventilation,delivered invasively (viaendotracheal tube or tracheotomytube) or non-invasively (via maskor nasal prongs)- Assist/Control, SIMV, orSpontaneous modes of ventilation	Same
Table 7-2Characteristic	Nihon Kohden NKV-550Series Ventilator System(Proposed Device)	Draeger Medical AG & Co.KG - Drager V500(Reference Device K093633)	Maquet Critical Care AB -Servo U(Reference Device K151814)	Puritan Bennett 980 SeriesVentilator System(Reference Device K162738)	Comparison
Environmentof Use	Hospitals, hospital-typefacilities and in-hospitaltransportation for patients whoneed ventilation therapy	Hospitals, hospital-typefacilities and in-hospitaltransportation for patients whoneed ventilation therapy	Professional healthcarefacilities and for transportwithin these facilities	It is suitable for service in hospital(institutions) and intra-hospitaltransport	Same
AnatomicalSite	Patient airways	Patient airways	Patient airways	Patient airways	Same
TargetPopulation	Adult, pediatric and neonatalpatients	Adult, pediatric and neonatalpatients	Adult, pediatric and neonatalpatients	Adult, pediatric and neonatalpatients	Same
Performance	Met ISO 80601-2-12requirements on essentialperformance of critical careventilator	Met ISO 80601-2-12requirements on essentialperformance of critical careventilator	Met ISO 80601-2-12requirements on essentialperformance of critical careventilator	Met ISO 80601-2-12 requirementson essential performance ofcritical care ventilator	Same
Design	Consists of a graphic userinterface to set and monitorventilation, breath deliveryunit, breathing circuit;Controls air and oxygendeliveries by proportionalvalves through microprocessors	Consists of a graphic userinterface to set and monitorventilation, breath deliveryunit, breathing circuit;Controls air and oxygendeliveries by proportionalvalves through microprocessors	Consists of a graphic userinterface to set and monitorventilation, breath deliveryunit, breathing circuit;Controls air and oxygendeliveries by proportionalvalves throughmicroprocessors	Consists of a graphic userinterface to set and monitorventilation, breath delivery unit,breathing circuit;Controls air and oxygen deliveriesby proportional valves throughmicroprocessors	SubstantiallyEquivalent
Delivered toPatient	Medical Air and Oxygen	Medical Air and Oxygen	Medical Air and Oxygen	Medical Air and Oxygen	Same
Delivervmethod toPatient	Positive pressure	Positive pressure	Positive pressure	Positive pressure	Same
Energy Usedfor Device	AC Power and DC Power(battery)	AC Power and DC Power(battery)	AC Power and DC Power(battery)	AC Power and DC Power(battery)	Same
Controlprinciple	time-cycled, volume-constant,pressure-controlled	time-cycled, volume-constant,pressure-controlled	time-cycled, volume-constant,pressure-controlled	time-cycled, volume-constant,pressure-controlled	Same

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Image /page/7/Picture/0 description: The image shows the logo for NIHON KOHDEN. The logo consists of a blue abstract symbol on the left and the company name "NIHON KOHDEN" in blue capital letters on the right. The symbol appears to be a stylized representation of a wave or a rising sun. The overall design is clean and corporate.

Nihon Kohden OrangeMed, Inc.

Traditional 510(k): NKV-550 Series Ventilator System k: 192307 510(k) Summary

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Image /page/8/Picture/0 description: The image contains the logo for NIHON KOHDEN. The logo consists of a blue abstract symbol on the left, followed by the company name "NIHON KOHDEN" in blue capital letters. The symbol appears to be a stylized representation of a wave or light beam.

Nihon Kohden OrangeMed, Inc.

Traditional 510(k): NKV-550 Series Ventilator System k: 192307 510(k) Summary

Nihon Kohden NKV-550 Draeger Medical AG & Co. Maquet Critical Care AB -Puritan Bennett 980 Series Table 7-2 Series Ventilator System KG - Drager V500 Servo U Ventilator System Comparison Characteristic (Reference Device K093633) (Reference Device K151814) (Reference Device K162738) (Proposed Device) Therapy Substantially Invasive, Non-invasive, O2 Intubated, Non-invasive, O2 Invasive and Non-invasive Invasive and Non-invasive Types Therapy Therapy Equivalent

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Image /page/9/Picture/0 description: The image contains the logo for Nihon Kohden OrangeMed, Inc. The logo consists of a blue abstract graphic to the left of the text "NIHON KOHDEN" in blue, block letters. Below this, the text "Nihon Kohden OrangeMed, Inc." is written in orange. The logo appears to be for a medical or healthcare-related company.

Summary of Non-Clinical Performance Data

Performance of the Nihon Kohden NKV-550 Series Ventilator System was demonstrated by the following testing performed in compliance with Design Controls:

. Software Verification
Electrical Safety & EMC Testing ●
. Device Functionality Testing
Performance of Therapy Types and Ventilation Modes
Environmental
Cleaning & Disinfection ●
. Risk Management
Accessory Compatibility
Regression ●

Additional biocompatibility testing was not required since no material changes were made to the gas path of the ventilator.

Summary of Clinical Performance Data

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

Conclusion

The evaluation and testing performed in compliance with Design Controls demonstrates that the modified Nihon Kohden NKV-550 Series Ventilator System is substantially equivalent to the legally marketed predicate device identified herein.

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).