Who is the manufacturer of Nihon Kohden NKV-550 Series Ventilator System?

Nihon Kohden Orangemed, LLC filed the 510(k) submission for Nihon Kohden NKV-550 Series Ventilator System (K231778).

What is the FDA product code for Nihon Kohden NKV-550 Series Ventilator System?

CBK. It is classified under 21 CFR 868.5895 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for Nihon Kohden NKV-550 Series Ventilator System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Nihon Kohden NKV-550 Series Ventilator System?

Nihon Kohden NKV-550 Series Ventilator System (K192307); Hamilton-G5 (K193228).

Who can help prepare an FDA 510(k) submission like Nihon Kohden NKV-550 Series Ventilator System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Nihon Kohden NKV-550 Series Ventilator System

K231778 · Nihon Kohden Orangemed, LLC · CBK · Mar 1, 2024 · Anesthesiology

Device Facts

Record ID	K231778
Device Name	Nihon Kohden NKV-550 Series Ventilator System
Applicant	Nihon Kohden Orangemed, LLC
Product Code	CBK · Anesthesiology
Decision Date	Mar 1, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5895
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

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 Story

NKV-550 Series Ventilator System provides continuous respiratory support via invasive or non-invasive modes. System comprises graphic user interface (GUI) and breath delivery unit (BDU). GUI allows clinician parameter setting (tidal volume, inspiratory pressure), alarm configuration, and waveform/loop monitoring. BDU utilizes microprocessor-controlled pneumatic system with proportional valves to deliver oxygen (21-100%) and medical air. Device supports A/CMV, SIMV, and SPONT modes; includes new Adaptive Ventilation Mode (AVM), Adaptive Trigger (ATRIG), and Adaptive Cycle (Acycle) software features. Used in hospitals and for in-hospital transport by healthcare professionals. Output provides mechanical ventilation and real-time respiratory monitoring to assist patient breathing; aids clinical decision-making through automated breath delivery and alarm management.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, software verification, device functionality testing, human factors/usability testing, and risk management/regression analysis. Compliance with ISO 80601-2-12 requirements for critical care ventilators confirmed.

Technological Characteristics

Continuous ventilator; AC/DC power; proportional valve pneumatic system; microprocessor-controlled. Features AVM, ATRIG, and Acycle software. Meets ISO 80601-2-12. No material changes to gas path; biocompatibility unchanged.

Indications for Use

Indicated for adult, pediatric, and neonatal patients requiring invasive or noninvasive respiratory support for continuous ventilation.

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

Nihon Kohden NKV-550 Series Ventilator System (K192307)
Hamilton-G5 (K193228)

Related Devices

K181695 — Nihon Kohden NKV-550 Series Ventilator System · Nihon Kohden Orangemed, Inc. · Dec 7, 2018
K192307 — Nihon Kohden NKV-550 Series Ventilator System · Nihon Kohden Orangemed, Inc. · Jan 10, 2020
K222644 — Nihon Kohden NKV-440 Ventilator System · Nihon Kohden Orangemed, Inc. · May 31, 2023
K970460 — NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840) · Puritan Bennett Corp. · Apr 30, 1998
K181170 — Trilogy Evo Universal · Respironics, Inc. · Jul 18, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Nihon Kohden OrangeMed, Inc. Sheryl Higgins V.P. of Regulatory Affairs & Quality Assurance 1800 E. Wilshire Avenue Santa Ana, California 92705 #### Re: K231778 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: February 6, 2024 Received: February 6, 2024 #### 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 (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" (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). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 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-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 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. 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-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, Digitally signed by John S. John S. Bender -S Date: 2024.03.01 10:47:10 Bender -S -05'00' for Ethan Nyberg Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K231778 Device Name Nihon Kohden NKV-550 Series Ventilator System Indications for Use (Describe) 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. | 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 PRAStaff(@fda.hhs.gov "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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for NIHON KOHDEN. The logo consists of a blue abstract graphic on the left, followed by the company name in blue capital letters. The graphic appears to be a stylized representation of a wave or a rising sun. # Section 5 - 510(k) Summary #### Submission Date February 29, 2024 ### Submitter / Manufacturing Location Nihon Kohden OrangeMed, LLC 1800 E. Wilshire Avenue Santa Ana, CA 92705 USA Phone: (949) 502-6448 ### Company Contact Sheryl Higgins Vice President of Regulatory Affairs and Quality Assurance shiggins@orange-med.com Email: (949) 502-6448 x7012 Phone: #### Establishment Registration Number 3014631252 - Nihon Kohden OrangeMed, LLC #### 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 - Continuous ventilator Device Class: II Review Panel: Anesthesiology 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. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for NIHON KOHDEN. The logo consists of a blue square with a white design inside, followed by the text "NIHON KOHDEN" in blue. The text is in a sans-serif font and is aligned to the right of the square. ### Primary Predicate Device | Trade Name: | Nihon Kohden NKV-550 Series Ventilator System | |-----------------------|-----------------------------------------------| | 510k #: | K192307 | | Product Code: | CBK | | Manufacturer: | Nihon Kohden OrangeMed, LLC | | Establishment Reg. #: | 3014631252 | #### Secondary Predicate Device | Trade Name: | Hamilton-G5 | |-----------------------|---------------------| | 510k #: | K193228 | | Product Code: | CBK | | Manufacturer: | Hamilton Medical AG | | Establishment Reg. #: | 3001421318 | ### 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. ### 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 non-invasively to patients who require Assisted/Control Mandatory Ventilation (A/CMV), Synchronized Intermittent Mandatory Ventilation (SIMV) or Spontaneous Ventilation (SPONT). ## Indication For Use (Intended Medical Indication) 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 hospitaltype facilities, as well as, for in-hospital transportation. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for NIHON KOHDEN. The logo consists of a blue square with a white design inside, followed by the text "NIHON KOHDEN" in blue. The design inside the square features a white curved line at the bottom and a white diagonal line extending from the bottom left corner to the top right corner. ### Summary of Technical Characteristics The Nihon Kohden NKV-550 Series Ventilator System technological characteristics with the addition of Adaptive Ventilation Mode (AVM) and Adaptive Trigger (ATRIG) /Adaptive Cycle (Acycle) are substantially equivalent as compared to the predicate device and the reference device as summarized in the table below. | Table 7-1 Characteristic | Nihon Kohden NKV-550 Series Ventilator System (Modified Device) | Nihon Kohden NKV-550 Series Ventilator System (Primary Predicate Device - k192307) | Hamilton G5 (Secondary Predicated Device - k193228) | Comparison | |--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Indication for Use | 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. | 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. | The Hamilton-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care | 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 | Hospital and institutional environment where health care professionals provide patient care | Same | | Anatomical Site | Patient airways | Patient airways | Patient airways | Same | | Target Population | Adult, pediatric and neonatal patients | 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 | Met ISO 80601-2-12 requirements on essential performance of critical care ventilator | Same | | Table 7-1 Characteristic | Nihon Kohden NKV-550 Series Ventilator System (Modified Device) | Nihon Kohden NKV-550 Series Ventilator System (Primary Predicate Device - k192307) | Hamilton G5 (Secondary Predicated Device - k193228) | Comparison | | 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 | 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 | Same | | Chemicals Delivered to Patient | Medical Air and Oxygen | Medical Air and Oxygen | Medical Air and Oxygen | Same | | Delivery method to Patient | Positive pressure | Positive pressure | Positive pressure | Same | | Energy Used for Device | AC Power and DC Power (battery) | 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 | time-cycled, volume- constant, pressure- controlled | Same | | Therapy Types | Invasive, Non- invasive, O2 Therapy | Invasive, Non- invasive, O2 Therapy | Invasive, Non- invasive, O2 Therapy | Same | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image features the logo of NIHON KOHDEN. The logo consists of a stylized blue graphic on the left, resembling a stylized mountain range or waveform. To the right of the graphic, the text "NIHON KOHDEN" is displayed in a bold, sans-serif blue font. The overall design is clean and corporate, suggesting a professional and established organization. The differences between the modified Nihon Kohden NKV-550 Ventilator System and the predicate device (k192307) are as follows: - The subject device adds a breath mode, Adaptive Ventilation Mode (AVM), as well 1. as Adaptive Trigger (ATRIG)/Adaptive Cycle (AcycLE). These are software-only features that do not require any new hardware. The differences between the modified Nihon Kohden NKV-550 Ventilator System and the secondary predicate device (k193228) are described in section 12 – Substantial Equivalent Discussion. In conjunction with AVM and Adaptive Trigger (ATRIG)/Adaptive Cycle (AcYCLE), this 510(k) brings FDA up-to-date on non-significant changes implemented since the last 510(k) clearance. Therefore, the following modifications are included: - 1. Mechanical Hardware changes - 2. Software Revision History changes - 3. Labeling changes Device modifications were made in compliance with Design Control procedures. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Nihon Kohden, a Japanese medical equipment manufacturer. The logo consists of a blue abstract graphic to the left of the company name, also in blue. The graphic appears to be a stylized representation of a wave or a wing. The text is in a sans-serif font and is easily readable. Traditional 510(k): NKV-550 Series Ventilator System 510(k) #: K231778 510(k) Summary OrangeMed ### 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 - Device Functionality Testing ● Human Factors/Usability Testing - Bench Test Comparison with Reference Device - Risk Management - . 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 Nihon Kohden NKV-550 Series Ventilator System is as safe and as effective as its primary and secondary predicate devices.