Nihon Kohden NKV-440 Ventilator System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable. May 31, 2023 Nihon Kohden OrangeMed, Inc. Sheryl Higgins Vice President of Regulatory Affairs & Quality Assurance 1800 E. Wilshire Avenue Santa Ana, California 92705 Re: K222644 Trade/Device Name: Nihon Kohden NKV-440 Ventilator System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK Dated: May 4, 2023 Received: May 4, 2023 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 {1}------------------------------------------------ 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 (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 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, # Ethan E. Nyberg -S for James Lee, Ph.D. Division 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222644 Device Name Nihon Kohden NKV-440 Ventilator System ### Indications for Use (Describe) The Nihon Kohden NKV-440 Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. The NKV-440 offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The NKV-440 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) | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | |-------------------------------------------------------------------------------------------------| | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | ### 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 contains the logo for Nihon Kohden OrangeMed, Inc. The logo consists of the company's name in two lines of text. The first line, "NIHON KOHDEN", is in blue, while the second line, "Nihon Kohden OrangeMed, Inc.", is in orange. To the left of the company name is a blue graphic element. # 510(k) Summary #### 1. Date May 04, 2023 #### 2. Submitter / Manufacturing Location Nihon Kohden OrangeMed, Inc. 1800 E. Wilshire Avenue Santa Ana, CA 92705 USA #### 3. Company Contact | Primary: | Sheryl Higgins<br>Vice President of Regulatory Affairs and Quality Assurance | |----------|------------------------------------------------------------------------------| | Email: | shiggins@orange-med.com | | Phone: | (949) 502-6448 x7012 | | | Secondary: Jacqueline Villanueva | |--------|----------------------------------| | | Director of Quality Assurance | | Email: | jvillanueva@orange-med.com | | Phone: | (949) 502-6448 x7045 | #### Common Name of Device 4. Critical Care Ventilator #### 5. Trade Name Nihon Kohden NKV-440 Ventilator System #### Classification Name 6. | Product Code: | CBK - Ventilator, Continuous, Facility Use | |--------------------|--------------------------------------------| | Regulation Number: | 21 CFR 868.5895 Continuous Ventilator | | Device Class: | II | | Review Panel: | Anesthesiology | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for Nihon Kohden OrangeMed, Inc. The logo consists of a blue graphic element on the left, followed by the text "NIHON KOHDEN" in blue. Below this, the text "Nihon Kohden OrangeMed, Inc." is displayed in orange. The logo is simple and professional, likely representing a medical or technology company. #### 7. Predicate Device | Product: | Nihon Kohden NKV-550 Ventilator System | |---------------|----------------------------------------| | 510k #: | K192307 | | Manufacturer: | Nihon Kohden OrangeMed, Inc. | #### 8. Reference Device | Product: | Hamilton-C3 | |---------------|---------------------| | 510k #: | K201306 | | Manufacturer: | Hamilton Medical AG | #### 9. Description of Device The NKV-440 is a servo-controlled ventilator that is designed to meet the gas delivery and performance requirements for neonate through adult patients. The NKV-440 design is comprised of two major components, a Breath Delivery Unit (BDU) and a Graphic User Interface (GUI). The GUI allows clinicians to set ventilator control parameters such as PEEP and inspiratory pressure, to set alarm limits such as high inspiratory pressure alarm, to view monitored numeric values, and to view waveforms. The BDU assembly contains a blower and the electronics required to perform breath delivery. Ambient air is taken into the blower and mixed with oxygen which is flow rate controlled by a proportional valve. The mixed gas is provided to the patient. The microprocessor controls the blower and the proportional valve to deliver the pressure and oxygen concentration which are set by the user. It also provides various alarms and other design features to maximize patient safety. ### 10. Product Intended Function The Nihon Kohden NKV-440 Ventilator System is intended to provide continuous ventilation using medical oxygen and an internal source of 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). {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Nihon Kohden OrangeMed, Inc. The logo consists of a blue square with a white design on the left, followed by the text "NIHON KOHDEN" in blue. Below that, the text "Nihon Kohden OrangeMed, Inc." is written in orange. ### 11. Indication for Use (Intended Medical Indication) The Nihon Kohden NKV-440 Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. The NKV-440 offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The NKV-440 is intended for use in hospitals and hospitaltype facilities, as well as, for in-hospital transportation. # 12. Intended Patient Population The intended patient population includes neonate through adult patients who require invasive or non-invasive respiratory support. # 13. Intended Part of the Body or Type of Tissue Applied to or Interacted with The device does not come into direct contact with the patient. The device is considered to be externally communicating with the patient airway because it delivers air/oxygen to the patient respiratory system. ### 14. Intended Environment of Use (Use Environment) The device is intended for use in hospitals and hospital-type facilities, which provide respiratory care for patients requiring respiratory support. The device may be used for intra-hospital transport within a hospital or hospital-type facility. The device is not intended for transport between hospitals or hospital-type facilities, therefore is not a transport ventilator as defined by ISO 80601-2-12 Section 201.1.1. The device is not to be used in the presence of flammable anesthetics and MRI applications. ### 15. Summary of Technical Characteristics The technological characteristics of the Nihon Kohden NKV-440 Ventilator System are substantially equivalent to the predicate device as compared and summarized in the table below. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for NIHON KOHDEN. The logo consists of a blue abstract symbol on the left, resembling a stylized wave or mountain range. To the right of the symbol is the company name, "NIHON KOHDEN," also in blue. The font is sans-serif and appears to be a bold typeface. Nihon Kohden OrangeMed, Inc. | Table 12-1 | Nihon Kohden<br>OrangeMed, Inc. | Nihon Kohden<br>OrangeMed, Inc. | Comparison | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company | | | | | Establishment | 3014631252 | 3014631252 | | | MODEL | NKV-440 | NKV-550 | | | 510(k) | This Submission | K192307 | | | Indications for<br>Use | The Nihon Kohden NKV-<br>440 Ventilator System is<br>intended to provide<br>continuous ventilation for<br>adult, pediatric and neonatal<br>patients who require invasive<br>or noninvasive respiratory<br>support. The NKV-440<br>offers mandatory and<br>spontaneous ventilation<br>modes as well as respiratory<br>monitoring. The NKV-440 is<br>intended for use in hospitals<br>and hospital-type facilities,<br>as well as, for in-hospital<br>transportation. | The Nihon Kohden NKV-<br>550 Series Ventilator System<br>is intended to provide<br>continuous ventilation for<br>adult, pediatric and neonatal<br>patients who require invasive<br>or noninvasive respiratory<br>support. The NKV-550<br>offers mandatory and<br>spontaneous ventilation<br>modes as well as respiratory<br>monitoring. The NKV-550 is<br>intended for use in hospitals<br>and hospital-type facilities,<br>as well as, for in-hospital<br>transportation. | Same | | Clinical<br>Conditions | Hospitals, hospital-type<br>facilities and in-hospital<br>transportation for patients<br>who need ventilation therapy | Hospitals, hospital-type<br>facilities and in-hospital<br>transportation for patients<br>who need ventilation therapy | Same | | Anatomical Site | Patient airways | Patient airways | Same | | Target<br>Population | Adult, pediatric and neonatal<br>patients | Adult, pediatric and neonatal<br>patients | Same | | Users | Trained clinicians, not lay<br>users | Trained clinicians, not lay<br>users | Same | | Clinical<br>Performance | Met ISO 80601-2-12<br>requirements on essential<br>performance of critical care<br>ventilator | Met ISO 80601-2-12<br>requirements on essential<br>performance of critical care<br>ventilator | Same | | Waveform<br>Comparison | Comparable waveform test<br>result | Comparable waveform test<br>result | Similar | | Table 12-1 | Nihon Kohden<br>OrangeMed, Inc. | Nihon Kohden<br>OrangeMed, Inc. | | | Company | OrangeMed, Inc. | OrangeMed, Inc. | | | Establishment | 3014631252 | 3014631252 | Comparison | | MODEL | NKV-440 | NKV-550 | | | 510(k) | This Submission | K192307 | | | Design | Consists of a graphic user<br>interface to set and monitor<br>ventilation, breath delivery<br>unit, breathing circuit, and<br>cart;<br>Controls air and oxygen<br>deliveries by a blower and<br>proportional valve through<br>microprocessors | Consists of a graphic user<br>interface to set and monitor<br>ventilation, breath delivery<br>unit, breathing circuit, and<br>cart;<br>Controls air and oxygen<br>deliveries by proportional<br>valves through<br>microprocessors | Similar<br>In the NKV-440, a built-<br>in blower draws the room<br>air in and controls the air<br>delivery. In the NKV-<br>550, an external air<br>compressor is the air gas<br>source, and a built-in<br>proportional valve<br>controls the air delivery. | | Conditions of<br>Use | Hospitals, hospital-type<br>facilities and in-hospital<br>transportation | Hospitals, hospital-type<br>facilities and in-hospital<br>transportation | Same | | Chemicals<br>Deployed to<br>Patient | Air and oxygen | Air and oxygen | Same | | Delivery method<br>to Patient | Positive pressure | Positive pressure | Same | | Energy Used for<br>Device | AC Power and internal DC<br>Power (Li-ion battery) | AC Power and internal DC<br>Power (Li-ion battery) | Same<br>Exactly same battery<br>packs are used in both<br>NKV-440 and NKV-550. | | Control<br>principle | time-cycled, volume-<br>constant, pressure-controlled | time-cycled, volume-<br>constant, pressure-controlled | Same | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image features the logo of NIHON KOHDEN. The logo consists of a blue square with a white abstract design inside, resembling a stylized wave or a rising sun. To the right of the square is the text "NIHON KOHDEN" in a bold, sans-serif font, also in blue. ### Nihon Kohden OrangeMed, Inc. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for NIHON KOHDEN. The logo consists of a blue square with a white curved line running through it, 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. Nihon Kohden OrangeMed, Inc. | Table 12-1 | Nihon Kohden | Nihon Kohden | Comparison | |------------------------------------|---------------------------|---------------------------|------------| | Company | OrangeMed, Inc. | OrangeMed, Inc. | | | Establishment | 3014631252 | 3014631252 | | | MODEL | NKV-440 | NKV-550 | | | 510(k) | This Submission | K192307 | | | Specifications:<br>Breathing Modes | Invasive Ventilation: | Invasive Ventilation: | | | | A/CMV-PC | A/CMV-PC | Same | | | A/CMV-VC | A/CMV-VC | | | | A/CMV-PRVC | A/CMV-PRVC | | | | SIMV-PC-PS | SIMV-PC-PS | | | | SIMV-VC-PS | SIMV-VC-PS | | | | SIMV-PRVC-PS | SIMV-PRVC-PS | | | | SPONT-CPAP | SPONT-CPAP | | | | SPONT-PS | SPONT-PS | | | | SPONT-VS | SPONT-VS | | | | APRV | APRV | | | | Non-Invasive Ventilation: | Non-Invasive Ventilation: | | | | A/CMV-PC | A/CMV-PC | | | | SIMV-PC-PS | SIMV-PC-PS | | | | SPONT-CPAP | SPONT-CPAP | | | | SPONT-PS | SPONT-PS | | | | APRV | APRV | | | | CPAP | CPAP | | | | O2 Therapy | O2 Therapy | | ### 16. Summary of Non-Clinical Performance Data Performance of the Nihon Kohden NKV-440 Ventilator was demonstrated by the following: - Agency Testing to Applicable Standards - Performance of Ventilation Modes . and Control Settings - Device/Software Functionality - . Power performance with AC power, External Battery, and Backup Battery - . Essential Performance and Worst Case VBS - Environmental - Waveform Comparison with Predicate - . Product Endurance/Reliability - . Biocompatibility - . Cleaning & Disinfection - EMC and Electrical Safety ● - Human Factors/Usability - Risk Management - Compatibility with 3rd Party Devices ● {9}------------------------------------------------ Image /page/9/Picture/0 description: The image features the logo for Nihon Kohden. The logo consists of a blue abstract graphic to the left of the company name, "NIHON KOHDEN," which is also in blue. Below the main logo, in orange text, is the text "Nihon Kohden OrangeMed, Inc." Where applicable, the Nihon Kohden NKV-440 Ventilator has been tested in compliance with the following standards: | Standard | Title | |----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | AIM 7351731 | Medical Electrical Equipment & System Electromagnetic Immunity Test for<br>RFID Readers | | Rev. 2 2017-02 | | | ANSI AAMI ES 60601-1 | Medical electrical equipment - Part 1: General requirements for basic safety | | 2005+AC1;A2 (R2012) | and essential performance (IEC 60601-1:2005, MOD) | | IEC 60601-1 | Medical Electrical Equipment - Part 1: General Requirements For Basic Safety<br>And Essential Performance | | Ed. 3.1 2012-08 | | | IEC 60601-1-2 | Medical Electrical Equipment - Part 1-2: General Requirements for Safety -<br>Collateral Standard: Electromagnetic Compatibility - Requirements and Tests | | Ed. 4.1 2020-09 | | | IEC 60601-1-6 | Medical electrical equipment - Part 1-6: General requirements for safety -<br>Collateral Standard: Usability | | Ed. 3.1 2013-10 | | | IEC 60601-1-8 | Medical Elec. Equip. - Part 1-8: General Req. for Basic Safety & Essential<br>Perf. - Collateral Standard: General Req., Tests & Guidance for Alarm<br>Systems in Medical Elec. Equip. & Medical Elec. Systems | | Ed 2.1 2012-11 | | | IEC 62133 | Secondary cells and batteries containing alkaline or other non-acid electrolytes<br>- Safety requirements for portable sealed Secondary cells, and for batteries<br>made from them, for use in portable applications | | Ed. 2.0 2012-12 | | | IEC 62304 | Medical device software - Software life cycle processes | | Ed. 1.1 2015-06 | | | IEC 62366-1 | Medical devices - Application of usability engineering to medical devices | | Ed. 1.0 2015-02 | | | ISO 10993-1 | Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing<br>within a Risk Management Process | | Ed. 5 2018-08 | | | ISO 14971 | Medical devices - Application of risk management to medical devices | | Ed. 3 2019-12 | | | ISO 18562-1 | Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare<br>Applications | | Ed. 1 2017-03 | | | ISO 80601-2-12 | Medical Electrical Equipment - Part 2-12: Particular Requirements for Basic<br>Safety and Essential Performance of Critical Care Ventilators | | Ed. 2 2020-02 | | | ISO 80601-2-55 | Medical Electrical Equipment – Part 2-55: Particular Requirements for The<br>Basic Safety and Essential Performance of Respiratory Gas Monitor | | Ed. 2 2018-02 | | | ISO 80601-2-61 | Medical electrical equipment - Part 2-61: Particular requirements for basic<br>safety and essential performance of pulse oximeter equipment | | Ed 2 2017-12 | | {10}------------------------------------------------ # 17. Summary of Animal Performance Data Not Applicable - Animal performance data was not required to demonstrate substantial equivalence. ### 18. Summary of Clinical Performance Data Not Applicable – Clinical performance data was not required to demonstrate substantial equivalence. ### 19. Conclusion The evaluation and testing performed demonstrates that the Nihon Kohden NKV-440 Ventilator System is substantially equivalent the predicate device.