Nihon Kohden NKV-550 Series Ventilator System

K181695 · Nihon Kohden Orangemed, Inc. · CBK · Dec 7, 2018 · Anesthesiology

Device Facts

• Record ID: K181695
• Device Name: Nihon Kohden NKV-550 Series Ventilator System
• Applicant: Nihon Kohden Orangemed, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Dec 7, 2018
• 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; utilizes medical oxygen and compressed air to deliver 21-100% oxygen concentrations. System comprises graphic user interface (GUI) and breath delivery unit (BDU). Clinicians use GUI to set parameters (tidal volume, inspiratory pressure), configure alarm limits, and monitor waveforms/loops. BDU uses microprocessors to control pneumatic system via proportional valves for breath delivery. Used in hospitals and during in-hospital transport. Output includes ventilation therapy and patient monitoring data; assists clinical decision-making by providing controlled respiratory support and real-time physiological feedback. Benefits patients by maintaining adequate ventilation and oxygenation.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including software verification, electrical safety/EMC, device functionality, therapy/mode performance, product endurance, power performance, environmental testing, cleaning/disinfection, gas path biocompatibility, human factors/usability, risk management, and waveform comparison.

Technological Characteristics

Critical care ventilator; positive pressure delivery; time-cycled, volume-constant, pressure-controlled. Components: GUI and BDU with microprocessors and proportional valves. Power: AC and DC (battery). Connectivity: Not specified. Biocompatibility: ISO 10993-1, ISO 18562-1 to 3. Safety/Performance: ISO 80601-2-12, ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62133, ISO 80601-2-55.

Indications for Use

Indicated for adult, pediatric, and neonatal patients requiring invasive or noninvasive respiratory support via mandatory or spontaneous ventilation modes.

Regulatory Classification

Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

Predicate Devices

• Evita Infinity® V500 (k093633)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 ([e-mail]) or phone [phone] 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)

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):

| <span></span> | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|------------------------------------------------------------|
| <span></span> | <span></span> 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 and OrangeMed Inc. The Nihon Kohden logo is a blue square with a white design inside, followed by the text "NIHON KOHDEN" in blue. Below that, the text "OrangeMed Inc." is written in orange.

## 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: [e-mail] Phone: [phone] x7012 Fax: [phone]

#### 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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Image /page/4/Picture/0 description: The image shows the logo for Nihon Kohden Orangemed Inc. The text "NIHON KOHDEN" is in blue, and the text "OrangeMed Inc." is in orange. To the left of the text is a blue graphic.

#### Predicate Device

| Product: | Evita Infinity® V500 |
|-----------------------|---------------------------|
| 510k #: | k093633 |
| Manufacturer: | Draegerwerk AG & Co. KGaA |
| Establishment Reg. #: | 9611500 |

#### 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.

#### 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.

#### 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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Image /page/5/Picture/0 description: The image contains the logo for NIHON KOHDEN, a medical equipment manufacturer. The logo consists of a blue abstract symbol on the left, followed by the company name in blue capital letters. Below the company name, "OrangeMed Inc." is written in orange letters. The logo is simple and professional, reflecting the company's focus on medical technology.

| Technical<br>Characteristic | Nihon Kohden NKV-550 Series<br>Ventilator System | Draeger Evita V500 Ventilation Unit*<br>(Predicate Device - k093633) | Comparison |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Indication for<br>Use | The Nihon Kohden NKV-550<br>Series Ventilator System is<br>intended to provide continuous<br>ventilation for adult, pediatric and<br>neonatal patients who require<br>invasive or noninvasive respiratory<br>support. The NKV-550 offers<br>mandatory and spontaneous<br>ventilation modes as well as<br>respiratory monitoring. The NKV-<br>550 is intended for use in hospitals<br>and hospital-type facilities, as well<br>as for in-hospital transportation. | The Evita V500 ventilation unit of the<br>Infinity Acute Care System is intended<br>for the ventilation of adult, pediatric and<br>neonatal patients. Evita V500 offers<br>mandatory ventilation modes and<br>ventilation modes for spontaneous breathing support and airway<br>monitoring. The Evita V500 ventilation<br>unit is used with Infinity C Series<br>Draeger Medical Cockpits. The Evita<br>V500 ventilation unit is intended for use<br>in different medical care areas. Evita<br>V500 is intended for stationary use in<br>hospitals and medical rooms or for<br>patient transportation within the hospital. | Same |
| Environment of<br>Use | Hospitals, hospital-type facilities<br>and in-hospital transportation for<br>patients who need ventilation<br>therapy | Hospitals, hospital-type facilities and in-<br>hospital transportation for patients who<br>need ventilation therapy | Same |
| Anatomical Site | Patient airways | Patient airways | Same |
| Target<br>Population | Adult, pediatric and neonatal<br>patients | Adult, pediatric and neonatal patients | Same |
| Performance | Met ISO 80601-2-12 requirements<br>on essential performance of critical<br>care ventilator | Met ISO 80601-2-12 requirements on<br>essential performance of critical care<br>ventilator | Same |
| Waveform<br>Comparison | Comparable waveform test result | Comparable waveform test result | Substantially<br>equivalent |
| Design | Consists of a graphic user interface<br>to set and monitor ventilation,<br>breath delivery unit, breathing<br>circuit;<br>Controls air and oxygen deliveries<br>by proportional valves through<br>microprocessors | Consists of a graphic user interface to set<br>and monitor ventilation, breath delivery<br>unit, breathing circuit;<br>Controls air and oxygen deliveries by<br>proportional valves through<br>microprocessors | Substantially<br>equivalent |
| Chemicals<br>Delivered to<br>Patient | Medical Air and Oxygen | Medical Air and Oxygen | Same |
| Delivery method<br>to Patient | Positive pressure | Positive pressure | Same |
| Energy Used for<br>Device | AC Power and DC Power (battery) | AC Power and DC Power (battery) | Same |
| Control principle | Time-cycled, volume-constant,<br>pressure-controlled | Time-cycled, volume-constant, pressure-<br>controlled | Same |
| Technical<br>Characteristic | Nihon Kohden NKV-550 Series<br>Ventilator System | Draeger Evita V500 Ventilation Unit*<br>(Predicate Device – k093633) | Comparison |
| Therapy Types | Invasive, Non-invasive, O2<br>Therapy | Intubated, Non-invasive, O2 Therapy | Same |

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Image /page/6/Picture/0 description: The image shows the logo for Nihon Kohden and OrangeMed Inc. The Nihon Kohden logo is in blue and consists of a stylized wave graphic and the company name. Below that, in orange text, is the name OrangeMed Inc.

*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 80601-2-12<br>2011/04/15 Ed: 1;<br>CORR 1: 2011/10/15 | Medical Electrical Equipment - Part 2-12: Particular Requirements for Basic<br>Safety and Essential Performance of Critical Care Ventilators |
| ANSI AAMI ES60601-1<br>2005+AC1;A2 (R2012) | Medical Electrical Equipment - Part 1: General Requirements for Basic Safety<br>and Essential Performance |
| IEC 60601-1-2<br>2014/02/25 Ed: 4 | Medical Electrical Equipment - Part 1-2: General Requirements for Safety -<br>Collateral Standard: Electromagnetic Compatibility - Requirements and Tests |
| IEC 60601-1-6<br>2013/10/28 Ed: 3.1 | Medical electrical equipment - Part 1-6: General requirements for safety -<br>Collateral Standard: Usability |
| IEC 60601-1-8<br>2012/11/28 Ed: 2.1 | 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 |
| IEC 62133<br>2012/12/06 Ed: 2.0 | Secondary cells and batteries containing alkaline or other non-acid electrolytes<br>- Safety requirements for portable sealed secondary lithium cells, and for<br>batteries made from them, for use in portable applications - Part 2: Lithium<br>systems |
| ISO 80601-2-55<br>2011/12/15 Ed: 1 | Medical Electrical Equipment - Part 2-55: Particular Requirements for The<br>Basic Safety and Essential Performance of Respiratory Gas Monitor |
| ISO 10993-1<br>2009/10/15 Ed: 4; TC 1 2010 | Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing<br>within a Risk Management Process |
| ISO 18562-1 to 3<br>2017/03 Ed: 1 | Biocompatibility Evaluation of Breathing Gas Pathways in<br>Healthcare Applications |

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Image /page/7/Picture/0 description: The image contains the logos for Nihon Kohden and OrangeMed Inc. The Nihon Kohden logo is a blue abstract shape, and the text "NIHON KOHDEN" is written in blue next to it. Below that, the text "OrangeMed Inc." is written in orange.

#### 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.