Nihon Kohden NKV-550 Series Ventilator System

K192307 · Nihon Kohden Orangemed, Inc. · CBK · Jan 10, 2020 · Anesthesiology

Device Facts

• Record ID: K192307
• Device Name: Nihon Kohden NKV-550 Series Ventilator System
• Applicant: Nihon Kohden Orangemed, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Jan 10, 2020
• 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; inputs include medical oxygen and compressed air; system uses microprocessors to control proportional valves for breath delivery; outputs include mandatory/spontaneous ventilation and respiratory monitoring (waveforms, loops, numeric values); used in hospitals and during in-hospital transport by clinicians; GUI allows parameter setting (tidal volume, inspiratory pressure) and alarm management; BDU ensures safety via valves and alarms; device benefits patients by providing controlled positive pressure ventilation; modifications include cooling, sealing, and storage improvements.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including software verification, electrical safety/EMC, device functionality, performance of therapy modes, environmental testing, cleaning/disinfection, and risk management.

Technological Characteristics

Critical care ventilator; positive pressure delivery; AC/DC power; time-cycled, volume-constant, pressure-controlled; GUI and BDU architecture; proportional valve control via microprocessors; meets ISO 80601-2-12 requirements.

Indications for Use

Indicated for adult, pediatric, and neonatal patients requiring invasive or noninvasive respiratory support in hospitals, hospital-type facilities, or during in-hospital transport.

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 (k181695)

Reference Devices

• Drager Medical AG & Co KG - Evita Infinity V500 (k093633)
• Maquet Critical Care AB - Servo U (k151814)
• Puritan Bennett 980 Ventilator System (k162738)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

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) | |
|---------------------------------------------------------------------------------------------------|--|
| <div> <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | |
| <div> <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | |

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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: [e-mail] Phone: [phone] 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 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.

## 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 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 7-1<br>Characteristic | Nihon Kohden NKV-550 Series<br>Ventilator System<br>(Proposed Device) | Nihon Kohden NKV-550 Series<br>Ventilator System<br>(Predicate Device – k181695) | Comparison |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indication for<br>Use | The Nihon Kohden NKV-550 Series<br>Ventilator System is intended to<br>provide continuous ventilation for<br>adult, pediatric and neonatal patients<br>who require invasive or noninvasive<br>respiratory support. The NKV-550<br>offers 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 Nihon Kohden NKV-550 Series<br>Ventilator System is intended to<br>provide continuous ventilation for<br>adult, pediatric and neonatal patients<br>who require invasive or noninvasive<br>respiratory support. The NKV-550<br>offers 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. | 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 7-1<br>Characteristic | Nihon Kohden NKV-550 Series<br>Ventilator System<br>(Proposed Device) | Nihon Kohden NKV-550 Series<br>Ventilator System<br>(Predicate Device – k181695) | Comparison |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 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<br>and in-hospital transportation for<br>patients who need ventilation<br>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 |
| Performance | Met ISO 80601-2-12 requirements<br>on essential performance of critical<br>care ventilator | Met ISO 80601-2-12 requirements<br>on essential performance of critical<br>care ventilator | Same |
| 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 | 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 | Same |
| | microprocessors | microprocessors | |
| 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,<br>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.
- 2. 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.
- 3. Replace the Exhalation Flow Sensor (SEN5505P) any time the sensor fails calibration or after 5 cycles of cleaning and disinfection, whichever occurs first.
- 4. 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 for<br>Use | The Nihon Kohden NKV-550<br>Series Ventilator System is<br>intended to provide continuous<br>ventilation for adult, pediatric<br>and neonatal patients who<br>require invasive or noninvasive<br>respiratory support. The NKV-<br>550 offers mandatory and<br>spontaneous ventilation modes<br>as well as respiratory<br>monitoring. The NKV-550 is<br>intended for use in hospitals<br>and hospital-type facilities, as<br>well as for in-hospital<br>transportation. | The Evita V500 ventilation unit<br>of the Infinity Acute Care<br>System is intended for the<br>ventilation of adult, pediatric<br>and neonatal patients. Evita<br>V500 offers mandatory<br>ventilation modes and<br>ventilation modes for<br>spontaneous breathing support<br>and airway monitoring. The<br>Evita V500 ventilation unit is<br>used with Infinity C Series<br>Draeger Medical Cockpits. The<br>Evita V500 ventilation unit is<br>intended for use in different<br>medical care areas. Evita V500<br>is intended for stationary use in<br>hospitals and medical rooms or<br>for patient transportation within<br>the hospital. | The SERVO-U ventilator<br>system is:<br>*intended for respiratory<br>support, monitoring and<br>treatment of neonatal,<br>pediatric and adult patients<br>*to be used only by<br>healthcare providers<br>*to be used only in<br>professional healthcare<br>facilities and for transport<br>within these facilities | The Puritan Bennett 980 Series<br>Ventilator System is designed for<br>use on patient population sizes<br>from Neonatal (NICU) through<br>Adult who require respiratory<br>support or mechanical ventilation<br>and weigh a minimum of 0.3kg<br>(0.66lb). It is suitable for service<br>in hospital (institutions) and intra-<br>hospital transport to provide<br>continuous positive pressure<br>ventilatory support using medical<br>oxygen and compressed medical<br>air from either an internal air<br>compressor or external air sources<br>to deliver oxygen concentrations<br>of 21% to 100%. Ventilatory<br>support can be delivered<br>invasively or non-invasively to<br>patients who require the following<br>types of ventilator support<br>- Positive Pressure Ventilation,<br>delivered invasively (via<br>endotracheal tube or tracheotomy<br>tube) or non-invasively (via mask<br>or nasal prongs)<br>- Assist/Control, SIMV, or<br>Spontaneous modes of ventilation | Same |
| Table 7-2<br>Characteristic | Nihon Kohden NKV-550<br>Series Ventilator System<br>(Proposed Device) | Draeger Medical AG & Co.<br>KG - Drager V500<br>(Reference Device K093633) | Maquet Critical Care AB -<br>Servo U<br>(Reference Device K151814) | Puritan Bennett 980 Series<br>Ventilator System<br>(Reference Device K162738) | Comparison |
| Environment<br>of Use | Hospitals, hospital-type<br>facilities and in-hospital<br>transportation for patients who<br>need ventilation therapy | Hospitals, hospital-type<br>facilities and in-hospital<br>transportation for patients who<br>need ventilation therapy | Professional healthcare<br>facilities and for transport<br>within these facilities | It is suitable for service in hospital<br>(institutions) and intra-hospital<br>transport | Same |
| Anatomical<br>Site | Patient airways | Patient airways | Patient airways | Patient airways | Same |
| Target<br>Population | Adult, pediatric and neonatal<br>patients | Adult, pediatric and neonatal<br>patients | Adult, pediatric and neonatal<br>patients | Adult, pediatric and neonatal<br>patients | Same |
| 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 | Met ISO 80601-2-12<br>requirements on essential<br>performance of critical care<br>ventilator | Met ISO 80601-2-12 requirements<br>on essential performance of<br>critical care ventilator | Same |
| Design | Consists of a graphic user<br>interface to set and monitor<br>ventilation, breath delivery<br>unit, breathing circuit;<br>Controls air and oxygen<br>deliveries by proportional<br>valves through microprocessors | Consists of a graphic user<br>interface to set and monitor<br>ventilation, breath delivery<br>unit, breathing circuit;<br>Controls air and oxygen<br>deliveries by proportional<br>valves through microprocessors | Consists of a graphic user<br>interface to set and monitor<br>ventilation, breath delivery<br>unit, breathing circuit;<br>Controls air and oxygen<br>deliveries by proportional<br>valves through<br>microprocessors | Consists of a graphic user<br>interface to set and monitor<br>ventilation, breath delivery unit,<br>breathing circuit;<br>Controls air and oxygen deliveries<br>by proportional valves through<br>microprocessors | Substantially<br>Equivalent |
| Delivered to<br>Patient | Medical Air and Oxygen | Medical Air and Oxygen | Medical Air and Oxygen | Medical Air and Oxygen | Same |
| Deliverv<br>method to<br>Patient | Positive pressure | Positive pressure | Positive pressure | Positive pressure | Same |
| Energy Used<br>for Device | AC Power and DC Power<br>(battery) | AC Power and DC Power<br>(battery) | AC Power and DC Power<br>(battery) | AC Power and DC Power<br>(battery) | Same |
| Control<br>principle | time-cycled, volume-constant,<br>pressure-controlled | time-cycled, volume-constant,<br>pressure-controlled | time-cycled, volume-constant,<br>pressure-controlled | time-cycled, volume-constant,<br>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.