Nihon Kohden NKV-330 Ventilator System

K213521 · Nihon Kohden Orangemed, Inc. · MNT · Jul 1, 2022 · Anesthesiology

Device Facts

• Record ID: K213521
• Device Name: Nihon Kohden NKV-330 Ventilator System
• Applicant: Nihon Kohden Orangemed, Inc.
• Product Code: MNT · Anesthesiology
• Decision Date: Jul 1, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Nihon Kohden NKV-330 Ventilator is intended to provide ventilation and oxygen concentration for patients who are breathing spontaneously but need partial ventilation support due to respiratory failure or chronic respiratory insufficiency. It is intended for children weighing 12.5 kg or greater to adult patients. It offers noninvasive ventilation, invasive ventilation, and respiratory monitoring. The NKV-330 is intended for use in hospital-type facilities, and in-hospital transportation by qualified and trained users under the directions of a physician.

Device Story

NKV-330 is a servo-controlled assist ventilator for pediatric (≥12.5 kg) and adult patients; provides invasive and non-invasive ventilation. System comprises a Breath Delivery Unit (BDU) and Graphic User Interface (GUI). BDU uses a blower and proportional valve to mix ambient air and oxygen; microprocessor controls gas delivery based on clinician-set parameters (PEEP, inspiratory pressure). Device monitors respiratory parameters, SpO2, and CO2. Used in hospitals and for intra-hospital transport by trained clinicians. Clinicians view waveforms and numeric values on GUI to adjust therapy. Benefits include respiratory support for patients with respiratory failure or chronic insufficiency. Includes battery backup (Ni-Mh and Li-ion) for safety.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including software verification, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), performance of ventilation modes, power performance, environmental testing, biocompatibility (ISO 10993-1), and waveform comparison with the predicate device.

Technological Characteristics

Servo-controlled ventilator; BDU with blower and proportional valve; GUI for parameter setting/monitoring. Energy: AC power, Ni-Mh and Li-ion batteries. Connectivity: Optional SpO2/CO2 monitoring. Standards: IEC 60601-1, IEC 60601-1-2, ISO 80601-2-12, ISO 80601-2-55, ISO 80601-2-61, ISO 10993-1, ISO 18562-1. Biocompatibility per ISO 10993-1. Software-controlled breath delivery.

Indications for Use

Indicated for pediatric patients (≥12.5 kg) and adults breathing spontaneously requiring partial ventilation support due to respiratory failure or chronic respiratory insufficiency. Supports invasive and non-invasive ventilation. Contraindicated for use in the presence of flammable anesthetics and MRI applications.

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

• V60 Ventilator with PPV and Auto-Trak + Software Options (k102985)

Reference Devices

• NKV-550 Series Ventilator System (k181695)

Submission Summary (Full Text)

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July 1, 2022

Nihon Kohden OrangeMed, Inc. Jacqueline Villanueva Quality Engineering Manager 1800 E. Wilshire Avenue Santa Ana, California 92705

Re: K213521

Trade/Device Name: Nihon Kohden NKV-330 Ventilator System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous ventilator Regulatory Class: Class II Product Code: MNT Dated: June 1, 2022 Received: June 3, 2022

Dear Jacqueline Villanueva:

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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Brandon Blakely, Ph.D. 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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K213521/S002

Device Name Nihon Kohden NKV-330 Ventilator System

### Indications for Use (Describe)

The Nihon Kohden NKV-330 Ventilator is intended to provide ventilation and oxygen concentration for patients who are breathing spontaneously but need partial ventilation support due to respiratory failure or chronic respiratory . It is intended for children weighing 12.5 kg or greater to adult patients. It offers noninvasive ventilation, invasive ventilation, and respiratory monitoring. The NKV-330 is intended for use in hospital-type facilities, and inhospital transportation by qualified and trained users under the directions of a physician.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/0 description: The image contains the logo for Nihon Kohden OrangeMed, Inc. The logo consists of a blue graphic element followed by the text "NIHON KOHDEN" in blue. Below this, the text "Nihon Kohden OrangeMed, Inc." is written in orange. The logo is simple and clean, with a focus on the company name.

# 510(k) Summary

#### 1. Date

July 1, 2022

#### 2. Submitter / Manufacturing Location

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

### Company Contact 3.

Jacqueline Villanueva – Quality Assurance Director Email: [e-mail] Phone: [phone] x7045

#### Common Name of Device 4.

Assist Ventilator

#### Trade Name ട്.

Nihon Kohden NKV-330 Ventilator System

#### 6. Classification Name

| Product Code: | MNT |
|--------------------|-------------------------------------------------------------------|
| | Ventilator, Continuous, Minimal Ventilatory Support, Facility Use |
| Regulation Number: | 21 CFR 868:5895 |
| Device Class: | II |
| Review Panel: | Anesthesiology |

### 7. Predicate Device

### Predicate Device

| Product: | V60 Ventilator with PPV and Auto-Trak + Software Options |
|---------------|----------------------------------------------------------|
| 510k #: | k102985 |
| Manufacturer: | Respironics California, LLC |

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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 stylized blue graphic to the left. Below the blue text is the text "Nihon Kohden OrangeMed, Inc." in orange. The logo is simple and clean, with a focus on the company name.

### Reference Device

| Product: | NKV-550 Series Ventilator System |
|---------------|----------------------------------|
| 510k #: | k181695 |
| Manufacturer: | Nihon Kohden OrangeMed, Inc. |

#### 8. Description of Device

The NKV-330 is a servo-controlled ventilator that is designed to meet the gas delivery and performance requirements for pediatric through adult patients. The NKV-330 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.

#### Product Intended Function 9.

The Nihon Kohden NKV-330 Ventilator is an assist ventilator intended to support adult and pediatric patients who are breathing spontaneously and require a tidal volume of 100mL or more with an oxygen concentration of 21 to 100%. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications.

### 10. Indication for Use (Intended Medical Indication)

The Nihon Kohden NKV-330 Ventilator is intended to provide ventilation and oxygen concentration for patients who are breathing spontaneously but need partial ventilation support due to respiratory failure or chronic respiratory insufficiency. It is intended for children weighing 12.5 kg or greater to adult patients. It offers noninvasive ventilation, invasive ventilation, and respiratory monitoring. The NKV-330 is intended for use in hospital-type facilities, and in-hospital transportation by qualified and trained users under the directions of a physician.

### 11. Intended Patient Population

Adult and pediatric patients that are breathing spontaneously but need partial ventilation support through invasive or non-invasive ventilation.

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Image /page/5/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 bolded.

Nihon Kohden OrangeMed, In

## 12. Intended Part of the Body or Type of Tissue Applied to or Interacted with

The device is intended for use with a breathing circuit attached to a patient interface for noninvasive ventilation or patients that are under invasive ventilation and meet the selection criteria for noninvasive application. For noninvasive ventilation, the part of the body or type of tissue applied to or interacted with would include a facial or nasal cannula, applied to the mouth and/or nose. For invasive ventilation, the part of the body or type of tissue applied to or interacted with would include an endotracheal tube inserted through the mouth or the nose or a tracheostomy tube inserted into the trachea.

### 13. 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-type facility. The device is not intended for transport between 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.

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# 14. Accessories

The NKV-330 is designed to be used with ventilator support accessories, such as, filters and breathing circuits. Optional accessories have been tested to be compatible with the NKV-330.

| Accessory | Description | Manufacturer | Model # Tested for System<br>Compatibility |
|-----------------------------------------|---------------------------------------------------------------|---------------------------|------------------------------------------------------------------------|
| Respiratory Gas<br>Humidifier | F&P MR850<br>Respiratory Humidifier | Fisher Paykel | MR850 |
| Heated Single Limb<br>Breathing Circuit | Fisher & Paykel Single Limb<br>Adult Circuit Kit with Chamber | Fisher Paykel | RT219 |
| Heated Single Limb<br>Breathing Circuit | Fisher & Paykel Single Limb<br>Adult Circuit Kit with Chamber | Fisher Paykel | RT202 |
| Breathing Circuit<br>Bacterial Filter | F&P Inspiratory/ Expiratory<br>Filter | Fisher Paykel | RT019 |
| Nasal Cannula | Teleflex Comfort Flow Plus<br>Cannula | Teleflex | 2412-13 (S)<br>2412-12 (M)<br>2412-11 (L) |
| NIV face mask | 6700 Series Non-vented Full<br>Face Mask | Hans Rudolph | 113550 (L), 113551 (M),<br>113552 (S), 113553 (XS),<br>113554 (Petite) |
| NIV face mask | Respironics PerforMax Pediatric<br>SE Total Face Mask | Philips | 1119026 (XS) |
| NIV Face Mask Set | NPPV Cap-ONE Mask Set | Nihon Kohden<br>OrangeMed | MSK3313P (L),<br>MSK3314P (M),<br>MSK3315P (S),<br>MSK3316P (XS) |
| SPO2 Monitor | Nihon Kohden SpO2 Monitor<br>Kit | Nihon Kohden Corp. | JL-500P1 |
| SPO2 Sensor | Nihon Kohden Finger Probe | Nihon Kohden Corp. | TL-201T |
| SPO2 Sensor | Nihon Kohden Multi-site Probe | Nihon Kohden Corp. | TL-220T |
| CO2<br>Monitor | Nihon Kohden CO2 Monitor Kit | Nihon Kohden Corp. | TG-980P |
| CO2<br>Airway Adapter | Nihon Kohden CO2 Airway<br>Adapter | Nihon Kohden Corp. | YG-211T |
| On Airway Flow<br>Sensor | EnviteC SpiroQuant H | EnviteC | TF-330Z<br>(E07-00-0001) |
| Exhalation Port | Exhalation Port | Nihon Kohden<br>OrangeMed | EXH3301P |

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# 15. Summary of Technical Characteristics

The technological characteristics of the Nihon Kohden NKV-330 Ventilator System are substantially equivalent to the predicate device as compared and summarized in the table below.

*Reference for predicate device information: "Respironics V60 Ventilator User Manual" (1047358 Rev C) and Philips V60 Ventilator Specification (Oct 2016).

| Technical<br>Characteristic | Nihon Kohden NKV-330<br>Ventilator System | Philips/Respironics V60<br>Ventilator* (Predicate<br>Device – k102985) | Comparison |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The Nihon Kohden NKV-<br>330 Ventilator is intended<br>to provide ventilation and<br>oxygen concentration for<br>patients who are<br><b>breathing spontaneously</b><br>but need partial ventilation<br>support due to respiratory<br>failure or chronic<br>respiratory insufficiency. It<br>is intended for children<br>weighing 12.5 kg or greater<br>to adult patients. It offers<br><b>noninvasive ventilation</b> ,<br><b>invasive ventilation</b> , and<br>respiratory monitoring. The<br>NKV-330 is intended for<br><b>use in hospitals, hospital-</b><br><b>type facilities, and in-</b><br><b>hospital transportation</b><br><b>by qualified and trained</b><br><b>users under the directions</b><br><b>of a physician.</b> | The Respironics V60<br>Ventilator is an assist<br>ventilator and is intended to<br>augment patient breathing.<br>It is intended for<br><b>spontaneously breathing</b><br><b>individuals</b> who require<br>mechanical ventilation:<br>patients with respiratory<br>failure, chronic respiratory<br>insufficiency, or obstructive<br>sleep apnea <b>in a hospital or</b><br><b>other institutional settings</b><br><b>under the direction of a</b><br><b>physician.</b><br>The ventilator is intended to<br>support pediatric patients<br>weighing 20 kg (44 lb)<br>or greater to adult patients.<br>It is also intended <b>for</b><br><b>intubated patients</b><br><b>meeting the same selection</b><br><b>criteria as the noninvasive</b><br><b>applications</b> . The ventilator<br>is intended to be used by<br>qualified medical<br>professionals, such as<br>physicians, nurses, and<br>respiratory therapists.<br>The ventilator is intended to<br>be used only with various<br>combinations of<br>Respironics-recommended<br>patient circuits,<br>interfaces (masks),<br>humidifiers, and other | Substantially equivalent<br><br>Both ventilators are<br>intended for patients who<br>have spontaneous breathes.<br>Both ventilators can be<br>used for invasive<br>ventilation (i.e., through<br>intubation) and<br>noninvasive ventilation.<br>The minimum patient<br>weights in both ventilators<br>(12.5 kg for the NKV-330<br>and 20 kg for the V60) are<br>within the same<br>subpopulation of<br>"Children" under the FDA<br>definition for Pediatrics. |
| Technical<br>Characteristic | Nihon Kohden NKV-330<br>Ventilator System | Philips/Respironics V60<br>Ventilator* (Predicate<br>Device - k102985) | Comparison |
| Intended<br>Environment of use | Intra-hospital transport<br>within a hospital or<br>hospital-type facility. The<br>device is not intended for<br>transport between hospitals<br>or hospital-type facilities,<br>therefore is not a transport<br>ventilator as defined by<br>ISO 80601-2-12 Section<br>201.1.1. | In a hospital or other<br>institutional settings under<br>the direction of a physician.<br>In other section than<br>intended use from the V60<br>manual, there is a<br>description to use the<br>ventilator during intra-<br>hospital transport | Same |
| Anatomical Site | Patient face and airways | Patient face and airways | Same |
| Target Population | Adult and pediatric patients | Adult and pediatric patients | Same |
| Waveform<br>Comparison | Comparable waveform test<br>result | Comparable waveform test<br>result | Substantially equivalent |
| Design | Consists of a graphic user<br>interface to set ventilation<br>and to monitor ventilation<br>and SpO2 and CO2, breath<br>delivery unit, breathing<br>circuit, and cart;<br>Controls oxygen delivery<br>through a proportional<br>valve and controls air<br>delivery through an internal<br>blower | Consists of a graphic user<br>interface to set ventilation<br>and to monitor ventilation,<br>breath delivery unit,<br>breathing circuit, and cart;<br>Controls oxygen delivery<br>through a proportional<br>valve and controls air<br>delivery through an internal<br>blower | Substantially equivalent<br>The NKV-330 has optional<br>SpO2 and CO2 monitors,<br>for the users who desire to<br>use these monitors for<br>added safety. The reference<br>device, NKV-550 Series<br>Ventilator System<br>(K181695), contains the<br>same optional SpO2 and<br>CO2 monitors. |
| Chemicals Deployed<br>to Patient | Ambient air and oxygen | Ambient air and oxygen | Same |
| Delivery method to<br>Patient | Positive pressure | Positive pressure | Same |
| Energy Used for<br>Device | AC Power, a backup<br>battery DC Power (Ni-Mh<br>battery), and a main battery<br>(Li-ion battery) | AC Power, and optional<br>internal DC Power (Li-ion<br>battery) | Substantially equivalent<br>The NKV-330 contains<br>two batteries for added<br>safety. The V60 has one<br>battery. |
| Control principle | Time-cycled, volume-<br>target, pressure-controlled | Time-cycled, volume-<br>target, pressure-controlled | Same |
| Technical<br>Characteristic | Nihon Kohden NKV-330<br>Ventilator System | Philips/Respironics V60<br>Ventilator* (Predicate<br>Device - k102985) | Comparison |
| Modes and Controls<br>Settings | PCV mode | PCV mode | Substantially equivalent |
| | PRVC mode (Volume<br>Target) | AVAPS mode (Volume<br>Target) | Substantially equivalent |
| | -Max Pressure for PRVC | Max Pressure for AVAPS | |
| | -Min Pressure for PRVC | Min Pressure for AVAPS | |
| | S/T mode (Spontaneous PS<br>/ Timed PCV) | S/T mode (Spontaneous PS<br>/ Timed PCV) | For trigger, both the NKV-<br>330 and the V60 use flow<br>shape method for<br>triggering. The NKV-330<br>provides conventional flow<br>trigger in addition. |
| | -IPAP | -IPAP | |
| | -EPAP/CPAP | -EPAP | |
| | Spont/PS mode (PS set to<br>zero is CPAP) | CPAP mode | |
| | Inspiratory Time or I:E | Inspiratory Time (i-Time) | NKV-330 uses a peak flow<br>% for cycling off. |
| | Pressure Release (pressure<br>relief during the active part<br>of exhalation only for<br>CPAP) | C-Flex (pressure relief<br>during the active<br>part of exhalation only for<br>CPAP) | V60 uses Auto-Track by<br>flow shape method. |
| | Trigger; flow trigger or<br>advanced trigger (Flow<br>shape method for trigger) | Trigger; auto-track trigger<br>(flow shape method for<br>trigger) | |
| | Cycling off; peak flow % | Cycling off; Auto-Track<br>(flow shape method) | |
| | PPV mode | PPV mode | |
| | Max E (PPV) | Max E (PPV)…