(240 days)
No
The description focuses on servo-controlled mechanics, microprocessor control, and user-set parameters. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
Yes
The device is intended to provide ventilation and oxygen concentration for patients with respiratory issues, indicating its therapeutic purpose to alleviate or treat a medical condition.
No
The device is a ventilator intended to provide ventilation and oxygen concentration for patients. While it offers respiratory monitoring, its primary function is therapeutic delivery of gas, not diagnosis. It allows clinicians to set ventilator control parameters and view monitored numeric values and waveforms, but these are for managing ventilation, not for diagnosing conditions.
No
The device description clearly states it is comprised of two major components: a Breath Delivery Unit (BDU) and a Graphic User Interface (GUI). The BDU contains hardware components like a blower, electronics, and a proportional valve for gas delivery, making it a hardware device with integrated software.
Based on the provided information, the Nihon Kohden NKV-330 Ventilator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for providing ventilation and oxygen concentration to patients. This is a direct interaction with the patient's respiratory system, not the examination of specimens derived from the human body.
- Device Description: The description details a servo-controlled ventilator that delivers gas to the patient. It does not mention any components or processes related to analyzing biological samples.
- Anatomical Site: The anatomical site is the patient's face and airways, which is consistent with a respiratory support device, not an IVD.
- Performance Studies: The performance studies listed focus on the device's functionality, safety, and performance in delivering ventilation, not on the accuracy or reliability of diagnostic tests performed on biological samples.
IVD devices are specifically designed to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. The NKV-330 Ventilator's function is to support breathing, which is a therapeutic and monitoring function, not an in vitro diagnostic one.
N/A
Intended Use / Indications for 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.
Product codes
MNT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient face and airways
Indicated Patient Age Range
children weighing 12.5 kg or greater to adult patients.
Intended User / Care Setting
qualified and trained users under the directions of a physician.
hospital-type facilities, and in-hospital transportation
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance of the Nihon Kohden NKV-330 Ventilator was demonstrated by the following:
- Software Verification .
- Electrical Safety & EMC Testing
- Agency Testing to Applicable Standards
- Performance of Ventilation Modes and Control Settings ●
- Device Functionality
- Power performance with AC Mains power or Reserve battery power
- . Endurance/Reliability
- Essential Performance and Worst Case VBS
- Environmental
- Cleaning & Disinfection
- Biocompatibility
- Waveform Comparison with Predicate ●
- Human Factors/Usability .
- Risk Management ●
- . Accessory Compatibility
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5895 Continuous ventilator.
(a)
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.(b)
Classification. Class II (performance standards).
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: jvillanueva@orange-med.com Phone: (949) 502-6448 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.
5
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.
6
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
Compatibility |
|-----------------------------------------|---------------------------------------------------------------|---------------------------|------------------------------------------------------------------------|
| Respiratory Gas
Humidifier | F&P MR850
Respiratory Humidifier | Fisher Paykel | MR850 |
| Heated Single Limb
Breathing Circuit | Fisher & Paykel Single Limb
Adult Circuit Kit with Chamber | Fisher Paykel | RT219 |
| Heated Single Limb
Breathing Circuit | Fisher & Paykel Single Limb
Adult Circuit Kit with Chamber | Fisher Paykel | RT202 |
| Breathing Circuit
Bacterial Filter | F&P Inspiratory/ Expiratory
Filter | Fisher Paykel | RT019 |
| Nasal Cannula | Teleflex Comfort Flow Plus
Cannula | Teleflex | 2412-13 (S)
2412-12 (M)
2412-11 (L) |
| NIV face mask | 6700 Series Non-vented Full
Face Mask | Hans Rudolph | 113550 (L), 113551 (M),
113552 (S), 113553 (XS),
113554 (Petite) |
| NIV face mask | Respironics PerforMax Pediatric
SE Total Face Mask | Philips | 1119026 (XS) |
| NIV Face Mask Set | NPPV Cap-ONE Mask Set | Nihon Kohden
OrangeMed | MSK3313P (L),
MSK3314P (M),
MSK3315P (S),
MSK3316P (XS) |
| SPO2 Monitor | Nihon Kohden SpO2 Monitor
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
Monitor | Nihon Kohden CO2 Monitor Kit | Nihon Kohden Corp. | TG-980P |
| CO2
Airway Adapter | Nihon Kohden CO2 Airway
Adapter | Nihon Kohden Corp. | YG-211T |
| On Airway Flow
Sensor | EnviteC SpiroQuant H | EnviteC | TF-330Z
(E07-00-0001) |
| Exhalation Port | Exhalation Port | Nihon Kohden
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
Characteristic | Nihon Kohden NKV-330
Ventilator System | Philips/Respironics V60
Ventilator* (Predicate
Device – K102985) | Comparison |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for 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 hospitals, hospital-
type facilities, and in-
hospital transportation
by qualified and trained
users under the directions
of a physician. | The Respironics V60
Ventilator is an assist
ventilator and is intended to
augment patient breathing.
It is intended for
spontaneously breathing
individuals who require
mechanical ventilation:
patients with respiratory
failure, chronic respiratory
insufficiency, or obstructive
sleep apnea in a hospital or
other institutional settings
under the direction of a
physician.
The ventilator is intended to
support pediatric patients
weighing 20 kg (44 lb)
or greater to adult patients.
It is also intended for
intubated patients
meeting the same selection
criteria as the noninvasive
applications . The ventilator
is intended to be used by
qualified medical
professionals, such as
physicians, nurses, and
respiratory therapists.
The ventilator is intended to
be used only with various
combinations of
Respironics-recommended
patient circuits,
interfaces (masks),
humidifiers, and other | Substantially equivalent
Both ventilators are
intended for patients who
have spontaneous breathes.
Both ventilators can be
used for invasive
ventilation (i.e., through
intubation) and
noninvasive ventilation.
The minimum patient
weights in both ventilators
(12.5 kg for the NKV-330
and 20 kg for the V60) are
within the same
subpopulation of
"Children" under the FDA
definition for Pediatrics. |
| Technical
Characteristic | Nihon Kohden NKV-330
Ventilator System | Philips/Respironics V60
Ventilator* (Predicate
Device - K102985) | Comparison |
| Intended
Environment of use | 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. | In a hospital or other
institutional settings under
the direction of a physician.
In other section than
intended use from the V60
manual, there is a
description to use the
ventilator during intra-
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
Comparison | Comparable waveform test
result | Comparable waveform test
result | Substantially equivalent |
| Design | Consists of a graphic user
interface to set ventilation
and to monitor ventilation
and SpO2 and CO2, breath
delivery unit, breathing
circuit, and cart;
Controls oxygen delivery
through a proportional
valve and controls air
delivery through an internal
blower | Consists of a graphic user
interface to set ventilation
and to monitor ventilation,
breath delivery unit,
breathing circuit, and cart;
Controls oxygen delivery
through a proportional
valve and controls air
delivery through an internal
blower | Substantially equivalent
The NKV-330 has optional
SpO2 and CO2 monitors,
for the users who desire to
use these monitors for
added safety. The reference
device, NKV-550 Series
Ventilator System
(K181695), contains the
same optional SpO2 and
CO2 monitors. |
| Chemicals Deployed
to Patient | Ambient air and oxygen | Ambient air and oxygen | Same |
| Delivery method to
Patient | Positive pressure | Positive pressure | Same |
| Energy Used for
Device | AC Power, a backup
battery DC Power (Ni-Mh
battery), and a main battery
(Li-ion battery) | AC Power, and optional
internal DC Power (Li-ion
battery) | Substantially equivalent
The NKV-330 contains
two batteries for added
safety. The V60 has one
battery. |
| Control principle | Time-cycled, volume-
target, pressure-controlled | Time-cycled, volume-
target, pressure-controlled | Same |
| Technical
Characteristic | Nihon Kohden NKV-330
Ventilator System | Philips/Respironics V60
Ventilator* (Predicate
Device - K102985) | Comparison |
| Modes and Controls
Settings | PCV mode | PCV mode | Substantially equivalent |
| | PRVC mode (Volume
Target) | AVAPS mode (Volume
Target) | Substantially equivalent |
| | -Max Pressure for PRVC | Max Pressure for AVAPS | |
| | -Min Pressure for PRVC | Min Pressure for AVAPS | |
| | S/T mode (Spontaneous PS
/ Timed PCV) | S/T mode (Spontaneous PS
/ Timed PCV) | For trigger, both the NKV-
330 and the V60 use flow
shape method for
triggering. The NKV-330
provides conventional flow
trigger in addition. |
| | -IPAP | -IPAP | |
| | -EPAP/CPAP | -EPAP | |
| | Spont/PS mode (PS set to
zero is CPAP) | CPAP mode | |
| | Inspiratory Time or I:E | Inspiratory Time (i-Time) | NKV-330 uses a peak flow
% for cycling off. |
| | Pressure Release (pressure
relief during the active part
of exhalation only for
CPAP) | C-Flex (pressure relief
during the active
part of exhalation only for
CPAP) | V60 uses Auto-Track by
flow shape method. |
| | Trigger; flow trigger or
advanced trigger (Flow
shape method for trigger) | Trigger; auto-track trigger
(flow shape method for
trigger) | |
| | Cycling off; peak flow % | Cycling off; Auto-Track
(flow shape method) | |
| | PPV mode | PPV mode | |
| | Max E (PPV) | Max E (PPV) | NKV-330 has additional |
| | Max R (PPV) | Max R (PPV) | settings for limiting Min |
| | Max P (PPV) | Max P (PPV) | and Max inspiratory time
(Ti). |
| | Max VT (PPV) | Max V (PPV) | |
| | O2 concentration (FiO2) | O2 concentration (FiO2) | |
| | Ramp up time | Ramp time | |
| | Resp Rate (frequency) | Resp Rate (frequency) | |
| | Slope (rise time) | Rise Time | |
| | Min/Max Ti | | |
| | O2 Therapy Mode
Flow (1-60 L/min)
Circuit Obstruction Alarm
(automatic) | | Substantially equivalent to
reference device, NKV-
550 Series Ventilator
System (K181695).**
O2 therapy mode delivers
only a constant flow at
FiO2 that is set by the user. |
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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 graphic on the left, followed by the company name "NIHON KOHDEN" in blue, sans-serif font. The graphic appears to be a stylized representation of waves or a similar abstract design.
Nihon Kohden OrangeMed, Inc.
9
Image /page/9/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 text on the right. The symbol appears to be a stylized representation of waves or a similar abstract design.
Nihon Kohden OrangeMed, Inc.
*Reference manufacturer's user manual "Respironics V60 Ventilator User Manual" (1047358 Rev C) and Philips V60 Ventilator Specification (Oct 2016)
** The O2 Therapy operation, applicable settings, monitors, and alarms are the same between proposed device, NKV-330 Series Ventilator System, and reference device, NKV-550 Series Ventilator System. NKV-330 added a Circuit Obstruction alarm. Ventilator performance during O2 Therapy comparison testing was completed and demonstrated substantial equivalence between proposed and reference device.
10
Image /page/10/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. Below this is the text "Nihon Kohden OrangeMed, Inc." in orange. The logo is simple and professional, likely representing a medical or technology company.
16. Summary of Non-Clinical Performance Data
Performance of the Nihon Kohden NKV-330 Ventilator was demonstrated by the following:
- Software Verification .
- Electrical Safety & EMC Testing
- Agency Testing to Applicable Standards
- Performance of Ventilation Modes and Control Settings ●
- Device Functionality
- Power performance with AC Mains power or Reserve battery power
- . Endurance/Reliability
- Essential Performance and Worst Case VBS
- Environmental
- Cleaning & Disinfection
- Biocompatibility
- Waveform Comparison with Predicate ●
- Human Factors/Usability .
- Risk Management ●
- . Accessory Compatibility
Where applicable, the Nihon Kohden NKV-330 Ventilator has been tested in compliance with the following standards:
| Standard | Title |
|---|---|
| ANSI AAMI ES 60601-1 | |
| 2005+AC1;A2 (R2012) | Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and |
| Essential Performance | |
| IEC 60601-1 | |
| Ed. 3.1 2012-08 | Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And |
| Essential Performance | |
| IEC 60601-1-2 | |
| Ed. 4.0 2014-02 | Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral |
| Standard: Electromagnetic Compatibility - Requirements and Tests | |
| IEC 60601-1-6 | |
| Ed. 3.1 2013-10 | Medical electrical equipment - Part 1-6: General requirements for safety - Collateral |
| Standard: Usability | |
| IEC 60601-1-8 | |
| Ed 2.1 2012-11 | Medical Elec. Equip. - Part 1-8: General Req. for Basic Safety & Essential Perf. – |
| Collateral Standard: General Req., Tests & Guidance for Alarm Systems in Medical | |
| Elec. Equip. & Medical Elec. Systems | |
| IEC 60601-1-9 | |
| Ed. 1.1 2013-06 | Medical electrical equipment - Part 1-9: General requirements for basic safety and |
| essential performance - Collateral Standard: Requirements for environmentally | |
| conscious design | |
| IEC 60601-2-49 | |
| Ed. 2.0 2011-02 | Particular requirements for the basic safety and essential performance of multifunction |
| patient monitoring equipment | |
| IEC 62133-2 | |
| Ed. 1.0 2017-02 | Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety |
| requirements for portable sealed secondary lithium cells, and for batteries made from | |
| them, for use in portable applications - Part 2: Lithium systems | |
| IEC 62366 | |
| Ed. 1.1 2014-01 | Medical devices — Application of usability engineering to medical devices — |
| Amendment 1 |
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Image /page/11/Picture/0 description: The image shows the logo for NIHON KOHDEN. The logo consists of a blue square with a white design inside, followed by the text "NIHON KOHDEN" in blue. The design inside the square appears to be a stylized wave or curve.
| Standard | Title |
|---|---|
| ISO 80601-2-12 | |
| Ed. 1 2011-04 | Medical Electrical Equipment - Part 2-12: Particular Requirements for Basic Safety |
| and Essential Performance of Critical Care Ventilators | |
| ISO 80601-2-55 | |
| Ed. 2 2018-02 | Medical Electrical Equipment - Part 2-55: Particular Requirements for The Basic |
| Safety and Essential Performance of Respiratory Gas Monitor | |
| ISO 80601-2-61 | |
| Ed. 2 2017-12 | Medical electrical equipment - Part 2-61: Particular requirements for basic safety and |
| essential performance of pulse oximeter equipment | |
| FDA Biocompatibility | |
| Guidance 2016-06 | Use of International Standard ISO 10993-1, “Biological Evaluation of Medical |
| Devices Part 1: Evaluation and testing within a risk management process”, | |
| Guidance for Industry and Food and Drug Administration Staff | |
| ISO 10993-1 | |
| Ed. 5 2018-08 | Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a |
| Risk Management Process | |
| ISO 18562-1 | |
| Ed. 1 2017-03 | Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications |
| ISO 14971 | |
| Ed. 3 2019-12 | Medical devices - Application of risk management to medical devices |
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-330 Ventilator is as safe and effective as the predicate device.