(259 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the description of the device's functionality is based on traditional control parameters and a microprocessor.
Yes.
The device provides "continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support," which is a therapeutic function.
No
This device is a ventilator system intended for respiratory support, not for diagnosing medical conditions. It provides ventilation and monitoring, but does not identify diseases or conditions.
No
The device description explicitly states it consists of a graphic user interface (GUI) and a breath delivery unit (BDU), which contains a microprocessor and controls a pneumatic system for breath delivery. This indicates the presence of significant hardware components beyond just software.
Based on the provided information, the Nihon Kohden NKV-550 Series Ventilator System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device provides "continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support." This describes a device that directly interacts with the patient's respiratory system to provide life support.
- Device Description: The description details a system that controls airflow and pressure to deliver breaths to the patient. It mentions a graphic user interface for setting parameters and a breath delivery unit that controls the pneumatic system. This aligns with the function of a ventilator.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to obtain diagnostic information. IVDs are typically used in laboratories or at the point of care to analyze biological samples.
Therefore, the Nihon Kohden NKV-550 Series Ventilator System is a therapeutic device used for respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / Indications 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 codes (comma separated list FDA assigned to the subject device)
CBK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient airways
Indicated Patient Age Range
adult, pediatric and neonatal patients
Intended User / Care Setting
Hospitals, hospital-type facilities and in-hospital transportation for patients who need ventilation therapy; health care professionals provide patient care
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-550 Series Ventilator System was demonstrated by the following testing performed in compliance with Design Controls:
- Software Verification
- Device Functionality Testing
- Human Factors/Usability Testing
- Bench Test Comparison with Reference Device
- Risk Management
- Regression
Additional biocompatibility testing was not required since no material changes were made to the gas path of the ventilator.
Clinical performance data was not required to demonstrate substantial equivalence.
Key results: The evaluation and testing performed in compliance with Design Controls demonstrates that the Nihon Kohden NKV-550 Series Ventilator System is as safe and as effective as its primary and secondary predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Nihon Kohden OrangeMed, Inc. Sheryl Higgins V.P. of Regulatory Affairs & Quality Assurance 1800 E. Wilshire Avenue Santa Ana, California 92705
Re: K231778
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: February 6, 2024 Received: February 6, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Digitally signed by John S. John S. Bender -S Date: 2024.03.01 10:47:10 Bender -S -05'00' for Ethan Nyberg 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 Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K231778
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 5 - 510(k) Summary
Submission Date
February 29, 2024
Submitter / Manufacturing Location
Nihon Kohden OrangeMed, LLC 1800 E. Wilshire Avenue Santa Ana, CA 92705 USA
Phone: (949) 502-6448
Company Contact
Sheryl Higgins Vice President of Regulatory Affairs and Quality Assurance
shiggins@orange-med.com Email:
(949) 502-6448 x7012 Phone:
Establishment Registration Number
3014631252 - Nihon Kohden OrangeMed, LLC
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 - Continuous ventilator Device Class: II Review Panel: Anesthesiology
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.
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Image /page/4/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 text is in a sans-serif font and is aligned to the right of the square.
Primary Predicate Device
| Trade Name: | Nihon Kohden NKV-550 Series Ventilator System |
|---|---|
| 510k #: | K192307 |
| Product Code: | CBK |
| Manufacturer: | Nihon Kohden OrangeMed, LLC |
| Establishment Reg. #: | 3014631252 |
Secondary Predicate Device
| Trade Name: | Hamilton-G5 |
|---|---|
| 510k #: | K193228 |
| Product Code: | CBK |
| Manufacturer: | Hamilton Medical AG |
| Establishment Reg. #: | 3001421318 |
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.
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 non-invasively to patients who require Assisted/Control Mandatory Ventilation (A/CMV), Synchronized Intermittent Mandatory Ventilation (SIMV) or Spontaneous Ventilation (SPONT).
Indication For Use (Intended Medical Indication)
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 hospitaltype facilities, as well as, for in-hospital transportation.
5
Image /page/5/Picture/0 description: The image contains 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 features a white curved line at the bottom and a white diagonal line extending from the bottom left corner to the top right corner.
Summary of Technical Characteristics
The Nihon Kohden NKV-550 Series Ventilator System technological characteristics with the addition of Adaptive Ventilation Mode (AVM) and Adaptive Trigger (ATRIG) /Adaptive Cycle (Acycle) are substantially equivalent as compared to the predicate device and the reference device as summarized in the table below.
| Table 7-1
Characteristic | Nihon Kohden
NKV-550 Series
Ventilator System
(Modified Device) | Nihon Kohden
NKV-550 Series
Ventilator System
(Primary
Predicate Device -
K192307) | Hamilton G5
(Secondary
Predicated Device
- K193228) | Comparison |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 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. | 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. | The Hamilton-G5
ventilator is designed
for intensive care
ventilation of adult
and pediatric
patients, and
optionally infant and
neonatal patients.
The device is
intended for use in
the hospital and
institutional
environment where
health care
professionals provide
patient care | Same |
| Environment of
Use | Hospitals, hospital-
type facilities and in-
hospital transportation
for patients who need
ventilation therapy | Hospitals, hospital-
type facilities and in-
hospital
transportation for
patients who need
ventilation therapy | Hospital and
institutional
environment where
health care
professionals provide
patient care | Same |
| Anatomical Site | Patient airways | Patient airways | Patient airways | Same |
| Target Population | Adult, pediatric and
neonatal patients | Adult, pediatric and
neonatal patients | Adult, pediatric, and
neonatal patients | Same |
| Performance | Met ISO 80601-2-12
requirements on
essential performance
of critical care
ventilator | Met ISO 80601-2-12
requirements on
essential performance
of critical care
ventilator | Met ISO 80601-2-12
requirements on
essential performance
of critical care
ventilator | Same |
| Table 7-1
Characteristic | Nihon Kohden
NKV-550 Series
Ventilator System
(Modified Device) | Nihon Kohden
NKV-550 Series
Ventilator System
(Primary
Predicate Device -
K192307) | Hamilton G5
(Secondary
Predicated Device - K193228) | Comparison |
| Design | Consists of a graphic
user interface to set
and monitor
ventilation, breath
delivery unit,
breathing circuit;
Controls air and
oxygen deliveries by
proportional valves
through
microprocessors | Consists of a graphic
user interface to set
and monitor
ventilation, breath
delivery unit,
breathing circuit;
Controls air and
oxygen deliveries by
proportional valves
through
microprocessors | Consists of a graphic
user interface to set
and monitor
ventilation, breath
delivery unit,
breathing circuit;
Controls air and
oxygen deliveries by
proportional valves
through
microprocessors | Same |
| Chemicals
Delivered to
Patient | Medical Air and
Oxygen | Medical Air and
Oxygen | Medical Air and
Oxygen | Same |
| Delivery method to
Patient | Positive pressure | Positive pressure | Positive pressure | Same |
| Energy Used for
Device | AC Power and DC
Power (battery) | AC Power and DC
Power (battery) | AC Power and DC
Power (battery) | Same |
| Control principle | time-cycled, volume-
constant, pressure-
controlled | time-cycled, volume-
constant, pressure-
controlled | time-cycled, volume-
constant, pressure-
controlled | Same |
| Therapy Types | Invasive, Non-
invasive, O2 Therapy | Invasive, Non-
invasive, O2 Therapy | Invasive, Non-
invasive, O2 Therapy | Same |
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Image /page/6/Picture/0 description: The image features the logo of NIHON KOHDEN. The logo consists of a stylized blue graphic on the left, resembling a stylized mountain range or waveform. To the right of the graphic, the text "NIHON KOHDEN" is displayed in a bold, sans-serif blue font. The overall design is clean and corporate, suggesting a professional and established organization.
The differences between the modified Nihon Kohden NKV-550 Ventilator System and the predicate device (K192307) are as follows:
- The subject device adds a breath mode, Adaptive Ventilation Mode (AVM), as well 1. as Adaptive Trigger (ATRIG)/Adaptive Cycle (AcycLE). These are software-only features that do not require any new hardware.
The differences between the modified Nihon Kohden NKV-550 Ventilator System and the secondary predicate device (K193228) are described in section 12 – Substantial Equivalent Discussion.
In conjunction with AVM and Adaptive Trigger (ATRIG)/Adaptive Cycle (AcYCLE), this 510(k) brings FDA up-to-date on non-significant changes implemented since the last 510(k) clearance. Therefore, the following modifications are included:
-
- Mechanical Hardware changes
-
- Software Revision History changes
-
- Labeling changes
Device modifications were made in compliance with Design Control procedures.
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Image /page/7/Picture/0 description: The image shows the logo for Nihon Kohden, a Japanese medical equipment manufacturer. The logo consists of a blue abstract graphic to the left of the company name, also in blue. The graphic appears to be a stylized representation of a wave or a wing. The text is in a sans-serif font and is easily readable.
Traditional 510(k): NKV-550 Series Ventilator System 510(k) #: K231778 510(k) Summary
OrangeMed
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
- Device Functionality Testing ●
Human Factors/Usability Testing
- Bench Test Comparison with Reference Device
- Risk Management
- . 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 Nihon Kohden NKV-550 Series Ventilator System is as safe and as effective as its primary and secondary predicate devices.