(163 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like DNN, training sets, or performance metrics typically associated with AI/ML models. The description focuses on standard ventilator components and functionalities controlled by a microprocessor.
Yes
The device is a ventilator, which provides respiratory support, directly treating a patient's medical condition.
No
The device is a ventilator system used for respiratory support and monitoring, not for diagnosing medical conditions.
No
The device description explicitly states it consists of a graphic user interface (GUI) and a breath delivery unit (BDU), with the BDU containing a microprocessor and controlling 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) device.
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 therapy.
- Device Description: The description details a system that controls airflow and pressure to deliver breaths to the patient. It mentions a breath delivery unit (BDU) and a graphic user interface (GUI) for setting parameters and monitoring. This aligns with the function of a ventilator.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a patient's health. The provided information does not mention any interaction with patient specimens or any diagnostic testing performed on 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
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.
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 and hospital-type facilities, as well as, for 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
Non-Clinical Performance Data:
- Software Verification
- Electrical Safety & EMC Testing
- Agency Testing to Applicable Standards
- Device Functionality Testing ●
- Performance of Therapy Types and ● Ventilation Modes
- Product Endurance
- Power Performance .
- Environmental ●
- Cleaning & Disinfection ●
- Gas Path Biocompatibility ●
- Human Factors/Usability Testing
- . Risk Management
- . Waveform Comparison with Predicate
- Accessory Compatibility
Clinical Performance Data:
Not Applicable - Clinical performance data was not required to demonstrate substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 7, 2018
Nihon Kohden OrangeMed, Inc. Sheryl Higgins Director of RA/OA 1800 E. Wilshire Ave. Santa Ana, California 92705
Re: K181695
Trade/Device Name: Nihon Kohden NKV-550 Series Ventilator System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK Dated: November 6, 2018 Received: November 7, 2018
Dear Sheryl Higgins:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
James J. Lee -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Nihon Kohden NKV-550 Series Ventilator System
Indications for Use (Describe)
The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. The NKV-550 offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The NKV-550 is intended for use in hospitals and hospital-type facilities, as well as, for in-hospital transportation.
Type of Use (Select one or both, as applicable):
| 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 shows the logo for Nihon Kohden and OrangeMed Inc. The Nihon Kohden logo is a blue square with a white design inside, followed by the text "NIHON KOHDEN" in blue. Below that, the text "OrangeMed Inc." is written in orange.
Section 5 - 510(k) Summary
Date
December 07, 2018
Submitter / Manufacturing Location
Nihon Kohden OrangeMed, Inc. 1800 E. Wilshire Avenue Santa Ana, CA 92705 USA
Company Contact
Sheryl Higgins - Director of Regulatory Affairs and Quality Assurance Email: shiggins@orange-med.com Phone: (949) 502-6448 x7012 Fax: (949) 748-8867
Common Name of Device
Critical Care Ventilator
Trade Name
Nihon Kohden NKV-550 Series Ventilator System
Classification Name
Product Code: CBK - Ventilator, Continuous, Facility Use Regulation Number: 21 CFR 868:5895 Device Class: II Review Panel: Anesthesiology
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Predicate Device
| Product: | Evita Infinity® V500 |
|---|---|
| 510k #: | K093633 |
| Manufacturer: | Draegerwerk AG & Co. KGaA |
| Establishment Reg. #: | 9611500 |
Device Description
The Nihon Kohden NKV-550 Series Ventilator System consists of a graphic user interface (GUI) and a breath delivery unit (BDU). The GUI allows clinicians to set ventilator control parameters such as tidal volume and inspiratory pressure, to set alarm limits such as high inspiratory pressure alarm, to view monitored numeric values, to view waveform and loops, and to operate various features through the apps.
The BDU contains a microprocessor that receives inputs from the electronic system and controls the pneumatic system for breath delivery to the patient. It also provides various alarms, a safety valve, and other design features.
Indication For Use
The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. The NKV-550 offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The NKV-550 is intended for use in hospitals and hospital-type facilities, as well as, for in-hospital transportation.
Product Intended Function
The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation using medical oxygen and external sources of compressed medical air to deliver oxygen concentrations of 21% to 100%. Ventilatory support is intended to be delivered invasively or noninvasively to patients who require Assisted/Control Mandatory Ventilation (A/CMV), Synchronized Intermittent Mandatory Ventilation (SIMV) or Spontaneous Ventilation (SPONT).
Summary of Technical Characteristics
The Nihon Kohden NKV-550 Series Ventilator System technological characteristics are substantially equivalent as compared to the predicate device and are summarized in the table below.
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Image /page/5/Picture/0 description: The image contains the logo for NIHON KOHDEN, a medical equipment manufacturer. The logo consists of a blue abstract symbol on the left, followed by the company name in blue capital letters. Below the company name, "OrangeMed Inc." is written in orange letters. The logo is simple and professional, reflecting the company's focus on medical technology.
| Technical
Characteristic | Nihon Kohden NKV-550 Series
Ventilator System | Draeger Evita V500 Ventilation Unit*
(Predicate Device - K093633) | 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 Evita V500 ventilation unit of the
Infinity Acute Care System is intended
for the ventilation of adult, pediatric and
neonatal patients. Evita V500 offers
mandatory ventilation modes and
ventilation modes for spontaneous breathing support and airway
monitoring. The Evita V500 ventilation
unit is used with Infinity C Series
Draeger Medical Cockpits. The Evita
V500 ventilation unit is intended for use
in different medical care areas. Evita
V500 is intended for stationary use in
hospitals and medical rooms or for
patient transportation within the hospital. | 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 | Same |
| Anatomical Site | Patient airways | Patient airways | Same |
| Target
Population | 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 | Same |
| Waveform
Comparison | Comparable waveform test result | Comparable waveform test result | Substantially
equivalent |
| 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 | Substantially
equivalent |
| Chemicals
Delivered to
Patient | Medical Air and Oxygen | Medical Air and Oxygen | Same |
| Delivery method
to Patient | Positive pressure | Positive pressure | Same |
| Energy Used for
Device | 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 | Same |
| Technical
Characteristic | Nihon Kohden NKV-550 Series
Ventilator System | Draeger Evita V500 Ventilation Unit*
(Predicate Device – K093633) | Comparison |
| Therapy Types | Invasive, Non-invasive, O2
Therapy | Intubated, Non-invasive, O2 Therapy | Same |
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Image /page/6/Picture/0 description: The image shows the logo for Nihon Kohden and OrangeMed Inc. The Nihon Kohden logo is in blue and consists of a stylized wave graphic and the company name. Below that, in orange text, is the name OrangeMed Inc.
*Information from manufacturer's "Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.1" (Ed: 3 - 2010-08)
Summary of Non-Clinical Performance Data
Performance of the Nihon Kohden NKV-550 Series Ventilator System was demonstrated by the following:
- Software Verification
- Electrical Safety & EMC Testing
- Agency Testing to Applicable Standards
- Device Functionality Testing ●
- Performance of Therapy Types and ● Ventilation Modes
- Product Endurance
- Power Performance .
- Environmental ●
- Cleaning & Disinfection ●
- Gas Path Biocompatibility ●
- Human Factors/Usability Testing
- . Risk Management
- . Waveform Comparison with Predicate
- Accessory Compatibility
Where applicable, the Nihon Kohden NKV-550 Series Ventilator System has been tested in compliance with the following standards:
| Standard | Testing |
|---|---|
| ISO 80601-2-12 | |
| 2011/04/15 Ed: 1; | |
| CORR 1: 2011/10/15 | Medical Electrical Equipment - Part 2-12: Particular Requirements for Basic |
| Safety and Essential Performance of Critical Care Ventilators | |
| ANSI AAMI ES60601-1 | |
| 2005+AC1;A2 (R2012) | Medical Electrical Equipment - Part 1: General Requirements for Basic Safety |
| and Essential Performance | |
| IEC 60601-1-2 | |
| 2014/02/25 Ed: 4 | Medical Electrical Equipment - Part 1-2: General Requirements for Safety - |
| Collateral Standard: Electromagnetic Compatibility - Requirements and Tests | |
| IEC 60601-1-6 | |
| 2013/10/28 Ed: 3.1 | Medical electrical equipment - Part 1-6: General requirements for safety - |
| Collateral Standard: Usability | |
| IEC 60601-1-8 | |
| 2012/11/28 Ed: 2.1 | 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 62133 | |
| 2012/12/06 Ed: 2.0 | 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 |
| ISO 80601-2-55
2011/12/15 Ed: 1 | Medical Electrical Equipment - Part 2-55: Particular Requirements for The
Basic Safety and Essential Performance of Respiratory Gas Monitor |
| ISO 10993-1
2009/10/15 Ed: 4; TC 1 2010 | Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
within a Risk Management Process |
| ISO 18562-1 to 3
2017/03 Ed: 1 | Biocompatibility Evaluation of Breathing Gas Pathways in
Healthcare Applications |
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Image /page/7/Picture/0 description: The image contains the logos for Nihon Kohden and OrangeMed Inc. The Nihon Kohden logo is a blue abstract shape, and the text "NIHON KOHDEN" is written in blue next to it. Below that, the text "OrangeMed Inc." is written in orange.
Summary of Clinical Performance Data
Not Applicable - Clinical performance data was not required to demonstrate substantial equivalence.
Conclusion
The evaluation and testing performed demonstrates that the Nihon Kohden NKV-550 Series Ventilator System is as safe and as effective as the predicate device.