(272 days)
The Nihon Kohden NKV-440 Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. The NKV-440 offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The NKV-440 is intended for use in hospitals and hospital-type facilities, as well as, for in-hospital transportation.
The NKV-440 is a servo-controlled ventilator that is designed to meet the gas delivery and performance requirements for neonate through adult patients. The NKV-440 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.
The provided document is an FDA 510(k) premarket notification for the Nihon Kohden NKV-440 Ventilator System. It details the device's indications for use, technological characteristics, and comparison to a predicate device (Nihon Kohden NKV-550 Ventilator System).
The document does not include information about AI/ML algorithm performance, acceptance criteria for such algorithms, or studies involving human readers or ground truth established by experts for image analysis. Therefore, I cannot address most of the specific points requested regarding acceptance criteria and the study proving the device meets them, as it relates to AI/ML device performance.
This 510(k) pertains to a physical medical device (a ventilator), and its substantial equivalence is demonstrated through engineering performance testing against established standards and comparison of technical characteristics with a legally marketed predicate device.
However, I can extract the general acceptance criteria for this type of device based on the information provided:
Summary of Acceptance Criteria and Device Performance (Based on the provided document for a Ventilator):
Since this is a ventilator and not an AI/ML diagnostic tool, the "acceptance criteria" discussed are related to performance against established engineering and safety standards, and functional equivalence to a predicate device, rather than diagnostic accuracy metrics.
| Acceptance Criteria (General for Ventilators) | Reported Device Performance (Nihon Kohden NKV-440 Ventilator System) |
|---|---|
| Intended Use Equivalence: Provide continuous ventilation for adult, pediatric, and neonatal patients requiring invasive or noninvasive respiratory support, including mandatory and spontaneous ventilation modes and respiratory monitoring, for use in hospitals and hospital-type facilities, as well as in-hospital transport. | Met: "The Nihon Kohden NKV-440 Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. The NKV-440 offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The NKV-440 is intended for use in hospitals and hospital-type facilities, as well as, for in-hospital transportation." (Identical to predicate) |
| Clinical Conditions Equivalence: Use in hospitals, hospital-type facilities, and in-hospital transportation for patients needing ventilation therapy. | Met: "Hospitals, hospital-type facilities and in-hospital transportation for patients who need ventilation therapy." (Identical to predicate) |
| Anatomical Site Equivalence: Patient airways. | Met: "Patient airways." (Identical to predicate) |
| Target Population Equivalence: Adult, pediatric, and neonatal patients. | Met: "Adult, pediatric and neonatal patients." (Identical to predicate) |
| User Equivalence: Trained clinicians, not lay users. | Met: "Trained clinicians, not lay users." (Identical to predicate) |
| Compliance with ISO 80601-2-12 (Essential Performance of Critical Care Ventilator): | Met: "Met ISO 80601-2-12 requirements on essential performance of critical care ventilator." (Identical to predicate) |
| Waveform Comparison: Comparable waveform test result to predicate device. | Met: "Comparable waveform test result." |
| Chemicals Deployed to Patient Equivalence: Air and oxygen. | Met: "Air and oxygen." (Identical to predicate) |
| Delivery Method to Patient Equivalence: Positive pressure. | Met: "Positive pressure." (Identical to predicate) |
| Energy Used for Device Equivalence: AC Power and internal DC Power (Li-ion battery). | Met: "AC Power and internal DC Power (Li-ion battery)." (Identical to predicate, noting "Exactly same battery packs are used in both NKV-440 and NKV-550.") |
| Control Principle Equivalence: Time-cycled, volume-constant, pressure-controlled. | Met: "time-cycled, volume-constant, pressure-controlled." (Identical to predicate) |
| Breathing Modes Equivalence: All specified invasive and non-invasive modes (A/CMV-PC, A/CMV-VC, A/CMV-PRVC, SIMV-PC-PS, SIMV-VC-PS, SIMV-PRVC-PS, SPONT-CPAP, SPONT-PS, SPONT-VS, APRV, CPAP, O2 Therapy). | Met: All listed modes are identical to the predicate device. |
| Compliance with Relevant Standards: (e.g., ANSI AAMI ES 60601-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62133, IEC 62304, IEC 62366-1, ISO 10993-1, ISO 14971, ISO 18562-1, ISO 80601-2-12, ISO 80601-2-55, ISO 80601-2-61). | Met: The device "has been tested in compliance with the following standards" (a comprehensive list is provided). |
| Other Non-Clinical Performance: Performance of Ventilation Modes and Control Settings, Device/Software Functionality, Power performance, Essential Performance and Worst Case VBS, Environmental, Product Endurance/Reliability, Biocompatibility, Cleaning & Disinfection, EMC and Electrical Safety, Human Factors/Usability, Risk Management, Compatibility with 3rd Party Devices. | Demonstrated: "Performance of the Nihon Kohden NKV-440 Ventilator was demonstrated by the following..." (followed by the list above). |
Regarding the points specific to AI/ML device studies, the document states "Not Applicable" for clinical and animal performance data, and does not mention any AI/ML components inherent to the device or its assessment.
Therefore, the following points cannot be answered from the provided text:
- Sample sizes used for the test set and the data provenance: Not applicable, as this is not an AI/ML clinical study. Performance is demonstrated through engineering tests and comparison to a predicate device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In conclusion, the supplied document describes the regulatory clearance for a conventional medical ventilator by demonstrating substantial equivalence to a predicate device through non-clinical performance data and adherence to recognized standards. It does not involve AI/ML technology or human reader studies.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.
May 31, 2023
Nihon Kohden OrangeMed, Inc. Sheryl Higgins Vice President of Regulatory Affairs & Quality Assurance 1800 E. Wilshire Avenue Santa Ana, California 92705
Re: K222644
Trade/Device Name: Nihon Kohden NKV-440 Ventilator System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK Dated: May 4, 2023 Received: May 4, 2023
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
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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 (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 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,
Ethan E. Nyberg -S
for James Lee, Ph.D. Division 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) K222644
Device Name Nihon Kohden NKV-440 Ventilator System
Indications for Use (Describe)
The Nihon Kohden NKV-440 Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. The NKV-440 offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The NKV-440 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 contains the logo for Nihon Kohden OrangeMed, Inc. The logo consists of the company's name in two lines of text. The first line, "NIHON KOHDEN", is in blue, while the second line, "Nihon Kohden OrangeMed, Inc.", is in orange. To the left of the company name is a blue graphic element.
510(k) Summary
1. Date
May 04, 2023
2. Submitter / Manufacturing Location
Nihon Kohden OrangeMed, Inc. 1800 E. Wilshire Avenue Santa Ana, CA 92705 USA
3. Company Contact
| Primary: | Sheryl HigginsVice President of Regulatory Affairs and Quality Assurance |
|---|---|
| Email: | shiggins@orange-med.com |
| Phone: | (949) 502-6448 x7012 |
| Secondary: Jacqueline Villanueva | |
|---|---|
| Director of Quality Assurance | |
| Email: | jvillanueva@orange-med.com |
| Phone: | (949) 502-6448 x7045 |
Common Name of Device 4.
Critical Care Ventilator
5. Trade Name
Nihon Kohden NKV-440 Ventilator System
Classification Name 6.
| Product Code: | CBK - Ventilator, Continuous, Facility Use |
|---|---|
| Regulation Number: | 21 CFR 868.5895 Continuous Ventilator |
| Device Class: | II |
| Review Panel: | Anesthesiology |
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Image /page/4/Picture/0 description: The image contains the logo for Nihon Kohden OrangeMed, Inc. The logo consists of a blue graphic element on the left, followed by the text "NIHON KOHDEN" in blue. Below this, the text "Nihon Kohden OrangeMed, Inc." is displayed in orange. The logo is simple and professional, likely representing a medical or technology company.
7. Predicate Device
| Product: | Nihon Kohden NKV-550 Ventilator System |
|---|---|
| 510k #: | K192307 |
| Manufacturer: | Nihon Kohden OrangeMed, Inc. |
8. Reference Device
| Product: | Hamilton-C3 |
|---|---|
| 510k #: | K201306 |
| Manufacturer: | Hamilton Medical AG |
9. Description of Device
The NKV-440 is a servo-controlled ventilator that is designed to meet the gas delivery and performance requirements for neonate through adult patients. The NKV-440 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.
10. Product Intended Function
The Nihon Kohden NKV-440 Ventilator System is intended to provide continuous ventilation using medical oxygen and an internal source of 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).
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Image /page/5/Picture/0 description: The image shows the logo for Nihon Kohden OrangeMed, Inc. The logo consists of a blue square with a white design on the left, followed by the text "NIHON KOHDEN" in blue. Below that, the text "Nihon Kohden OrangeMed, Inc." is written in orange.
11. Indication for Use (Intended Medical Indication)
The Nihon Kohden NKV-440 Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. The NKV-440 offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The NKV-440 is intended for use in hospitals and hospitaltype facilities, as well as, for in-hospital transportation.
12. Intended Patient Population
The intended patient population includes neonate through adult patients who require invasive or non-invasive respiratory support.
13. Intended Part of the Body or Type of Tissue Applied to or Interacted with
The device does not come into direct contact with the patient. The device is considered to be externally communicating with the patient airway because it delivers air/oxygen to the patient respiratory system.
14. 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 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.
The device is not to be used in the presence of flammable anesthetics and MRI applications.
15. Summary of Technical Characteristics
The technological characteristics of the Nihon Kohden NKV-440 Ventilator System are substantially equivalent to the predicate device as compared and summarized in the table below.
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Image /page/6/Picture/0 description: The image shows the logo for NIHON KOHDEN. The logo consists of a blue abstract 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 a bold typeface.
Nihon Kohden OrangeMed, Inc.
| Table 12-1 | Nihon KohdenOrangeMed, Inc. | Nihon KohdenOrangeMed, Inc. | Comparison |
|---|---|---|---|
| Company | |||
| Establishment | 3014631252 | 3014631252 | |
| MODEL | NKV-440 | NKV-550 | |
| 510(k) | This Submission | K192307 | |
| Indications forUse | The Nihon Kohden NKV-440 Ventilator System isintended to providecontinuous ventilation foradult, pediatric and neonatalpatients who require invasiveor noninvasive respiratorysupport. The NKV-440offers mandatory andspontaneous ventilationmodes as well as respiratorymonitoring. The NKV-440 isintended for use in hospitalsand hospital-type facilities,as well as, for in-hospitaltransportation. | The Nihon Kohden NKV-550 Series Ventilator Systemis intended to providecontinuous ventilation foradult, pediatric and neonatalpatients who require invasiveor noninvasive respiratorysupport. The NKV-550offers mandatory andspontaneous ventilationmodes as well as respiratorymonitoring. The NKV-550 isintended for use in hospitalsand hospital-type facilities,as well as, for in-hospitaltransportation. | Same |
| ClinicalConditions | Hospitals, hospital-typefacilities and in-hospitaltransportation for patientswho need ventilation therapy | Hospitals, hospital-typefacilities and in-hospitaltransportation for patientswho need ventilation therapy | Same |
| Anatomical Site | Patient airways | Patient airways | Same |
| TargetPopulation | Adult, pediatric and neonatalpatients | Adult, pediatric and neonatalpatients | Same |
| Users | Trained clinicians, not layusers | Trained clinicians, not layusers | Same |
| ClinicalPerformance | Met ISO 80601-2-12requirements on essentialperformance of critical careventilator | Met ISO 80601-2-12requirements on essentialperformance of critical careventilator | Same |
| WaveformComparison | Comparable waveform testresult | Comparable waveform testresult | Similar |
| Table 12-1 | Nihon KohdenOrangeMed, Inc. | Nihon KohdenOrangeMed, Inc. | |
| Company | OrangeMed, Inc. | OrangeMed, Inc. | |
| Establishment | 3014631252 | 3014631252 | Comparison |
| MODEL | NKV-440 | NKV-550 | |
| 510(k) | This Submission | K192307 | |
| Design | Consists of a graphic userinterface to set and monitorventilation, breath deliveryunit, breathing circuit, andcart;Controls air and oxygendeliveries by a blower andproportional valve throughmicroprocessors | Consists of a graphic userinterface to set and monitorventilation, breath deliveryunit, breathing circuit, andcart;Controls air and oxygendeliveries by proportionalvalves throughmicroprocessors | SimilarIn the NKV-440, a built-in blower draws the roomair in and controls the airdelivery. In the NKV-550, an external aircompressor is the air gassource, and a built-inproportional valvecontrols the air delivery. |
| Conditions ofUse | Hospitals, hospital-typefacilities and in-hospitaltransportation | Hospitals, hospital-typefacilities and in-hospitaltransportation | Same |
| ChemicalsDeployed toPatient | Air and oxygen | Air and oxygen | Same |
| Delivery methodto Patient | Positive pressure | Positive pressure | Same |
| Energy Used forDevice | AC Power and internal DCPower (Li-ion battery) | AC Power and internal DCPower (Li-ion battery) | SameExactly same batterypacks are used in bothNKV-440 and NKV-550. |
| Controlprinciple | time-cycled, volume-constant, pressure-controlled | time-cycled, volume-constant, pressure-controlled | Same |
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Image /page/7/Picture/0 description: The image features the logo of NIHON KOHDEN. The logo consists of a blue square with a white abstract design inside, resembling a stylized wave or a rising sun. To the right of the square is the text "NIHON KOHDEN" in a bold, sans-serif font, also in blue.
Nihon Kohden OrangeMed, Inc.
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Image /page/8/Picture/0 description: The image shows the logo for NIHON KOHDEN. The logo consists of a blue square with a white curved line running through it, 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.
Nihon Kohden OrangeMed, Inc.
| Table 12-1 | Nihon Kohden | Nihon Kohden | Comparison |
|---|---|---|---|
| Company | OrangeMed, Inc. | OrangeMed, Inc. | |
| Establishment | 3014631252 | 3014631252 | |
| MODEL | NKV-440 | NKV-550 | |
| 510(k) | This Submission | K192307 | |
| Specifications:Breathing Modes | Invasive Ventilation: | Invasive Ventilation: | |
| A/CMV-PC | A/CMV-PC | Same | |
| A/CMV-VC | A/CMV-VC | ||
| A/CMV-PRVC | A/CMV-PRVC | ||
| SIMV-PC-PS | SIMV-PC-PS | ||
| SIMV-VC-PS | SIMV-VC-PS | ||
| SIMV-PRVC-PS | SIMV-PRVC-PS | ||
| SPONT-CPAP | SPONT-CPAP | ||
| SPONT-PS | SPONT-PS | ||
| SPONT-VS | SPONT-VS | ||
| APRV | APRV | ||
| Non-Invasive Ventilation: | Non-Invasive Ventilation: | ||
| A/CMV-PC | A/CMV-PC | ||
| SIMV-PC-PS | SIMV-PC-PS | ||
| SPONT-CPAP | SPONT-CPAP | ||
| SPONT-PS | SPONT-PS | ||
| APRV | APRV | ||
| CPAP | CPAP | ||
| O2 Therapy | O2 Therapy |
16. Summary of Non-Clinical Performance Data
Performance of the Nihon Kohden NKV-440 Ventilator was demonstrated by the following:
- Agency Testing to Applicable Standards
- Performance of Ventilation Modes . and Control Settings
- Device/Software Functionality
- . Power performance with AC power, External Battery, and Backup Battery
- . Essential Performance and Worst Case VBS
- Environmental
- Waveform Comparison with Predicate
- . Product Endurance/Reliability
- . Biocompatibility
- . Cleaning & Disinfection
- EMC and Electrical Safety ●
- Human Factors/Usability
- Risk Management
- Compatibility with 3rd Party Devices ●
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Image /page/9/Picture/0 description: The image features the logo for Nihon Kohden. The logo consists of a blue abstract graphic to the left of the company name, "NIHON KOHDEN," which is also in blue. Below the main logo, in orange text, is the text "Nihon Kohden OrangeMed, Inc."
Where applicable, the Nihon Kohden NKV-440 Ventilator has been tested in compliance with the following standards:
| Standard | Title |
|---|---|
| AIM 7351731 | Medical Electrical Equipment & System Electromagnetic Immunity Test forRFID Readers |
| Rev. 2 2017-02 | |
| ANSI AAMI ES 60601-1 | Medical electrical equipment - Part 1: General requirements for basic safety |
| 2005+AC1;A2 (R2012) | and essential performance (IEC 60601-1:2005, MOD) |
| IEC 60601-1 | Medical Electrical Equipment - Part 1: General Requirements For Basic SafetyAnd Essential Performance |
| Ed. 3.1 2012-08 | |
| IEC 60601-1-2 | Medical Electrical Equipment - Part 1-2: General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility - Requirements and Tests |
| Ed. 4.1 2020-09 | |
| IEC 60601-1-6 | Medical electrical equipment - Part 1-6: General requirements for safety -Collateral Standard: Usability |
| Ed. 3.1 2013-10 | |
| IEC 60601-1-8 | Medical Elec. Equip. - Part 1-8: General Req. for Basic Safety & EssentialPerf. - Collateral Standard: General Req., Tests & Guidance for AlarmSystems in Medical Elec. Equip. & Medical Elec. Systems |
| Ed 2.1 2012-11 | |
| IEC 62133 | Secondary cells and batteries containing alkaline or other non-acid electrolytes- Safety requirements for portable sealed Secondary cells, and for batteriesmade from them, for use in portable applications |
| Ed. 2.0 2012-12 | |
| IEC 62304 | Medical device software - Software life cycle processes |
| Ed. 1.1 2015-06 | |
| IEC 62366-1 | Medical devices - Application of usability engineering to medical devices |
| Ed. 1.0 2015-02 | |
| ISO 10993-1 | Biological Evaluation of Medical Devices - Part 1: Evaluation and Testingwithin a Risk Management Process |
| Ed. 5 2018-08 | |
| ISO 14971 | Medical devices - Application of risk management to medical devices |
| Ed. 3 2019-12 | |
| ISO 18562-1 | Biocompatibility Evaluation of Breathing Gas Pathways in HealthcareApplications |
| Ed. 1 2017-03 | |
| ISO 80601-2-12 | Medical Electrical Equipment - Part 2-12: Particular Requirements for BasicSafety and Essential Performance of Critical Care Ventilators |
| Ed. 2 2020-02 | |
| ISO 80601-2-55 | Medical Electrical Equipment – Part 2-55: Particular Requirements for TheBasic Safety and Essential Performance of Respiratory Gas Monitor |
| Ed. 2 2018-02 | |
| ISO 80601-2-61 | Medical electrical equipment - Part 2-61: Particular requirements for basicsafety and essential performance of pulse oximeter equipment |
| Ed 2 2017-12 |
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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-440 Ventilator System is substantially equivalent the predicate device.
§ 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).