The Invacare® Platinum® 5NXG Oxygen Concentrator is indicated for patients with respiratory disorders requiring supplemental oxygen at flow rates of 1 to 5 liters per minute. For flow rates below 1 liter per minute use with Invacare Pediatric Flowmeter accessory. It is not intended to sustain or support life.

Device Description

The subject Invacare® Platinum® 5NXG Oxygen Concentrator device is used by patients who require supplemental oxygen. The device is not intended to sustain or support life. The oxygen concentration level of the output gas ranges from 87% to 96% at an output flow rate range of 1 to 5 liters per minute (LPM). The oxygen is delivered to the user through the use of a nasal cannula. The concentrator provides supplemental oxygen to patients with respiratory disorders, in the home, long term care facility or other non-acute patient care facilities. It is not intended to sustain or support life. It is to be used indoors and is intended to support the patient's lifestyle within the home or care facility. The device operates at a nominal 120VAC/60 Hertz supply.

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification for the Invacare Platinum 5NXG Oxygen Concentrator. It describes the device, its intended use, and compares it to a predicate device (Invacare Perfecto2™V Oxygen Concentrator K200890) to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a "table of acceptance criteria and reported device performance" in the format of pass/fail measurements against specific numerical criteria for all aspects. Instead, it describes general performance categories and states that the device "met the performance requirements" or "demonstrates that the subject device meets performance specifications and requirements."

However, we can infer some criteria and reported performance from the "Design Characteristics Comparison" table on page 6 and the "Performance Testing – Bench" section on page 9.

Acceptance Criteria (Inferred from Predicate/Standards)	Reported Device Performance (Invacare Platinum 5NXG Oxygen Concentrator)
Oxygen Output Concentration Levels	87% to 96% at all flow rates
(Predicate was 95.6% to 87% at all flow rates)
Maximum Flow Rate	5.0 L/min
(Same as predicate)
Adjustable Flow Range	1 to 5 L/min in 0.5 L/min increments
(Same as predicate)
Oxygen Purity Fault Indication	If oxygen purity falls below 82% but above 50%
(Predicate was if oxygen purity falls below 85% (±2%) but above 73% (±3%))
Rated Current Input	3.0 A
(Predicate was 3.2 A)
Electrical Requirements	120 VAC ±10%, 60 Hz
(Same as predicate)
Weight	33 ± 2 lbs.
(Predicate was 40 lbs.)
Height	24 ± 3/8"
(Predicate was 23 ± 3/8")
Width	16 ± 3/8"
(Predicate was 15 ± 3/8")
Depth	12 ± 3/8"
(Same as predicate)
Basic Safety and Essential Performance	Device meets performance specifications and requirements
(Assessed against ISO 80601-2-69, AAMI ES60601-1, IEC 60601-1 etc.)
Risk Management	Risk profile unchanged, no significant impact on safety/effectiveness.
(In accordance with ISO 14971:2012)
Software Functionality (including alarms and indicators)	Evaluated and verified
(In accordance with FDA guidance and IEC 62304:2006, ISO 80601-2-69)
Electrical Safety and EMC	Confirmed post-change functionality, demonstrated equivalence
(Against various IEC and AAMI standards)
Biocompatibility	Performed on components; met requirements for inorganic gases (CO, CO2, O2) and odor.
(In accordance with ISO 18562 series and USP monograph)
Power and Oxygen Output Performance	Met performance specifications and requirements
Transportation Testing (ISTA 2A)	Successfully performed
Sound Testing	Successfully performed

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "design verification testing data" and "bench performance testing." These are laboratory or engineering tests performed on the device itself (or its components) rather than clinical data from a human population. Therefore, the concept of a "sample size" in the clinical sense (e.g., number of patients) is not applicable here. The testing involves physical devices.
The provenance of the data is internal to the manufacturer (Invacare Corporation) as it describes their internal verification testing. The document does not specify the country of origin of the test data (e.g., if the tests were performed in the US, or elsewhere) nor does it explicitly state whether the testing was prospective (done specifically for this submission) or retrospective (using existing data), though the context of "design verification testing" implies it was specifically conducted for the submission.

3. 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)

This product is an oxygen concentrator, a medical device for delivering oxygen. It is not an AI/imaging device requiring expert interpretation for ground truth. Therefore, the concept of "experts establishing ground truth for a test set" with qualifications such as radiologists is not applicable to this submission. The ground truth for performance is established by objective measurements and adherence to recognized consensus standards by qualified testing engineers and laboratories.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As noted above, this device does not involve human interpretation requiring adjudication for establishing ground truth. Performance is measured objectively.

5. 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. The device is an oxygen concentrator, not an AI-assisted diagnostic tool. No MRMC study was performed, nor is it relevant to the device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. The device is an oxygen concentrator, not an algorithm or software-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's performance is established by objective measurements against defined engineering specifications and recognized consensus standards. This includes:

Measurements of oxygen concentration, flow rates, electrical characteristics, weight, dimensions, and sound levels.
Adherence to specific clauses and requirements within international standards like ISO 80601-2-69 (specific for oxygen concentrators), AAMI ES60601-1, IEC 60601-1 (general medical electrical equipment safety), IEC 62304 (software life cycle), ISO 14971 (risk management), and ISO 18562 series (biocompatibility).

8. The sample size for the training set

Not applicable. This is a hardware medical device, not an AI/machine learning model that requires a "training set" of data.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this type of medical device.

Summary

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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 and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the words "U.S. Food & Drug Administration."

April 12, 2021

Invacare Corporation Elijah Wreh Regulatory Affairs Manager One Invacare Way Elyria, Ohio 44035

Re: K203210

Trade/Device Name: Invacare Platinum 5NXG Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: March 10, 2021 Received: March 11, 2021

Dear Elijah Wreh:

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 vour device in the Federal Register.

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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 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/cdrl-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-ind-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,

Todd D. Courtney -S

Todd Courtney Assistant Director DHT1C: Division of ENT, 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

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

Invacare® Platinum® 5NXG Oxygen Concentrator

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

Page 1 of 1

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510(k) Summary

SUBMITTER per 21 CFR 807.92(a)(1):

Invacare Corporation One Invacare Way Elyria, OH 44035 Phone: (440) 329-6840 Email: ewreh@invacare.com

CONTACT PERSON:

Elijah Wreh Regulatory Affairs Manager

MANUFACTURER:

Invacare Corporation 1200 Taylor Street Elyria, OH 44035

Date Prepared per 21 CFR 807.92(a)(1):

March 8, 2021

DEVICE INFORMATION per 21 CFR 807.92(a)(2)

Name of Device:	Invacare® Platinum® 5NXG Oxygen Concentrator
Common or Usual Name:	Portable Oxygen Generator
Classification Name:	Generator, Oxygen, Portable 21 CFR 868.5440
Regulatory Class:	2
Product Code:	CAW
PREDICATE DEVICE:	Invacare® Perfecto2™V Oxygen Concentrator (K200890)
Patient Population:	Patients with respiratory disorders requiring supplementaloxygen at flow rates of 1 to 5 liters per minute

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DEVICE DESCRIPTION per 21 CFR 808.92(a)(4)

The concentrator provides supplemental oxygen to patients with respiratory disorders, in the home, long term care facility or other non-acute patient care facilities. It is not intended to sustain or support life. It is to be used indoors and is intended to support the patient's lifestyle within the home or care facility. The device operates at a nominal 120VAC/60 Hertz supply.

INTENDED USE per 21 CFR 807.92(A)(5)

The Invacare® Platinum® 5NXG Oxygen Concentrator is intended for patients with respiratory disorders requiring supplemental oxygen at flow rates of 1 to 5 liters per minute. For flow rates below 1 liter per minute use with Invacare Pediatric Flowmeter accessory. It is not intended to sustain or support life.

INDICATIONS FOR USE per FORM FDA 3881

INDICATIONS FOR USE (IFU) COMPARISON

The Indications for Use statement for the subject device is the same as the previously cleared predicate device.

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COMPARISON of TECHNOLOGICAL CHARACTERISTICS with the PREDICATE DEVICE per 21 CFR 807.92(a)(6)

The device comparison shows that the subject device is substantially equivalent in intended use, design, materials, and operational principles to the previously cleared predicate device. The subject and predicate devices use the same technology to extract nitrogen from air. The subject device components met the performance requirements and is substantially equivalent to the predicate device identified throughout this submission and do not raise different questions of safety and effectiveness. The different technological characteristics do not raise different questions of safety and effectiveness as compared to the predicate device.

BASIS of SUBSTANTIAL EQUIVALENCE per 21 CFR 807.100(b)(2)(ii)(A)

The substantial equivalence of the subject device was determined as per the FDA guidance document, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)/' and the technological characteristics which include materials, design, and other device related features, as defined in section 513(i)(1)(B) of the FD&C Act and 21 CFR 807.100(b)(2)(ii)(A).

The differences between the new and predicate devices are as a result of updating the pneumatic system, complying to the latest version of ISO 80601-2-69, updating the general structure, and upgrading the operating system, hardware and firmware. The sum of the changes can be assessed using the same consensus standards and acceptance criteria that were used for the predicate device.

The design verification testing and device comparison below demonstrates that the subject device is substantially equivalent to the predicate device. The data generated from the subject device design verification test reports support a finding of substantial equivalence regarding device function and performance and comparison of device specifications and characteristics supports they are substantially equivalent.

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Design Characteristics Comparison

Design and Technological Characteristics	Subject Device	Predicate Device
Device Name	Invacare® Platinum® 5NXG Oxygen Concentrator	Invacare® Perfecto2™V Oxygen Concentrator (K200890)
Manufacturer	Invacare Corporation	Same
Intended Use	The Invacare® Platinum® 5NXG oxygen concentrator isintended for patients with respiratory disorders requiringsupplemental oxygen at flow rates of 1 to 5 liters per minute. Forflow rates below 1 liter per minute use with Invacare PediatricFlowmeter accessory. It is not intended to sustain or support life.	Same
Indications for Use	The Invacare® Platinum® 5NXG oxygen concentrator isindicated for patients with respiratory disorders requiringsupplemental oxygen at flow rates of 1 to 5 liters per minute. Forflow rates below 1 liter per minute use with Invacare PediatricFlowmeter accessory. It is not intended to sustain or support life.	Same
Type of Use	Prescription (Rx Only)	Same
Patient Population	Patients with respiratory disorders requiring supplementaloxygen at flow rates of 1 to 5 liters per minute	Same
Oxygen Outlet	Port supplying produced concentrated oxygen	Same
Flowmeter	Adjusts oxygen flow to prescribed setting	Same
Maximum Flow Rate	5.0 L/min	Same
Adjustable Flow Range	1 to 5 L/min in 0.5 L/min increments	Same
Elapsed Time Meter	Displays the cumulative number of hours the unit has operated	Same
Oxygen Purity Fault	If oxygen purity falls below 82% but above 50%	If oxygen purity falls below 85% (±2%) but above 73% (±3%)
Power Indicator	Indicates Device Power Status On/Off	Same
Rated Current Input	3.0 A	3.2 A
Electrical Requirements	120 VAC ±10%, 60 Hz	Same
Oxygen Output Concentration Levels	87% to 96% at all flow rates	95.6% to 87% at all flow rates
Weight	33 ± 2 lbs.	40 lbs.
Height	24 ± 3/8"	23 ± 3/8"
Width	16 ± 3/8"	15 ± 3/8"
Depth	12 ± 3/8"	Same

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DESIGN VERIFICATION TESTING DATA

Design verification testing was performed using the same consensus standards and acceptance criteria that were used for the predicate device to demonstrate a finding of substantial equivalence. The subject device met the performance requirements and is substantially equivalent to the predicate device and do not raise any new questions of safety and effectiveness.

Risk Management

Risk Management has been conducted in accordance with ISO 14971:2012 - Medical Devices -Application of Risk Management to Medical Devices for the subject Invacare® Platinum® 5NXG Oxygen Concentrator. The risk-based assessment concluded that the subject device's risk profile remained unchanged and there is no significant impact on the safety or effectiveness of the subject device. The Risk Management File was updated to our current format.

Software Verification Testing

Software Verification Testing, including testing per ISO 80601-2-69 on the finished product, was performed to evaluate the functionality of the subject device, including alarms and indicators. Software verification testing was conducted on the subject device as recommended by the FDA's

guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and IEC 62304:2006 – Medical device software – Software Life Cycle Processes.

Level of Concern: The Level of Concern for the subject device is Moderate.

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical Safety and Electromagnetic Compatibility (EMC) testing was performed to confirm post-change functionality of the subject device. This includes the following:

. AAMI ES60601-1: Medical Electrical Equipment - Part 1 : General Requirements for Basic Safety and Essential Performance
IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for Basic . Safety & Essential Performance
ISO 80601-2-69 Medical electrical equipment Part 2: Particular Requirements for the . Basic Safety and Essential Performance of Oxygen Concentrator Equipment

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IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General Requirements for . Basic Safety and Essential performance – Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
. IEC 60601-1-6: Medical Electrical Equipment Part 1-6 General Requirements for Safety - Collateral Standard: Usabilitv
. IEC 62366: Medical Devices – Application of Usability Engineering to Medical Devices
. IEC 60601-1-11: Medical Electrical Equipment – Part 1-11: General Requirements for Basic Safety and Essential performance – Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
. IEC 60601-1-8: Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

In summary, the sum of the changes can be assessed using the same consensus standards and acceptance criteria that were used for the predicate device and returned substantially the same results as the predicate device demonstrating that the subject device is equivalent in electrical and electromagnetic safety performance to the predicate device.

Biocompatibility Testing

Biocompatibility testing was performed on the subject device components in accordance with FDA guidance document entitled "Use of International Standard ISO 18562-1, "Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications- Part 1 : Evaluation and Testing within a Risk Management Process." The battery of testing was performed to the following FDA recognized consensus standards:

ISO 18562-1:2017, Biocompatibility Evaluation of Breathing Gas Pathways in .
Healthcare Applications Part 1: Evaluation and Testing within a Risk Management .
. Process
. ISO 18562-2:2017, Biocompatibility Evaluation of Breathing Gas Pathways in
Healthcare Applications Part 2: Tests for Emissions of Particulate Matter .
ISO 18562-3:2017. Biocompatibility Evaluation of Breathing Gas Pathways in .
Healthcare Applications Part 3 : Tests for Emissions of Volatile Organic Compounds .

Testing to detect inorganic gases including Carbon Monoxide (CO) and Carbon Dioxide (CO2), Oxygen (O2) and odour was performed on the subject device. The objective of the test was to assess CO. CO2. O2. and odour and compare their PPM (parts per million) for eas biocompatibility according to the requirements of the "Oxygen 93 %" USP monograph directly to patients.

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Performance Testing – Bench

The Invacare® Platinum® 5NXG Oxygen Concentrator is tested to recognized consensus standards for basic safety and essential performance, which can be found in Section "Electromagnetic Compatibility and Electrical Safety." Additional respiratory testing has been performed on the subject device to demonstrate a finding of substantial equivalence to the predicate device. The battery of testing includes:

. Power and oxygen output performance testing
. ISTA 2A
Weight .
Sound Testing .

ISO 80601-2-69 Medical electrical equipment Part 2: Particular Requirements for the Basic Safety and Essential Performance of Oxygen Concentrator Equipment In summary, the testing demonstrates that the subject device meets performance specifications and requirements and is substantially equivalent to the predicate device identified throughout this 510(k) submission. The data generated from the performance testing demonstrated that the

subject device meets all the performance specifications and requirements and is substantially equivalent to the predicate device.

Animal Study

Animal testing is not required for this submission.

Clinical Testing

Clinical testing is not required for this submission.

CONCLUSIONS per 21 CFR 807.92(b)(3)

The subject device has the same intended use and technological characteristics as the predicate device. The design verification results support a finding of substantial equivalence of the subject device and demonstrate that the subject device will perform as intended in the specified use conditions.

Regulation Number and Section

§ 868.5440 Portable oxygen generator.

(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).