The Invacare® Platinum™ Mobile Oxygen Concentrator is intended to provide supplemental oxygen to patients with respiratory disorders. The device can be used in a home, institution, vehicle, or other environments outside the home.

Device Description

The Invacare® Platinum™ Mobile Oxygen Concentrator is a portable oxygen concentrator that provides oxygen in pulsed demand flow dosages at settings of P1 through P4. The oxygen concentration level of the output gas ranges from 87% to 95.6%. The device is used with a nasal cannula to direct oxygen from the device to the patient. The Invacare® Platinum™ Mobile Oxygen Concentrator can be used in a home, institution, vehicle, or other environments outside the home. The device is not intended to be life supporting or life sustaining.

AI/ML Overview

This document is a 510(k) premarket notification for the "Invacare® Platinum™ Mobile Oxygen Concentrator." It asserts that the device is substantially equivalent to a legally marketed predicate device. The information provided heavily focuses on non-clinical performance and comparison to a predicate, rather than an AI/ML-driven device with detailed acceptance criteria for diagnostic performance outcomes.

Given the nature of the document, the questions about acceptance criteria and study details for an AI/ML device are not directly applicable. This is a traditional medical device submission, not specifically one for software as a medical device (SaMD) or an AI/ML diagnostic tool. Therefore, many of the requested fields about AI/ML specific criteria (like "multi-reader multi-case comparative effectiveness study," "standalone algorithm performance," "sample size for training set," "number of experts," etc.) cannot be answered from this document.

However, I can extract the closest analogous information from the provided text regarding performance testing and acceptance.

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

The document does not explicitly present a table of "acceptance criteria" against which specific numerical performance metrics are reported in the way demanded by an AI/ML diagnostic device (e.g., sensitivity, specificity, AUC). Instead, it lists various performance tests that were conducted to ensure the device's functionality, safety, and equivalence to the predicate. The implication is that successful completion of these tests, demonstrating that the device operates within expected parameters and similar to the predicate, serves as the acceptance basis for this type of device.

Test Category	Specific Tests Performed	Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Respiratory Testing	- Product Weight Test- Pulse Volume/Pulse Time/Trigger Sensitivity / Oxygen Purity Test- External Battery Charger Charge Time- Oxygen Sensor Accuracy- Oxygen Purity at AC Supply Mains Extremes- Oxygen Purity at DC Power Extremes- Oxygen Purity after Storage Thermal Cycling- Oxygen Purity at Low and High Temperature- Hot – Swapping Batteries- Battery Discharge Times- Battery Charge Times- Oxygen Purity at Low and High Altitude- Software Functional Test- Oxygen Alarms Test- Operational Alarms Test- Full Assembly Sound Performance Test- POC1 Battery Charge Time When POC1 Unit Not Running	- Device consistently provides oxygen within specified ranges (87% to 95.6% purity).- Alarms function correctly (e.g., low oxygen purity, oxygen sensor failure, no breath detect indication).- Battery performance (charge/discharge) meets specifications.- Device maintains performance under various environmental conditions (temperature, altitude, power extremes).- Product weight is as specified.- Software functions as intended.- Pulse volume, pulse time, and trigger sensitivity are within specifications.	- Output gas ranges from 87% to 95.6%.- Alarms for low oxygen purity and oxygen sensor failure are present. (The predicate device had "No breath detect" with specific actions, while the subject device lists "No breath detect" as an alarm, but without detailed actions, noting "No 'Auto-Pulse' feature").- Overall Conclusion: "The non-clinical laboratory data support the substantial equivalence of Invacare® Platinum™ Mobile Oxygen Concentrator and demonstrates that the subject device performs as intended in the specified use conditions." Specific numerical results for each test are not provided in this summary.
Electrical Safety and EMC	- AAMI ES60601-1- IEC 60601-1- ISO 80601-2-67- ISO 80601-2-69- IEC 60601-1-2- IEC 60601-1-6- IEC 62366- IEC 60601-1-8- IEC 60601-1-11	- Compliance with all listed consensus standards for electrical safety, electromagnetic compatibility, usability, and alarm systems.	- Overall Conclusion: "The non-clinical laboratory data support the substantial equivalence of Invacare® Platinum™ Mobile Oxygen Concentrator and demonstrates that the subject device performs as intended in the specified use conditions." Implies successful compliance with all standards.
Software Verification Testing	- Testing conducted as recommended by "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."	- Software functions correctly and reliably, consistent with a "minor level of concern" where failure will not result in injury (as the device is not life-supporting).	- Overall Conclusion: "The non-clinical laboratory data support the substantial equivalence of Invacare® Platinum™ Mobile Oxygen Concentrator and demonstrates that the subject device performs as intended in the specified use conditions." Implies successful verification.
Biocompatibility Testing	- AAMI / ANSI / ISO 10993-5 (in vitro Cytotoxicity)- AAMI / ANSI / ISO 10993-10 (Skin Irritation)- ISO 10993-11 (Systemic Toxicity)- Volatile Organic Chemicals Using the EPA TO-17 Method- Particulate Matter (PM)	- Raw materials making contact with the patient meet biocompatibility standards as per ISO 10993 series and FDA guidance.	- "The test results demonstrated that the subject device is biocompatible."

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

This information is not provided in a detailed format within this 510(k) summary. For device testing (e.g., respiratory, electrical safety, biocompatibility), the "sample size" would typically refer to the number of device units tested. This is usually a small number (e.g., 3-5 units) sufficient to demonstrate manufacturing consistency and design performance. The document only states that "Respiratory testing was performed," "Electrical Safety and Electromagnetic Compatibility testing was performed," etc., without specifying the number of units or any "data provenance" like country of origin for the data. This type of testing is typically prospective, performed in a lab setting by the manufacturer, rather than on patient data.

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)

Not applicable. This device is a portable oxygen concentrator, not an AI/ML diagnostic device requiring expert interpretation for ground truth. The "ground truth" for this device's performance is established through physical measurements, adherence to engineering specifications, and compliance with recognized standards.

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

Not applicable. No expert adjudication method is mentioned or required for the type of testing described (physical performance, electrical safety, biocompatibility).

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. No MRMC study was conducted. This is not an AI/ML diagnostic device for human reader assistance.

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

Not applicable. This is not an algorithm-only device. It's a hardware device with embedded software for control and monitoring. Its performance is inherent in the device's physical operation.

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

For this device, the "ground truth" is based on:

Physical Measurements and Engineering Specifications: Regarding oxygen purity, flow rates, battery life, weight, dimensions, alarm thresholds, etc.
Compliance with Recognized Standards: Such as those for electrical safety (IEC 60601 series), biocompatibility (ISO 10993 series), and software validation.
Functional Verification: Ensuring the device operates as designed under various conditions.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of machine learning or AI models. It's not an AI/ML device.

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

Not applicable. As there is no training set for AI/ML, there is no ground truth established in that context.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 27, 2016

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

Re: K160630

Trade/Device Name: Invacare® Platinum™ Mobile Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: August 25, 2016 Received: August 26, 2016

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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH 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

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Indications for Use

510(k) Number (if known) K160630

Device Name

Invacare® Platinum™ Mobile 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)
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510(k) Summary

SUBMITTER:	Invacare CorporationOne Invacare WayElyria, OH 44035
CONTACT PERSON:	Elijah N. WrehRegulatory Affairs Manager (Pre-Market)Phone: (440) 329-6840Email: ewreh@invacare.com
Date Prepared:	September 22, 2016
DEVICEName of Device:Common or Usual Name:Classification Name:	Invacare® Platinum™ Mobile Oxygen ConcentratorGenerator, Oxygen, PortablePortable Oxygen Generator 21 CFR §868.5440
Regulatory Class:	II
Product Code:	CAW: Generator, Oxygen, Portable
PREDICATE DEVICE:	The Invacare Flyer (Model XPO100) (K071928)No reference devices were used in this submission
Patient Population:	Adult Patient Only
Environment of Use:	Home, institution, vehicle, or other environments outside thehome

DEVICE DESCRIPTION

This Traditional [510(k)] submission is being supplied to the U.S. FDA to obtain authorization to market the Invacare® Platinum™ Mobile Oxygen Concentrator. The Invacare® Platinum™ Mobile Oxygen Concentrator is a portable oxygen concentrator that provides oxygen in pulsed demand flow dosages at settings of P1 through P4. The oxygen concentration level of the output gas ranges from 87% to 95.6%. The device is used with a nasal cannula to direct oxygen from the device to the patient. The Invacare® Platinum™ Mobile Oxygen Concentrator can be used in a home, institution, vehicle, or other environments outside the home. The device is not intended to be life supporting or life sustaining. There is no prior submission for the subject device.

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The associated accessories include:

Invacare® Battery .
. Invacare® Battery Charger
AC Adapter ●
DC Power Cable .
Carry Bag .

INDICATIONS FOR USE

INTENDED USE

The Invacare® Platinum™ Mobile Oxygen Concentrator is intended to provide supplemental oxygen to patients with respiratory disorders. The Invacare® Platinum™ Mobile Oxygen Concentrator can be used in a home, institution, vehicle, or other environments outside the home. The device is not intended to be life supporting or life sustaining.

INDICATIONS FOR USE COMPARISON

The subject device and the previously cleared predicate device is indicated to provide supplemental oxygen to patients with respiratory disorders. The subject device and the predicate device is intended to be used in a home, institution, vehicle, or other environments outside the home. The subject device is substantially equivalent to the predicate device in regards to intended use to provide supplemental oxygen to patients with respiratory disorders.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The device comparison demonstrates that the subject device is substantially equivalent in design, materials, and operational principles to the previously cleared The Invacare Flyer (Model XPO100) (K071928).

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Design Characteristics Comparison

No.	Feature	Subject DevicePlatinum Mobile Oxygen Concentrator(K160630)	Predicate DeviceThe Invacare Flyer (Model XPO100)(K071928)
1.	Sieve Bed Material	Synthetic zeolite OP-76	Synthetic zeolite Z12-07
2.	Height	9.45" max	10.0" +/- 1"
	Width	7.5" max	7.0" +/- 1"
	Depth	3.88" max	4.3" +/-1"
	DimensionsWeight	< 5 lbs. (with standard removable battery)	≤ 7 lbs. (with non-removable internal battery)
3.	Oxygen Purity Sensor	Yes	No
4.	Flow Rates	Pulse flow P1, P2, P3, P4Flow volume per minute is 220-880ml	Pulse flow 1, 2, 3, 4, 5Flow volume per minute is 300-840ml
5.	Alarms	Low oxygenpurity	Yes	No
		Oxygen sensorfailure	Yes	No
		No breath detect	Will supply bolus of O2 if no inhalation detected in 15seconds. Unit will shut down if no breath is detected for >120 seconds.	No "Auto-Pulse" feature

PERFORMANCE DATA

Respiratory Testing

Respiratory testing was performed to evaluate the functionality of the design, materials, and operational principles of the subject device. This includes the following:

Product Weight Test
Pulse Volume/Pulse Time/Trigger Sensitivity / Oxygen Purity Test ●
External Battery Charger Charge Time ●
Oxygen Sensor Accuracy ●
Oxygen Purity at AC Supply Mains Extremes
Oxygen Purity at DC Power Extremes ●
Oxygen Purity after Storage Thermal Cycling
Oxygen Purity at Low and High Temperature ●
. Hot – Swapping Batteries
Battery Discharge Times
Battery Charge Times
Oxygen Purity at Low and High Altitude
Software Functional Test ●
Oxygen Alarms Test
Operational Alarms Test ●
Full Assembly Sound Performance Test ●
POC1 Battery Charge Time When POC1 Unit Not Running ●

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical Safety and Electromagnetic Compatibility testing was performed to evaluate the functionality of the design, materials, and operational principles of the subject device. This includes the following:

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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 80601-2-67: Medical Electrical Equipment Part 2-67: Particular Requirements . for Basic Safety and Essential Performance of Oxygen Conserving Equipment
ISO 80601-2-69 Medical electrical equipment Part 2: Particular requirements for the . basic safety and essential performance of oxygen concentrator equipment
. 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: Usability
IEC 62366: Medical devices Application of usability engineering to medical devices ●
IEC 60601-1-8: Medical electrical equipment 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
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

Software Verification Testing

Software Verification Testing was performed to evaluate the functionality of the design, materials, and operational principles of the subject device. This includes the following: 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."

Level of Concern: The software for this device was considered as a minor level of concern because the subject device is a supplement to a patient's normal oxygen intake. A software failure will not result in injury to a patient or user. The device is not intended to be life supporting or life sustaining.

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Biocompatibility Testing

Biocompatibility testing was performed on the subject device raw materials and the test results demonstrated that the subject device is biocompatible. The testing was conducted in accordance with the FDA Blue Book Memorandum #G95 – 1 "Use of International Standard ISO – 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"' May 1, 1995, and International Standard ISO 10993 – 1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

AAMI / ANSI / ISO 10993-5:2009. Biological Evaluation of Medical Devices Part 5: . Tests for in vitro Cytotoxicity
. AAMI / ANSI / ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Skin Irritation
. ISO 10993-11:2010, Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity
. Volatile Organic Chemicals Using the EPA TO-17 Method
. Particulate Matter (PM)

Animal Study

Animal testing was not required for this submission.

Clinical Testing

Clinical testing was not required to demonstrate substantial equivalence to the predicate device.

CONCLUSIONS

The subject device has the same intended use and similar technological characteristics as the predicate device. The non-clinical laboratory data support the substantial equivalence of Invacare® Platinum™ Mobile Oxygen Concentrator and demonstrates that the subject device performs as intended in the specified use conditions. Therefore, the subject Invacare® Platinum™ Mobile Oxygen Concentrator is substantially equivalent to the predicate device.

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).