(204 days)
No reference devices were used in this submission
No
The summary describes a portable oxygen concentrator with standard functionalities and testing, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is described as providing "supplemental oxygen to patients with respiratory disorders," which directly addresses a health condition for treatment or mitigation.
No
Explanation: The device provides supplemental oxygen to patients; it does not perform diagnosis.
No
The device description clearly states it is a "portable oxygen concentrator" and mentions hardware components like a nasal cannula and batteries, indicating it is a physical device with embedded software, not a software-only medical device.
Based on the provided information, the Invacare® Platinum™ Mobile Oxygen Concentrator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide supplemental oxygen to patients with respiratory disorders. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description focuses on its function of concentrating oxygen from the air and delivering it to the patient via a nasal cannula. It does not mention analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
The device is clearly described as a medical device used for treatment (providing oxygen), not for diagnosis.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
CAW
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.
The associated accessories include:
- Invacare® Battery .
- . Invacare® Battery Charger
- AC Adapter ●
- DC Power Cable .
- Carry Bag .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult Patient Only
Intended User / Care Setting
Home, institution, vehicle, or other environments outside the home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- 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 on alarm systems for 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The Invacare Flyer (Model XPO100) (K071928)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5440 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often used as a symbol of medicine. The logo is presented in black and white.
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.
1
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
2
Indications for Use
510(k) Number (if known) K160630
Device Name
Invacare® Platinum™ Mobile Oxygen Concentrator
Indications for Use (Describe)
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.
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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3
510(k) Summary
| SUBMITTER: | Invacare Corporation
One Invacare Way
Elyria, OH 44035 |
|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Elijah N. Wreh
Regulatory Affairs Manager (Pre-Market)
Phone: (440) 329-6840
Email: ewreh@invacare.com |
| Date Prepared: | September 22, 2016 |
| DEVICE
Name of Device:
Common or Usual Name:
Classification Name: | Invacare® Platinum™ Mobile Oxygen Concentrator
Generator, Oxygen, Portable
Portable 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 the
home |
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.
4
The associated accessories include:
- Invacare® Battery .
- . Invacare® Battery Charger
- AC Adapter ●
- DC Power Cable .
- Carry Bag .
INDICATIONS FOR USE
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.
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).
5
Design Characteristics Comparison
| No. | Feature | Subject Device
Platinum Mobile Oxygen Concentrator
(K160630) | Predicate Device
The 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" | |
| | Dimensions
Weight |
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:
6
- 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.
7
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.