(175 days)
The Inogen Rove 6 Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. It may be used in the home, institution, and transport modalities. This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.
The Inogen Rove 6 Portable Oxygen Concentrator (Inogen Rove 6) is a Class 2, low risk, portable oxygen generator that provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. It may be used in home, institution, vehicle, and other transport modalities. It is used with a nasal cannula to channel oxygen from the device to the patient. The concentrator and the nasal cannula are non-sterile. The Inogen Rove 6 Portable Oxygen Concentrator is capable of continuous use in a home, institution, vehicle, and various mobile environments. Power options include 100 - 240 V-AC (50-60Hz) power supply, rechargeable battery packs, or a 13.5 -15.0 V-DC power cable. The Inogen Rove 6 Portable Oxygen Concentrator uses molecular sieve/pressure swing adsorption technology. Ambient air is drawn through particle filters by a compressor and forced through molecular sieve beds, which adsorb nitrogen and allow oxygen to pass. The airflow is then changed, and nitrogen is desorbed from the molecular sieve, allowing it to adsorb again during the next cycle. Oxygen is collected in an accumulator reservoir. Waste nitrogen is exhausted back into the room. A series of sieve beds, manifolds and precision valves, sensors and embedded software are used to control the cycle to make the system function. Oxygen is delivered to the patient on a pulse dose basis in precise amounts during the inhalation part of the breathing cycle. This conserver technology eliminates waste of unused oxygen at other times in the breathing cycle when it is not needed. The Inogen Rove 6 Portable Oxygen Concentrator senses the beginning of the inhalation cvcle and releases a specified dose of oxygen enriched gas from the accumulator reservoir, through a final filter, into the connected nasal cannula and on to the patient. The Inogen Rove 6 Portable Oxygen Concentrator utilizes Bluetooth technology that pairs the portable oxygen concentrator to a mobile device or tablet using the Inogen Connect App.
This is information extracted from a medical device 510(k) submission.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Inogen Rove 6 Portable Oxygen Concentrator are based on comparison to its predicate device (Inogen Rove 4) and a reference device (GCE Zen-O), as well as compliance with relevant international standards.
| Acceptance Criteria Category | Specific Criteria (Predicate/Reference) | Reported Device Performance (Inogen Rove 6) |
|---|---|---|
| Indications for Use | The Inogen Rove 4 Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. It may be used in home, institution, and transport modalities. (K222086) | Provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. It may be used in home, institution, vehicle, and other transport modalities. Substantially equivalent to predicate. |
| Fundamental Scientific Technology | Breath detection technology, Molecular Sieve/pressure swing adsorption technology (Predicate and Reference) | Breath detection technology, Molecular Sieve/pressure swing adsorption technology. Substantially equivalent. |
| Patient Use | Patients requiring supplemental oxygen (Predicate). Adult patients with chronic pulmonary diseases such as chronic bronchitis, emphysema, asthma, or lung cancer, those in the terminal stage of cancer, or any patient requiring supplemental oxygen (Reference). | Patients requiring respiratory therapy on a prescriptive basis. Substantially equivalent to predicate. |
| Oxygen Concentration | 90% -3%/+6% at all settings (Predicate and Reference) | 90% -3%/+6% at all settings. Substantially equivalent. |
| Output Flow | Predicate (Inogen Rove 4): - Setting 1 (10-40 BPM): 7.0-21.0 ml/breath - Setting 4 (10-40 BPM): 21.0-84.0 ml/breath - Max total volume per minute: 840 ml/min. Reference (GCE Zen-O): - Pulse mode settings 1-6 (15-40 BPM): ml/breath varies from 5.25 ml/breath at setting 1, 40 BPM to 66ml/breath at setting 6, 15-35 BPM. Max total volume per minute: e.g., setting 6 at 35 breath/min = 2310 ml/min. | Inogen Rove 6: - Setting 1 (10-40 BPM): 5.25-21.0 ml/breath - Setting 6 (10-40 BPM): 31.5-126.0 ml/breath - Max total volume per minute: 1260 ml/min. Similar, with 2 additional flow settings delivering a higher maximum output. The maximum output is similar to Zen-O setting 6 at 20 breaths/min (1320 ml/min). |
| Maximum Outlet Pressure | < 22 PSI (129 kPa) ± 10% (Predicate, Inogen Rove 4) 20.5 PSI (Reference, GCE Zen-O) | <28.9 PSI (199 kPa). Test results show actual outlet pressures in the range of 24-25 PSI. Similar, but higher than predicate. This higher pressure is still below the FAA maximum oxygen pressure restriction and similar to another cleared device (Invacare Platinum Mobile Oxygen Concentrator K160630, <28.5 PSI). |
| Performance Standards | Compliance with various IEC 60601 series and ISO 80601 series standards (as listed for predicate and reference devices). Usability testing per IEC 62366-1 (only mentioned for subject device, not predicate/reference explicitly for performance). | Full compliance with IEC 60601-1:2012, IEC 60601-1-2:2012, IEC 60601-1-6:2020, IEC 60601-1-8:2012, IEC 60601-1-11:2015, ISO 80601-2-69:2020, ISO 80601-2-67:2020, and IEC 62366-1. Substantially equivalent to predicate/reference in standards. |
| Biocompatibility | Externally Communicating, Tissue, Permanent Duration (>30 days) per ISO 18562-2: 2017 (Particulate matter) and ISO 18562-3:2017 (Volatile organic compounds) (Predicate). Externally Communicating, Tissue, Limited duration (< 24h) per ISO 10993-1 (Reference). | Externally Communicating, Tissue, Permanent Duration (>30 days) per ISO 18562-2: 2017 (Particulate matter) and ISO 18562-3:2017 (Volatile organic compounds). Similar to predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test sets in non-clinical testing. It only mentions "Inogen performed testing to demonstrate and support safety and effectiveness when compared to the predicate and the applicable standards."
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It refers to "Bench Testing" and "testing at a nationally registered test laboratory," implying laboratory-based testing rather than clinical data from human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given document. The testing described is non-clinical bench testing and compliance with performance standards, which does not typically involve expert ground truth establishment in the same way clinical studies or image-based AI studies do.
4. Adjudication Method for the Test Set
This information is not applicable/provided. The document describes non-clinical bench testing against technical specifications and performance standards, not a study requiring adjudication of human-read results.
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
This information is not applicable/provided. The Inogen Rove 6 Portable Oxygen Concentrator is a hardware medical device (portable oxygen generator), not an AI-assisted diagnostic or interpretative tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not have been performed for this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable/provided. As explained above, this device is not an AI algorithm. Its performance is evaluated through bench testing of its mechanical and electrical functions and oxygen delivery specifications. The device does contain "embedded software" (page 4), and "Software verification and validation" (page 19) was performed, indicating standalone testing of the software components. However, this is not an "algorithm only" study in the context of AI performance, but rather software testing for the device's operational control.
7. The Type of Ground Truth Used
For the non-clinical testing, the "ground truth" is defined by:
- Established Technical Specifications: Such as oxygen concentration levels (90% -3%/+6%), pulse volumes (± 15% of rated volume), pressure values, sound levels, etc.
- International Standards: Specifically, ISO 80601-2-69, ISO 80601-2-67, various parts of IEC 60601, and IEC 62366-1.
- Comparison to Predicate and Reference Devices: Demonstrating "substantial equivalence" to the performance and characteristics of previously cleared devices, particularly for aspects like oxygen delivery mode, purity, and flow.
This is primarily performance data and compliance with objective technical and regulatory standards, not expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
This information is not applicable/provided. No AI model requiring a "training set" in the context of machine learning is described for this device. The software validation mentioned refers to verification of the device's embedded control software.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided, as no AI model with a training set is described.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo includes the Department of Health & Human Services logo on the left. To the right of that is the FDA logo in blue. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
June 30, 2023
Inogen, Inc Carole Harris Vice President, Regulatory Affairs 301 Coromar Drive Goleta, California 93117
Re: K230052
Trade/Device Name: Inogen Rove 6 Portable Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: June 1, 2023 Received: June 2, 2023
Dear Carole Harris:
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,
James J. Lee -S
James J. Lee, Ph.D. 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230052
Device Name Inogen Rove 6 Portable Oxygen Concentrator
Indications for Use (Describe)
The Inogen Rove 6 Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. It may be used in the home, institution, and transport modalities. This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.
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
Date Prepared: June 28, 2023
- I Sponsor: Inogen, Inc. 301 Coromar Drive Goleta, California 93117
Sponsor Contact: Carole E.N. Harris VP Quality & Regulatory Affairs charris@jinogen.net Phone: 470-757-7036
Submission Correspondent: Carole Harris
Confidentiality
Inogen, Inc requests as outlined under 21 CFR 20.61 that FDA treat this premarket notification and Inogen's intent to market as confidential commercial information.
II Device
Proprietary or Trade Name: Inogen Rove 6 Portable Oxygen Concentrator, K230052 Common/Usual Name: Generator, Oxygen, Portable Regulation Number: 868.5440 Device Class: 2 Product Code: CAW
Predicate Device: Inogen Rove 4 Portable Oxygen Concentrator, K222086 III Common/Usual Name: Generator, Oxygen, Portable Regulation Number: 868.5440 Device Class: 2 Product Code: CAW
IV Reference Device: GCE Zen-O Portable Oxygen Concentrator Model RS-00500, K162433 Common/Usual Name: Generator, Oxygen, Portable Regulation Number: 868.5440 Device Class: 2 Product Code: CAW
IV Device Description:
The Inogen Rove 6 Portable Oxygen Concentrator (Inogen Rove 6) is a Class 2, low risk, portable oxygen generator that provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. It may be used in home, institution, vehicle, and other transport modalities. It is used with a nasal cannula to channel oxygen from the device to the patient. The concentrator and the nasal cannula are non-sterile.
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The Inogen Rove 6 Portable Oxygen Concentrator is capable of continuous use in a home, institution, vehicle, and various mobile environments. Power options include 100 - 240 V-AC (50-60Hz) power supply, rechargeable battery packs, or a 13.5 -15.0 V-DC power cable.
The Inogen Rove 6 Portable Oxygen Concentrator uses molecular sieve/pressure swing adsorption technology. Ambient air is drawn through particle filters by a compressor and forced through molecular sieve beds, which adsorb nitrogen and allow oxygen to pass. The airflow is then changed, and nitrogen is desorbed from the molecular sieve, allowing it to adsorb again during the next cycle. Oxygen is collected in an accumulator reservoir. Waste nitrogen is exhausted back into the room. A series of sieve beds, manifolds and precision valves, sensors and embedded software are used to control the cycle to make the system function.
Oxygen is delivered to the patient on a pulse dose basis in precise amounts during the inhalation part of the breathing cycle. This conserver technology eliminates waste of unused oxygen at other times in the breathing cycle when it is not needed. The Inogen Rove 6 Portable Oxygen Concentrator senses the beginning of the inhalation cvcle and releases a specified dose of oxygen enriched gas from the accumulator reservoir, through a final filter, into the connected nasal cannula and on to the patient.
The Inogen Rove 6 Portable Oxygen Concentrator utilizes Bluetooth technology that pairs the portable oxygen concentrator to a mobile device or tablet using the Inogen Connect App.
The design of the Inogen Rove 6 Portable Oxygen Concentrator has focused on maximizing subsystem efficiencies and miniaturizing components to enable continuous duty use and to provide minimal weight with battery operation for mobile use.
The basic technology of the Inogen Rove 6 Portable Oxygen Concentrator is equivalent to other approved oxygen concentrators. The principles of operation are equivalent to the predicate device: Inogen Rove 4 Portable Oxygen Concentrator, K222086, and the reference device: GCE Zen-O Portable Oxygen Concentrator Model RS-00500. K162433 noted above.
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Image of the Inogen Rove 6 Portable Oxygen Concentrator:
Image /page/5/Picture/2 description: The image shows a white Inogen Rove 6 portable oxygen concentrator. The device has a control panel on the top with a small display screen and several buttons. There is a blue handle on the side of the device. The Inogen Rove 6 is designed to provide supplemental oxygen to people with respiratory conditions.
SPECIFICATIONS:
| Specifications: | |
|---|---|
| Mains Isolation | Remove both the DC input cord from device aswell as the battery pack. |
| Dimensions: | |
| With standard battery | 7.2 x 3.3 x 8.1 in (18.2 x 8.3 x 20.7 cm) |
| With extended battery | 7.2 x 3.3 x 9.0 in (18.2 x 8.3 x 22.9 cm) |
| Weight: | |
| With standard battery | 4.8 pounds (2.2kg) |
| With extended battery | 5.8 pounds (2.6kg) |
| Nominal sound level | 39 dBA at setting 2 (MDS-Hi)Maximum system sound power of 62 dBAMaximum system sound pressure of 54 dBA |
| Warm up time | 2 minutes |
| Oxygen concentration* | 90% -3%/+6% at all settings |
| Inspiratory trigger sensitivity | <0.12 cmH2O |
| Flow control settings | Pulse dose setting 1,2,3,4,5,6 |
| Bolus setting and size per bolus | See table below. Based upon Breath rate and |
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| Maximum outlet pressure | <28.5 PSI (199 kPa) |
|---|---|
| AC Power | 100 to 240 VAC, 50 to 60 HzAutosensing 2.0 – 1.0A |
| DC Power | 13.5-15.0, 24 VDC, 120WMax voltage: 12.0 to 16.8 VDC (± 0.5) |
| Battery type | Lithium Ion |
| Rechargeable battery: | 12.0 to 16.8 VDC (± 0.5) |
| Battery re-charge time | Standard (BA-500 & BA-508): up to 3 hoursExtended (BA-516): up to 4 hours |
| Operating temperature** | 41 to 104°F (5 to 40°C) |
| Operating humidity | 15% to 90%, non-condensing |
| Operating altitude** | 0 to 10,000 ft (0 to 3048 meters) |
| Shipping and storage temperature | -13 to 158°F (-25 to 70°C) |
| Shipping and storage humidity | Up to 90%, non-condensingStore in a dry environment. |
| Measurement uncertainties: | Pulse volumes: ± 15% of rated volumePressure: ± 0.03 psig (General) / ± 0.05 cm H2O (Inspiratory Trigger Sensitivity)Oxygen concentration: ± 3% (not accounting for temperature, barometric pressure, and time from measurement device calibration) |
*Based on atmospheric pressure of 14.7 psi (101 kPa) at 68°F (20°C) & Dry (STPD)
** Operating outside of these operational specifications can limit the concentrator's ability to meeting Oxygen Concentration specification at higher liter flow settings.
V Indications for Use:
The Inogen Rove 6 Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. It may be used in home, institution, vehicle, and other transport modalities. This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.
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VI Comparison of Technological Characteristics and Performance with the Predicate
The table below povides a side comparison of the Interface elements with respect to the predicate device, the Inogen Rove 4. The user interface features are broken down by category and the elements of early of User Interface elements have been found to be substantially equivalent to the predicate device, the Inogen Rove 4. Refer to Table 5.1.
All hogen Rove 6 User Interface elements have bear to that of the reference device, GC Zan-O Portable Oxygen Concentrator Model RS-01500. Refer to table 5.2
| Predicate Device: Inogen Rove 4 | Subject Device: Inogen Rove 6 | Comparison | |
|---|---|---|---|
| 510K# | K222086 | K230052 | N/A |
| Product Code | CAW | CAW | Substantiallyequivalent |
| CFR | 21 CFR 868.5440 | 21 CFR 868.5440 | Substantiallyequivalent |
| Classification | 2 | 2 | Substantiallyequivalent |
| Indications forUse | The Inogen Rove 4 Portable Oxygen Concentrator provides a highconcentration of supplemental oxygen to patients requiring respiratorytherapy on a prescriptive basis. It may be used in home, institution, andtransport modalities. | The Inogen Rove 6 Portable Oxygen Concentrator provides a highconcentration of supplemental oxygen to patients requiring respiratorytherapy on a prescriptive basis. It may be used in home, institution,vehicle, and other transport modalities. | Substantiallyequivalent |
| Prescriptive | Yes | Yes | Substantiallyequivalent |
| Fundamentalscientifictechnology | Breath detection technology Molecular Sieve/pressure swing adsorption technology | Breath detection technology Molecular Sieve/pressure swing adsorption technology | Substantiallyequivalent |
| Patient use | Patients requiring supplemental oxygen | Patients requiring supplemental oxygen | Substantiallyequivalent |
| User/PatientInterface | User interface panel | User interface panel | Substantiallyequivalent |
| LCD Display to convey information about operating status in numbers andsymbols. | LCD Display to convey information about operating status in numbersand symbols. | SubstantiallyequivalentSetting, battery, andauditory alarm statusare displayed. | |
| Predicate Device: Inogen Rove 4 | Subject Device: Inogen Rove 6 | Comparison | |
| Alarm Indicator – yellow LED on UIP above "Alarm/Warning" trianglesymbol that illuminates to indicate abnormal operating conditions incompliance with ISO 60601-1-8 | Alarm Indicator – yellow LED on UIP above “Alarm/Warning" trianglesymbol that illuminates to indicate abnormal operating conditions incompliance with ISO 60601-1-8 | Substantiallyequivalent | |
| Breath Detect Notification - Green LED on UIP illuminates when a breath isdetected, and an oxygen pulse is triggered. | Breath Detect Notification – Green LED on UIP illuminates when abreath is detected, and an oxygen pulse is triggered | Substantiallyequivalent. | |
| Auditory Buzzer – Audible beeps are emitted to indicate alarm or statuschange conditions in compliance with ISO 60601-1-8. | Auditory Speaker – Audible beeps are emitted to indicate alarm or statuschange conditions in compliance with ISO 60601-1-8. | Substantiallyequivalent. | |
| Battery release latch – Patient removable battery using push latch to releasebattery then slide off bottom of concentrator. | Battery release latch – Patient removable battery using push latch torelease battery then slide off bottom of concentrator. | Substantiallyequivalent. | |
| Sieve beds – Users may send device to provider for sieve bed replacement, orusers may replace sieves. Sieve beds are user replaceable using M6 hex Allenkey to unscrew and slide out single piece sieve beds, then slide inreplacements and screw back into concentrator. | Sieve beds – Users may send device to provider for sieve bedreplacement, or users may replace sieves. Sieve beds are user replaceableby pulling the wire handle while depressing the retaining tab to pull thecolumns out. The replacement columns are installed by pushing them inuntil the retaining tab snaps into place. | SubstantiallyEquivalent.Both the Inogen Rove6 and Inogen Rove 4have user replaceablesieve beds. | |
| Particle Filter – Patient instructed to clean particle filters once per week. | Particle Filter – Patient instructed to clean particle filters once per week. | Substantiallyequivalent | |
| Optional accessories - Carry Bag, Backpack, External Battery Charger, HipBag | Optional accessories - Carry Bag, Backpack, Cart, External BatteryCharger | Substantiallyequivalent.Inogen Rove 6 has acart available fortransport, and InogenRove 4 has a hip bag. | |
| Predicate Device: Inogen Rove 4 | Subject Device: Inogen Rove 6 | Comparison | |
| External Battery Charger (EBC) – Optional accessory. Independent batterycharger that utilizes an AC/DC power supply. The EBC slides onto theInogen Rove 4 battery to charge outside of the concentrator. | External Battery Charger (EBC) – Optional accessory. Independentbattery charger that utilizes an AC/DC power supply. The EBC slidesonto the Inogen Rove 6 battery to charge outside of the concentrator. | Substantiallyequivalent.Both Inogen Rove 6and Inogen Rove 4batteries can becharged externallyfrom the concentrator. | |
| Inogen Connect Mobile Application – Optional mobile application forviewing device settings, battery information, and current alerts, available foriOS and Android in English, French. | Inogen Connect Mobile Application – Optional mobile application forviewing device settings, battery information, and current alerts, availablefor iOS and Android in English, French. | Substantiallyequivalent | |
| User Manual – Device information including Indications for Use,Contraindications and Precautions, Operating Principles, Cautions andWarnings, Device Descriptions, General Instructions, Audible and VisibleSignals, Alarm/Alert System, Troubleshooting, Cleaning, Care andMaintenance, and Specifications and Technical Description | User Manual - Device information including Indications for Use,Contraindications and Precautions, Operating Principles, Cautions andWarnings, Device Descriptions, General Instructions, Audible andVisible Signals, Alarm/Alert System, Troubleshooting, Cleaning, Careand Maintenance, and Specifications and Technical Description | SubstantiallyEquivalent.The Inogen Rove 6and Inogen Rove 4User Manuals containequivalent informationfor the user. | |
| OperatingSystem | Software monitored | Software monitored | SubstantiallyEquivalent |
| BluetoothTechnology | Inogen Connect App - BLE Connection to Android or iPhone. | Inogen Connect App - BLE Connection to Android or iPhone. | SubstantiallyEquivalent |
| The Inogen Rove 4 Oxygen Concentrator is capable of Bluetoothfunctionality with the Inogen Connect App. | The Inogen Rove 6 Oxygen Concentrator is capable of Bluetoothfunctionality with the Inogen Connect App. | ||
| Components | AC/DC Power Adapter – Utilizes 100-240V, 50/60Hz AC power supply andcord for power and charging with wall adapter and barrel jack connection toconcentrator. | AC/DC Power Adapter - Utilizes 100-240V, 50/60Hz AC power supplyand cord for power and charging with wall adapter and barrel jackconnection to concentrator. | Substantiallyequivalent |
| DC Power Cable – cord and adapter to allow for connection to 12-volt DCoutlet with cigarette lighter connector and barrel jack connection toconcentrator. | DC Power Cable - cord and adapter to allow for connection to 12-voltDC outlet with cigarette lighter connector and barrel jack connection toconcentrator. | Substantiallyequivalent | |
| Predicate Device: Inogen Rove 4 | Subject Device: Inogen Rove 6 | Comparison | |
| Cannula -- Patient breaths through off the shelf nasal cannula attached to a recessed metal cannula barb on the concentrator. | Cannula -- Patient breaths through off the shelf nasal cannula attached to a recessed metal cannula barb on the concentrator. | Substantially equivalent | |
| Battery - utilizes a 4 or 8-cell lithium battery. To attach the battery, slide it on to the base of the concentrator. | Battery - utilizes an 8 or 16-cell lithium battery. To attach the battery, slide it on to the base of the concentrator. | Substantially equivalent. | |
| Battery release latch – Patient removable battery by pressing and holding the battery latch button and slide the battery off the device. | Battery release latch – Patient removable battery by pressing and holding the battery latch button and slide the battery off the device. | Rove 6 is compatible with larger battery sizes. | |
| Size | With 8-cell battery: 8.1"H x 2.7"W x 5.9"D | With standard 8-cell battery: 8.1" H, 3.3" W, 7.2" D | Similar: Rove 6 is larger |
| Principle of Operation | The Inogen Rove 4 Portable Oxygen Concentrator uses molecular sieve/pressure swing adsorption technology. Ambient air is drawn through particle filters by a compressor and forced through molecular sieve beds, which adsorb nitrogen and allow oxygen to pass. The airflow is then changed, and nitrogen is desorbed from the molecular sieve, allowing it to adsorb again during the next cycle. Oxygen is collected in an accumulator reservoir. Waste nitrogen is exhausted back into the room. A series of sieve beds, manifolds and precision valves, sensors and embedded software are used to control the cycle to make the system function. Oxygen is delivered to the patient on a pulse dose basis in precise amounts during the inhalation part of the breathing cycle. This conserver technology eliminates waste of unused oxygen at other times in the breathing cycle when it is not needed. Inogen Rove 6 Portable Oxygen Concentrator senses the beginning of the inhalation cycle and releases a specified dose of oxygen enriched gas from the accumulator reservoir, through a final filter, into the connected nasal cannula and on to the patient. | The Inogen Rove 6 Portable Oxygen Concentrator uses molecular sieve/pressure swing adsorption technology. Ambient air is drawn through particle filters by a compressor and forced through molecular sieve beds, which adsorb nitrogen and allow oxygen to pass. The airflow is then changed, and nitrogen is desorbed from the molecular sieve, allowing it to adsorb again during the next cycle. Oxygen is collected in an accumulator reservoir. Waste nitrogen is exhausted back into the room. A series of sieve beds, manifolds and precision valves, sensors and embedded software are used to control the cycle to make the system function. Oxygen is delivered to the patient on a pulse dose basis in precise amounts during the inhalation part of the breathing cycle. This conserver technology eliminates waste of unused oxygen at other times in the breathing cycle when it is not needed. Inogen Rove 6 Portable Oxygen Concentrator senses the beginning of the inhalation cycle and releases a specified dose of oxygen enriched gas from the accumulator reservoir, through a final filter, into the connected nasal cannula and on to the patient. | Substantially equivalent |
| Performance | |||
| Oxygen Delivery Mode | Pulse Dose | Pulse Dose | Substantially equivalent. |
Table 5.1: Comparison of the Predicate device vs. the Subject Device and References
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| Predicate Device: Inogen Rove 4 | Subject Device: Inogen Rove 6 | Comparison | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Output Flow | BREATHS PER MINUTE | Setting 1 | Setting 2 | Setting 3 | Setting 4 | BREATHS PER MINUTE | Setting 1 | Setting 2 | Setting 3 | Setting 4 | Setting 5 | Setting 6 | |
| 10 | 21.0 | 42.0 | 63.0 | 84.0 | 10 | 21.0 | 42.0 | 63.0 | 84.0 | 105.0 | 126.0 | Similar: Rove 6 has 2 additional flow settings, delivering a higher maximum output. | |
| 15 | 14.0 | 28.0 | 42.0 | 56.0 | 15 | 14.0 | 28.0 | 42.0 | 56.0 | 70.0 | 84.0 | ||
| 20 | 10.5 | 21.0 | 31.5 | 42.0 | 20 | 10.5 | 21.0 | 31.5 | 42.0 | 52.5 | 63.0 | ||
| 25 | 8.4 | 16.8 | 25.2 | 33.6 | 25 | 8.4 | 16.8 | 25.2 | 33.6 | 42.0 | 50.4 | ||
| 30 | 7.0 | 14.0 | 21.0 | 28.0 | 30 | 7.0 | 14.0 | 21.0 | 28.0 | 35.0 | 42.0 | ||
| 35 | 6.0 | 12.0 | 18.0 | 24.0 | 35 | 6.0 | 12.0 | 18.0 | 24.0 | 30.0 | 36.0 | ||
| 40 | 5.25 | 10.5 | 15.75 | 21.0 | 40 | 5.25 | 10.5 | 15.75 | 21.0 | 26.3 | 31.5 | ||
| TOTAL VOLUME PER MINUTE (ml/min) | 210 | 420 | 630 | 840 | TOTAL VOLUME PER MINUTE (ml/min) | 210 | 420 | 630 | 840 | 1050 | 1260 | ||
| Oxygen Purity | 90% - 3%/+6% at all settings | 90% - 3%/+6% at all settings | Substantially equivalent. | ||||||||||
| Maximum Outlet Pressure | < 22 PSI18.7 PSI (129 kPa) ± 10% | <28.9 PSI (199 kPa) | SimilarRove 6 has a higher maximum outlet pressure which falls below the FAA maximum oxygen pressure restriction. Test results for the Rove 6 demonstrate actual outlet pressures in the range of 24-25 PSI. Difference discussed further in Section VIII. | ||||||||||
| Performance StandardsPerformanceElectrical Safety and EMC | • IEC 60601-1:2012• IEC 60601-1-2: 2012 | • IEC 60601-1:2012• IEC 60601-1-2: 2012 | Substantially equivalent. |
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| Predicate Device: Inogen Rove 4 | Subject Device: Inogen Rove 6 | Comparison | |
|---|---|---|---|
| • IEC 60601-1-6:2020 | • IEC 60601-1-6:2020 | No difference. | |
| • IEC 60601-1-8:2012 | • IEC 60601-1-8:2012 | ||
| • IEC 60601-1-11:2015 | • IEC 60601-1-11:2015 | ||
| • ISO 80601-2-69:2020 | • ISO 80601-2-69:2020 | ||
| • ISO 80601-2-67:2020 | • ISO 80601-2-67:2020 | ||
| • IEC 62366-1 | • IEC 62366-1 | ||
| Communications | |||
| Power / EnergySource | AC/DC Power Adapter – Utilizes 100-240V, 50/60Hz AC power supply andcord for power and charging with wall adapter and barrel jack connection toconcentrator. | AC/DC Power Adapter – Utilizes 100-240V, 50/60Hz AC power supplyand cord for power and charging with wall adapter and barrel jackconnection to concentrator. | Substantiallyequivalent. |
| DC Power Cable – cord and adapter to allow for connection to 12-volt DCoutlet with cigarette lighter connector and barrel jack connection toconcentrator. | DC Power Cable – cord and adapter to allow for connection to 12-voltDC outlet with cigarette lighter connector and barrel jack connection toconcentrator. | Inogen Rove 6 iscompatible with largerbatteries. | |
| Battery - utilizes a 4 or 8-cell lithium battery. | Battery - utilizes an 8 or 16-cell lithium battery. | ||
| Biocompatibility | Externally Communicating, Tissue, Permanent Duration (>30 days)ISO 18562-2: 2017 Particulate matterISO 18562-3:2017 Volatile organic compounds | Externally Communicating, Tissue,Permanent Duration (>30 days)ISO 18562-2: 2017 Particulate matterISO 18562-3:2017 Volatile organic compounds | Substantiallyequivalent. |
| No Difference. | |||
| Reference Device: Oxus GCE Zen-O | Subject Device: Inogen Rove 6 | Comparison | |
| 510K# | K162433 | K230052 | N/A |
| Product Code | CAW | CAW | Substantially equivalent |
| CFR | 21 CFR 868.5440 | 21 CFR 868.5440 | Substantially equivalent |
| Classification | 2 | 2 | Substantially equivalent |
| Indications forUse | The Portable Oxygen Concentrator is intended to provide supplementaloxygen in a home, institutional, or travel environment. | The Inogen Rove 6 Portable Oxygen Concentrator provides a highconcentration of supplemental oxygen to patients requiring respiratorytherapy on a prescriptive basis. It may be used in home, institution, andtransport modalities. | Substantially equivalent |
| Prescriptive | Yes | Yes | Substantially equivalent |
| Fundamentalscientifictechnology | • Breath detection technology• Molecular Sieve/pressure swing adsorption technology | • Breath detection technology• Molecular Sieve/pressure swing adsorption technology | Substantially equivalent |
| Patient use | Adult patients with chronic pulmonary diseases such as chronic bronchitis,emphysema, asthma, or lung cancer, those in the terminal stage of cancer, orany patient requiring supplemental oxygen. | Patients requiring respiratory therapy on a prescriptive basis. | Similar.Reference device mentionsspecific adult patients as wellas any patient requiringsupplemental oxygen. Rove 6is substantially equivalent tothe predicate Rove 4 device. |
| User/PatientInterface | User interface panel | User interface panel | Substantially equivalent |
| LCD Display to convey information about operating status in numbers andsymbols. | LCD Display to convey information about operating status in numbers andsymbols. | Substantially equivalentSetting, battery, and auditoryalarm status are displayed. | |
| Alarm Indicator - yellow LED on UIP above "Alarm/Warning" trianglesymbol that illuminates to indicate abnormal operating conditions incompliance with ISO 60601-1-8 | Alarm Indicator - yellow LED on UIP above "Alarm/Warning" trianglesymbol that illuminates to indicate abnormal operating conditions incompliance with ISO 60601-1-8 | Substantially equivalent | |
| Breath Detect Notification - Green LED on UIP illuminates when a breath isdetected, and an oxygen pulse is triggered | Breath Detect Notification - Green LED on UIP illuminates when a breath isdetected, and an oxygen pulse is triggered | Substantially equivalent. | |
| Reference Device: Oxus GCE Zen-O | Subject Device: Inogen Rove 6 | Comparison | |
| Auditory Buzzer – Audible beeps are emitted to indicate alarm or statuschange conditions in compliance with ISO 60601-1-8. | Auditory Speaker - Audible beeps are emitted to indicate alarm or statuschange conditions in compliance with ISO 60601-1-8. | Substantially equivalent.Both meet sound levelscompliant to the standard. | |
| Battery release button - Patient removable battery using push button torelease battery then slide out of top of concentrator. | Battery release latch - Patient removable battery using push latch to releasebattery then slide off bottom of concentrator. | Substantially equivalent. | |
| Sieve module is an internal component and is only replaceable by a trainedperson. | Sieve beds - Users may send device to provider for sieve bed replacement,or users may replace sieves. Sieve beds are user replaceable by pulling thewire handle while depressing the retaining tab to pull the columns out. Thereplacement columns are installed by pushing them in until the retaining tabsnaps into place. | Similar.Both the Inogen Rove 6 andOxus GCE Zen-O havereplaceable sieve beds.Inogen Rove 6 and thepredicate device offers theconvenience of userreplaceable sieve beds. | |
| Particle Filter - Patient instructed to clean particle filters once per week. | Particle Filter - Patient instructed to clean particle filters once per week. | Substantially equivalent | |
| Accessories - Carry Bag, Cart, Battery, Accessory Bag, Rechargeable battery,External battery charger, humidifier kit | Optional accessories - Carry Bag, Backpack, Cart, External Battery Charger | Substantially equivalent. | |
| External Battery Charger (EBC) -The battery can be charged inside theconcentrator when installed into the concentrator that is connected to theAC/DC power supply, or outside of the concentrator in the approved EBC. | External Battery Charger (EBC) – Optional accessory. Independent batterycharger that utilizes an AC/DC power supply. The EBC slides onto theInogen Rove 6 battery to charge outside of the concentrator. | Substantially equivalent.Both Inogen Rove 6 and GCEZen-O batteries can becharged externally from theconcentrator. | |
| Mobile Application not available. | Inogen Connect Mobile Application – Optional mobile application forviewing device settings, battery information, and current alerts, available foriOS and Android in English, French. | SimilarInogen Rove 6 allowsconcentrator information tobe viewed on a mobile deviceas well as on the concentratordisplay. The sameinformation is available on | |
| Reference Device: Oxus GCE Zen-O | Subject Device: Inogen Rove 6 | Comparison | |
| User Manual – Device information including Indications for Use, Contraindications and Precautions, Operating Principles, Cautions and Warnings, Device Descriptions, General Instructions, Audible and Visible Signals, Alarm/Alert System, Troubleshooting, Cleaning, Care and Maintenance, and Specifications and Technical Description | User Manual – Device information including Indications for Use, Contraindications and Precautions, Operating Principles, Cautions and Warnings, Device Descriptions, General Instructions, Audible and Visible Signals, Alarm/Alert System, Troubleshooting, Cleaning, Care and Maintenance, and Specifications and Technical Description | the Oxus GCE Zen-Oconcentrator display only.Substantially Equivalent.The Inogen Rove 6 andInogen Rove 4 User Manualscontain equivalentinformation for the user. | |
| OperatingSystem | Software monitored | Software monitored | Substantially Equivalent |
| BluetoothTechnology | N/A | Inogen Connect App - BLE Connection to Android or iPhone.The Inogen Rove 6 Oxygen Concentrator is capable of Bluetoothfunctionality with the Inogen Connect App. | SimilarInogen Rove 6 allowsconcentrator information tobe viewed on a mobile deviceas well as on the concentratordisplay. The sameinformation is available onthe Oxus GCE Zen-Oconcentrator display only. |
| Components | AC/DC Power Adapter - Utilizes 100-240V, 50/60Hz AC power supply andcord for power and charging with wall adapter and barrel jack connection toconcentrator. | AC/DC Power Adapter – Utilizes 100-240V, 50/60Hz AC power supply andcord for power and charging with wall adapter and barrel jack connection toconcentrator. | Substantially equivalent |
| DC Power Cable – cord and adapter to allow for connection to 12-volt DCoutlet with cigarette lighter connector and barrel jack connection toconcentrator. | DC Power Cable - cord and adapter to allow for connection to 12-volt DCoutlet with cigarette lighter connector and barrel jack connection toconcentrator. | Substantially equivalent | |
| Cannula -- Patient breaths through off the shelf 4', 7', 25' or 50' nasalcannula attached to a recessed metal cannula barb on the concentrator. | Cannula -- Patient breaths through off the shelf nasal cannula attached to arecessed metal cannula barb on the concentrator. | Substantially equivalent | |
| Battery - Utilizes one or two or rechargeable lithium batteries. To attach thebattery, slide it into the top of the concentrator. Two batteries can be placed inthe concentrator battery slots or one battery can be placed in either slot | Battery - utilizes an 8 or 16-cell lithium battery. To attach the battery, slideit on to the base of the concentrator. | Substantially equivalent. | |
| Reference Device: Oxus GCE Zen-O | Subject Device: Inogen Rove 6 | Comparison | |
| Battery release button - Patient removable battery using push button torelease battery then slide out of top of concentrator. | Battery release latch - Patient removable battery by pressing and holding thebattery latch button and slide the battery off the device. | Rove 6 is compatible withlarger battery sizes. | |
| Size | 12.3"H x 8.3"W x 6.6"D | With standard 8-cell battery: 8.1" H, 3.3" W, 7.2" D | Similar: Rove 6 is smaller |
| Weight | 10.25 lbs | With Standard Battery: 4.8 lbsWith Extended Batter: 5.8 lbs | Inogen Rove 6 is substantiallylighter in weight. |
| Principle ofOperation | The GCE Zen-O Portable Oxygen Concentrator uses molecular sieve/pressureswing adsorption technology. Ambient air is drawn through particle filters bya compressor and forced through molecular sieve beds, which adsorb nitrogenand allow oxygen to pass. The airflow is then changed, and nitrogen isdesorbed from the molecular sieve, allowing it to adsorb again during the nextcycle. Oxygen is collected in an accumulator reservoir. Waste nitrogen isexhausted back into the room. A series of sieve beds, manifolds and precisionvalves, sensors and embedded software are used to control the cycle to makethe system function. Oxygen is delivered to the patient on a pulse dose mode,continuous mode Auto Mode or ECO Mode basis in precise amounts duringthe inhalation part of the breathing cycle. In standard Pulse Mode, the devicewill give you the same amount of oxygen every breath, regardless of yourbreath rate. This can consume more battery power at higher breath rates. InEco Mode, the device will deliver a fixed volume of oxygen per minuteregardless of breath rate, and will give an extended battery duration. In AutoMode: If no inhalation is detected for 60 seconds when in pulse mode, the"Check Cannula" alarm will be activated and the device will automaticallyenter Auto-Mode and continue to deliver oxygen at a rate of 18 breaths perminute. When an inhalation is detected, the device will clear the "CheckCannula" alarm and exit Auto-Mode. | The Inogen Rove 6 Portable Oxygen Concentrator uses molecularsieve/pressure swing adsorption technology. Ambient air is drawn throughparticle filters by a compressor and forced through molecular sieve beds,which adsorb nitrogen and allow oxygen to pass. The airflow is thenchanged, and nitrogen is desorbed from the molecular sieve, allowing it toadsorb again during the next cycle. Oxygen is collected in an accumulatorreservoir. Waste nitrogen is exhausted back into the room. A series of sievebeds, manifolds and precision valves, sensors and embedded software areused to control the cycle to make the system function.Oxygen is delivered to the patient on a pulse dose basis in precise amountsduring the inhalation part of the breathing cycle. This conserver technologyeliminates waste of unused oxygen at other times in the breathing cyclewhen it is not needed. Inogen Rove 6 Portable Oxygen Concentrator sensesthe beginning of the inhalation cycle and releases a specified dose of oxygenenriched gas from the accumulator reservoir, through a final filter, into theconnected nasal cannula and on to the patient. | Substantially equivalent |
| Oxygen DeliveryMode | Pulse Dose, Eco Mode, Auto Mode, Continuous Mode Flow | Pulse Dose | Similar: Rove 6 offers pulsedose mode. |
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Table 5.2: Comparison of the Reference device vs. the Subject Device and References
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| Reference Device: Oxus GCE Zen-O | Subject Device: Inogen Rove 6 | Comparison | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Output Flow | Pulse mode | Similar: Both devices offersix (6) settings, but theInogen Rove 6 delivers a setoutput per minute (ml/min)whereas the Zen-O delivers aset output per breath(ml/breath). | |||||||||||||
| BREATHSPERMINUTE | Setting1 | Setting2 | Setting3 | Setting4 | Setting5 | Setting6 | BREATHSPERMINUTE | Setting1 | Setting2 | Setting3 | Setting4 | Setting5 | Setting6 | ||
| 15 | 14.0 | 28.0 | 42.0 | 56.0 | 55 | 66 | 10 | 21.0 | 42.0 | 63.0 | 84.0 | 105.0 | 126.0 | When comparing the totaloutput per minute, themaximum output from theInogen Rove 6 (1260 ml/min)is similar to the Zen-O setting6 at 20 breaths/min, (20breath/min x 66ml/min =1320 ml/min). Zen-O highestoutput is setting 6 at 35breath/min, totaling 2310mil/min. | |
| 20 | 10.5 | 21.0 | 31.5 | 42.0 | 55 | 66 | 15 | 14.0 | 28.0 | 42.0 | 56.0 | 70.0 | 84.0 | ||
| 25 | 8.4 | 16.8 | 25.2 | 33.6 | 55 | 66 | 20 | 10.5 | 21.0 | 31.5 | 42.0 | 52.5 | 63.0 | ||
| 30 | 7.0 | 14.0 | 21.0 | 28.0 | 55 | 66 | 25 | 8.4 | 16.8 | 25.2 | 33.6 | 42.0 | 50.4 | ||
| 35 | 6.0 | 12.0 | 18.0 | 24.0 | 55 | 66 | 30 | 7.0 | 14.0 | 21.0 | 28.0 | 35.0 | 42.0 | ||
| 40 | 5.25 | 10.5 | 15.75 | 21.0 | 50 | 50 | 35 | 6.0 | 12.0 | 18.0 | 24.0 | 30.0 | 36.0 | ||
| 40 | 5.25 | 10.5 | 15.75 | 21.0 | 26.3 | 31.5 | |||||||||
| All values +/- 15% over all operating conditions | TOTALVOLUMEPERMINUTE(ml/min) | 210 | 420 | 630 | 840 | 1050 | 1260 | Substantially equivalent. | |||||||
| Oxygen Purity | 90% - 3%/+6% at all settings | 90% - 3%/+6% at all settings | |||||||||||||
| MaximumOutlet Pressure | 20.5 PSI | <28.9 PSI (199 kPa) | SimilarRove 6 has a highermaximum outlet pressurewhich falls below the FAAmaximum oxygen pressurerestriction. Test results forthe Rove 6 demonstrate actualoutlet pressures in the rangeof 24-25 PSI. Differencediscussed further in SectionVIII. | ||||||||||||
| Performance Standards |
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| Reference Device: Oxus GCE Zen-O | Subject Device: Inogen Rove 6 | Comparison | |
|---|---|---|---|
| PerformanceElectrical Safetyand EMC | • IEC 60601-1• IEC 60601-1-2• IEC 60601-1-6• IEC 60601-1-8• IEC 60601-1-11• ISO 80601-2-69• ISO 80601-2-67• Usability testing was performed. Unknown per IEC 62366-1 | • IEC 60601-1:2012• IEC 60601-1-2: 2012• IEC 60601-1-6:2020• IEC 60601-1-8:2012• IEC 60601-1-11:2015• ISO 80601-2-69:2020• ISO 80601-2-67:2020• IEC 62366-1 | Similar.Usability was conducted onthe Inogen Rove 6 per IEC62366-1. |
| Communications | |||
| Power / EnergySource | AC/DC Power Adapter - Utilizes 100-240V, 50/60Hz AC power supply andcord for power and charging with wall adapter and barrel jack connection toconcentrator.DC Power Cable – cord and adapter to allow for connection to 12-volt DCoutlet to concentrator.Battery - utilizes a rechargeable lithium battery. | AC/DC Power Adapter – Utilizes 100-240V, 50/60Hz AC power supply andcord for power and charging with wall adapter and barrel jack connection toconcentrator.DC Power Cable – cord and adapter to allow for connection to 12-volt DCoutlet with cigarette lighter connector and barrel jack connection toconcentrator.Battery - utilizes an 8 or 16-cell rechargeable lithium battery. | Substantially equivalent. |
| Biocompatibility | Externally Communicating, Tissue, Limited duration (< 24h)ISO 10993-1: Biologicalevaluation of medical devices - Part 1: Evaluation and testing within a riskmanagement process" | Externally Communicating, Tissue,Permanent Duration (>30 days)ISO 18562-2: 2017 Particulate matterISO 18562-3:2017 Volatile organic compounds | Similar.Inogen Rove 6 was tested perthe duration of patientcontact. |
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VII Substantial Equivalence Discussion
Intended Use/ Indications for Use
The Inogen Rove 6, the Inogen Rove 4 and the Oxus GCE Zen-O have similar Intended Use/Indications for use. Both devices provide a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. They both may be used in home, institution, vehicle, and other transport modalities.
Technological Characteristics and Principles of Operation
The Inogen Rove 6, the Inogen Rove 4 and the Oxus GCE Zen-O operate on Pressure Swing Adsorption (PSA) technology to produce oxygen and deliver it to the patient via a standard nasal cannula. They deliver a bolus of oxygen upon sensing a pressure change at the start of inhalation.
There are no differences which raise different questions of safety or effectiveness.
Non-clinical Testing
Inogen performed testing to demonstrate and support safety and effectiveness when compared to the predicate and the applicable standards.
Testing included:
- · ISO 80601-2-69 Medical Electrical Equipment Part 2-69: Particular Requirements For Basic Safety And Essential Performance Of Oxygen Concentrator Equipment
- · ISO 80601-2-67 Medical Electrical Equipment Part 2-67: Particular Requirements For Basic Safety And Essential Performance Of Oxygen-Conserving Equipment
Bench Testing included:
- Pulse, volume; Pulse Time; Trigger Sensitivity; Oxygen Purity under various conditions; . Oxygen Sensor Accuracy: Alarms
- Software verification and validation
- Electrical / EMC / RFID including battery charge and discharge .
- Biocompatibility
- ISO 18562-2:2017 - Particulate matter
- ISO 18562-3:2017 - Volatile organic compounds
The device met all requirements.
VIII Discussion of Differences
The subject device and the predicate device have been found to be substantially equivalent. All devices have a similar fundamental scientific technology, operating system, components and principle of operation. All are indicated for home, institution, and travel/mobile environments outside the home.
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The major technical differences between the Inogen Rove 6 and the predicate device. Inogen Rove 4, are:
- The Inogen Rove 4 with a 8-cell battery measures 7.6"H, 2.9"W, 7.3"D. The Inogen . Rove 6 with a 8-cell battery measures 8.1"H, 3.3"W, 7.2"D. The Inogen Rove 6 is slightly larger in size.
- The Inogen Rove 6 provides two additional dose settings, offering an overall maximum ● dose of oxygen at 1260 ml/min as compared to the maximum of 840 ml/min from the Inogen Rove 4. The higher maximum output of the Rove 6 device remains below the maximum level of other cleared portable oxygen concentrators (see similarities with the Reference device below).
- The Maximum Outlet Pressure claimed for Inogen Rove 6 is < 28.9 PSI, whereas the Rove 4 is <22 PSI. The Inogen Rove 6 Maximum Outlet Pressure is claimed at a level similar to the previously cleared Invacare Platinum Mobile Oxygen Concentrator (K160630) with a maximum outlet pressure of <28.5 PSI. Both maintain outlet pressures below that of compressed gas. Test results for the Rove 6 demonstrate actual outlet pressures in the range of 24-25 PSI.
The similarities between the Reference Device, Oxus GCE Zen-O (K162433), and the Rove 6 confirms as the scientific basis the additional settings and higher output of the Rove 6 (as compared to the Rove 4 major technical differences) are still within a safe range and do not raise different questions of safety and effectiveness.
- . The Oxus GCE Zen-O measures 12.3"H x 8.3"W x 6.6"D and weighs 10.25 lbs. The Inogen Rove 6 with a 8-cell battery measures 8.1"H, 3.3"W, 7.2"D and weighs 4.8 lbs. The Inogen Rove 6 is smaller in size and weight.
- . Both devices offer six (6) settings, but the Inogen Rove 6 delivers a set output per minute (ml/min) whereas the Zen-O delivers a set output per breath (ml/breath). When comparing the total output per minute, the maximum output from the Inogen Rove 6 (1260 ml/min) is similar to the Zen-O setting 6 at 20 breaths/min. (20 breath/min x 66ml/min = 1320 ml/min). Zen-O highest output is setting 6 at 35 breath/min, totaling 2310 mil/min.
IX Substantial Equivalence Conclusion
The subject device and the predicate device have been found to be substantially equivalent. Both devices have a similar fundamental scientific technology, operating system, components, and principle of operation. Both are indicated for home, institution, and travel/mobile environments outside the home.
The Inogen Rove 6 and the Inogen Rove 4 meet safety and performance standards required for portable oxygen concentrators verified through testing at a nationally registered test laboratory. The differences noted between the subject and predicate devices do not raise any additional concerns regarding safety or effectiveness.
§ 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).