(175 days)
GCE Zen-O Portable Oxygen Concentrator Model RS-00500.,K162433
No
The description details standard pressure swing adsorption technology and embedded software for control, with no mention of AI or ML for decision-making or optimization. The Bluetooth connectivity is for app pairing, not AI/ML functionality.
Yes
The device is described as providing "supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis," which indicates it is used for medical treatment.
No
Explanation: The device description states it is an "oxygen generator that provides a high concentration of supplemental oxygen to patients requiring respiratory therapy." Its purpose is to deliver oxygen, not to diagnose a medical condition.
No
The device description clearly outlines a physical hardware device (portable oxygen concentrator) that uses various components like a compressor, molecular sieve beds, valves, sensors, and embedded software to generate and deliver oxygen. While it includes embedded software and connects to a mobile app via Bluetooth, it is fundamentally a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Inogen Rove 6 Portable Oxygen Concentrator is a device that generates and delivers oxygen to a patient. It does not analyze any biological samples from the patient.
- Intended Use: The intended use clearly states it provides "a high concentration of supplemental oxygen to patients requiring respiratory therapy." This is a therapeutic function, not a diagnostic one.
- Device Description: The description details the process of concentrating oxygen from ambient air and delivering it to the patient via a nasal cannula. There is no mention of collecting or analyzing biological specimens.
Therefore, the Inogen Rove 6 Portable Oxygen Concentrator is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes
CAW
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.
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 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 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.
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
Not Found
Intended User / Care Setting
Home, institution, vehicle, and other transport modalities.
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)
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
Results: The device met all requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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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
1
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
2
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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3
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.
4
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.
5
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 as |
| well 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 dBA | |
| Maximum system sound pressure of 54 dBA | |
| Warm up time | 2 minutes |
| Oxygen concentration* | 90% -3%/+6% at all settings |
| Inspiratory trigger sensitivity | 30 days) |
| ISO 18562-2: 2017 Particulate matter | |
| ISO 18562-3:2017 Volatile organic compounds | Externally Communicating, Tissue, |
| Permanent Duration (>30 days) | |
| ISO 18562-2: 2017 Particulate matter | |
| ISO 18562-3:2017 Volatile organic compounds | Substantially |
| equivalent. | |
| Reference Device: Oxus GCE Zen-O | |
| 510K# | K162433 |
| Product Code | CAW |
| CFR | 21 CFR 868.5440 |
| Classification | 2 |
| Indications for | |
| Use | The Portable Oxygen Concentrator is intended to provide supplemental |
| oxygen in a home, institutional, or travel environment. | 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, and | |
| transport modalities. | Substantially equivalent |
| Prescriptive | Yes |
| Fundamental | |
| scientific | |
| technology | • 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, or | |
| any patient requiring supplemental oxygen. | Patients requiring respiratory therapy on a prescriptive basis. |
| Reference device mentions | |
| specific adult patients as well | |
| as any patient requiring | |
| supplemental oxygen. Rove 6 | |
| is substantially equivalent to | |
| the predicate Rove 4 device. | |
| User/Patient | |
| Interface | User interface panel |
| LCD Display to convey information about operating status in numbers and | |
| symbols. | LCD Display to convey information about operating status in numbers and |
| symbols. | Substantially equivalent |
| Setting, battery, and auditory | |
| alarm status are displayed. | |
| Alarm Indicator - yellow LED on UIP above "Alarm/Warning" triangle | |
| symbol that illuminates to indicate abnormal operating conditions in | |
| compliance with ISO 60601-1-8 | Alarm Indicator - yellow LED on UIP above "Alarm/Warning" triangle |
| symbol that illuminates to indicate abnormal operating conditions in | |
| compliance with ISO 60601-1-8 | Substantially equivalent |
| Breath Detect Notification - Green LED on UIP illuminates when a breath is | |
| detected, and an oxygen pulse is triggered | Breath Detect Notification - Green LED on UIP illuminates when a breath is |
| detected, and an oxygen pulse is triggered | Substantially equivalent. |
| Reference Device: Oxus GCE Zen-O | Subject Device: Inogen Rove 6 |
| Auditory Buzzer – Audible beeps are emitted to indicate alarm or status | |
| change conditions in compliance with ISO 60601-1-8. | Auditory Speaker - Audible beeps are emitted to indicate alarm or status |
| change conditions in compliance with ISO 60601-1-8. | Substantially equivalent. |
| Both meet sound levels | |
| compliant to the standard. | |
| Battery release button - Patient removable battery using push button to | |
| release battery then slide out of top of concentrator. | Battery release latch - Patient removable battery using push latch to release |
| battery then slide off bottom of concentrator. | Substantially equivalent. |
| Sieve module is an internal component and is only replaceable by a trained | |
| person. | Sieve beds - Users may send device to provider for sieve bed replacement, |
| or users may replace sieves. Sieve beds are user replaceable by pulling the | |
| wire handle while depressing the retaining tab to pull the columns out. The | |
| replacement columns are installed by pushing them in until the retaining tab | |
| snaps into place. | Similar. |
| Both the Inogen Rove 6 and | |
| Oxus GCE Zen-O have | |
| replaceable sieve beds. | |
| Inogen Rove 6 and the | |
| predicate device offers the | |
| convenience of user | |
| replaceable sieve beds. | |
| Particle Filter - Patient instructed to clean particle filters once per week. | Particle Filter - Patient instructed to clean particle filters once per week. |
| Accessories - Carry Bag, Cart, Battery, Accessory Bag, Rechargeable battery, | |
| External battery charger, humidifier kit | Optional accessories - Carry Bag, Backpack, Cart, External Battery Charger |
| External Battery Charger (EBC) -The battery can be charged inside the | |
| concentrator when installed into the concentrator that is connected to the | |
| AC/DC power supply, or outside of the concentrator in the approved EBC. | External Battery Charger (EBC) – Optional accessory. Independent battery |
| charger that utilizes an AC/DC power supply. The EBC slides onto the | |
| Inogen Rove 6 battery to charge outside of the concentrator. | Substantially equivalent. |
| Both Inogen Rove 6 and GCE | |
| Zen-O batteries can be | |
| charged externally from the | |
| concentrator. | |
| Mobile Application not available. | Inogen Connect Mobile Application – Optional mobile application for |
| viewing device settings, battery information, and current alerts, available for | |
| iOS and Android in English, French. | Similar |
| Inogen Rove 6 allows | |
| concentrator information to | |
| be viewed on a mobile device | |
| as well as on the concentrator | |
| display. The same | |
| information is available on | |
| Reference Device: Oxus GCE Zen-O | |
| 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 | |
| concentrator display only. | |
| Substantially Equivalent. | |
| The Inogen Rove 6 and | |
| Inogen Rove 4 User Manuals | |
| contain equivalent | |
| information for the user. | |
| Operating | |
| System | Software monitored |
| Bluetooth | |
| Technology | N/A |
| The Inogen Rove 6 Oxygen Concentrator is capable of Bluetooth | |
| functionality with the Inogen Connect App. | Similar |
| Inogen Rove 6 allows | |
| concentrator information to | |
| be viewed on a mobile device | |
| as well as on the concentrator | |
| display. The same | |
| information is available on | |
| the Oxus GCE Zen-O | |
| concentrator display only. | |
| Components | AC/DC Power Adapter - Utilizes 100-240V, 50/60Hz AC power supply and |
| cord for power and charging with wall adapter and barrel jack connection to | |
| concentrator. | AC/DC Power Adapter – Utilizes 100-240V, 50/60Hz AC power supply and |
| cord for power and charging with wall adapter and barrel jack connection to | |
| concentrator. | Substantially equivalent |
| DC Power Cable – cord and adapter to allow for connection to 12-volt DC | |
| outlet with cigarette lighter connector and barrel jack connection to | |
| concentrator. | DC Power Cable - cord and adapter to allow for connection to 12-volt DC |
| outlet with cigarette lighter connector and barrel jack connection to | |
| concentrator. | Substantially equivalent |
| Cannula -- Patient breaths through off the shelf 4', 7', 25' or 50' 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 one or two or rechargeable lithium batteries. To attach the | |
| battery, slide it into the top of the concentrator. Two batteries can be placed in | |
| the 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, slide |
| it on to the base of the concentrator. | Substantially equivalent. |
| Reference Device: Oxus GCE Zen-O | |
| Battery release button - Patient removable battery using push button to | |
| release battery then slide out of top of concentrator. | 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 | 12.3"H x 8.3"W x 6.6"D |
| Weight | 10.25 lbs |
| With Extended Batter: 5.8 lbs | Inogen Rove 6 is substantially |
| lighter in weight. | |
| Principle of | |
| Operation | The GCE Zen-O 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 mode, | |
| continuous mode Auto Mode or ECO Mode basis in precise amounts during | |
| the inhalation part of the breathing cycle. In standard Pulse Mode, the device | |
| will give you the same amount of oxygen every breath, regardless of your | |
| breath rate. This can consume more battery power at higher breath rates. In | |
| Eco Mode, the device will deliver a fixed volume of oxygen per minute | |
| regardless of breath rate, and will give an extended battery duration. In Auto | |
| Mode: If no inhalation is detected for 60 seconds when in pulse mode, the | |
| "Check Cannula" alarm will be activated and the device will automatically | |
| enter Auto-Mode and continue to deliver oxygen at a rate of 18 breaths per | |
| minute. When an inhalation is detected, the device will clear the "Check | |
| Cannula" alarm and exit Auto-Mode. | 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 |
| Oxygen Delivery | |
| Mode | Pulse Dose, Eco Mode, Auto Mode, Continuous Mode Flow |
| dose mode. |
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Table 5.2: Comparison of the Reference device vs. the Subject Device and References
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15
16
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| Reference Device: Oxus GCE Zen-O | Subject Device: Inogen Rove 6 | Comparison | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Output Flow | Pulse mode | Similar: 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). | |||||||||||||||
| BREATHS | |||||||||||||||
| PER | |||||||||||||||
| MINUTE | Setting | ||||||||||||||
| 1 | Setting | ||||||||||||||
| 2 | Setting | ||||||||||||||
| 3 | Setting | ||||||||||||||
| 4 | Setting | ||||||||||||||
| 5 | Setting | ||||||||||||||
| 6 | BREATHS | ||||||||||||||
| PER | |||||||||||||||
| MINUTE | Setting | ||||||||||||||
| 1 | Setting | ||||||||||||||
| 2 | Setting | ||||||||||||||
| 3 | Setting | ||||||||||||||
| 4 | Setting | ||||||||||||||
| 5 | Setting | ||||||||||||||
| 6 | |||||||||||||||
| 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 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. | |||||||||||||||
| 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 | TOTAL | ||||||||||||||
| VOLUME | |||||||||||||||
| PER | |||||||||||||||
| MINUTE | |||||||||||||||
| (ml/min) | 210 | 420 | 630 | 840 | 1050 | 1260 | Substantially equivalent. | ||||||||
| Oxygen Purity | 90% - 3%/+6% at all settings | 90% - 3%/+6% at all settings | |||||||||||||
| Maximum | |||||||||||||||
| Outlet Pressure | 20.5 PSI | 30 days) | |||||||||||||
| ISO 18562-2: 2017 Particulate matter | |||||||||||||||
| ISO 18562-3:2017 Volatile organic compounds | Similar. |
Inogen Rove 6 was tested per
the duration of patient
contact. |
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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