(147 days)
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.
This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.
The Inogen Rove™ 4 Portable Oxygen Concentrator is a 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 and transport modalities. It is used with a nasal cannula to deliver oxygen from the device to the patient. This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.
The Inogen Rove 4 Portable Oxygen Concentrator is capable of continuous use in a home, institution, 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 cord.
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, valves, sensors, and software are used to control the cycle to make the system function.
Oxygen is delivered to the patient on a pulse dose basis in pre-set 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 4 Portable Oxygen Concentrator senses the beginning of the inhalation cycle and releases a specified dose of oxygen enriched gas.
The Inogen Rove 4 Portable Oxygen Concentrator utilizes Bluetooth technology that pairs the portable oxygen concentrator to a mobile device or tablet using the Inogen Connect App.
The Inogen Rove™ 4 Portable Oxygen Concentrator's acceptance criteria and the study that proves its performance are described below.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Specification | Predicate Device: Belluscura X-PLO₂R Performance | Subject Device: Inogen Rove 4 Performance (Reported as 'Similar' or specific values) | Comparison |
|---|---|---|---|
| K Number | K203086 | K222086 | 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 for Use | Supplemental oxygen for patients requiring high concentrations, portable, continuous use in home, institutional, and travel/mobile environments. Not life-sustaining. | High concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. Used in home, institution, and transport modalities. Not life-sustaining or life-supporting. | Substantially equivalent. |
| Prescriptive | Yes | Yes | Substantially equivalent |
| Fundamental scientific technology | Breath detection, Molecular Sieve/pressure swing adsorption. | Breath detection, Molecular Sieve/pressure swing adsorption. | Substantially equivalent |
| Patient use | Adult patient only | Adult patient only | Substantially equivalent |
| User/Patient Interface - Type | User interface panel | User interface panel | Substantially equivalent |
| User/Patient Interface - Display | LCD Display (numbers, text, symbols) | LCD Display (numbers, symbols) | Substantially equivalent. Setting, battery, and auditory alarm status are displayed. |
| User/Patient Interface - Alarm Indicator | Yellow "Alarm/Warning" triangle symbol on LCD display (ISO 60601-1-8 compliant) | Yellow LED on UIP above "Alarm/Warning" triangle symbol that illuminates (ISO 60601-1-8 compliant) | Substantially equivalent. Both use "Alarm/Warning" triangle symbol. |
| User/Patient Interface - Breath Detect Notification | Breath detect icon pops up on LCD display. | Green LED on UIP illuminates. | Substantially equivalent. Both indicate when a breath is detected and oxygen pulse delivered. |
| User/Patient Interface - Auditory Buzzer | Audible beeps for alarm/status change (ISO 60601-1-8 compliant) | Audible beeps for alarm/status change (ISO 60601-1-8 compliant) | Substantially equivalent. |
| User/Patient Interface - Sieve beds | User replaceable using cartridge pull handle. | User replaceable using M6 hex Allen key. | Substantially Equivalent. Both allow user replacement, but with different tools. |
| User/Patient Interface - Air Intake Filter | Clean once per week. | Clean particle filters once per week. | Substantially equivalent. |
| Optional accessories | Carry Bag, Strap, Backpack, External Battery Charger | Carry Bag, Backpack, External Battery Charger | Substantially equivalent. (Strap is missing from subject device list, but generally comparable). |
| Mobile Application | No | Inogen Connect Mobile Application (iOS/Android) for viewing settings, battery, alerts. | Substantially equivalent. Inogen Rove 4 allows information on mobile device and concentrator display. Predicate only on display. |
| Operating System | Software monitored | Software monitored | Substantially Equivalent |
| Bluetooth Technology | No | Yes (BLE Connection to Android or iPhone with Inogen Connect App) | Substantially Equivalent. (See Mobile Application comparison). |
| AC/DC Power Adapter | 100-240V, 50/60Hz AC. | 100-240V, 50/60Hz AC. | Substantially equivalent. |
| DC Power Cable | 12-volt DC outlet connection. | 12-volt DC outlet connection. | Substantially equivalent. |
| Cannula | Off the shelf 7' nasal cannula. | User supplied off-the-shelf. | Substantially equivalent. |
| Battery | 4 or 8-cell lithium battery, slide-in attachment. | 4 or 8-cell lithium battery, slide-in attachment. | Substantially equivalent. |
| Size (4-cell battery) | 7.0"H, 7.3"W, 2.9"D | 7.5"H, 6.0"W, 2.7"D | Similar: Inogen Rove 4 is smaller. |
| Principle of Operation | Pressure Swing Adsorption (PSA) technology, pulse dose upon inhalation detection. | Molecular sieve / pressure swing adsorption technology, pulse dose upon inhalation detection. | Substantially equivalent. |
| Operating Conditions | Portable. Home, institutional, travel/mobile environments. | Portable. Home, institution and transport modalities. | Substantially equivalent. |
| Oxygen Delivery Mode | Pulse Dose | Pulse Dose | Substantially equivalent. |
| Output Flow (Total Volume/Minute) | 200 ml/min (Setting 1) to 800 ml/min (Setting 4) (at 15-40 BPM) | Higher volumes (e.g., 21.0 ml/min at 10 BPM for Setting 1) | Similar volumes. Inogen Rove 4 has higher volumes per minute for each setting. |
| Oxygen Purity | 82% to 92% at all settings | 87% to 96% at all settings | Similar. Inogen Rove 4 has higher oxygen concentrations per minute for each setting. |
| Maximum Outlet Pressure | 10psig (41.37 kPa) | < 22 PSI, 18.7 PSI (129 kPa) ± 10% | Inogen Rove 4 has a higher maximum outlet pressure. Differences are discussed in Section VIII. |
| Performance Standards | IEC 60601-1, -1-2, -1-6, -1-8, -1-11, ISO 80601-2-69, ISO 80601-2-67, IEC 62366-1 | IEC 60601-1:2012, -1-2: 2020, -1-6:2020, -1-8:2012, -1-11:2015, ISO 80601-2-69:2020, ISO 80601-2-67:2020, IEC 62366-1 | Similar (updated versions of standards for subject device). |
| Biocompatibility | Externally Communicating, Tissue, Permanent Duration (>30 days). ISO 18562-2:2017 (Particulate matter), ISO 18562-3:2017 (VOCs). | Externally Communicating, Tissue, Permanent Duration (>30 days). ISO 18562-2:2017 (Particulate matter), ISO 18562-3:2017 (VOCs). | Substantially equivalent. |
2. Sample size used for the test set and the data provenance
The submission does not explicitly detail a "test set" in the context of clinical data for performance evaluation that would typically measure diagnostic accuracy. Instead, the testing described is primarily non-clinical bench testing to demonstrate safety and effectiveness against standards and comparison to a predicate device's specifications.
Therefore, for aspects like pulse volume, oxygen purity, trigger sensitivity, alarms, software verification/validation, electrical/EMC/RFID, and biocompatibility, there isn't a "test set" sample size in the traditional sense of patient data. The "test set" would consist of the performance parameters measured on the device itself under various conditions.
The provenance of this data is from bench testing conducted by the manufacturer and a nationally registered test laboratory. No specific country of origin for this testing is mentioned, nor is it categorized as retrospective or prospective clinical data, as it is technical performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the evaluation relies on objective performance measurements against established engineering standards and technical specifications (e.g., oxygen concentration, pressure), rather than expert interpretation of medical images or patient conditions to establish a "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the performance evaluation is based on objective measurements against engineering standards and specifications, not expert consensus on qualitative data.
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 as the device is a portable oxygen concentrator, not an AI-assisted diagnostic or interpretative medical device. The submission describes a comparison between the subject device and a predicate device based on technical specifications and non-clinical testing, not a study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable for the core function of the oxygen concentrator. The device does have "Software verification and validation" and a mobile app, but this does not imply a "standalone algorithm-only" performance evaluation in the context of diagnostic accuracy or a similar clinical endpoint. The mobile app's function is for displaying device settings and alerts to the user, not for standalone diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance evaluation is based on:
- Established engineering standards: e.g., IEC 60601 series, ISO 80601 series, IEC 62366-1.
- Objective physical measurements: such as oxygen purity, flow rates, output pressure, trigger sensitivity, battery life, sound levels, dimensions, and weight.
- Predicate device specifications: used as a benchmark for comparison during the "Substantial Equivalence Discussion."
There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for this device.
8. The sample size for the training set
This information is not applicable. The submission describes the premarket notification for a medical device (portable oxygen concentrator) based on physical and technical performance testing, not a machine learning model that would require a "training set."
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" for a machine learning model in this submission.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo for the U.S. Food and Drug Administration (FDA). The logo includes the Department of Health & Human Services seal on the left. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked above the word "ADMINISTRATION".
December 9, 2022
Inogen Sandra Leclair Regulatory Affairs Specialist, IV 301 Coromar Drive Goleta. California 93117
Re: K222086
Trade/Device Name: Inogen Rove 4 Portable Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: November 9, 2022 Received: November 9, 2022
Dear Sandra Leclair:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
{1}------------------------------------------------
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
Page 2
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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).
Sincerelv.
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)
K222086
Device Name
Inogen Rove™ 4 Portable Oxygen Concentrator Portable Oxygen Concentrator
Indications for Use (Describe)
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.
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)
| XX Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. "
FORM FDA 3881 (7/17)
Page 1 of 1
C Publishing Services (301)
{3}------------------------------------------------
Page 1 of 11
Date Prepared:
9-Dec-22
I Inogen. Inc. Sponsor: 301 Coromar Drive Goleta, California 93117
Sponsor Contact: Sandy LeClair Regulatory Affairs Specialist, IV sleclair@inogen.net Phone: 315-868-1202
II Device
Proprietary or Trade Name: Inogen Rove 4 Portable Oxygen Concentrator Common/Usual Name: Generator, Oxygen, Portable Regulation Number: 868.5440 Product Code: CAW
III Predicate Device: Proprietary or Trade Name: X-PLO2R, K203086 Common/Usual Name: Generator, Oxygen, Portable Regulation Number: 868.5440 Product Code: CAW
IV Device Description:
The Inogen Rove™ 4 Portable Oxygen Concentrator is a 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 and transport modalities. It is used with a nasal cannula to deliver oxygen from the device to the patient. This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.
The Inogen Rove 4 Portable Oxygen Concentrator is capable of continuous use in a home, institution, 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 cord.
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, valves, sensors, and software are used to control the cycle to make the system function.
Oxygen is delivered to the patient on a pulse dose basis in pre-set 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 4 Portable Oxygen Concentrator senses the beginning of the inhalation cycle and releases a specified dose of oxygen enriched gas.
The Inogen Rove 4 Portable Oxygen Concentrator utilizes Bluetooth technology that pairs the portable oxygen concentrator to a mobile device or tablet using the Inogen Connect App.
{4}------------------------------------------------
Page 2 of 11
The basic technology of the Inogen Rove 4 Portable Oxygen Concentrator is equivalent to other cleared oxygen concentrators. The principles of operation are equivalent to the predicate device noted above: X-PLO2R, K203086.
| Specifications: | |
|---|---|
| Dimensions: | |
| With 4-cell battery | 6 x 2.7 x 7.5 in (15.1 x 6.9 x 19.1 cm) |
| With 8-cell battery | 6 x 2.7 x 7.8 in (15.1 x 6.9 x 19.7 cm) |
| Weight: | |
| With 4-cell battery | 3.0 pounds (1.4kg) |
| With 8-cell battery | 3.3 pounds (1.5kg) |
| Nominal sound level | 39 dBA at setting 2 (MDS-Hi) |
| Maximum system sound power of 59 dBA | |
| Maximum system sound pressure of 51 dBA | |
| Typical alarm sound pressure of 57 dBA | |
| Mains Isolation | Remove both the DC input cord from device aswell as the battery pack. |
| 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 |
| Maximum outlet pressure | <22 PSI |
| 18.7 PSI (129 kPa) ±10% | |
| AC Power | 100 to 240 VAC, 50 to 60 HzAutosensing 2.0 – 1.0A |
| DC Power | 13.5-15.0 VDC, 100WMax 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 | 4-cell (BA-404): up to 3 hours8-cell (BA-408): 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 | 5% to 95%, non-condensingStore in a dry environment. |
| Measurement uncertainties: | Flow rates: ± 2% of readingPulse volumes: ±3% of reading or 3ml(whichever is greater)Pressure: ± 0.03 psig (General)/±0.05 cm H2O(Inspiratory Trigger Sensitivity)Oxygen concentration: ±0.4% (not accounting fortemperature, barometric pressure, and time frommeasurement device calibration) |
*Based on atmospheric pressure of 14.7 psi (101 kPa) at 70°F (21°C)
** Operating outside of these operational specifications can limit the concentrator's ability to meeting Oxygen Concentration specification at higher liter flow settings.
{5}------------------------------------------------
Page 46 of 11
Indications for Use: V
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.
This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.
VI Comparison of Technological Characteristics and Performance with the Predicate
The table below provides a side-by-side comparison of the Inogen Rove 4 User Interface elements with respect to the predicate device, the Belluscura X-PLOR. The user interface features are broken down by category and the elements of each category.
All Inogen Rove 4 User Interface elements have been found to be substantially equivalent to that of the Belluscura X-PLOR.
{6}------------------------------------------------
| Table 5.1: Comparison of the Predicate device vs. the Subject Device and References | ||
|---|---|---|
| -- | -- | ------------------------------------------------------------------------------------- |
| Predicate Device: Belluscura X-PLO₂R | Subject Device: Inogen Rove 4 | Comparison | |
|---|---|---|---|
| 510K# | K203086 | K222086 | 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 X-PLO2R is a transportable, software-monitoreddevice designed to be used by patients as a portableoxygen delivery system requiring highconcentrations of oxygen on a supplemental basis. Itis small, portable, and is capable of continuous use inhome, institutional, and travel/ mobile environments.This device is to be used as an oxygen supplementand is not intended to be life sustaining or lifesupporting. | The Inogen Rove 4 Portable Oxygen Concentratorprovides a high concentration of supplemental oxygento patients requiring respiratory therapy on a prescrip-tive basis. It may be used in home, institution andtransport modalities. | Substantially equivalentThe predicate device andsubject device providesupplemental oxygen topatients prescribedrespiratory therapy. |
| Prescriptive | Yes | Yes | Substantially equivalent |
| Fundamentalscientifictechnology | Breath detection technology•Molecular Sieve/pressure swing adsorptiontechnology | Breath detection technology•Molecular Sieve/pressure swing adsorptiontechnology | Substantially equivalent |
| Patient use | Adult patient only | Adult patient only | Substantially equivalent |
| User/PatientInterface | User interface panel | User interface panel | Substantially equivalent |
| LCD Display to convey information about operatingstatus in numbers, text, and symbols. | LCD Display to convey information about operatingstatus in numbers and symbols. | Substantially equivalentSetting, battery, andauditory alarm status aredisplayed. | |
| Alarm Indicator – yellow "Alarm/Warning" trianglesymbol on LCD display is to indicate abnormaloperating conditions in compliance with ISO 60601-1-8 | Alarm Indicator – yellow LED on UIP above"Alarm/Warning" triangle symbol that illuminates toindicate abnormal operating conditions in compliancewith ISO 60601-1-8 | Substantially equivalent.Both the Inogen Rove 4 andBelluscura X-PLOR use"Alarm/Warning" trianglesymbol to indicated alarmfunction. | |
| Breath Detect Notification – breath detect icon popsup on the LCD display when a breath is detected, andan oxygen pulse is triggered. | Breath Detect Notification – Green LED on UIPilluminates when a breath is detected, and an oxygenpulse is triggered. | Substantially equivalent.Both the Inogen Rove 4 andBelluscura X-PLOR havean indicator for when abreath has been detected | |
| Predicate Device: Belluscura X-PLO₂R | Subject Device: Inogen Rove 4 | Comparison | |
| Auditory Buzzer – Audible beeps are emitted toindicate alarm or status change conditions incompliance with ISO 60601-1-8. | Auditory Buzzer – Audible beeps are emitted toindicate alarm or status change conditions incompliance with ISO 60601-1-8. | and a pulse of oxygen hasbeen delivered.Substantially equivalent. | |
| Sieve beds – Sieve beds are user replaceable by usingthe cartridge pull handle to pull the cartridgeassembly out of the POC. Then, push in the newreplacement all the way into the unit so the handlelays flat. | Sieve beds – Users may send device to provider forsieve bed replacement, or users may replace sieves.Sieve beds are user replaceable using M6 hex Allenkey to unscrew and slide out single piece sieve beds,then slide in replacements and screw back intoconcentrator. | Substantially Equivalent.Both the Inogen Rove 4 andBelluscura X-PLOR allowSieve Beds to be userreplaceable. The InogenRove 4 are replaced withthe aid of a commonhousehold tool, an Allenkey, while the BelluscuraX-PLOR utilizes a pull tab. | |
| Air Intake Filter - Patient instructed to clean the airintake filter once per week. | Particle Filter – Patient instructed to clean particlefilters once per week. | Substantially equivalent. | |
| Optional accessories - Carry Bag, Strap, Backpack,External Battery Charger | Optional accessories - Carry Bag, Backpack, ExternalBattery Charger | Substantially equivalent. | |
| No Mobile Application | Inogen Connect Mobile Application - Optional mobileapplication for viewing device settings, batteryinformation, and current alerts, available for iOS andAndroid in English, French. | Substantially equivalent.The Inogen Rove 4 allowsconcentrator information tobe viewed on a mobiledevice as well as on theconcentrator display. Thesame information isavailable on the BelluscuraX-PLOR concentratordisplay only. | |
| Operating System | Software monitored | Software monitored | Substantially Equivalent |
| BluetoothTechnology | No Bluetooth technology | Inogen Connect App - BLE Connection to Android oriPhone.The Inogen Rove 4 Oxygen Concentrator is capable ofBluetooth functionality with the Inogen Connect App. | Substantially EquivalentThe Inogen Rove 4 allowsconcentrator information tobe viewed on a mobiledevice as well as on theconcentrator display. Thesame information is |
| Predicate Device: Belluscura X-PLO₂R | Subject Device: Inogen Rove 4 | Comparison | |
| available on the BelluscuraX-PLOR concentratordisplay only. | |||
| Components | AC/DC Power Adapter – Utilizes 100-240V,50/60Hz AC power supply and cord for power andcharging with wall adapter and barrel jackconnection to concentrator. | AC/DC Power Adapter – Utilizes 100-240V, 50/60HzAC power supply and cord for power and chargingwith wall adapter and barrel jack connection toconcentrator. | Substantially equivalent. |
| DC Power Cable – cord and adapter to allow forconnection to 12-volt DC outlet with cigarette lighterconnector and barrel jack connection to concentrator. | DC Power Cable – cord and adapter to allow forconnection to 12-volt DC outlet with cigarette lighterconnector and barrel jack connection to concentrator. | Substantially equivalent. | |
| Cannula - Off the shelf 7' nasal cannula | Cannula – Is user supplied off-the-shelf | Substantially equivalent. | |
| Battery - utilizes a 4 or 8-cell lithium battery.To attach the battery, slide it on to the base of theconcentrator until the latch is in the locked position. | Battery - utilizes a 4 or 8-cell lithium battery. To attachthe battery, slide it on to the base of the concentrator. | Substantially equivalent. | |
| Size | With 4-cell battery: 7.0"H, 7.3" W, 2.9"D | With 4-cell battery: 7.5"H, 6.0" W, 2.7" D | Similar: Inogen is smaller |
| Principle ofOperation | The Belluscura X-PLO2R Portable OxygenConcentrator (POC) utilizes Pressure SwingAdsorption (PSA) technology to produce 82 to 92%oxygen and deliver it to patients though a standard,single-lumen nasal cannula on a pulse dose basis.The alternate filling and purging of these tubes isknown as PSA. Oxygen in the reservoir tank is thendelivered to the patient when an inhalation isdetected. An electronically controlled manifold opensthe delivery valve for a defined amount of timedepending on the measured breath rate and flowsetting to ensure the patient is receiving the bolusvolume defined for that flow setting. | The Inogen Rove™ 4 Portable Oxygen Concentratoruses molecular sieve / pressure swing adsorptiontechnology. Ambient air is drawn through particlefilters by a compressor and forced by pressure throughmolecular sieve beds, which adsorb nitrogen and allowoxygen to pass. Oxygen is collected in an accumulatorreservoir. The airflow is then changed, and nitrogen isdesorbed from the molecular sieve, allowing it toadsorb again during the next cycle. Waste nitrogen isexhausted back into the room. A series of sieve beds, amanifold with precision valves, sensors, and embeddedsoftware to control the cycle are used to make thesystem function.Oxygen is delivered to the patient on a demand flowbasis during the inhalation part of the breathing cycle.This conserver technology eliminates waste of unusedoxygen at other times in the breathing cycle when it isnot needed. The Inogen Rove™ 4 Portable OxygenConcentrator senses the beginning of the inhalationcycle and releases a specified dose of oxygen enrichedgas from the accumulator reservoir, through a finalfilter, into the connected nasal cannula and onto thepatient. Pressure sensors and embedded software areused to control the conserving function. | Substantially equivalent. |
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
Page 50 of 11
| Predicate Device: Belluscura X-PLO₂R | Subject Device: Inogen Rove 4 | Comparison | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| OperatingConditions | Portable. For use in home institutional, and travel ormobile environments. | Portable. For use in home, institution and transportmodalities. | Substantially equivalent. | ||||||||
| Performance | |||||||||||
| Oxygen DeliveryMode | Pulse Dose | Pulse Dose | Substantially equivalent. | ||||||||
| Output Flow | BREATHSPERMINUTE | Setting1 | Setting2 | Setting3 | Setting4 | BREATHSPERMINUTE | Setting1 | Setting2 | Setting3 | Setting4 | Similar volumes. Inogenhas higher volumes perminute for each setting. |
| 15 | 14 | 27 | 40 | 53 | 10 | 21.0 | 42.0 | 63.0 | 84.0 | ||
| 20 | 10 | 20 | 30 | 40 | 15 | 14.0 | 28.0 | 42.0 | 56.0 | ||
| 25 | 8 | 16 | 24 | 32 | 20 | 10.5 | 21.0 | 31.5 | 42.0 | ||
| 30 | 7 | 14 | 20 | 27 | 25 | 8.4 | 16.8 | 25.2 | 33.6 | ||
| 35 | 6 | 12 | 17 | 23 | 30 | 7.0 | 14.0 | 21.0 | 28.0 | ||
| 40 | 5 | 10 | 15 | 20 | 35 | 6.0 | 12.0 | 18.0 | 24.0 | ||
| TOTALVOLUMEPERMINUTE(ml/min) | 200 | 400 | 600 | 800 | 40TOTALVOLUMEPERMINUTE(ml/min) | 5.25 | 10.5 | 15.75 | 21.0 | ||
| Oxygen Purity | 82% to 92% at all settings | 87% to 96% at all settings | Similar. Inogen has higheroxygen concentrations perminute for each setting. | ||||||||
| Maximum OutletPressure | 10psig (41.37 kPa) | < 22 PSI18.7 PSI (129 kPa) ± 10% | Inogen has a highermaximum outlet pressure.Difference discussedfurther in section VIIIDiscussion of Differences. | ||||||||
| Performance standards | |||||||||||
| Performance andElectrical 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 | • IEC 60601-1:2012• IEC 60601-1-2: 2020• IEC 60601-1-6:2020• IEC 60601-1-8:2012• IEC 60601-1-11:2015• ISO 80601-2-69:2020 | Similar |
{10}------------------------------------------------
| Predicate Device: Belluscura X-PLO₂R | Subject Device: Inogen Rove 4 | Comparison | |
|---|---|---|---|
| • ISO 80601-2-67 | • ISO 80601-2-67:2020 | ||
| • IEC 62366-1 | • IEC 62366-1 | ||
| Communications | |||
| Power / Energy Source | 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. | ||
| Battery - utilizes a 4 or 8-cell lithium battery. | Battery - utilizes a 4 or 8-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 | Substantially equivalent |
{11}------------------------------------------------
VII Substantial Equivalence Discussion
Intended Use/ Indications for Use
The Inogen Rove 4 and the Belluscura X-PLO2R 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 and transport environments. Both devices are to be used as an oxygen supplement and is not intended to be life sustaining or life supporting. Inogen has included this statement as part of the Intended Use/Indications for Use statement.
Technological Characteristics and Principles of Operation
The Inogen Rove 4 and the Belluscura X-PLO2R both operate on Pressure Swing Adsorption (PSA) technology to produce oxygen and deliver it to patient via a standard oxygen 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. 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 major technical differences between the Inogen Rove™ 4 and the predicate device, Belluscura X-PLO2R are:
- The Belluscura X-PLO2R with a 4-cell battery measures 7.0"H, 7.3"W, 2.9"D. The Inogen Rove . 4 with a 4-cell battery measures 7.5"H, 6.0"W, 2.7"D. The Inogen Rove™ 4 is smaller in size.
- The Beluscura X-PLO2R with a 4-cell battery claims a battery duration of up to 2.5 hours, the ● Inogen Rove 4 with a 4-cell battery has a duration of 4:57 hours.
- The Belluscura X-PLO2R does not have a mobile application. The Inogen Rove™ 4 has a ●
{12}------------------------------------------------
Page 53 of 11
Inogen Connect Mobile Application - Optional mobile application for viewing device settings, battery information, and current alerts, available for iOS and Android in English, French allows concentrator The Inogen Rove™ 4 allows information to be viewed on a mobile device as well as on the concentrator display. The same information is available on the Belluscura X-PLO2R concentrator display only.
- . The Belluscura X-PLO2R does not have Bluetooth technology. Inogen Rove 4 features Bluetooth technology using the Inogen Connect App - BLE Connection to Android or iPhone.
- . The Maximum Outlet Pressure for Inogen Rove 4 is < 22 PSI, 18.7 PSI (129 kPa) ± 10% whereas the Belluscura X-PLO2R is 10psig (41.37 kPa). The Inogen Rove 4 Maximum Outlet Pressure is similar to previously cleared portable oxygen concentrators:
- . The Inogen Rove 4 and the Belluscura X-PLO2R both 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.
Substantial Equivalence Conclusion IX
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.
§ 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).