Inogen Rove 4 Portable Oxygen Concentrator

K222086 · Inogen · CAW · Dec 9, 2022 · Anesthesiology

Device Facts

• Record ID: K222086
• Device Name: Inogen Rove 4 Portable Oxygen Concentrator
• Applicant: Inogen
• Product Code: CAW · Anesthesiology
• Decision Date: Dec 9, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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. This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.

Device Story

Inogen Rove 4 is a portable oxygen concentrator (POC) for supplemental oxygen delivery. It uses molecular sieve/pressure swing adsorption (PSA) technology to extract oxygen from ambient air. Input: ambient air drawn by compressor; Output: pulse-dose oxygen delivered via nasal cannula. Operation: device senses inhalation trigger (<0.12 cmH2O) to release oxygen bolus from accumulator reservoir. Used in home, institution, and transport settings by patients. Includes Bluetooth connectivity for Inogen Connect App (iOS/Android) to view settings, battery, and alerts. Healthcare providers prescribe the device; patients operate it. Benefits: provides portable, on-demand oxygen therapy, improving patient mobility compared to stationary systems.

Clinical Evidence

Bench testing only. No clinical data. Testing included pulse volume, trigger sensitivity, oxygen purity, alarm functionality, electrical/EMC safety, battery performance, and biocompatibility (ISO 18562-2/3). Device met all requirements for safety and essential performance per ISO 80601-2-69 and ISO 80601-2-67.

Technological Characteristics

Molecular sieve/pressure swing adsorption (PSA) technology. Lithium-ion battery (4 or 8-cell) or AC/DC power. Pulse dose delivery. Bluetooth connectivity. Dimensions: 6 x 2.7 x 7.5/7.8 in. Weight: 3.0-3.3 lbs. Standards: 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, IEC 62366-1. Biocompatibility: ISO 18562-2/3.

Indications for Use

Indicated for adult patients requiring supplemental oxygen therapy on a prescriptive basis. May be used in home, institution, and transport environments. Not for life-sustaining or life-supporting use.

Regulatory Classification

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).

Predicate Devices

• X-PLO2R (K203086)

Reference Devices

• Respironics SimplyGo Portable Oxygen Concentrator (K111885)
• GCE Zen-O Portable Oxygen Concentrator (K162433)

Submission Summary (Full Text)

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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

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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

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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 [phone] 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

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### 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)

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Date Prepared:

9-Dec-22

I Inogen. Inc. Sponsor: 301 Coromar Drive Goleta, California 93117

> Sponsor Contact: Sandy LeClair Regulatory Affairs Specialist, IV [e-mail] Phone: [phone]

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.

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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 as<br>well 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 Hz<br>Autosensing 2.0 – 1.0A |
| DC Power | 13.5-15.0 VDC, 100W<br>Max 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 hours<br>8-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-condensing<br>Store in a dry environment. |
| Measurement uncertainties: | Flow rates: ± 2% of reading<br>Pulse volumes: ±3% of reading or 3ml<br>(whichever is greater)<br>Pressure: ± 0.03 psig (General)/±0.05 cm H2O<br>(Inspiratory Trigger Sensitivity)<br>Oxygen concentration: ±0.4% (not accounting for<br>temperature, barometric pressure, and time from<br>measurement 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.

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#### 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.

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| | | 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 for<br>Use | The X-PLO2R is a transportable, software-monitored<br>device designed to be used by patients as a portable<br>oxygen delivery system requiring high<br>concentrations of oxygen on a supplemental basis. It<br>is small, portable, and is capable of continuous use in<br>home, institutional, and travel/ mobile environments.<br>This device is to be used as an oxygen supplement<br>and is not intended to be life sustaining or life<br>supporting. | The Inogen Rove 4 Portable Oxygen Concentrator<br>provides a high concentration of supplemental oxygen<br>to patients requiring respiratory therapy on a prescrip-<br>tive basis. It may be used in home, institution and<br>transport modalities. | Substantially equivalent<br>The predicate device and<br>subject device provide<br>supplemental oxygen to<br>patients prescribed<br>respiratory therapy. |
| Prescriptive | Yes | Yes | Substantially equivalent |
| Fundamental<br>scientific<br>technology | Breath detection technology<br>•<br>Molecular Sieve/pressure swing adsorption<br>technology | Breath detection technology<br>•<br>Molecular Sieve/pressure swing adsorption<br>technology | Substantially equivalent |
| Patient use | Adult patient only | Adult patient only | Substantially equivalent |
| User/Patient<br>Interface | User interface panel | User interface panel | Substantially equivalent |
| | LCD Display to convey information about operating<br>status in numbers, text, and symbols. | LCD Display to convey information about operating<br>status in numbers and symbols. | Substantially equivalent<br>Setting, battery, and<br>auditory alarm status are<br>displayed. |
| | Alarm Indicator – yellow "Alarm/Warning" triangle<br>symbol on LCD display is to indicate abnormal<br>operating conditions in compliance with ISO 60601-<br>1-8 | Alarm Indicator – yellow LED on UIP above<br>"Alarm/Warning" triangle symbol that illuminates to<br>indicate abnormal operating conditions in compliance<br>with ISO 60601-1-8 | Substantially equivalent.<br>Both the Inogen Rove 4 and<br>Belluscura X-PLOR use<br>"Alarm/Warning" triangle<br>symbol to indicated alarm<br>function. |
| | Breath Detect Notification – breath detect icon pops<br>up on the LCD display when a breath is detected, and<br>an oxygen pulse is triggered. | Breath Detect Notification – Green LED on UIP<br>illuminates when a breath is detected, and an oxygen<br>pulse is triggered. | Substantially equivalent.<br>Both the Inogen Rove 4 and<br>Belluscura X-PLOR have<br>an indicator for when a<br>breath has been detected |
| | Predicate Device: Belluscura X-PLO₂R | Subject Device: Inogen Rove 4 | Comparison |
| | Auditory Buzzer – Audible beeps are emitted to<br>indicate alarm or status change conditions in<br>compliance with ISO 60601-1-8. | Auditory Buzzer – Audible beeps are emitted to<br>indicate alarm or status change conditions in<br>compliance with ISO 60601-1-8. | and a pulse of oxygen has<br>been delivered.<br>Substantially equivalent. |
| | Sieve beds – Sieve beds are user replaceable by using<br>the cartridge pull handle to pull the cartridge<br>assembly out of the POC. Then, push in the new<br>replacement all the way into the unit so the handle<br>lays flat. | Sieve beds – Users may send device to provider for<br>sieve bed replacement, or users may replace sieves.<br>Sieve beds are user replaceable using M6 hex Allen<br>key to unscrew and slide out single piece sieve beds,<br>then slide in replacements and screw back into<br>concentrator. | Substantially Equivalent.<br>Both the Inogen Rove 4 and<br>Belluscura X-PLOR allow<br>Sieve Beds to be user<br>replaceable. The Inogen<br>Rove 4 are replaced with<br>the aid of a common<br>household tool, an Allen<br>key, while the Belluscura<br>X-PLOR utilizes a pull tab. |
| | Air Intake Filter - Patient instructed to clean the air<br>intake filter once per week. | Particle Filter – Patient instructed to clean particle<br>filters once per week. | Substantially equivalent. |
| | Optional accessories - Carry Bag, Strap, Backpack,<br>External Battery Charger | Optional accessories - Carry Bag, Backpack, External<br>Battery Charger | Substantially equivalent. |
| | No Mobile Application | Inogen Connect Mobile Application - Optional mobile<br>application for viewing device settings, battery<br>information, and current alerts, available for iOS and<br>Android in English, French. | Substantially equivalent.<br>The Inogen Rove 4 allows<br>concentrator information to<br>be viewed on a mobile<br>device as well as on the<br>concentrator display. The<br>same information is<br>available on the Belluscura<br>X-PLOR concentrator<br>display only. |
| Operating System | Software monitored | Software monitored | Substantially Equivalent |
| Bluetooth<br>Technology | No Bluetooth technology | Inogen Connect App - BLE Connection to Android or<br>iPhone.<br>The Inogen Rove 4 Oxygen Concentrator is capable of<br>Bluetooth functionality with the Inogen Connect App. | Substantially Equivalent<br>The Inogen Rove 4 allows<br>concentrator information to<br>be viewed on a mobile<br>device as well as on the<br>concentrator display. The<br>same information is |
| | Predicate Device: Belluscura X-PLO₂R | Subject Device: Inogen Rove 4 | Comparison |
| | | | available on the Belluscura<br>X-PLOR concentrator<br>display only. |
| Components | AC/DC Power Adapter – Utilizes 100-240V,<br>50/60Hz AC power supply and cord for power and<br>charging with wall adapter and barrel jack<br>connection to concentrator. | AC/DC Power Adapter – Utilizes 100-240V, 50/60Hz<br>AC power supply and cord for power and charging<br>with wall adapter and barrel jack connection to<br>concentrator. | Substantially equivalent. |
| | DC Power Cable – cord and adapter to allow for<br>connection to 12-volt DC outlet with cigarette lighter<br>connector and barrel jack connection to concentrator. | DC Power Cable – cord and adapter to allow for<br>connection to 12-volt DC outlet with cigarette lighter<br>connector and barrel jack connection to concentrator.…