Inogen Rove 6

K230052 · Inogen, Inc. · CAW · Jun 30, 2023 · Anesthesiology

Device Facts

• Record ID: K230052
• Device Name: Inogen Rove 6
• Applicant: Inogen, Inc.
• Product Code: CAW · Anesthesiology
• Decision Date: Jun 30, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Portable oxygen concentrator; uses molecular sieve/pressure swing adsorption (PSA) technology to extract oxygen from ambient air. Compressor draws air through filters; nitrogen adsorbed by sieve beds; oxygen collected in accumulator reservoir. Delivers pulse dose oxygen via nasal cannula; senses inhalation to trigger delivery; conserves oxygen by avoiding waste during exhalation. Used in home, institution, and mobile environments; operated by patient. Includes Bluetooth connectivity for Inogen Connect App (iOS/Android) to view device status. Powered by AC/DC adapter or rechargeable lithium-ion batteries. Healthcare providers use device to provide supplemental oxygen; output affects respiratory therapy management; benefits include mobility and consistent oxygen delivery.

Clinical Evidence

Bench testing only. Performance verified against ISO 80601-2-69 and ISO 80601-2-67. Testing included pulse volume, trigger sensitivity, oxygen purity, alarm accuracy, electrical safety/EMC, and biocompatibility (ISO 18562-2/3).

Technological Characteristics

Molecular sieve/PSA technology. Lithium-ion battery (8 or 16-cell). Dimensions: 7.2 x 3.3 x 8.1 in (standard). Weight: 4.8-5.8 lbs. Connectivity: Bluetooth (BLE). 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, ISO 18562-2/3.

Indications for Use

Indicated for patients requiring supplemental oxygen therapy on a prescriptive basis. Suitable for use in home, institution, and transport modalities. 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

• Inogen Rove 4 Portable Oxygen Concentrator (K222086)

Reference Devices

• GCE Zen-O Portable Oxygen Concentrator Model RS-00500 (K162433)
• Invacare Platinum Mobile Oxygen Concentrator (K160630)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo includes the Department of Health & Human Services logo on the left. To the right of that is the FDA logo in blue. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

June 30, 2023

Inogen, Inc Carole Harris Vice President, Regulatory Affairs 301 Coromar Drive Goleta, California 93117

Re: K230052

Trade/Device Name: Inogen Rove 6 Portable Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: June 1, 2023 Received: June 2, 2023

Dear Carole Harris:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

James J. Lee -S

James J. Lee, Ph.D. Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K230052

Device Name Inogen Rove 6 Portable Oxygen Concentrator

### Indications for Use (Describe)

The Inogen Rove 6 Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. It may be used in the home, institution, and transport modalities. This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 16px;">☑</span> |
|----------------------------------------------|-----------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="font-size: 16px;">☐</span> |

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## 510(k) Summary

Date Prepared: June 28, 2023

- I Sponsor: Inogen, Inc. 301 Coromar Drive Goleta, California 93117
Sponsor Contact: Carole E.N. Harris VP Quality & Regulatory Affairs [e-mail] Phone: [phone]

## Submission Correspondent: Carole Harris

## Confidentiality

Inogen, Inc requests as outlined under 21 CFR 20.61 that FDA treat this premarket notification and Inogen's intent to market as confidential commercial information.

#### II Device

Proprietary or Trade Name: Inogen Rove 6 Portable Oxygen Concentrator, K230052 Common/Usual Name: Generator, Oxygen, Portable Regulation Number: 868.5440 Device Class: 2 Product Code: CAW

Predicate Device: Inogen Rove 4 Portable Oxygen Concentrator, K222086 III Common/Usual Name: Generator, Oxygen, Portable Regulation Number: 868.5440 Device Class: 2 Product Code: CAW

IV Reference Device: GCE Zen-O Portable Oxygen Concentrator Model RS-00500, K162433 Common/Usual Name: Generator, Oxygen, Portable Regulation Number: 868.5440 Device Class: 2 Product Code: CAW

#### IV Device Description:

The Inogen Rove 6 Portable Oxygen Concentrator (Inogen Rove 6) is a Class 2, low risk, portable oxygen generator that provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. It may be used in home, institution, vehicle, and other transport modalities. It is used with a nasal cannula to channel oxygen from the device to the patient. The concentrator and the nasal cannula are non-sterile.

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The Inogen Rove 6 Portable Oxygen Concentrator is capable of continuous use in a home, institution, vehicle, and various mobile environments. Power options include 100 - 240 V-AC (50-60Hz) power supply, rechargeable battery packs, or a 13.5 -15.0 V-DC power cable.

The Inogen Rove 6 Portable Oxygen Concentrator uses molecular sieve/pressure swing adsorption technology. Ambient air is drawn through particle filters by a compressor and forced through molecular sieve beds, which adsorb nitrogen and allow oxygen to pass. The airflow is then changed, and nitrogen is desorbed from the molecular sieve, allowing it to adsorb again during the next cycle. Oxygen is collected in an accumulator reservoir. Waste nitrogen is exhausted back into the room. A series of sieve beds, manifolds and precision valves, sensors and embedded software are used to control the cycle to make the system function.

Oxygen is delivered to the patient on a pulse dose basis in precise amounts during the inhalation part of the breathing cycle. This conserver technology eliminates waste of unused oxygen at other times in the breathing cycle when it is not needed. The Inogen Rove 6 Portable Oxygen Concentrator senses the beginning of the inhalation cvcle and releases a specified dose of oxygen enriched gas from the accumulator reservoir, through a final filter, into the connected nasal cannula and on to the patient.

The Inogen Rove 6 Portable Oxygen Concentrator utilizes Bluetooth technology that pairs the portable oxygen concentrator to a mobile device or tablet using the Inogen Connect App.

The design of the Inogen Rove 6 Portable Oxygen Concentrator has focused on maximizing subsystem efficiencies and miniaturizing components to enable continuous duty use and to provide minimal weight with battery operation for mobile use.

The basic technology of the Inogen Rove 6 Portable Oxygen Concentrator is equivalent to other approved oxygen concentrators. The principles of operation are equivalent to the predicate device: Inogen Rove 4 Portable Oxygen Concentrator, K222086, and the reference device: GCE Zen-O Portable Oxygen Concentrator Model RS-00500. K162433 noted above.

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# Image of the Inogen Rove 6 Portable Oxygen Concentrator:

Image /page/5/Picture/2 description: The image shows a white Inogen Rove 6 portable oxygen concentrator. The device has a control panel on the top with a small display screen and several buttons. There is a blue handle on the side of the device. The Inogen Rove 6 is designed to provide supplemental oxygen to people with respiratory conditions.

## SPECIFICATIONS:

| Specifications: | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Mains Isolation | Remove both the DC input cord from device as<br>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)<br>Maximum system sound power of 62 dBA<br>Maximum system sound pressure of 54 dBA |
| Warm up time | 2 minutes |
| Oxygen concentration* | 90% -3%/+6% at all settings |
| Inspiratory trigger sensitivity | <0.12 cmH2O |
| Flow control settings | Pulse dose setting 1,2,3,4,5,6 |
| Bolus setting and size per bolus | See table below. Based upon Breath rate and |

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| Maximum outlet pressure | <28.5 PSI (199 kPa) |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AC Power | 100 to 240 VAC, 50 to 60 Hz<br>Autosensing 2.0 – 1.0A |
| DC Power | 13.5-15.0, 24 VDC, 120W<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 | Standard (BA-500 & BA-508): up to 3 hours<br>Extended (BA-516): up to 4 hours |
| Operating temperature** | 41 to 104°F (5 to 40°C) |
| Operating humidity | 15% to 90%, non-condensing |
| Operating altitude** | 0 to 10,000 ft (0 to 3048 meters) |
| Shipping and storage temperature | -13 to 158°F (-25 to 70°C) |
| Shipping and storage humidity | Up to 90%, non-condensing<br>Store in a dry environment. |
| Measurement uncertainties: | Pulse volumes: ± 15% of rated volume<br>Pressure: ± 0.03 psig (General) / ± 0.05 cm H2O (Inspiratory Trigger Sensitivity)<br>Oxygen concentration: ± 3% (not accounting for temperature, barometric pressure, and time from measurement device calibration) |

*Based on atmospheric pressure of 14.7 psi (101 kPa) at 68°F (20°C) & Dry (STPD)

** Operating outside of these operational specifications can limit the concentrator's ability to meeting Oxygen Concentration specification at higher liter flow settings.

#### V Indications for Use:

The Inogen Rove 6 Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. It may be used in home, institution, vehicle, and other transport modalities. This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.

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### VI Comparison of Technological Characteristics and Performance with the Predicate

The table below povides a side comparison of the Interface elements with respect to the predicate device, the Inogen Rove 4. The user interface features are broken down by category and the elements of early of User Interface elements have been found to be substantially equivalent to the predicate device, the Inogen Rove 4. Refer to Table 5.1.

All hogen Rove 6 User Interface elements have bear to that of the reference device, GC Zan-O Portable Oxygen Concentrator Model RS-01500. Refer to table 5.2

| | Predicate Device: Inogen Rove 4 | Subject Device: Inogen Rove 6 | Comparison |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| 510K# | K222086 | K230052 | N/A |
| Product Code | CAW | CAW | Substantially<br>equivalent |
| CFR | 21 CFR 868.5440 | 21 CFR 868.5440 | Substantially<br>equivalent |
| Classification | 2 | 2 | Substantially<br>equivalent |
| Indications for<br>Use | The Inogen Rove 4 Portable Oxygen Concentrator provides a high<br>concentration of supplemental oxygen to patients requiring respiratory<br>therapy on a prescriptive basis. It may be used in home, institution, and<br>transport modalities. | The Inogen Rove 6 Portable Oxygen Concentrator provides a high<br>concentration of supplemental oxygen to patients requiring respiratory<br>therapy on a prescriptive basis. It may be used in home, institution,<br>vehicle, and other transport modalities. | Substantially<br>equivalent |
| Prescriptive | Yes | Yes | Substantially<br>equivalent |
| Fundamental<br>scientific<br>technology | Breath detection technology Molecular Sieve/pressure swing adsorption technology | Breath detection technology Molecular Sieve/pressure swing adsorption technology | Substantially<br>equivalent |
| Patient use | Patients requiring supplemental oxygen | Patients requiring supplemental oxygen | Substantially<br>equivalent |
| User/Patient<br>Interface | User interface panel | User interface panel | Substantially<br>equivalent |
| | LCD Display to convey information about operating status in numbers and<br>symbols. | LCD Display to convey information about operating status in numbers<br>and symbols. | Substantially<br>equivalent<br>Setting, battery, and<br>auditory alarm status<br>are displayed. |
| Predicate Device: Inogen Rove 4 | Subject Device: Inogen Rove 6 | Comparison | |
| Alarm Indicator – yellow LED on UIP above "Alarm/Warning" triangle<br>symbol that illuminates to indicate abnormal operating conditions in<br>compliance with ISO 60601-1-8 | Alarm Indicator – yellow LED on UIP above “Alarm/Warning" triangle<br>symbol that illuminates to indicate abnormal operating conditions in<br>compliance with ISO 60601-1-8 | Substantially<br>equivalent | |
| Breath Detect Notification - Green LED on UIP illuminates when a breath is<br>detected, and an oxygen pulse is triggered. | Breath Detect Notification – Green LED on UIP illuminates when a<br>breath is detected, and an oxygen pulse is triggered | Substantially<br>equivalent. | |
| Auditory Buzzer – Audible beeps are emitted to indicate alarm or status<br>change conditions in compliance with ISO 60601-1-8. | Auditory Speaker – Audible beeps are emitted to indicate alarm or status<br>change conditions in compliance with ISO 60601-1-8. | Substantially<br>equivalent. | |
| Battery release latch – Patient removable battery using push latch to release<br>battery then slide off bottom of concentrator. | Battery release latch – Patient removable battery using push latch to<br>release battery then slide off bottom of concentrator. | Substantially<br>equivalent. | |
| Sieve beds – Users may send device to provider for sieve bed replacement, or<br>users may replace sieves. Sieve beds are user replaceable using M6 hex Allen<br>key to unscrew and slide out single piece sieve beds, then slide in<br>replacements and screw back into concentrator. | Sieve beds – Users may send device to provider for sieve bed<br>replacement, or users may replace sieves. Sieve beds are user replaceable<br>by pulling the wire handle while depressing the retaining tab to pull the<br>columns out. The replacement columns are installed by pushing them in<br>until the retaining tab snaps into place. | Substantially<br>Equivalent.<br>Both the Inogen Rove<br>6 and Inogen Rove 4<br>have user replaceable<br>sieve beds. | |
| Particle Filter – Patient instructed to clean particle filters once per week. | Particle Filter – Patient instructed to clean particle filters once per week. | Substantially<br>equivalent | |
| Optional accessories - Carry Bag, Backpack, External Battery Charger, Hip<br>Bag | Optional accessories - Carry Bag, Backpack, Cart, External Battery<br>Charger | Substantially<br>equivalent.<br>Inogen Rove 6 has a<br>cart available for<br>transport, and Inogen<br>Rove 4 has a hip bag. | |
| Predicate Device: Inogen Rove 4 | Subject Device: Inogen Rove 6 | Comparison | |
| External Battery Charger (EBC) – Optional accessory. Independent battery<br>charger that utilizes an AC/DC power supply. The EBC slides onto the<br>Inogen Rove 4 battery to charge outside of the concentrator. | External Battery Charger (EBC) – Optional accessory. Independent<br>battery charger that utilizes an AC/DC power supply. The EBC slides<br>onto the Inogen Rove 6 battery to charge outside of the concentrator. | Substantially<br>equivalent.<br><br>Both Inogen Rove 6<br>and Inogen Rove 4<br>batteries can be<br>charged externally<br>from the concentrator. | |
| Inogen Connect Mobile Application – Optional mobile application for<br>viewing device settings, battery information, and current alerts, available for<br>iOS and Android in English, French. | Inogen Connect Mobile Application – Optional mobile application for<br>viewing device settings, battery information, and current alerts, available<br>for iOS and Android in English, French. | Substantially<br>equivalent…