(147 days)
No
The summary describes standard oxygen concentration technology and mentions software for control, but there is no mention of AI or ML capabilities. The Bluetooth connectivity is for app pairing, not necessarily for AI/ML functions.
Yes
The device "provides a high concentration of supplemental oxygen to patients requiring respiratory therapy," which is a form of medical treatment.
No
The device is described as an oxygen concentrator that provides supplemental oxygen to patients. Its function is to deliver oxygen, not to diagnose a medical condition.
No
The device description clearly details hardware components such as a compressor, molecular sieve beds, valves, sensors, and a battery. While it mentions software is used to control the system, it is an integral part of a physical device that generates and delivers oxygen.
Based on the provided information, the Inogen Rove™ 4 Portable Oxygen Concentrator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Inogen Rove™ 4 Portable Oxygen Concentrator is a therapeutic device that provides supplemental oxygen directly to a patient through a nasal cannula. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states it provides "a high concentration of supplemental oxygen to patients requiring respiratory therapy." This is a treatment, not a diagnostic process.
Therefore, the Inogen Rove™ 4 Portable Oxygen Concentrator falls under the category of a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Inogen Rove™ 4 Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. It may be used in home, institution and transport modalities.
This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.
Product codes (comma separated list FDA assigned to the subject device)
CAW
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.
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
Adult patient only
Intended User / Care Setting
Home, institution and 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:
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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)
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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 as |
| well as the battery pack. | |
| Warm up time | 2 minutes |
| Oxygen concentration* | 90% - 3%/+6% at all settings |
| Inspiratory trigger sensitivity | 15 |
| 20 | |
| 25 | |
| 30 | |
| 35 | |
| 40 | |
| TOTAL | |
| VOLUME | |
| PER | |
| MINUTE | |
| (ml/min) | 200 |
| TOTAL | |
| VOLUME | |
| PER | |
| MINUTE | |
| (ml/min) | 5.25 |
| Oxygen Purity | 82% to 92% at all settings |
| oxygen concentrations per | |
| minute for each setting. | |
| Maximum Outlet | |
| Pressure | 10psig (41.37 kPa) |
| 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 |
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