(316 days)
Not Found
No
The description focuses on standard oxygen concentration technology (Pressure Swing Adsorption) and embedded software for system control, with no mention of AI or ML capabilities.
Yes
The device is used by patients requiring supplemental oxygen, providing a high concentration of oxygen and channeling it to the patient via a nasal cannula, which explicitly defines it as a therapeutic device.
No
The device is an oxygen concentrator used to supply supplemental oxygen to patients; it does not perform any diagnostic function.
No
The device description explicitly details hardware components like a nasal cannula, power cord, sieve beds, valves, and sensors, and mentions utilizing Pressure Swing Adsorption (PSA) technology, which is a physical process. While it includes embedded software, it is not solely software.
Based on the provided information, the Inogen At Home Oxygen Concentrator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide supplemental oxygen directly to a patient requiring it, using a nasal cannula. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details how it generates oxygen from ambient air and delivers it to the patient. It does not mention any analysis of biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
The Inogen At Home is a medical device used for respiratory support, which falls under a different category than in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Inogen At Home Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Inogen At Home Oxygen Concentrator may be used in a home or institution.
Product codes (comma separated list FDA assigned to the subject device)
CAW
Device Description
The Inogen At Home is a stationary concentrator providing approximately 90% oxygen to patients on a continuous flow basis at a rate of 1.0 liter per minute (LPM) to 5.0 liters per minute (LPM), in 1.0 liter per minute (LPM) increments. Nasal cannula channels oxygen from device to patient; both concentrator and nasal cannula are non-sterile. The device is capable of continuous use in the home or in an institutional setting.
The Inogen At Home can be powered by mains AC power found in the home or in an institutional setting. The Inogen At Home includes a detachable AC power cord to make the electrical connection to the AC mains.
The Inogen At Home utilizes Pressure Swing Adsorption (PSA) technology to produce oxygen. Oxygen is separated from ambient air under pressure by molecular characteristics and affinity for adsorbent material. The molecular sieve preferentially adsorbs nitrogen, allowing enriched oxygen to collect in an accumulator; the process then swings to low pressure to desorb the nitrogen, exhausting it back into the environment. A series of sieve beds, manifold with precision valves, sensors, and embedded software are used collectively to govern system functionality.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescriptive basis by patients; home or institution
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 Performance Data:
The Inogen At Home conforms with EN ISO 8359:2012, Oxygen Concentrators for Medical Use - Safety Requirements (ISO 8359:1996, Second edition, Amendment 1), ASTM F 1464:2005, Oxygen Concentrators for Domiciliary Use, IEC 60601-1, Medical Electrical Equipment -- Part 1: General requirements for safety, 1988; Amendment1, 1991-11, Amendment2, 1995.
Biocompatability testing included the evaluation of particulate matter, Ozone, Volatile Organic Compounds, Carbon Dioxide, and Carbon Monoxide. Performance testing included the assessment of electrical safety/ compatability, software functionality, fire mitigation and noise, temperature and altitude ranges, outlet pressure, flow indicator accuracy, and oxygen concentration.
This supports a determination of substantial equivalence.
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.
Not Found
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
JUN 2 0 2014
5. 510(k) Summary
| 510(k) Owner/ Submitter: | Inogen, Inc.
326 Bollay Drive
Goleta, California 93117
P: (805) 562-0500
F: (805) 562-0516 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mara Korsunsky
Inogen, Inc.
Director, Quality, Regulatory, and Compliance
P: (805) 562-0629
F: (805) 562-0516
E: mkorsunsky@inogen.net |
| Date Prepared: | August 5, 2013 |
| Trade Name: | Inogen At Home Oxygen Concentrator (AKA Inogen At Home/ Model GS-100) |
| Device Type:
(Common Name) | Oxygen Concentrator |
| Classification Name: | Portable Oxygen Generator |
| Classification Regulation: | 868.5440 |
| Class: | II |
| Panel: | Anesthesiology |
| Product Code: | CAW |
| Predicate Device(s): | Respironics, Inc., Respironics L4 Oxygen Concentrator (EverFlo),
K061261 |
| | Inogen, Inc., Inogen One Oxygen Concentrator, K032818 |
Device Description:
The Inogen At Home is a stationary concentrator providing approximately 90% oxygen to patients on a continuous flow basis at a rate of 1.0 liter per minute (LPM) to 5.0 liters per minute (LPM), in 1.0 liter per minute (LPM) increments. Nasal cannula channels oxygen from device to patient; both concentrator
1
and nasal cannula are non-sterile. The device is capable of continuous use in the home or in an institutional setting.
The Inogen At Home can be powered by mains AC power found in the home or in an institutional setting. The Inogen At Home includes a detachable AC power cord to make the electrical connection to the AC mains.
The Inogen At Home utilizes Pressure Swing Adsorption (PSA) technology to produce oxygen. Oxygen is separated from ambient air under pressure by molecular characteristics and affinity for adsorbent material. The molecular sieve preferentially adsorbs nitrogen, allowing enriched oxygen to collect in an accumulator; the process then swings to low pressure to desorb the nitrogen, exhausting it back into the environment. A series of sieve beds, manifold with precision valves, sensors, and embedded software are used collectively to govern system functionality.
Intended Use/ Indications for Use:
The Inogen At Home Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Inogen At Home Oxygen Concentrator may be used in a home or institution.
Technological Characteristics:
The Inogen At Home has a similar indications statement and technological characteristics (materials, design, and energy source) as the predicate devices. It raises neither new nor different questions of safety and effectiveness compared to the predicate devices; it is substantially equivalent.
Non-clinical Performance Data:
The Inogen At Home conforms with EN ISO 8359:2012, Oxygen Concentrators for Medical Use - Safety Requirements (ISO 8359:1996, Second edition, Amendment 1), ASTM F 1464:2005, Oxygen Concentrators for Domiciliary Use, IEC 60601-1, Medical Electrical Equipment -- Part 1: General requirements for safety, 1988; Amendment1, 1991-11, Amendment2, 1995.
Biocompatability testing included the evaluation of particulate matter, Ozone, Volatile Organic Compounds, Carbon Dioxide, and Carbon Monoxide. Performance testing included the assessment of electrical safety/ compatability, software functionality, fire mitigation and noise, temperature and altitude ranges, outlet pressure, flow indicator accuracy, and oxygen concentration.
This supports a determination of substantial equivalence.
Conclusion:
The Inogen At Home is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three bars extending from the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 20, 2014
Inogen, Inc. Mara Korsunsky Director, Quality, Regulatory, and Compliance 326 Bollay Drive Goleta, California 93117
Re: K132489
Trade/Device Name: Inogen At Home Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable oxygen generator Regulatory Class: II Product Code: CAW Dated: May 21, 2014 Received: May 22, 2014
Dear Ms. Korsunsky:
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. 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.
3
Page 2 - Ms. Korsunsky
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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Tejashri Purohit-Sheth, M.D. Tejashri Purofist-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ≤132489
Device Name: Inogen At Home Oxygen Concentrator
Indications for Use:
The Inogen At Home Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Inogen At Home Oxygen Concentrator may be used in a home or institution.
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
:
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Concurrence of Center for Devices and Radiological Health (CDRH)
Anya C. Harry -S 2014.06.19 13:43:53 -04'00'
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