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.

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.

AI/ML Overview

The provided document describes the Inogen At Home Oxygen Concentrator, a medical device for supplemental oxygen delivery. It includes details about its purpose, technological characteristics, and conformance to relevant standards. However, the document does not contain a study that validates the device against specific acceptance criteria in the format requested.

Here's an analysis based on the information provided in the document, highlighting what is missing for a complete answer to your request:

The document clearly states the device's conformance to several international and national standards (EN ISO 8359:2012, ASTM F 1464:2005, IEC 60601-1). It also lists "performance testing" that was done, but does not provide specific acceptance criteria for these tests or the reported performance data in a quantitative table.

Here's a breakdown of what can and cannot be answered based solely on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Mentioned (Implicitly by conformance to standards or general tests):
- Oxygen Concentration: Approximately 90% (This is a design spec, not explicitly an "acceptance criterion" from a study).
- Flow Rate: 1.0 to 5.0 LPM in 1.0 LPM increments (Design spec).
- Electrical Safety/Compatibility: Conformance to IEC 60601-1.
- Software Functionality: Tested.
- Fire Mitigation: Tested.
- Noise, Temperature, and Altitude Ranges: Tested.
- Outlet Pressure: Tested.
- Flow Indicator Accuracy: Tested.
- Particulate Matter, Ozone, Volatile Organic Compounds, Carbon Dioxide, Carbon Monoxide: Biocompatibility testing included evaluation of these.
- Overall safety requirements per EN ISO 8359:2012 and ASTM F 1464:2005.
Reported Device Performance: The document states that "Performance testing included the assessment of electrical safety/ compatibility, software functionality, fire mitigation and noise, temperature and altitude ranges, outlet pressure, flow indicator accuracy, and oxygen concentration." It also mentions "Biocompatibility testing included the evaluation of particulate matter, Ozone, Volatile Organic Compounds, Carbon Dioxide, and Carbon Monoxide." However, no specific quantitative results or performance data against numerical acceptance criteria are provided in the text. For example, it doesn't say "oxygen concentration met specific criteria of X% +/- Y%" or "noise levels were Z dB below threshold."

Therefore, a table cannot be fully constructed with specific quantitative acceptance criteria or reported performance from this document.

Regarding the study that proves the device meets the acceptance criteria:

The document describes "Non-clinical Performance Data" and "Performance testing" as well as "Biocompatibility testing." These are the studies mentioned. However, the details required for points 2-9 are not present in the provided text.

Missing Information:

2. Sample sized used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device testing. "Ground truth" in this context would be objective measurements from calibrated equipment, not expert consensus interpretation.
4. Adjudication method for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical oxygen concentrator, not an algorithm.
7. The type of ground truth used: For performance tests, the ground truth would be objective measurements from calibrated sensors and analytical equipment (e.g., oxygen analyzers, flow meters, pressure gauges, sound level meters, gas chromatographs for impurities). For biocompatibility, it would be analytical results against established safe limits. This is implied by the testing, but not explicitly detailed.
8. The sample size for the training set: Not applicable. This is a hardware device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary:

The provided text serves as a 510(k) summary for a medical device (oxygen concentrator). It broadly discusses performance and biocompatibility testing and conformance to standards to demonstrate "substantial equivalence" to predicate devices. However, it does not detail a specific quantitative study with acceptance criteria and results in the manner typically expected for AI/diagnostic devices as implied by your questions, which are more tailored to software-based systems or image analysis. The "acceptance criteria" here are largely defined by compliance with the cited medical device standards (EN ISO 8359, ASTM F 1464, IEC 60601-1) and internal design specifications.

Summary

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JUN 2 0 2014

5. 510(k) Summary

510(k) Owner/ Submitter:	Inogen, Inc.326 Bollay DriveGoleta, California 93117P: (805) 562-0500F: (805) 562-0516
Contact Person:	Mara KorsunskyInogen, Inc.Director, Quality, Regulatory, and ComplianceP: (805) 562-0629F: (805) 562-0516E: 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:

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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:

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.

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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.

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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

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Indications for Use

510(k) Number (if known): ≤132489

Device Name: Inogen At Home Oxygen Concentrator

Indications for Use:

× 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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Regulation Number and Section

§ 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).