Actives DUO2 Oxygen Concentrator System is used on a prescriptive basis by adult patients who are diagnosed as requiring supplemental oxygen. The oxygen concentrator will provide supplemental, high concentration oxygen to these patients. It is not life supporting nor life sustaining. It may be used continuously in a home or institutional/hospital setting.

Device Description

The Activox DUO2 Oxygen Concentrator is designed to be primarily a stationary device for home/institutional use. The LifeChoice Activox POC is a portable device that provides additional functionality of the Activox DUO2Oxygen Concentrator System. The Activox DUO2 Oxygen Concentrator base unit must be connected to the LifeChoice Activox POC a minimum of once every 45 days in order for the base unit to function as intent of this feature is to ensure the user at least periodically charges the battery powered LifeChoice Activox POC. While the Activox DUO2 is connected, it will charge the internal battery for the LifeChoice Activox POC. The Activox DUO2 can also charge the external battery (sold separately) for the LifeChoice Activox POC after the internal battery is charged.

AI/ML Overview

This submission for the Activox DUO2 Oxygen Concentrator System focuses on demonstrating substantial equivalence to predicate devices rather than proving a new or novel performance claim. Therefore, the traditional concept of "acceptance criteria" and a "study proving the device meets acceptance criteria" as might be seen for an AI/ML diagnostic device with performance metrics like sensitivity, specificity, or AUC, is not directly applicable here.

Instead, the acceptance criteria are implicitly met by demonstrating that the Activox DUO2 System is "as safe and as effective" as the predicate devices based on design verification tests and a comparison of technological characteristics.

Here’s a breakdown of the information as requested, adapted to the context of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of submission, "acceptance criteria" are the characteristics of the predicate devices that the new device must match or be equivalent to. The "reported device performance" is how the Activox DUO2 demonstrates this equivalence.

Characteristic	Predicate #1 (Respironics L4 / EverFlo)	Predicate #2 (LifeChoice Activox)	Subject Device (Activox DUO2)	Acceptance Criteria Met (Yes/No)
Intended Use	Supplemental oxygen therapy, home/hospital (not life-supporting/sustaining)	Supplemental oxygen therapy, portable (not life-supporting/sustaining)	Supplemental oxygen therapy, home/institutional/hospital (not life-supporting/sustaining)	Yes
Operation Principle	Pressure Swing Adsorption (PSA)	Pressure Swing Adsorption (PSA)	Pressure Swing Adsorption (PSA)	Yes
Flow Rate (LPM)	0.5 - 5 LPM Continuous	1 - 3 LPM PULSE-WAVE	0 - 5 LPM Continuous	Yes (Equivalent)
O2 Concentration	90% - 96%	87% - 93%	90% - 96%	Yes (Equivalent)
Power Supply	100-240 VAC, 50-60 Hz	100-240 VAC, 50-60 Hz	120 VAC / 60 Hz, 230 VAC / 50 Hz	Yes (Global requirements met)
Dimensions (cm)	35x58x24	24x19x7.9	Base Unit: 36x57x34	Yes (Equivalent)
Weight (kg)	14 to 15	2.3	Base Unit: 16.5	Yes (Equivalent)
Alarm Conditions	Power Failure, Low Flow, Low O2	Power Failure, Low Flow, Low O2	Power Failure, Low Flow, Low O2	Yes
Operational Temp.	13°C to 32°C	5°C to 40°C	10°C to 35°C	Yes (within acceptable range)
Operational Humidity	15% - 95%, Non-cond.	20% - 95%, Non-cond.	15% - 95%, Non-cond.	Yes
Average Power	Up to 350W (base unit)	Up to 120W (POC)	Up to 372W (base unit)	Yes (within 6.3% of predicate)
Safety features	Circuit Breaker, Humidifier Bottle, Cabinet Air Filter, Oxygen Filter, Power LED, Alarm LED, Audible Alarm, Low O2 Purity, Protection for over-heat/over-load, safety valve (or equivalent)	Circuit Breaker (POC), Oxygen Filter, Power LED, Alarm LED, Audible Alarm, Low O2 Purity, Protection for over-heat/over-load, high pressure alarm	Circuit Breaker, Humidifier Bottle, Cabinet Air Filter, Oxygen Filter, Power LED, Alarm LED, Audible Alarm, Low O2 Purity, Protection for over-heat/over-load, high pressure alarm	Yes

2. Sample Size Used for the Test Set and Data Provenance

This submission does not involve a "test set" in the sense of patient data for evaluating diagnostic performance. Instead, the "testing" refers to design verification tests on the physical device. The sample size for these engineering tests (e.g., number of units tested for vibration, shock, EMC) is not specified in this summary. The data provenance would be internal to Inova Labs, based on their engineering and quality assurance processes, and would be prospective testing of the manufactured devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. "Ground truth" in the context of expert review of patient data is not relevant for this engineering device submission. The "truth" is established by adherence to engineering specifications and international standards.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication process for this type of technical device testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of a diagnostic aid (often AI-based) on human reader performance, which doesn't apply to an oxygen concentrator.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, "standalone performance" in the context of an algorithm or AI is not applicable here. This device is a mechanical/electronic medical device.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating the safety and effectiveness of the Activox DUO2 System is multi-faceted:

Engineering Specifications: The device's performance characteristics (e.g., oxygen concentration, flow rate, alarm thresholds) are designed to meet predefined internal specifications.
International Standards: The device's performance and safety are measured against recognized national and international standards for oxygen concentrators (e.g., IEC 60601-1, IEC 60601-1-2, ISO 8359).
Predicate Device Performance: The "truth" for substantial equivalence is the established performance and safety profile of the legally marketed predicate devices. The Activox DUO2 must perform equivalently or better.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm that learns from data.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set.

Summary

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JUN 0 6 2014

Submitter:

Inova Labs, Inc.
3500 Comsouth Drive
Austin, TX 78744
(512) 617-1700 (T)
(512) 617-1692 (F)

25 April 2014

Contact:

Ron Yarbrough Vice President of Regulatory Affairs and Quality Assurance (512) 617-1652 (1) (512) 617-1692 (F)

Summary Preparation Date:

Device Name(s): Common Name: Classification Number: Device Classification: Product Code: Predicate Device(s):

Activox DUO2 Oxygen Concentrator System Oxygen Concentrator System 21 CFR 868.5440 ll CAW Respironics L4/Everflo (K061261) Inova Activox (K072688)

Product Description:

Indications for Use:

The Activox DUO2 Oxygen Concentrator System is used on a prescriptive basis by patients who are diagnosed as requiring supplemental oxygen concentrator will provide supplemental, high oxygen concentration to these patients. It is not life supporting nor life sustaining. It may be used continuously in a home or institutional/hospital setting.

Summary of Technological Characteristics:

The technical characteristics of the Activox DUO₂Oxygen Concentrator System by Inova Labs are equivalent to those of the predicate devices. DUO2 and the L4 / EverFlo devices operate on the principle of pressure swing adsorption (PSA) of atmospheric nitrogen onto zeolite materials to produce concentrated oxygen from air. The oxygen concentration for the subject DUO2 device is(90-96%)which is the same as the predicate EverFlo device) The flow rate for both subject and predicate devices are substantially equivalent up to 5 LPM continuous flow. The power supply for both subject and predicate devices meet global requirements. The Activox DUO₂ offers a portable oxygen concentrator (POC) connection for battery charging not present on the L4 / EverFlo predicate device.

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Substantial Equivalence:

The Activox DUO2Oxygen Concentrator System shares the same indications for use, device operation, overall technical and functional capabilities and therefore is substantially equivalent to the predicate device(s). The subject device, Activox DUO₂Oxygen Concentrator System has the following similarities to the previously cleared predicate devices: same intended use, same operating principle and same technology. Design verification tests were performed on the Activox DUO2 Oxygen Concentrator System based on input from risk analysis and product requirements. Testing performed under design controls verified the design outputs meet the required acceptance criterion and determined the subject device is substantially equivalent to the predicate device. In summary, the subject device described in this submission K132205 is as safe and as effective as the predicate Respironics L4 / EverFlo device cleared in K061261 by comparison. Following is a summary of the substantial equivalence comparison table provided within K132205 (this submission).

Characteristics	Predicate #1(HomeConcentrator)	Predicate #2(POC)	Subject Device1(POC and HomeConcentrator)	Identical and/orSubstantiallyEquivalent
Company Name	Respironics, Inc.	Inova Labs, Inc.	Inova Labs, Inc.	N/A
Product Name	L4 / Ever FloOxygenConcentrator	LifeChoice OxygenConcentrator	DUO OxygenConcentrator Systemwith Base Unit /Portable Componentand Accessories	N/A
510(k) number	K061261	K072688	K132205	N/A
Pro Code	CAW	CAW	CAW	Yes
Classification	Class II	Class II	Class II	Yes
Regulation	21 CFR 868.5440	21 CFR 868.5440	21 CFR 868.5440	Yes
Intended Use	The Respironics L4OxygenConcentrator isintended to providesupplementaloxygen to personsrequiring oxygentherapy. The deviceis not intended tobe life supportingor life sustaining.The Respironics L4OxygenConcentrator isintended for use inthe home orhospital /institutionalenvironment.	The LifeChoiceOxygenConcentrator is aprescriptive deviceintended to providesupplemental, highoxygenconcentration topatients.The LifeChoice isalso portable andmay be usedcontinuously in ahome, institution ortravel environment.	The Activox DUO2oxygen concentratorsystem is used on aprescriptive basis bypatients who arediagnosed as requiringsupplemental oxygen.The oxygenconcentrator willprovide supplemental,high concentrationoxygen to thesepatients. It is not lifesupporting nor lifesustaining. It may beused continuously in ahome orinstitutional/hospitalsetting.	Yes
Operation Principle	Operates on theprinciple ofpressure swingadsorption (PSA) of	Operates on theprinciple ofpressure swingadsorption (PSA) of	Operates on theprinciple of pressureswing adsorption (PSA)of atmospheric	Yes
Characteristics	Predicate #1(HomeConcentrator)	Predicate #2(POC)	Subject Device1(POC and HomeConcentrator)	Identical and/orSubstantiallyEquivalent
	atmosphericnitrogen ontozeolite materials toproduceconcentratedoxygen from air.	atmosphericnitrogen onto zeolitematerials to produceconcentratedoxygen from air.	nitrogen onto zeolitematerials to produceconcentrated oxygenfrom air.
Power On/OffSwitch	Yes	Yes	Yes	Yes
Circuit Breaker	Yes	N/A	Yes	Yes
Humidifier Bottle	Yes	N/A	Yes	Yes
FlowMeter/AdjustableKnob [l/min]	Yes	N/A	Yes	Yes
Cabinet Air Filter	Yes	N/A	Yes	Yes
Oxygen Filter	Information notavailable	Yes	Yes	Yes
Power Cord	Yes	Yes	Yes	Yes
Power LED(Indicator Light)	Yes	Yes	Yes	Yes
Alarm IndicatorLED	Yes	Yes	Yes	Yes
Audible Alarm	Yes	Yes	Yes	Yes
Low Oxygen PurityDetection	OPI model only	Yes	Yes	Yes
Runtime Counter	Information notavailable	Yes	Yes	Yes
Handle	Yes	Yes	Yes	Yes
Specifications	(Home Unit)	(Portable)	Base Unit	N/A
DimensionsW x H x D	35x58x24 cm	24x19x7.9 cm	36x57x34 cm	Yes
Weight	14 to 15 kg.	2.3 kg	16.5 kg	Yes
Flow	0.5 - 5 LPMContinuous	1 - 3 LPM PULSE-WAVE	0 - 5 LPM Continuous	Yes
O2 Concentration	90% - 96%	87% - 93%	90% - 96%	Yes
Alarm Conditions
Power FailureAlarm	Yes	Yes	Yes	Yes
Low FlowCondition(via Pressure)	Yes	Yes	Yes	Yes
Low OxygenCondition	Yes	Yes	Yes	Yes
Protection forover-heat andover-load	Information notavailable	Yes	Yes	Yes
Characteristics	Predicate #1(HomeConcentrator)	Predicate #2(POC)	Subject Device(POC and HomeConcentrator)	Identical and/orSubstantiallyEquivalent
Safety Valve oncompressor outlet	Information notavailable	No (Unit has a highpressure alarm)	No (Unit has a highpressure alarm)	Yes
Environmental Conditions
Operationtemperature	13°C to 32°C	5°C to 40°C	10°C to 35°	Yes(Subject devicehas slightlygreater operatingtemperaturerange)
Operationalhumidity range	15% - 95%, Non-cond.	20% - 95%, Non-cond.	15% - 95%, Non-cond.	Yes
Storagetemperature	-34°C to 71°C	-20°C to 60°C	0°C to 60°C	Yes
Storage HumidityRange	15% - 95%, Non-cond.	20% - 95%, Non-cond.	15% - 95%, Non-cond.	Yes
Power
Power supplyglobalrequirements100 to 240 VAC50-60 Hz	120 VAC / 230 VAC60 / 50 Hz	120 VAC / 230 VAC50 / 60 Hz	120 VAC / 60 Hz230 VAC / 50 Hz	Yes
Average Power	Up to 350W(dependent onmodel)	Up to 120W	Up to 372W	Yes(within 6.3%based on theHomeConcentratorpredicate)

Substantial Equivalence Comparison Summary Table for the Activox DUO₂ System

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¹ NOTE: The DUO> System is comprised of two components, the portable oxygen concentrator (LifeChoice Activox) and the (Home) Concentrator DUOz Base Unit. The LifeChoice Activox is an integral part included in the purchase of the base unit. The base unit is a new product added to the Inova Labs POC product line. The LifeChoice Activox component of the DUO is an existing product offered by Inova Labs, previously cleared under 510(k) #K072688 and modified in K113317.

N/A = Not Applicable

Summary of Non-clinical Testing:

Inova Labs utilized hardware testing based on IEC 60601-1, IEC 60601-1-2; electromagnetic testing based on IEC 60601-1-2; environmental (random vibration and shock) testing based on IEC 60608-2-64, IEC 60608-2-6, IEC 60608-2-27; software testing based on ISO 62304; packaging based on ISO 2248; and device standard ISO 8359 to establish a basis for the determination of equivalence. The Activox DUQ performance characteristics were established by referencing the known performance characteristics of the predicate device(s). Specifications for the Activox DUG> System were established to assure that the predicate systems and the Activox DUO₂ System performed in an equivalent manner. Performance specifications were set utilizing national and international standards for oxygen concentrators with respect to output, indications for use, safety features and electromagnetic interference where it was established as suitable for the environment of use.

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All testing was conducted which established that the Activox DUO₂ System met or exceeded its design specifications and performed equally or better than the stated performance of the predicate device(s). Conclusions drawn from this non-clinical testing demonstrate that the subject device is as safe and as effective in comparison to the aforementioned predicate devices Respironics L4 / EverFlo cleared in K061261 and LifeChoice Activox cleared in K072688 and modified in K113317.

Safety and Effectiveness Information:

The review of the indications for use and the technical characteristics demonstrate that the Activox DUO₂ Oxygen Concentrator System is substantially equivalent to the predicate devices.

Conclusion:

The Activox DUO₂ Oxygen Concentrator System was found to be substantially equivalent to the predicate device(s). The Activox DUO₂ Oxygen Concentrator System shares the same indications for use, similar design features and functional features and thus is as safe and as effective in comparison to the predicate devices.

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Image /page/5/Picture/0 description: The image shows a logo on the left and the word "DEPARTMENT" on the right. The logo on the left is a circular seal with three lines extending from the bottom. The word "DEPARTMENT" is in bold, uppercase letters. There is a line underneath the word "DEPARTMENT".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 6, 2014

Inova Labs, Inc. Ron Yarbrough Vice President, Regulatory Affairs & Quality Control 3500 Comsouth Drive, Suite 100 Austin, TX 78744

Re: K132205

Trade/Device Name: Activox DUO2™ Oxygen Concentrator System Regulation Number: 21 CFR 868.5440 Regulation Name: Oxygen Concentrator System Regulatory Class: II Product Code: CAW Dated: May 02, 2014 Received: May 08, 2014

Dear Mr. Yarbrough:

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 - Mr. Ron Yarbrough

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 dcvice-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/ReportalProblem/dcfault.hum 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Tejashri Purohit-Sheth, M.D.
Tejasfiri Purohit 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K132205

Device Name

Activox DUO2 Oxygen Concentrator System

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

] Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Form Approved: OMB No: 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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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).