ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM

{0}------------------------------------------------ # 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: 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. #### 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. {1}------------------------------------------------ ## 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<br>(Home<br>Concentrator) | Predicate #2<br>(POC) | Subject Device1<br>(POC and Home<br>Concentrator) | Identical and/or<br>Substantially<br>Equivalent | |----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| | Company Name | Respironics, Inc. | Inova Labs, Inc. | Inova Labs, Inc. | N/A | | Product Name | L4 / Ever Flo<br>Oxygen<br>Concentrator | LifeChoice Oxygen<br>Concentrator | DUO Oxygen<br>Concentrator System<br>with Base Unit /<br>Portable Component<br>and 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 L4<br>Oxygen<br>Concentrator is<br>intended to provide<br>supplemental<br>oxygen to persons<br>requiring oxygen<br>therapy. The device<br>is not intended to<br>be life supporting<br>or life sustaining.<br>The Respironics L4<br>Oxygen<br>Concentrator is<br>intended for use in<br>the home or<br>hospital /<br>institutional<br>environment. | The LifeChoice<br>Oxygen<br>Concentrator is a<br>prescriptive device<br>intended to provide<br>supplemental, high<br>oxygen<br>concentration to<br>patients.<br>The LifeChoice is<br>also portable and<br>may be used<br>continuously in a<br>home, institution or<br>travel environment. | The Activox DUO2<br>oxygen concentrator<br>system is used on a<br>prescriptive basis by<br>patients who are<br>diagnosed as requiring<br>supplemental oxygen.<br>The oxygen<br>concentrator will<br>provide supplemental,<br>high concentration<br>oxygen to these<br>patients. It is not life<br>supporting nor life<br>sustaining. It may be<br>used continuously in a<br>home or<br>institutional/hospital<br>setting. | Yes | | Operation Principle | Operates on the<br>principle of<br>pressure swing<br>adsorption (PSA) of | Operates on the<br>principle of<br>pressure swing<br>adsorption (PSA) of | Operates on the<br>principle of pressure<br>swing adsorption (PSA)<br>of atmospheric | Yes | | Characteristics | Predicate #1<br>(Home<br>Concentrator) | Predicate #2<br>(POC) | Subject Device1<br>(POC and Home<br>Concentrator) | Identical and/or<br>Substantially<br>Equivalent | | | atmospheric<br>nitrogen onto<br>zeolite materials to<br>produce<br>concentrated<br>oxygen from air. | atmospheric<br>nitrogen onto zeolite<br>materials to produce<br>concentrated<br>oxygen from air. | nitrogen onto zeolite<br>materials to produce<br>concentrated oxygen<br>from air. | | | Power On/Off<br>Switch | Yes | Yes | Yes | Yes | | Circuit Breaker | Yes | N/A | Yes | Yes | | Humidifier Bottle | Yes | N/A | Yes | Yes | | Flow<br>Meter/Adjustable<br>Knob [l/min] | Yes | N/A | Yes | Yes | | Cabinet Air Filter | Yes | N/A | Yes | Yes | | Oxygen Filter | Information not<br>available | Yes | Yes | Yes | | Power Cord | Yes | Yes | Yes | Yes | | Power LED<br>(Indicator Light) | Yes | Yes | Yes | Yes | | Alarm Indicator<br>LED | Yes | Yes | Yes | Yes | | Audible Alarm | Yes | Yes | Yes | Yes | | Low Oxygen Purity<br>Detection | OPI model only | Yes | Yes | Yes | | Runtime Counter | Information not<br>available | Yes | Yes | Yes | | Handle | Yes | Yes | Yes | Yes | | Specifications | (Home Unit) | (Portable) | Base Unit | N/A | | Dimensions<br>W 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 LPM<br>Continuous | 1 - 3 LPM PULSE-<br>WAVE | 0 - 5 LPM Continuous | Yes | | O2 Concentration | 90% - 96% | 87% - 93% | 90% - 96% | Yes | | Alarm Conditions | | | | | | Power Failure<br>Alarm | Yes | Yes | Yes | Yes | | Low Flow<br>Condition<br>(via Pressure) | Yes | Yes | Yes | Yes | | Low Oxygen<br>Condition | Yes | Yes | Yes | Yes | | Protection for<br>over-heat and<br>over-load | Information not<br>available | Yes | Yes | Yes | | Characteristics | Predicate #1<br>(Home<br>Concentrator) | Predicate #2<br>(POC) | Subject Device<br>(POC and Home<br>Concentrator) | Identical and/or<br>Substantially<br>Equivalent | | Safety Valve on<br>compressor outlet | Information not<br>available | No (Unit has a high<br>pressure alarm) | No (Unit has a high<br>pressure alarm) | Yes | | Environmental Conditions | | | | | | Operation<br>temperature | 13°C to 32°C | 5°C to 40°C | 10°C to 35° | Yes<br>(Subject device<br>has slightly<br>greater operating<br>temperature<br>range) | | Operational<br>humidity range | 15% - 95%, Non-<br>cond. | 20% - 95%, Non-<br>cond. | 15% - 95%, Non-cond. | Yes | | Storage<br>temperature | -34°C to 71°C | -20°C to 60°C | 0°C to 60°C | Yes | | Storage Humidity<br>Range | 15% - 95%, Non-<br>cond. | 20% - 95%, Non-<br>cond. | 15% - 95%, Non-cond. | Yes | | Power | | | | | | Power supply<br>global<br>requirements<br>100 to 240 VAC<br>50-60 Hz | 120 VAC / 230 VAC<br>60 / 50 Hz | 120 VAC / 230 VAC<br>50 / 60 Hz | 120 VAC / 60 Hz<br>230 VAC / 50 Hz | Yes | | Average Power | Up to 350W<br>(dependent on<br>model) | Up to 120W | Up to 372W | Yes<br>(within 6.3%<br>based on the<br>Home<br>Concentrator<br>predicate) | ## Substantial Equivalence Comparison Summary Table for the Activox DUO₂ System {2}------------------------------------------------ {3}------------------------------------------------ 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. {4}------------------------------------------------ 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. {5}------------------------------------------------ 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. {6}------------------------------------------------ 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 {7}------------------------------------------------ #### 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) 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. 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. Image /page/7/Figure/11 description: This image shows a portion of an FDA form. The text indicates that it is for FDA use only and includes the concurrence of the Center for Devices and Radiological Health (CDRH). The form includes the name Anya C. Harry, along with a date and time stamp of 2014.06.05 15:46:01 -04'00'. The form number is FDA 3881 (9/13) and it is page 1 of 2. 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