(325 days)
No
The summary does not mention AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms. The performance studies focus on hardware, software, and environmental testing based on established standards.
Yes
The device is used to provide supplemental oxygen to patients requiring it, which is a therapeutic intervention.
No
The device is an oxygen concentrator system, which provides supplemental oxygen, rather than diagnosing a medical condition. Its function is therapeutic, not diagnostic.
No
The device description and performance studies clearly indicate that this is a hardware device (oxygen concentrator) with associated software, not a software-only medical device. The testing includes hardware, electromagnetic, and environmental testing in addition to software testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to provide "supplemental, high concentration oxygen to these patients." This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a system for generating and delivering oxygen, which aligns with a therapeutic device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on biological samples to gain information about a person's health status. This device is designed to directly provide a therapeutic intervention (oxygen).
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CAW
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 DUO2 Oxygen 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.
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 patients
Intended User / Care Setting
home or institutional/hospital setting
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)
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.
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.
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
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
(Home
Concentrator) | Predicate #2
(POC) | Subject Device1
(POC and Home
Concentrator) | Identical and/or
Substantially
Equivalent |
|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Company Name | Respironics, Inc. | Inova Labs, Inc. | Inova Labs, Inc. | N/A |
| Product Name | L4 / Ever Flo
Oxygen
Concentrator | LifeChoice Oxygen
Concentrator | DUO Oxygen
Concentrator System
with Base Unit /
Portable Component
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
Oxygen
Concentrator is
intended to provide
supplemental
oxygen to persons
requiring oxygen
therapy. The device
is not intended to
be life supporting
or life sustaining.
The Respironics L4
Oxygen
Concentrator is
intended for use in
the home or
hospital /
institutional
environment. | The LifeChoice
Oxygen
Concentrator is a
prescriptive device
intended to provide
supplemental, high
oxygen
concentration to
patients.
The LifeChoice is
also portable and
may be used
continuously in a
home, institution or
travel environment. | The Activox DUO2
oxygen concentrator
system is used on a
prescriptive basis by
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. | Yes |
| Operation Principle | Operates on the
principle of
pressure swing
adsorption (PSA) of | Operates on the
principle of
pressure swing
adsorption (PSA) of | Operates on the
principle of pressure
swing adsorption (PSA)
of atmospheric | Yes |
| Characteristics | Predicate #1
(Home
Concentrator) | Predicate #2
(POC) | Subject Device1
(POC and Home
Concentrator) | Identical and/or
Substantially
Equivalent |
| | atmospheric
nitrogen onto
zeolite materials to
produce
concentrated
oxygen from air. | atmospheric
nitrogen onto zeolite
materials to produce
concentrated
oxygen from air. | nitrogen onto zeolite
materials to produce
concentrated oxygen
from air. | |
| Power On/Off
Switch | Yes | Yes | Yes | Yes |
| Circuit Breaker | Yes | N/A | Yes | Yes |
| Humidifier Bottle | Yes | N/A | Yes | Yes |
| Flow
Meter/Adjustable
Knob [l/min] | Yes | N/A | Yes | Yes |
| Cabinet Air Filter | Yes | N/A | Yes | Yes |
| Oxygen Filter | Information not
available | Yes | Yes | Yes |
| Power Cord | Yes | Yes | Yes | Yes |
| Power LED
(Indicator Light) | Yes | Yes | Yes | Yes |
| Alarm Indicator
LED | Yes | Yes | Yes | Yes |
| Audible Alarm | Yes | Yes | Yes | Yes |
| Low Oxygen Purity
Detection | OPI model only | Yes | Yes | Yes |
| Runtime Counter | Information not
available | Yes | Yes | Yes |
| Handle | Yes | Yes | Yes | Yes |
| Specifications | (Home Unit) | (Portable) | Base Unit | N/A |
| Dimensions
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
Continuous | 1 - 3 LPM PULSE-
WAVE | 0 - 5 LPM Continuous | Yes |
| O2 Concentration | 90% - 96% | 87% - 93% | 90% - 96% | Yes |
| Alarm Conditions | | | | |
| Power Failure
Alarm | Yes | Yes | Yes | Yes |
| Low Flow
Condition
(via Pressure) | Yes | Yes | Yes | Yes |
| Low Oxygen
Condition | Yes | Yes | Yes | Yes |
| Protection for
over-heat and
over-load | Information not
available | Yes | Yes | Yes |
| Characteristics | Predicate #1
(Home
Concentrator) | Predicate #2
(POC) | Subject Device
(POC and Home
Concentrator) | Identical and/or
Substantially
Equivalent |
| Safety Valve on
compressor outlet | Information not
available | No (Unit has a high
pressure alarm) | No (Unit has a high
pressure alarm) | Yes |
| Environmental Conditions | | | | |
| Operation
temperature | 13°C to 32°C | 5°C to 40°C | 10°C to 35° | Yes
(Subject device
has slightly
greater operating
temperature
range) |
| Operational
humidity range | 15% - 95%, Non-
cond. | 20% - 95%, Non-
cond. | 15% - 95%, Non-cond. | Yes |
| Storage
temperature | -34°C to 71°C | -20°C to 60°C | 0°C to 60°C | Yes |
| Storage Humidity
Range | 15% - 95%, Non-
cond. | 20% - 95%, Non-
cond. | 15% - 95%, Non-cond. | Yes |
| Power | | | | |
| Power supply
global
requirements
100 to 240 VAC
50-60 Hz | 120 VAC / 230 VAC
60 / 50 Hz | 120 VAC / 230 VAC
50 / 60 Hz | 120 VAC / 60 Hz
230 VAC / 50 Hz | Yes |
| Average Power | Up to 350W
(dependent on
model) | Up to 120W | Up to 372W | Yes
(within 6.3%
based on the
Home
Concentrator
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)
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8
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