(104 days)
No reference devices were used in this submission.
No
The summary describes a portable oxygen concentrator with data transmission capabilities (DNA technology) and breath detection for oxygen delivery, but it does not mention or imply the use of AI or ML for any function.
Yes
The device is indicated for the administration of supplemental oxygen, which is a therapeutic intervention for patients requiring it.
No
The device is described as an oxygen concentrator for administering supplemental oxygen, not for diagnosing medical conditions. It explicitly states it does not provide "any patient monitoring capabilities."
No
The device description clearly states it is a "portable oxygen concentrator" and details hardware components and functions like delivering oxygen, detecting breaths, and operating in different modes. The performance studies also include hardware-specific testing like biocompatibility, electrical safety, and mechanical testing.
Based on the provided information, the O2 Concepts Oxlife Independence is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the administration of supplemental oxygen to patients. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a portable oxygen concentrator that delivers oxygen directly to the patient. It does not analyze biological samples (like blood, urine, or tissue).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic measurements, or the use of reagents, which are typical characteristics of IVD devices.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The Oxlife Independence provides a treatment (oxygen delivery) based on a pre-existing diagnosis or need for supplemental oxygen.
N/A
Intended Use / Indications for Use
The O2 Concepts Oxlife Independence is indicated on a prescription basis for the administration of supplemental oxygen. It is not intended for life support, nor does it provide any patient monitoring capabilities.
Product codes
CAW
Device Description
The Oxlife Independence is a portable oxygen concentrator that enables patients requiring supplemental oxygen to be treated in a home environment, in an institutional environment or in a vehicle/mobile environment. The Oxlife Independence utilizes O2 Concepts' Dynamic Network Analysis (DNA) technology to provide equipment performance, location and usage data to O2 Concepts and its customers via cellular and GPS connection.
The device delivers 87%-95% pure oxygen to a patient through a standard single lumen nasal cannula. The Independence detects a patient breath and delivers a bolus of oxygen during the inhalation period in pulse mode or delivers a continuous flow of oxygen in continuous mode.
The Oxlife Independence can be set to deliver flowrates in pulse mode settings of 0.5 to 6.0 of 8ml - 96ml and in continuous mode of 0.5 to 3.0 liters per minute (LPM). Setting can be adjusted in increments of 0.5 for both modes.
Device standard power options include a 100-240VAC Power Supply, 10-15VDC Power Supply and rechargeable batteries.
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 with chronic pulmonary diseases such as chronic bronchitis, emphysema, asthma, or lung cancer, those in the terminal stages of cancer or any patient requiring supplemental oxygen.
Intended User / Care Setting
Home, Travel 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)
Biocompatibility Testing
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Guidance Document, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" as recognized by FDA.
Particulate Matter 2.5 micron (PM2.5 testing was completed and the POC emitted a mean PM 2.5 level less than the EPA PM2.5 level of 15 µg/m3.
Inorganic gases (ozone. CO2, and CO) were evaluated with low levels detected of CO2; no level of CO and an ozone concentration less than the EPA allowed 0.050pm.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing was conducted on the O2 Concepts Oxlife Independence.
Verification and Validation Testing
Verification and Validation testing was conducted in accordance with ISO 80601-2-69 1st edition and documented which included device software, acoustic testing and packaging testing. The software for this device was considered a "moderate" level of concern, since a failure or latent flaw in the software could result in Minor Injury, either to a patient or to a user of the device. Mechanical and electrical safety testing was performed according to the performance standards listed above and internal test protocols to identify test methods.
The O2 Concepts Oxlife Independence was evaluated in accordance with ISO 80601-2-69 1 st edition to assure it performs as intended and met user needs including the following:
Verification Testing - Testing of prototype devices to confirm that design outputs meet the design input requirements.
Validation Testing - Testing of production units to ensure that devices conform to user needs and intended uses.
Software Validation Testing - Testing of device software to ensure it meets the required specifications.
Usability Validation - Testing to ensure that users can be successfully operate the device using the supplied collateral.
Usability Study
Usability testing was conducted with 10 users and included appropriate tasks based on the intended patient population in an environment representative of the intended conditions of use. Testing found that the design of the device and the instructions for use were appropriate for the intended user population.
Animal Studies
Not applicable for this device
Clinical Studies
No clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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O2 Concepts LLC % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street. Nw Buffalo, Minnesota 55313
Re: K182454
Trade/Device Name: O2 Concepts Oxlife Independence Model 301-0001 Regulation Number: 21 CFR 868.5440 Regulation Name: Portable oxygen generator Regulatory Class: Class II Product Code: CAW Dated: November 2, 2018 Received: November 5, 2018
Dear Mark Job:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Todd D. Courtney -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182454
Device Name Oxlife Independence
Indications for Use (Describe)
The O2 Concepts Oxlife Independence is indicated on a prescription basis for the administration of supplemental oxygen. It is not intended for life support, nor does it provide any patient monitoring capabilities.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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5. 510 k) Summary
Submitter I.
O2 Concepts LLC 199 Park Road Extension Middlebury, CT 06762 Phone: 877-867-4008 Contact Person: Kate Forgione, Director of Quality Date Prepared: December 17, 2018
II. Name of Device
Name of Device: O2 Concepts Oxlife Independence Model 301-0001
Common or Usual Name: Portable Oxygen Concentrator
CFR Regulation Number: 21 CFR 868.5440
Classification Panel: Anesthesiology
Regulatory Class: II
Product Code: CAW
- III. Predicate Device: Sequal Eclipse Portable Oxygen Concentrator (K013931) This predicate has not been subject to a design related recall. No reference devices were used in this submission.
IV. Device Description
The Oxlife Independence is a portable oxygen concentrator that enables patients requiring supplemental oxygen to be treated in a home environment, in an institutional environment or in a vehicle/mobile environment. The Oxlife Independence utilizes O2 Concepts' Dynamic Network Analysis (DNA) technology to provide equipment performance, location and usage data to O2 Concepts and its customers via cellular and GPS connection.
The device delivers 87%-95% pure oxygen to a patient through a standard single lumen nasal cannula. The Independence detects a patient breath and delivers a bolus of oxygen during the inhalation period in pulse mode or delivers a continuous flow of oxygen in continuous mode.
4
The Oxlife Independence can be set to deliver flowrates in pulse mode settings of 0.5 to 6.0 of 8ml - 96ml and in continuous mode of 0.5 to 3.0 liters per minute (LPM). Setting can be adjusted in increments of 0.5 for both modes.
Device standard power options include a 100-240VAC Power Supply, 10-15VDC Power Supply and rechargeable batteries.
V. Indications for Use
The O2 Concepts Oxlife Independence is indicated on a prescription basis for the administration of supplemental oxygen. It is not intended for life support, nor does it provide any patient monitoring capabilities.
Patient Population
Adult patients with chronic pulmonary diseases such as chronic bronchitis, emphysema, asthma, or lung cancer, those in the terminal stages of cancer or any patient requiring supplemental oxygen. It is a prescription device designed for indoor and outdoor use.
Environment of Use
Home, Travel or Institution
VI. Comparison of Technological Characteristics with the Predicate Device
Pressure Swing Absorption (PSA) is the technological principle for both the subject and predicate devices. It is based on molecular sieve/pressure swing absorption technology which draws in ambient air, pushes it through a sieve bed and then utilizes pressure swing absorption to convert the ambient air to pure oxygen.
Table 1 compares the key features of the proposed O2 Concepts Oxlife Independence with the identified predicate, the Sequal Eclipse.
5
| Attribute | Predicate Device:
Sequal Eclipse K013931 | Proposed Device:
O2 Concepts Oxlife
Independence |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Image: Sequal Eclipse K013931 | Image: O2 Concepts Oxlife Independence |
| Indications for Use | The Eclipse Oxygen System is
intended for administration of
supplemental oxygen. The
Eclipse is not intended for life
supporting or life sustaining
applications nor does it provide
any patient monitoring
capabilities. | The O2 Concepts Oxlife
Independence is indicated on a
prescription basis for the
administration of supplemental
oxygen. It is not intended for
life support, nor does it provide
any patient monitoring
capabilities. |
| Environments of Use | Travel, Home or Institution | Travel, Home or Institution |
| Prescription Use | Yes | Yes |
| Patient Population | Adult | Adult |
| Single Patient
Multi Use | Yes | Yes |
| Patient Interface | Cannula port | Cannula port |
| Technology | Pressure Swing Adsorption
with molecular sieve | Pressure Swing Adsorption
with molecular sieve |
| Dimensions (HxWxD) | 19.3" x 12.3" x 7.1" | 20.29" x 10.85" x 9.45" |
| Weight | 17.9 lbs. | 16.7lbs. |
| Oxygen Concentration | 87-95.6% | 87-95% |
| Equivalent Flow Rates | Continuous 0.5 – 3.0LPM in
0.5 LPM increments
Pulse Dose Settings 1-6 | Continuous 0.5 – 3.0LPM in
0.5 LPM increments
Pulse Dose Settings 0.5-6 |
| Dose at Specified Flow | 8 mL | 8 mL |
| Filters | Air Inlet Filter | Air Intake Filter |
| User Interface | Buttons/LCD Display | Buttons/LCD Display |
| Electrical | 100-240 VAC, 50/60 Hz
11.5-16V DC | 100-240 VAC, 50/60 Hz
12-15V DC |
| Software | Embedded | Embedded |
| Acoustic Noise | 48 dBA | 56 dBA |
| Alarms | Unit Malfunction | Unauthorized battery |
| | Loss of Power | No external power |
| | | High external power |
| | | Low external power |
| | Low Battery | Low battery |
| | Low Oxygen Output | Low purity |
| | Flow Restricted | No Flow |
| | Power Cartridge Temperature | Over Temperature |
| | | Invalid Motor Temperature |
| | | Invalid Box Temperature |
| | No Inspiration in Pulse Mode | No Breath in Pulse Mode |
| Status Indicators | Battery/Power Condition | Battery/Power Condition |
| | Delivery Mode | Delivery Mode |
| | Flow Setting | Flow Setting |
| | Pulse Dose Breath Indicator | Pulse Dose Breath Indicator |
| | Alerts/Alarms | Alerts/Alarms |
| | | History Log |
| | | Diagnostics |
| Battery Duration | Approximately 2.4 hours at 2.0
Continuous | Approximately 2.5 hours at 2.0
Continuous |
| Operating | Temperature 50°F to 104°F
Humidity 10% to 95% @ 82.4°
F | Temperature 50°F to 104°F
Humidity 10% to 95% @ 82.4°
F |
| Shipping/Storage | Temperature -4°F to 140°F
Humidity Up to 95% non-
condensing | Temperature -4°F to 140°F
Humidity 0-95% non-
condensing |
| Electrical Safety | AAMI IEC 60601-1-2:2007 | IEC 60601-1
IEC 60601-1-2 |
| Mechanical Safety | AAMI ANSI ES60601-1:2005 | IEC 60601-1 |
| Chemical Safety | N/A | N/A |
| Thermal Safety | AAMI ANSI ES60601-1:2005 | IEC 60601-1 |
| Type of Protection
again electric shock | Type BF - Not for cardiac | Type BF - Not for cardiac |
| Biocompatibility | 4 VOC's less than ambient
Pass ISO 10993-5 | 4 VOC's less than ambient |
TABLE 1 – COMPARISON OF PROPOSED DEVICE TO PREDICATE
6
7
| Standards Met | ||
|---|---|---|
| AAMI ANSI ES60601- | ||
| 1:2005/(R)2012 and A1:2012, | ||
| C1:2009/(R)2012 and | ||
| A2:2010/(R)2012 | IEC 60601-1 | |
| ANSI AAMI IEC 60601-1- | ||
| 2:2007/(R)2012 | IEC 60601-1-2 | |
| ANSI AAMI IEC 60601-1- | ||
| 8:2006 and A1:2012 | ||
| ANSI AAMI HA60601-1- | ||
| 11:2015 | ||
| ANSI AAMI IEC 62366-1:2015 | ||
| ISO 80601-2-69 1st ed. | ||
| ISO 8359:1996 | ||
| ISO 10993-2, 2006 | ||
| ISO 10993-5, 2014 | ||
| ISO 10993-10, 2010 | ||
| ISO 10993-12, 2012 | ||
| ISO 18562-2, 2017 | ||
| ISO 18562-3, 2017 |
Comparison Discussion
Indications for Use
The indications for use are equivalent when compared to the predicate device.
Patient Population
The patient populations are equivalent when compared to the predicate device. Adult patients with chronic pulmonary diseases such as chronic bronchitis, emphysema, asthma or lung cancer or those in the terminal stages of cancer, or any patient requiring supplemental oxygen.
Environment of Use
The environment of use is equivalent when compared to the predicate device. Both devices are used in the home, for travel or in an institution.
8
Principle of Operation & Technology
The essential design, components and principle operation of the Oxlife Independence based on molecular sieve/pressure swing absorption technology, to draw ambient air, push it through a sieve bed and then utilize pressure swing absorption to convert the ambient air to pure oxygen is equivalent to the predicate device.
The devices offer equivalent flow rates of oxygen and have equivalent alerts and alarms.
The difference between the device and the predicate is that the Oxlife Independence offers an optional technology, Dynamic Network Analysis (DNA), that providers can use to track device location, performance/usage data and alarms, via a cell and GPS module.
This technology does not change any performance characteristics of the device.
Both devices meet the requirements related to performance applicable to the portable oxygen concentrator and the differences noted in the comparison do not raise different questions of safety or effectiveness and therefore the subject device is substantially equivalent to the predicate device.
VII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Guidance Document, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" as recognized by FDA.
Particulate Matter 2.5 micron (PM2.5 testing was completed and the POC emitted a mean PM 2.5 level less than the EPA PM2.5 level of 15 µg/m3.
Inorganic gases (ozone. CO2, and CO) were evaluated with low levels detected of CO2; no level of CO and an ozone concentration less than the EPA allowed 0.050pm.
Patient contact with the device is limited to:
- Handle
- Device Enclosure
- Battery ●
- . Interface panel
9
The route of exposure to these materials would be through incidental contact with the patient's skin and does not contact the patient during normal device use. However, the oxygen that passes through the subject device per Annex A of ISO 10993-1:2009(E) is:
- . Category: External communicating device
- Contact: Tissue
- . Duration: C - Permanent (>30 days)
The POC is considered permanent contacting because the oxygen that passes through the device is inhaled by the patients through nasal tissue.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing was conducted on the O2 Concepts Oxlife Independence. The system complies with the following:
AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 AAMI IEC 60601-1-2:2007/(R)2012 ANSI AAMI IEC 60601-1-8:2006 and A1:2012 ANSI AAMI HA60601-1-11:2015 ANSI AAMI IEC 62366-1:2015 ISO 80601-2-69 1ª ed. IEC 62304 Edition 1.1 2015-06
Verification and Validation Testing
Verification and Validation testing was conducted in accordance with ISO 80601-2-69 1st edition and documented which included device software, acoustic testing and packaging testing. The software for this device was considered a "moderate" level of concern, since a failure or latent flaw in the software could result in Minor Injury, either to a patient or to a user of the device. Mechanical and electrical safety testing was performed according to the performance standards listed above and internal test protocols to identify test methods.
The O2 Concepts Oxlife Independence was evaluated in accordance with ISO 80601-2-69 1 st edition to assure it performs as intended and met user needs including the following:
Verification Testing - Testing of prototype devices to confirm that design outputs meet the design input requirements.
Validation Testing - Testing of production units to ensure that devices conform to user needs and intended uses.
Software Validation Testing - Testing of device software to ensure it meets the required specifications.
Usability Validation - Testing to ensure that users can be successfully operate the device using the supplied collateral.
10
Usability Study
Usability testing was conducted with 10 users and included appropriate tasks based on the intended patient population in an environment representative of the intended conditions of use. Testing found that the design of the device and the instructions for use were appropriate for the intended user population.
Animal Studies
Not applicable for this device
Clinical Studies
No clinical studies were performed.
11
VIII. Conclusions
As detailed, the indications for use, patient population, environment of use, technology and principles of operation and performance are substantially equivalent to the predicate. The identified differences between the subject device and the predicate device conclude that there are no new risks and thus the subject device can be determined to be substantially equivalent.