(104 days)
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.
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.
This document describes the O2 Concepts Oxlife Independence Model 301-0001, a portable oxygen concentrator, and its 510(k) submission for FDA clearance. The information provided is primarily focused on demonstrating substantial equivalence to a predicate device, rather than an AI/ML software as a medical device (SaMD). As such, the request for specific AI/ML-related acceptance criteria and study details (like MRMC studies, ground truth establishment for training sets, or sample sizes for test/training sets in the context of AI model performance) are not directly applicable or available in the provided text.
The document focuses on engineering and usability testing for a hardware device, not the performance claims of an AI algorithm.
However, I can extract and present the available acceptance criteria and performance data for this hardware device based on the provided text, while explicitly stating where requested information related to AI/ML is not applicable or not found.
Here's an attempt to structure the information based on your request, noting the limitations of the provided document in the context of AI/ML performance studies:
Acceptance Criteria and Device Performance for O2 Concepts Oxlife Independence Model 301-0001
This device is a hardware portable oxygen concentrator, and its clearance is based on demonstrating substantial equivalence to a predicate device, primarily through engineering performance testing and usability studies. It is not an AI/ML algorithm or SaMD. Therefore, many of the requested criteria related to AI/ML performance (e.g., AUC, sensitivity/specificity, MRMC studies, training set details for an AI model) are not relevant or described in this submission.
1. Table of Acceptance Criteria and Reported Device Performance
The document describes performance in terms of meeting various standards and demonstrating equivalence to the predicate. The "acceptance criteria" here are largely implied by compliance with recognized standards and successful verification/validation testing.
| Acceptance Criteria (Implied by Standards/Testing) | Reported Device Performance |
|---|---|
| Oxygen Concentration | |
| Deliver 87-95% pure oxygen. | Achieves 87-95% oxygen concentration. |
| Flow Rates | |
| Deliver specified flow rates in pulse and continuous modes. | Pulse mode settings: 0.5 to 6.0 (8ml - 96ml). Continuous mode settings: 0.5 to 3.0 LPM. Adjustable in 0.5 increments for both modes. |
| Biocompatibility | |
| Compliance with ISO 10993-1. | Evaluation conducted in accordance with FDA Guidance Document on ISO 10993-1. PM2.5 levels < EPA PM2.5 (15 µg/m3). Low CO2 detected, no CO, ozone < EPA (0.050 ppm). |
| Electrical Safety | |
| Compliance with AAMI ANSI ES60601-1, AAMI IEC 60601-1-2, AAMI IEC 60601-1-8, ANSI AAMI HA60601-1-11, ANSI AAMI IEC 62366-1. | Device complies with all listed electrical safety and EMC standards. |
| Software Validation | |
| Software meets required specifications. | Software validation testing performed; device software considered "moderate" level of concern. |
| Usability | |
| Users can successfully operate the device using supplied collateral; design and instructions are appropriate for intended user population. | Usability testing conducted with 10 users. Found device design and instructions appropriate for the intended user population. |
| Acoustic Noise | |
| No explicit acceptance criterion given, but compared to predicate. | 56 dBA (Predicate: 48 dBA). (Difference noted but considered not to raise new safety/effectiveness questions). |
| Battery Duration (at 2.0 Continuous) | |
| Comparable to predicate | Approximately 2.5 hours (Predicate: approx 2.4 hours). |
| Operating Temperature & Humidity | |
| Compliance with specified ranges. | Temp: 50°F to 104°F. Humidity: 10% to 95% @ 82.4°F. |
| Shipping/Storage Temperature & Humidity | |
| Compliance with specified ranges. | Temp: -4°F to 140°F. Humidity: 0-95% non-condensing. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The "test set" in this context refers to the physical devices and materials subjected to engineering and usability testing, not a dataset for an AI model.
- Sample Size:
- Usability Testing: 10 users were involved.
- Other Testing (Biocompatibility, Electrical Safety, V&V): The document does not specify the exact number of physical units tested for each specific engineering test. It refers to "testing of prototype devices" and "testing of production units."
- Data Provenance: The testing was conducted internally by O2 Concepts LLC (or through contracted labs, as implied by compliance statements). No information on country of origin of data or specific retrospective/prospective data collection is relevant or provided, as this is hardware testing for regulatory compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable in the AI/ML context. This device is a hardware product. Ground truth for its performance is established through physical measurements, compliance with engineering standards, and usability observations, not expert consensus on medical images or patient outcomes data as would be the case for an AI diagnostic tool.
- For usability: "10 users" were involved in the usability study, implying they represent the "intended user population." Their specific qualifications are not detailed beyond being representative users.
4. Adjudication Method for the Test Set
- Not Applicable in the AI/ML context. Adjudication methods (2+1, 3+1) refer to procedures for resolving disagreements among multiple human readers when establishing ground truth for AI model performance. As this is a hardware device, such methods are not relevant.
- For engineering tests: Pass/fail criteria against established standards (e.g., IEC 60601-1) or design specifications serve as the "adjudication."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is a clinical study design used to evaluate the performance of diagnostic tools (often AI/ML) by comparing multiple readers' interpretations of cases with and without AI assistance. This is a hardware oxygen concentrator, not a diagnostic AI tool, so this type of study was not performed or applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI algorithm. Its performance is inherent to its mechanical and electronic design. The closest equivalent would be the various engineering performance tests (e.g., oxygen concentration, flow rate accuracy, electrical safety) that demonstrate the device's functional integrity.
7. The Type of Ground Truth Used
- For device performance: The "ground truth" for this device's performance is established by:
- Physical Measurements: Direct measurements of oxygen concentration, flow rates, acoustic noise, battery duration, etc., using calibrated equipment.
- Compliance with Recognized Standards: Meeting the requirements of international and national standards for medical electrical equipment (e.g., ISO 80601-2-69, IEC 60601 series, ISO 10993 for biocompatibility).
- User Observations: For usability, "successful operation" by intended users per the study protocol.
8. The Sample Size for the Training Set
- Not Applicable. This is a hardware medical device, not an AI/ML algorithm. There is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no AI/ML training set, this question is not relevant.
Summary of Device Nature:
The O2 Concepts Oxlife Independence Model 301-0001 is a portable oxygen concentrator, a Class II hardware medical device. Its 510(k) clearance relied on demonstrating substantial equivalence to a predicate device, primarily evidenced through engineering performance tests (e.g., oxygen purity, flow rates, electrical safety), biocompatibility testing, and a usability study. The concept of an AI model, training data, test data for AI, or AI-specific performance metrics are not applicable to this submission.
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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
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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
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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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Image /page/3/Picture/1 description: The image shows the logo for O2 Concepts. The logo features a blue circle with a white swoosh across the top. The number "2" is inside the circle. Below the circle, the word "Concepts" is written in a sans-serif font.
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.
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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.
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| Attribute | Predicate Device:Sequal Eclipse K013931 | Proposed Device:O2 Concepts OxlifeIndependence |
|---|---|---|
| Image: Sequal Eclipse K013931 | Image: O2 Concepts Oxlife Independence | |
| Indications for Use | The Eclipse Oxygen System isintended for administration ofsupplemental oxygen. TheEclipse is not intended for lifesupporting or life sustainingapplications nor does it provideany patient monitoringcapabilities. | The O2 Concepts OxlifeIndependence is indicated on aprescription basis for theadministration of supplementaloxygen. It is not intended forlife support, nor does it provideany patient monitoringcapabilities. |
| Environments of Use | Travel, Home or Institution | Travel, Home or Institution |
| Prescription Use | Yes | Yes |
| Patient Population | Adult | Adult |
| Single PatientMulti Use | Yes | Yes |
| Patient Interface | Cannula port | Cannula port |
| Technology | Pressure Swing Adsorptionwith molecular sieve | Pressure Swing Adsorptionwith 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 in0.5 LPM incrementsPulse Dose Settings 1-6 | Continuous 0.5 – 3.0LPM in0.5 LPM incrementsPulse 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 Hz11.5-16V DC | 100-240 VAC, 50/60 Hz12-15V 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 2.0Continuous | Approximately 2.5 hours at 2.0Continuous |
| Operating | Temperature 50°F to 104°FHumidity 10% to 95% @ 82.4°F | Temperature 50°F to 104°FHumidity 10% to 95% @ 82.4°F |
| Shipping/Storage | Temperature -4°F to 140°FHumidity Up to 95% non-condensing | Temperature -4°F to 140°FHumidity 0-95% non-condensing |
| Electrical Safety | AAMI IEC 60601-1-2:2007 | IEC 60601-1IEC 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 Protectionagain electric shock | Type BF - Not for cardiac | Type BF - Not for cardiac |
| Biocompatibility | 4 VOC's less than ambientPass ISO 10993-5 | 4 VOC's less than ambient |
TABLE 1 – COMPARISON OF PROPOSED DEVICE TO PREDICATE
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| Standards Met | ||
|---|---|---|
| AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 andA2:2010/(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.
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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
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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.
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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.
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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.
§ 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).