(782 days)
Not Found
No
The device is a refurbished replacement part (sieve bed) for an oxygen concentrator and the description focuses on its function in generating oxygen and meeting performance standards, with no mention of AI or ML.
No.
The device itself is a replacement part for an oxygen concentrator, which is a therapeutic device. However, the replacement column (sieve bed) alone does not administer therapy; it enables the therapeutic device to function correctly.
No
The device is described as a replacement part (sieve bed) for an oxygen concentrator, which supplies supplemental oxygen to patients. Its function is to generate oxygen by removing nitrogen and other gases from room air. There is no information suggesting that it is used to identify or diagnose a disease or condition.
No
The device is a refurbished replacement part (sieve bed) for an oxygen concentrator, which is a hardware component. The description focuses on the physical characteristics and performance of this hardware part.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is a replacement part for an oxygen concentrator used to provide supplemental oxygen to patients. This is a therapeutic and life-support function, not a diagnostic one.
- Device Description: The device is a sieve bed that filters air to produce oxygen. This is a mechanical process, not a test performed on biological samples to diagnose a condition.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) or to provide information for the diagnosis, monitoring, or treatment of a disease or condition based on such analysis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Refurbished Replacement Column (Sieve Bed) are regular replacement parts for Inogen One G3 Oxygen Concentrator.
The Inogen One Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Inogen One Oxygen Concentrator may be used in a home, institution, vehicles and various mobile environments.
Product codes (comma separated list FDA assigned to the subject device)
CAW
Device Description
The subject device is a compatible replacement part of the Inogen One G3 portable oxygen concentrator. ("POC"). Standard portable oxygen concentrators generate oxygen from room air by use of a sieve bed that removes nitrogen, other gases and impurities from the room air and generates oxygen for patients requiring supplement oxygen.
These sieve beds must be replaced on a schedule in order to maintain the POC's ability to deliver the require % oxygen. The subject device is refurbished with existing Inogen One G3 components with a new sieve bed. The final product is equivalent to the Inogen one G3 replacement sieve bed cartridge.
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
Not Found
Intended User / Care Setting
Home, institution, vehicles and various mobile environments
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)
Non-clinical Testing
Performance testing demonstrated that the Oxus Refurbished sieve bed met its acceptance criteria. Testing included:
Bench
- Fill Volume
- Oxygen Purity over time per applicable parts of ISO 80601-2-69:2020 clause 201.12.1.103 (Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment) testing was done at intervals up to 8 hours with performance compared to the predicate.
- Leakage
- Package integrity
Biocompatibility
- ISO 18562-2:2017 Particulate Matter compared with predicate and subject device after 10 cleaning / refurbishing cycles
- ISO 18562-3:2017 VOC compared with predicate and subject device after 10 cleaning / refurbishing cycles
- Inorganic gases CO, CO2, Ozone
- Toxicological Risk Assessment
Key results: The Oxus Refurbished sieve bed has similar intended use and indications, technological characteristics, principles of operation and performance as the predicate. The performance testing supports substantial equivalence to the Inogen One G3 replacement sieve bed cartridges, K032818.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Oxygen Purity >= 90% Purity at Setting 5 at various temperature, humidity and altitude conditions
Bed Leak Rate
§ 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The text is in blue, with "FDA" in a larger font size and enclosed in a blue square.
May 31, 2023
Oxus, Inc. % Paul Dryden President ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704
Re: K211056
Trade/Device Name: Refurbished Replacement Column (Sieve Bed) Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: November 28, 2022 Received: November 28, 2022
Dear Paul Dryden:
We have reviewed vour 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/ofdocs/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
1
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
James J. Lee -S
James J. Lee, PhD Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211056
Device Name
Refurbished Replacement Column (Sieve Bed)
Indications for Use (Describe)
Refurbished Replacement Column (Sieve Bed) are regular replacement parts for Inogen One G3 Oxygen Concentrator.
The Inogen One Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Inogen One Oxygen Concentrator may be used in a home, institution, vehicles and various mobile environments.
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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3
510(k) Summary Page 1 of 4
| Date Prepared: | 31-May-23 |
|---|---|
| Sponsor: | Oxus, Inc. |
| 2046 Brown Rd. | |
| Auburn Hills, MI 48326 | |
| Sponsor Contact: | Ryan Lenarcic |
| Quality & Regulatory Manager | |
| Tel - 248-475-0925 | |
| Submission Correspondent: | Paul Dryden |
| ProMedic, LLC | |
| Proprietary or Trade Name: | Refurbished Replacement Column (Sieve Bed) |
| Common/Usual Name: | Replacement Sieve Bed for Portable Oxygen Concentrator |
| Classification Name: | |
| CFR | |
| Product Code | Generator, Oxygen, Portable |
| CFR 868.5440 | |
| CAW | |
| Predicate Device: | |
| Classification Name: | |
| CFR | |
| Product Code | K032818, Inogen One G3 Portable Oxygen Concentrator |
| Generator, Oxygen, Portable | |
| CFR 868.5440 | |
| CAW |
Device Description:
The subject device is a compatible replacement part of the Inogen One G3 portable oxygen concentrator. ("POC"). Standard portable oxygen concentrators generate oxygen from room air by use of a sieve bed that removes nitrogen, other gases and impurities from the room air and generates oxygen for patients requiring supplement oxygen.
These sieve beds must be replaced on a schedule in order to maintain the POC's ability to deliver the require % oxygen. The subject device is refurbished with existing Inogen One G3 components with a new sieve bed. The final product is equivalent to the Inogen one G3 replacement sieve bed cartridge.
Principle of Operation:
The composition of air (78% Nitrogen, 21% Oxygen and 1% other gases like Carbon Dioxide, Argon, etc.) clearly shows that air is mainly comprised of two gases: Nitrogen and Oxygen [together 99%]. If Nitrogen is removed from air, the primary gas remaining would be Oxygen with purity of about 90-95%. An Oxygen Concentrator uses this idea with the basic principle of Pressure Swing Adsorption (PSA) to deliver 90-95% pure oxygen. Since the subject device is a refurbished sieve bed utilizing the Inogen One G3 components with the sieve bed replenished.
Indications for Use:
Refurbished Replacement Column (Sieve Bed) are regular replacement parts for Inogen One G3 Oxygen Concentrator.
The Inogen One Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal camula to
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510(k) Summary Page 2 of 4
channel oxygen from the concentrator to the patient. The Inogen One Oxygen Concentrator may be used in a home, institution, vehicles and various mobile environments.
Patient Population:
Patients who are on supplemental oxygen and needs replacement sieve beds.
Environments of use:
Home, institution, vehicles and various mobile environments
Table 1 is a comparison - Subject Device vs. the Predicate, K032818 - Inogen G3 POC. Note that the comparison to the predicate is based upon available technical specifications.
Substantial Equivalence Discussion
The subject device utilizes similar components of the predicate sieve bed and has similar indications, technological characteristics, principles of operation and performance as the predicate Inogen One G3, K032818, replaceable sieve beds. The subject device does not raise different questions of safety and effectiveness compared to the predicate.
Non-clinical Testing
Performance testing demonstrated that the Oxus Refurbished sieve bed met its acceptance criteria. Testing included:
Bench
- . Fill Volume
- Oxygen Purity over time per applicable parts of ISO 80601-2-69:2020 clause 201.12.1.103 ● (Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment) testing was done at intervals up to 8 hours with performance compared to the predicate.
- Leakage
- . Package integrity
Biocompatibility
- ISO 18562-2:2017 Particulate Matter compared with predicate and subject device after 10 ● cleaning / refurbishing cycles
- ISO 18562-3:2017 VOC compared with predicate and subject device after 10 cleaning / ● refurbishing cycles
- Inorganic gases CO, CO2, Ozone ●
- Toxicological Risk Assessment
Substantial Equivalence Conclusion
The Oxus Refurbished sieve bed has similar intended use and indications, technological characteristics, principles of operation and performance as the predicate.
The performance testing supports substantial equivalence to the Inogen One G3 replacement sieve bed cartridges, K032818.
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510(k) Summary Page 3 of 4
Table 1 - Comparison - Subject vs. Predicate
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Oxus Refurbished Sieve Bed | Inogen One G3 – K032818 | ||
| Manufacturer | Oxus | Inogen | |
| Classification | 21 C.F.R. § 868.5440 | ||
| Portable Oxygen Generator Product Code – | |||
| CAW, (Class II) | 21 C.F.R. § 868.5440 | ||
| Portable Oxygen Generator | |||
| Product Code – CAW, (Class II) | Similar | ||
| Subject device is only the | |||
| replaceable sieve bed | |||
| cartridge | |||
| Fundamental | |||
| scientific | |||
| technology | Sieve beds operate as part of the basic principle | ||
| of Pressure Swing Adsorption (PSA) to deliver | |||
| 90-95% pure oxygen. | Sieve beds operate as part of the basic principle of | ||
| Pressure Swing Adsorption (PSA) to deliver 90- | |||
| 95% pure oxygen. | Similar | ||
| Indications for | |||
| Use | Refurbished Replacement Column (Sieve Bed) | ||
| are regular replacement parts for Inogen One G3 | |||
| Oxygen Concentrator. | |||
| The Inogen One Oxygen Concentrator is used on | |||
| a prescriptive basis by patients requiring | |||
| supplemental oxygen. It supplies a high | |||
| concentration of oxygen and is used with a nasal | |||
| cannula to channel oxygen from the concentrator | |||
| to the patient. The Inogen One Oxygen | |||
| Concentrator may be used in a home, institution, | |||
| vehicles and various mobile environments. | |||
| Has replaceable sieve bed cartridges. | The Inogen One Oxygen Concentrator is used on | ||
| a prescriptive basis by patients requiring | |||
| supplemental oxygen. It supplies a high | |||
| concentration of oxygen and is used with a nasal | |||
| cannula to channel oxygen from the concentrator | |||
| to the patient. The Inogen One Oxygen | |||
| Concentrator may be used in a home, | |||
| institution, vehicles and various mobile | |||
| environments. | |||
| Has replaceable sieve bed cartridges | Similar as the subject device | ||
| is only the replaceable sieve | |||
| bed cartridge and not the | |||
| system. | |||
| User Installed | User can order replacements and install | User can order replacements and install | Same |
| Environment of | |||
| Use | Home | Home | Similar |
| Patient | Patients on supplemental oxygen | Patients on supplemental oxygen | Similar |
| Population | |||
| Subject Device | Predicate Device | Comparison | |
| Oxus Refurbished Sieve Bed | Inogen One G3 – K032818 | ||
| Models | High flow rate - 1 to 5 | ||
| Low flow rate - 1 to 4 | High flow rate - 1 to 5 | ||
| Low flow rate - 1 to 4 | Same | ||
| Components of | |||
| Replaceable Sieve | |||
| bed | Recycled Sieve tube, Wave spring, Sieve | ||
| CapNew Plastic diffuser, O-rings, Seal, Zeolite | |||
| Alumina, Label | Sieve tube, Wave spring, Sieve Cap, Plastic | ||
| diffuser, O-rings, Seal, Zeolite, Alumina, Label | The parts are similar and each | ||
| recycled cartridge is tested | |||
| Biocompatibility | Externally Communicating, Tissue | ||
| Permanent (> 30 days) | |||
| ISO 18562-2 - PM 2.5 and 10 microns | |||
| ISO 18562-3 - VOC | |||
| Inorganic - CO, CO2, Ozone | |||
| Toxicological Risk Assessment | Externally Communicating, Tissue | ||
| Permanent (> 30 days) | |||
| Testing not known | Similar patient contact and | ||
| testing to current standards | |||
| Testing performed post- | |||
| recycling vs. predicate | |||
| Performance | |||
| Testing | Oxygen Purity >= 90% Purity at Setting 5 at | ||
| various temperature, humidity and altitude | |||
| conditions | |||
| Bed Leak Rate = 90% Purity at Setting 5 | |||
| Bed Leak Rate not stated | Similar |
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