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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device: a Refurbished Replacement Column (Sieve Bed) for the Inogen One G3 Oxygen Concentrator. However, the document does not contain information related to an AI/ML-enabled device or a study involving human readers or expert consensus for ground truth establishment for such an AI/ML device.

The document outlines acceptance criteria and performance testing for a refurbished physical component (sieve bed), not an AI model. Therefore, I cannot extract the information required for the questions regarding AI/ML device performance, ground truth, expert adjudication, or MRMC studies.

Here's an attempt to answer the questions based only on the information present in the provided document, highlighting where the information is not applicable (N/A) because it pertains to an AI/ML study, not a physical device performance study.

1. A table of acceptance criteria and the reported device performance

The document lists performance tests and acceptance criteria in a descriptive manner, not in a formal table with reported numeric results for each criterion. It generally states that the device "met its acceptance criteria" and provides some of the criteria.

Acceptance Criteria (Bench Testing)	Reported Device Performance (Summary)
Fill Volume	Met acceptance criteria
Oxygen Purity over time per applicable parts of ISO 80601-2-69:2020 clause 201.12.1.103 at intervals up to 8 hours (compared to predicate)	Oxygen Purity >= 90% Purity at Setting 5 at various temperature, humidity, and altitude conditions. Performance compared to predicate. Met acceptance criteria.
Leakage	Bed Leak Rate < 0.5 lpm at ~ 28.5 PSIG
Package integrity	Met acceptance criteria
Biocompatibility (as per ISO 18562-2:2017 Particulate Matter, ISO 18562-3:2017 VOC, Inorganic gases CO, CO2, Ozone, Toxicological Risk Assessment) compared with predicate and subject device after 10 cleaning/refurbishing cycles	Testing performed post-recycling vs. predicate. Met acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size for the "test set" (which refers to physical units of the sieve bed for testing). It also does not mention data provenance (country, retrospective/prospective), as this is not typical for testing of a physical medical device component like a sieve bed. The tests appear to be bench tests conducted on the physical device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A. This pertains to AI/ML model validation, where human experts establish ground truth for AI model performance evaluation. For a physical device component, "ground truth" is established by direct physical or chemical measurements and adherence to engineering specifications and international standards (e.g., ISO). No human experts were involved in "establishing ground truth" in the context of an AI model's output.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. Adjudication methods like 2+1 or 3+1 are used in AI/ML validation studies to resolve disagreements among human readers or experts when establishing ground truth. This is not relevant for the bench testing of a physical device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. No MRMC study was conducted. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a refurbished oxygen concentrator component.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. There is no AI algorithm involved in this device. Performance testing was conducted on the physical sieve bed component in isolation within an oxygen concentrator system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this physical device, the "ground truth" is based on:

Physical/Chemical measurements and adherence to specifications: e.g., fill volume, leakage rates, oxygen purity percentage.
Compliance with international standards: e.g., ISO 80601-2-69:2020 for oxygen purity, ISO 18562 for biocompatibility (particulate matter, VOCs, inorganic gases).
Comparison to predicate device performance: The refurbished sieve bed's performance was compared directly to that of the original Inogen One G3 replacement sieve bed cartridge.

8. The sample size for the training set

N/A. There is no AI/ML model, and therefore no training set.

9. How the ground truth for the training set was established

N/A. There is no AI/ML model, and therefore no training set or ground truth establishment process for a training set.

Summary

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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

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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

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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.

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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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 LenarcicQuality & Regulatory ManagerTel - 248-475-0925
Submission Correspondent:	Paul DrydenProMedic, LLC
Proprietary or Trade Name:	Refurbished Replacement Column (Sieve Bed)
Common/Usual Name:	Replacement Sieve Bed for Portable Oxygen Concentrator
Classification Name:CFRProduct Code	Generator, Oxygen, PortableCFR 868.5440CAW
Predicate Device:Classification Name:CFRProduct Code	K032818, Inogen One G3 Portable Oxygen ConcentratorGenerator, Oxygen, PortableCFR 868.5440CAW

Device Description:

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. § 868.5440Portable Oxygen Generator Product Code –CAW, (Class II)	21 C.F.R. § 868.5440Portable Oxygen GeneratorProduct Code – CAW, (Class II)	SimilarSubject device is only thereplaceable sieve bedcartridge
Fundamentalscientifictechnology	Sieve beds operate as part of the basic principleof Pressure Swing Adsorption (PSA) to deliver90-95% pure oxygen.	Sieve beds operate as part of the basic principle ofPressure Swing Adsorption (PSA) to deliver 90-95% pure oxygen.	Similar
Indications forUse	Refurbished Replacement Column (Sieve Bed)are regular replacement parts for Inogen One G3Oxygen Concentrator.The Inogen One Oxygen Concentrator is used ona prescriptive basis by patients requiringsupplemental oxygen. It supplies a highconcentration of oxygen and is used with a nasalcannula to channel oxygen from the concentratorto the patient. The Inogen One OxygenConcentrator may be used in a home, institution,vehicles and various mobile environments.Has replaceable sieve bed cartridges.	The Inogen One Oxygen Concentrator is used ona prescriptive basis by patients requiringsupplemental oxygen. It supplies a highconcentration of oxygen and is used with a nasalcannula to channel oxygen from the concentratorto the patient. The Inogen One OxygenConcentrator may be used in a home,institution, vehicles and various mobileenvironments.Has replaceable sieve bed cartridges	Similar as the subject deviceis only the replaceable sievebed cartridge and not thesystem.
User Installed	User can order replacements and install	User can order replacements and install	Same
Environment ofUse	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 5Low flow rate - 1 to 4	High flow rate - 1 to 5Low flow rate - 1 to 4	Same
Components ofReplaceable Sievebed	Recycled Sieve tube, Wave spring, SieveCapNew Plastic diffuser, O-rings, Seal, ZeoliteAlumina, Label	Sieve tube, Wave spring, Sieve Cap, Plasticdiffuser, O-rings, Seal, Zeolite, Alumina, Label	The parts are similar and eachrecycled cartridge is tested
Biocompatibility	Externally Communicating, TissuePermanent (> 30 days)ISO 18562-2 - PM 2.5 and 10 micronsISO 18562-3 - VOCInorganic - CO, CO2, OzoneToxicological Risk Assessment	Externally Communicating, TissuePermanent (> 30 days)Testing not known	Similar patient contact andtesting to current standardsTesting performed post-recycling vs. predicate
PerformanceTesting	Oxygen Purity >= 90% Purity at Setting 5 atvarious temperature, humidity and altitudeconditionsBed Leak Rate < 0.5 lpm at ~ 28.5 PSIGPackaging integrityLabeling	Oxygen Purity >= 90% Purity at Setting 5Bed Leak Rate not stated	Similar

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K211056

510(k) Summary Page 4 of 4

Regulation Number and Section

§ 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).