The SeQual Model T2000 Series, MESA II Oxygen Concentrator, is intended for the administration of supplemental oxygen up to 10 LPM. The device is not intended for life support nor does it provide any patient monitoring capabilities. The device has no contraindications.
The MESA II Oxygen Concentrator (Model No.: T2000 Series) is intended to provide supplemental oxygen. It is not intended for life supporting, or life sustaining applications nor does it provide any patient monitoring capabilities.

Device Description

The SeQual Model T2000 Series, MESA II Oxygen Concentrator, is a 0.5 to 10.0 Liter per minute (LPM) continuous flow pressure swing adsorption (PSA) type system that produces oxygen.
The SeQual Model T2000 Series, MESA II Oxygen Concentrator, consists of pneumatic and electrical components. The system has inlet filtration, air compressors, heat exchanger, and Synthetic Zeolite molecular sieve beds with a rotary valve, outlet filtration, electronic flow control and audible / visual alarms.

AI/ML Overview

The SeQual MESA II Oxygen Concentrator (Model T2000 Series) undergoes performance testing to confirm its specifications and demonstrate substantial equivalence to predicate devices, as per the ISO 8359 and ASTM 1464 standards. The key performance metric is oxygen concentration, measured at various flow rates.

1. Acceptance Criteria and Reported Device Performance

Device Name	MESA II (10LPM) (Reported Performance)	Acceptance Criteria (Predicate: INTEGRA E-Z (10LPM) / RESPIRONICS M10 Concentrator)
Oxygen Concentration (OC)
8-10 LPM	91 ± 3	91 ± 3 / 92 ± 4
3-7 LPM	94 ± 3	94 ± 3 / 94 ± 2
1-2 LPM	94 ± 3	94 ± 3 / 92 ± 4

Note: The acceptance criteria are based on the performance ranges of the predicate devices. The MESA II's reported performance falls within or matches these established ranges.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample size used for the oxygen concentration testing. However, it indicates compliance with ISO 8359 (Oxygen concentrators for medical use — Safety requirements) and ASTM 1464 (Standard Practice for Oxygen Concentrators for Medical Use). These international standards prescribe methodologies for testing medical devices, which typically involve testing multiple units to ensure reliability and reproducibility.

The data provenance is not explicitly stated as "retrospective" or "prospective." Given that these are performance tests of a manufactured device against established standards, they are inherently prospective in nature, conducted on new or production units of the MESA II Oxygen Concentrator by the manufacturer, SeQual Technologies Co., Ltd. The country of origin for the data generation would be Taiwan (R.O.C.), where the submitter SeQual Technologies Co., Ltd is located.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not applicable. The study described is a performance validation of a physical medical device (oxygen concentrator) against technical standards (ISO 8359 and ASTM 1464) for oxygen output. It does not involve human interpretation of data (e.g., medical images) where expert ground truth would be required. The "ground truth" here is the result of direct physical measurement of oxygen concentration by calibrated instruments.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human reviewers provide subjective assessments that need to be reconciled, such as in clinical trials involving image interpretation. For device performance testing, objective measurements are taken, and results are compared directly to defined specification limits.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for evaluating the impact of AI systems on human performance, particularly in diagnostic tasks. The device in question is an oxygen concentrator, which is a therapeutic device, and its performance is assessed directly through physical measurements, not through human interpretation or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance assessment was done. The "Performance Data" section explicitly states: "Results of the oxygen concentraton testing to ISO 8359 and ASTM 1464 standards confirm the device meets specifications..." This indicates that the device's performance (oxygen concentration output) was measured directly and objectively, without human intervention or interpretation influencing the output, and then compared to the specified criteria. This is a standalone assessment of the device's functional performance.

7. The Type of Ground Truth Used

The ground truth used is objective physical measurement of oxygen concentration. This is established by laboratory testing using calibrated equipment that measures the percentage of oxygen produced by the concentrator at various flow rates. These measurements are then compared against the specified performance ranges defined by the ISO 8359 and ASTM 1464 standards, and critically, against the performance of predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. The MESA II Oxygen Concentrator is a physical medical device that operates based on established engineering principles (Pressure Swing Adsorption). Its design and functionality do not involve machine learning algorithms or AI models that require a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set involved for this device.

Summary

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510(k) Summary

Submitter Information:

K100920

Submitter:

SeQual Technologies Co., Ltd 6F-7, No.136, Sec.3, Ren-ai Rd. 10657, Taipei, Taiwan (R.O.C.)

NOV 2 9 2010

Contact:

Cearo Huang, Director, Engineering & Research Division

Phone: Fax:

886-2-2700-2737 886-2-2707-9253

February 5, 2010 Date of Summary:

Device Name:

Proprietary Name:	MESA II Oxygen Concentrator, Model T2000 Series
Common Name:	Oxygen Concentrator
Classification of Device:	Generator, Oxygen, Portable as per 21 CFR 868.5440

Predicate Device Equivalence:

SeQual Technologies Co., Ltd is claiming substantial equivalence to the following legally marketed predicate devices: K042262 – INTEGRA E-Z Oxygen Concentrators Model 63230M-10

K043006 - Respironics Millennium M10 Oxygen Concentrator

Description of Device:

The SeQual Model T2000 Series, MESA II Oxygen Concentrator, is a 0.5 to 10.0 Liter per minute (LPM) continuous flow pressure swing adsorption (PSA) type system that produces oxygen.

The SeQual Model T2000 Series, MESA II Oxygen Concentrator, consists of pneumatic and electrical components. The system has inlet filtration, air compressors, heat exchanger, and Synthetic Zeolite molecular sieve beds with a rotary valve, outlet filtration, electronic flow control and audible / visual alarms.

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Predicate Product Comparison Table:

Device Name	MESA II (10LPM)	INTEGRA E-Z (10LPM)	RESPIRONICS M10Concentrator
OxygenGeneratingSystem	12-Column PressureSwing Adsorption	12-Column Pressure SwingAdsorption	Time Cycle/Pressure SwingAdsorption
Valve Type	Single Rotary ValveDriven by Gear Motor	Single Rotary Valve Drivenby Gear Motor	Exclusive Rotary ValveSystem
Compressor	Thomas 2660CE48	Thomas 2660CE48	Thomas 2660CE54
Filtration	Glass Microfiber, HEPA,0.3µm at Outle	Glass Microfiber, HEPA,0.3µm at Outlet	Final Bacteria Filter, HEPA
Control andCommunicationSystem	PCBA/MembraneSwitch/RS-232***	PCBA/Membrane Switch	CommunicationPort/Compensated FlowMeter
Equipment Classand Type	Class II / BF	Class II / BF	Class II / B
EMCCompliance	60601-1-2	60601-1-2	60601-1-2
Dimension
Height (mm)	580	660	686
Width (mm)	400	370	483
Depth (mm)	500	500	330
Volume (L)	116.0	122.1	109.3
Weight (kg)	23	26.0	24.0
Oxygen Concentration (OC)*
8-10 LPM	91 ± 3	91 ± 3	92 ± 4
3-7 LPM	94 ± 3	94 ± 3	94 ± 2
1-2 LPM	94 ± 3	94 ± 3	92 ± 4
Operation Condition
Flow Rate (LPM)	0.5~10.0 LPM by 0.5LPM Increment	0.5~10.0 LPM by 0.5 LPMIncrement	1.0~10.0 LPM
Outlet Pressure(psig)	5.0~10.0	7.5~11.0	2.7
Electrical Input	115VAC +10% ~ -15%60Hz	115VAC +10% ~ -15%60Hz ± 3Hz	115VAC +10% ~ -15%60HZ
OxygenConcentrationMonitor	PRO-WAVE ModelGAS400**	PRO-WAVE ModelGAS400**	Oxygen PercentageIndicator, OPI,
Alarms	Power/CompressorMalfunction/AbnormalFlowrate /Low OC/OverTemperature	Power/CompressorMalfunction/AbnormalFlowrate /Low OC/OverTemperature	High/low pressure, lowoxygen, power failure, nooxygen flow

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Manufacturer	SeQual TechnologiesCo., Ltd.	SeQual Technologies Inc.	Respironics Inc.
510(k) No.	N/A	K042262	K043006
Intended Use	The SeQual MESA IIOxygen Concentrator isintended to providesupplemental oxygen.Itis not intended for lifesupporting, or lifesustaining applicationsnor does it provide anypatient monitoringcapabilities.	The SeQual Integra OxygenConcentrator is intended toprovide supplementaloxygen. It is not intendedfor life supporting, or lifesustaining applications nordoes it provide any patientmonitoring capabilities.	The Respironics M10Concentrator is intended toprovide supplementaloxygen to persons requiringlow flow oxygen therapy.The device is not intendedto be life supporting norlife sustaining.
Interface	A standard discrete logicand analog circuitry(PCBA system) is usedfor all monitoring andalarm functions.	A standard discrete logicand analog circuitry (PCBAsystem) is used for allmonitoring and alarmfunctions.	Oxygen PercentageIndicator(OPI) ultronicallymeasures the oxygen outputas purity indication.

*: OC represents oxygen concentration.

**: Where equipped. Measure the output as an oxygen concentration monitor.

***: Where equipped. RS-232 communication channel provide technician detail system information from PCBA.

Intended Use:

Technological Characteristics:

The SeQual Model T2000 Series, MESA II Oxygen Concentrator, operates comparably to the listed predicate devices. The technology employed to generate the oxygen is well established, and therefore, raise no new questions of safety and effectiveness.

Performance Data:

Results of the oxygen concentraton testing to ISO 8359 and ASTM 1464 standards confirm the device meets specifications and is substantially equivalent to the predicate devices.

Conclusion:

Based on the design, performance specifications, tests and intended use, the SeQual Model T2000 Series, MESA II Oxygen Concentrator is substantially equivalent to the currently marketed devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three heads, representing the department's focus on health and human services. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" which is arranged vertically along the left side of the logo.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Cearo Huang Director, Engineering & Research Division SeQual Technologies Company, Limited 6F-7, No.136, Sec.3, Ren-ai Rd.. 10657, Taipei, Taiwan (R.O.C.)

NOV 2 9 2010

Re: K100920 Trade/Device Name: MESA II Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Oxygen Concentrator Regulatory Class: II Product Code: CAW Dated: November 10, 2010 Received: November 12, 2010

Dear Mr. Huang:

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.

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Page 2- Huang

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 device-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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/default.htm 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.

Wh foc

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/1 description: The image shows the text "K100920" above the word "SEQUAL" with a logo to the left of the word. The logo appears to be a stylized image of water. The text is in a simple, sans-serif font and is black and white. The image is likely a logo or branding element for a company or product called "SEQUAL".

Indications for Use

510(k) Number (if known):

NOV 2 9 2010

Device Name: MESA II Oxygen Concentrator Indications For Use:

The MESA II Oxygen Concentrator (Model No.: T2000 Series) is intended to provide supplemental oxygen. It is not intended for life supporting, or life sustaining applications nor does it provide any patient monitoring capabilities.

AND/OR Over-The-Counter Use _ Prescription Use X (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of 1

510(k) Number:

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).