Who is the manufacturer of MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES?

Sequal Technologies Co., Ltd. filed the 510(k) submission for MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES (K100920).

What is the FDA product code for MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES?

CAW. It is classified under 21 CFR 868.5440 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES?

510(k) clearance (submission type: Abbreviated).

What are the predicate devices for MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES?

INTEGRA E-Z Oxygen Concentrators Model 63230M-10 (K042262); Respironics Millennium M10 Oxygen Concentrator (K043006).

Who can help prepare an FDA 510(k) submission like MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES

K100920 · Sequal Technologies Co., Ltd. · CAW · Nov 29, 2010 · Anesthesiology

Device Facts

Record ID	K100920
Device Name	MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES
Applicant	Sequal Technologies Co., Ltd.
Product Code	CAW · Anesthesiology
Decision Date	Nov 29, 2010
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 868.5440
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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.

Device Story

MESA II Oxygen Concentrator (T2000 Series) is a 0.5–10.0 LPM continuous flow pressure swing adsorption (PSA) system. Inputs: ambient air. Transformation: 12-column PSA process using synthetic zeolite molecular sieve beds; rotary valve driven by gear motor; air compressor; heat exchanger. Outputs: concentrated oxygen. Used in clinical or home settings; operated by patients or caregivers. System includes inlet/outlet filtration (HEPA, glass microfiber), electronic flow control, and audible/visual alarms for power, compressor malfunction, abnormal flow, low oxygen concentration, and over-temperature. Healthcare providers use output to deliver supplemental oxygen therapy. Benefits: provides consistent oxygen supply for patients with respiratory needs.

Clinical Evidence

Bench testing only. Performance testing conducted per ISO 8359 and ASTM 1464 standards to verify oxygen concentration output across flow rates (0.5–10 LPM) and alarm functionality. No clinical data presented.

Technological Characteristics

12-column pressure swing adsorption (PSA) system. Materials: synthetic zeolite molecular sieve beds, glass microfiber/HEPA filters. Energy: 115VAC 60Hz. Dimensions: 580x400x500mm. Connectivity: RS-232 port for technician diagnostics. Control: PCBA with discrete logic and analog circuitry. Sterilization: N/A (not sterile).

Indications for Use

Indicated for patients requiring supplemental oxygen therapy up to 10 LPM. Not for life-supporting or life-sustaining applications. No patient monitoring capabilities. No contraindications.

Regulatory Classification

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).

Predicate Devices

INTEGRA E-Z Oxygen Concentrators Model 63230M-10 (K042262)
Respironics Millennium M10 Oxygen Concentrator (K043006)

Related Devices

K091541 — MESA OXYGEN CONCENTRATOR, MODEL 2-6000 SERIES · Sequal Technologies Co., Ltd. · Dec 31, 2009
K132489 — INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME) · Inogen, Inc. · Jun 20, 2014
K042262 — INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10 · Sequal Technologies, Inc. · Sep 10, 2004
K013931 — OMNI OXYGEN SYSTEM, MODEL 1000 · Sequal Technologies, Inc. · Mar 27, 2002
K222920 — Oxygen concentrator · Zhengzhou Olive Electronic Technology Co., Ltd. · Jul 20, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ # 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. {1}------------------------------------------------ # Predicate Product Comparison Table: | Device Name | MESA II (10LPM) | INTEGRA E-Z (10LPM) | RESPIRONICS M10 Concentrator | |----------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|--------------------------------------------------------------------| | Oxygen Generating System | 12-Column Pressure Swing Adsorption | 12-Column Pressure Swing Adsorption | Time Cycle/Pressure Swing Adsorption | | Valve Type | Single Rotary Valve Driven by Gear Motor | Single Rotary Valve Driven by Gear Motor | Exclusive Rotary Valve System | | 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 and Communication System | PCBA/Membrane Switch/RS-232*** | PCBA/Membrane Switch | Communication Port/Compensated Flow Meter | | Equipment Class and Type | Class II / BF | Class II / BF | Class II / B | | EMC Compliance | 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 0.5 LPM Increment | 0.5~10.0 LPM by 0.5 LPM Increment | 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 | | Oxygen Concentration Monitor | PRO-WAVE Model GAS400** | PRO-WAVE Model GAS400** | Oxygen Percentage Indicator, OPI, | | Alarms | Power/Compressor Malfunction/Abnormal Flowrate /Low OC/Over Temperature | Power/Compressor Malfunction/Abnormal Flowrate /Low OC/Over Temperature | High/low pressure, low oxygen, power failure, no oxygen flow | {2}------------------------------------------------ | Manufacturer | SeQual Technologies Co., Ltd. | SeQual Technologies Inc. | Respironics Inc. | |--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) No. | N/A | K042262 | K043006 | | Intended Use | The SeQual MESA II Oxygen Concentrator 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. | The SeQual Integra Oxygen Concentrator 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. | The Respironics M10 Concentrator is intended to provide supplemental oxygen to persons requiring low flow oxygen therapy. The device is not intended to be life supporting nor life sustaining. | | Interface | A standard discrete logic and analog circuitry (PCBA system) is used for all monitoring and alarm functions. | A standard discrete logic and analog circuitry (PCBA system) is used for all monitoring and alarm functions. | Oxygen Percentage Indicator(OPI) ultronically measures the oxygen output as 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: 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. ### 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. {3}------------------------------------------------ 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. {4}------------------------------------------------ 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 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for TATUNG. The logo consists of a stylized symbol on the left and the word "TATUNG" in bold, sans-serif letters on the right. The symbol appears to be a stylized representation of a water droplet or flame, with concentric circles forming its shape. The text is in all caps and has a slightly distressed or textured appearance. 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: