(241 days)
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No
The document describes a standard oxygen concentrator with pneumatic and electrical components, and there is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as an "Oxygen Concentrator" intended for "administration of supplemental oxygen" which is a therapeutic function.
No
Explanation: The "Intended Use / Indications for Use" section states that the device is "not intended for life support nor does it provide any patient monitoring capabilities." Diagnostic devices typically involve monitoring or identifying a medical condition. This device's sole purpose is to administer supplemental oxygen, which is a treatment, not a diagnostic function.
No
The device description explicitly states it consists of pneumatic and electrical components, including compressors, heat exchangers, and sieve beds, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "administration of supplemental oxygen." This is a therapeutic use, delivering a substance to the patient's body.
- Device Description: The description details a system that produces oxygen from air using physical processes (pressure swing adsorption). It does not involve analyzing biological samples (blood, urine, tissue, etc.) which is the hallmark of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on biological specimens.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This oxygen concentrator does not perform any of these functions on biological samples.
N/A
Intended Use / Indications for 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.
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.
Product codes
CAW
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.
Mentions image processing
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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
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
510(k) Summary
Submitter Information:
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 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) | 0.510.0 LPM by 0.510.0 LPM by 0.5 LPM
LPM Increment | 0.5
Increment | 1.010.0 LPM |10.0 | 7.5~11.0 | 2.7 |
| Outlet Pressure
(psig) | 5.0
| 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 |
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| 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.
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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.
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
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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
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510(k) Number: