(219 days)
The MESA Oxygen Concentrator (Model No .: 2-6000 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.
The SeQual Model 2-6000 Series, MESA Oxygen Concentrator, is a 0.5 to 5.0 Liter per minute (LPM) continuous flow pressure swing adsorption (PSA) type system that produces oxygen. The SeQual Model 2-6000 Series, MESA 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.
The provided 510(k) summary for the SeQual MESA Oxygen Concentrator describes a medical device, not an AI/ML software. Therefore, the questions related to AI/ML specific criteria like ground truth, experts, adjudication, MRMC studies, and sample sizes for training/test sets are not applicable to this submission.
The acceptance criteria and study described are for a traditional medical device demonstrating substantial equivalence to predicates based on performance specifications.
Here's the information extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Standard/Parameter | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Oxygen Concentration | Meets specifications as per ISO 8359 and ASTM 1464 standards (required for predicate equivalence) | "confirm the device meets specifications" |
| Flow Rate Range | 0.5 to 5.0 Liters per minute (LPM) continuous flow (inherent to device description) | Described as a "0.5 to 5.0 Liter per minute (LPM) continuous flow" system |
| Intended Use | Administration of supplemental oxygen up to 5 LPM; NOT for life support or patient monitoring | Stated as the intended use; no contraindications |
| Technological Characteristics | Comparable to predicate devices, no new safety/effectiveness questions | "operates comparably to the listed predicate devices" |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for performance testing. Medical device testing for physical devices typically involves engineering verification and validation, which might use a small number of units for testing to standards.
- Data Provenance: Not applicable in the context of clinical data for AI/ML. The device itself is manufactured by SeQual Technologies Co., Ltd in Taipei, Taiwan. The performance testing refers to international and US standards (ISO 8359 and ASTM 1464).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is a physical medical device, not an AI/ML software requiring expert-established ground truth. Performance is assessed against engineering specifications and industry standards.
4. Adjudication Method for the Test Set
- Not Applicable. As this is a physical device, there is no "adjudication" of expert opinions. Performance is measured objectively against defined technical standards.
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
- Not Applicable. This device is a physical oxygen concentrator, not an AI/ML software designed to assist human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This device is a physical medical device; there is no algorithm in the AI/ML sense to test in "standalone" mode.
7. The Type of Ground Truth Used
- Not Applicable. For this physical device, "ground truth" refers to objective measurements of oxygen concentration and flow rate, validated against established industry standards (ISO 8359 and ASTM 1464) and the device's own specifications. It is not an expert consensus, pathology, or outcomes data in the context of an AI/ML diagnostic device.
8. The Sample Size for the Training Set
- Not Applicable. This is a physical device, not an AI/ML model that is "trained." The "design" and "performance specifications" are developed through engineering and manufacturing processes, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no AI/ML training set, there is no corresponding ground truth establishment methodology.
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109154
510(k) Summary
Submitter Information:
| Submitter: | SeQual Technologies Co., Ltd6F-7, No.136, Sec.3, Ren-ai Rd.10657, Taipei, Taiwan (R.O.C.) |
|---|---|
| Contact: | Cearo Huang, Director, Engineering & Research Division |
| Phone: | 886-2-2700-2737 |
| Fax: | 886-2-2707-9253 |
| Date of Summary: | January 5, 2009 |
| Device Name: | |
| Proprietary Name: | MESA Oxygen Concentrator, Model 2-6000 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: K003472 - Integra Oxygen Concentrators Model 6400-OM K071397 – DEVILBISS 5 Liter Compact Oxygen Concentrator
Description of Device:
The SeQual Model 2-6000 Series, MESA Oxygen Concentrator, is a 0.5 to 5.0 Liter per minute (LPM) continuous flow pressure swing adsorption (PSA) type system that produces oxygen.
The SeQual Model 2-6000 Series, MESA Oxygen Concentrator, consists of pneumatic and electrical components. The system has inlet filtration, air compressors, heat exchanger, and
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Synthetic Zeolite molecular sieve beds with a rotary valve, outlet filtration, electronic flow control and audible / visual alarms.
Intended Use:
The SeQual Model 2-6000 Series, MESA Oxygen Concentrator, is intended for the administration of supplemental oxygen up to 5 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 2-6000 Series, MESA 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 concentration 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 2-6000 Series, MESA Oxygen Concentrator is substantially equivalent to the currently marketed devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Mr. Cearo Huang Director, Engineering & Research SeQual Technologies Company, Limited 6F-7, No. 136, Sec.3, Ren-ai Rd. Taipei CHINA (TAIWAN) 10657
DEC 3 1 2009
Re: K091541
Trade/Device Name: MESA Oxygen Concentrator, Model 2-6000 Series Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: December 17, 2009 Received: December 23, 2009
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.
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. Register. Begister
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Page 2 - Mr. 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours, i
h for
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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SEQUAL
Indications for Use
510(k) Number (if known): Device Name: MESA Oxygen Concentrator Indications For Use:
The MESA Oxygen Concentrator (Model No .: 2-6000 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.
Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091541
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§ 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).