(179 days)
The Oxygen Concentrators are indicated for provide supplemental oxygen when the patient is away from their primary home oxygen source. The devices are not intended for life support nor do they provide any patient monitoring capabilities.
The Merits Health Products Portable Oxygen Concentrator is the prescription device designed to use in an automobile, with power from the automobile's battery and for use with an AC power supply. It is not for life-supporting nor life-sustaining devices. The devices operate through the use of molecular sieve material that binds with the water and nitrogen in filtered room air to leave a gas that is approximately 90% oxygen when delivered to the patient. The compressor creates a vacuum to draw room air into a holding tank. At the same time, downstream of the compressor, the air from the previous cycle is pressurized into one of the two aluminum welded molecular sieve tanks. As the oxygen is forced out of the end of the tank, it enters a "T" fitting that directs most of the gas to flush the nitrogen out of the second molecular sieve tank into the ambient air. The remaining oxygen is delivered to the patient. On the next cycle, the air is directed into the second molecular sieve tank with the oxygen generated flushing the first tank and continuing the supply to the patient. This repetitive cycle generates the oxygen necessary to flush and prepare the saturated sieve tank while supplying the patient with a continuous flow of high concentration oxygen. This submission covers a model that has 1-liters per minute continuous flow output and 2-6 liters per minute for demand flow which is actuated by breathing and detecting oxygen concentration whenever greater than 85%. An oxygen alarm is built in the oxygen concentrator.
The provided text is a 510(k) summary for Merits Health Products Oxygen Concentrators. This document describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or a detailed study proving the device meets said criteria in a quantifiable manner typical for studies involving AI/ML devices.
The document generally states: "The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device." without elaborating on what those specifications are or what specific tests were performed beyond general performance and design.
Therefore, many of the requested categories cannot be filled from the provided text.
Here's an attempt to extract what information is present and indicate where information is missing:
Acceptance Criteria and Device Performance Study for Merits Health Products Oxygen Concentrator
Based on the provided K053230 510(k) summary, specific acceptance criteria and detailed study results demonstrating the device meets those criteria are not explicitly provided in a quantifiable table format. The document generally states that the device "meets specifications" and is "substantially equivalent to the predicate device."
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (General statements from document) |
|---|---|
| Specific quantifiable criteria for oxygen concentration, flow rates, alarm thresholds not provided. | "provides a continuous flow of high concentration oxygen." "approximately 90% oxygen when delivered to the patient." "1-liters per minute continuous flow output and 2-6 liters per minute for demand flow" "actuated by breathing and detecting oxygen concentration whenever greater than 85%. An oxygen alarm is built in the oxygen concentrator." "The results of the testing confirm that the device meets specifications." |
Missing Information: Comprehensive, quantifiable acceptance criteria (e.g., minimum oxygen purity at specific flow rates, alarm activation thresholds, pressure specifications, battery life, etc.) are not detailed in this summary.
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified. The document refers to "testing" but does not detail the size or nature of the test subjects or samples.
- Data provenance: Not specified. It can be inferred that testing was conducted by Merits Health Products Co., LTD. (Taiwan) but details on the type of data (e.g., patient data, engineering test data) or its origin are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable to this type of device and submission. The device is a hardware oxygen concentrator, not an AI/ML-driven diagnostic or prognostic tool that would typically require expert-established ground truth for a test set. The performance would be measured against engineering specifications and industry standards.
4. Adjudication method for the test set
- Not applicable. This is typically relevant for studies involving human interpretation or AI output review against a gold standard. Device performance for an oxygen concentrator is assessed through engineering and functional testing.
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 is an oxygen concentrator, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a hardware device; there is no "algorithm only" performance to evaluate in this context. The device's function is standalone in its operation to produce oxygen.
7. The type of ground truth used
- Type of ground truth: Implied to be engineering specifications and established performance standards for oxygen concentrators (e.g., oxygen purity measured by analytical equipment, flow rates verified by flow meters). The document indicates "comparison to currently marketed devices" (predicate device: Innosan Travelair "S" Plus Portable Oxygen Concentrator K971947), suggesting the predicate's performance or relevant standards serve as a benchmark.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device that requires ground truth for a training set.
Summary of Study:
The provided document describes a 510(k) submission for an oxygen concentrator. The "study" mentioned is general "testing" to confirm the device meets specifications and is "substantially equivalent" to a predicate device (Innosan Travelair "S" Plus Portable Oxygen Concentrator - K971947). The submission relies on established technologies (molecular sieve material, demand flow delivery systems) and claims that "There are no major technologies differences." The document does not provide a detailed, quantitative study with specific acceptance criteria, sample sizes, or detailed performance metrics. Instead, it makes a high-level assertion of compliance and equivalence.
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"510(k) SUMMARY"
MAY 16 2005
Submitter: 9.1
9.3
9.4
Steve Chao Merits Health Products Co., LTD. 9. Road 36. Taichung Industrial Park Taichung, Taiwan R.O.C. Tel: 886-4-2359-4985 ext. 240 Fax: 886-4-2359-4992 E-mail: stevechao@merits.com.tw
Prepared - March 25, 2005
Trade/Proprietary Name: 9.2
Common/Usual Name:
Classification Name:
Merits Health Products Oxygen Concentrators Oxygen Concentrator Portable Oxygen Generator
A. Introduction: Social Media and Public Relations
Comparison to Currently Marketed Devices 9.5 The modified 1-liter & 2-liter continuous flow/2.5-6liter for demand flow Merits Health Products Portable Oxygen Concentrators are substantially equivalent to the currently marketed Innosan Travelair "S" Plus Portable Oxygen Concentrator (K971947).
છે.દિ Device Description
The Merits Health Products Portable Oxygen Concentrator is the prescription device designed to use in an automobile, with power from the automobile's battery and for use with an AC power supply. It is not for life-supporting nor life-sustaining devices. The devices operate through the use of molecular sieve material that binds with the water and nitrogen in filtered room air to leave a gas that is approximately 90% oxygen when delivered to the patient. The compressor creates a vacuum to draw room air into a holding tank. At the same time, downstream of the compressor, the air from the previous cycle is pressurized into one of the two aluminum welded molecular sieve tanks. As the oxygen is forced out of the end of the tank, it enters a "T" fitting that directs most of the gas to flush the nitrogen out of the second molecular sieve tank into the ambient air. The remaining oxygen is delivered to the patient. On the next cycle, the air is directed into the second molecular sieve tank with the oxygen generated flushing the first tank and continuing the supply to the patient. This repetitive cycle generates the oxygen necessary to flush and prepare the saturated sieve tank while supplying the patient with a continuous flow of high concentration oxygen.
This submission covers a model that has 1-liters per minute continuous flow output and 2-6 liters per minute for demand flow which is actuated by breathing and detecting oxygen concentration whenever greater than 85%. An oxygen alarm is built in the oxygen concentrator.
9.7 Indications for Use
The Portable Oxygen Concentrators are intended to provide supplemental oxygen when the patient is away from their primary home oxygen source. The devices are not intended for life support nor do they provide any patient monitoring capabilities.
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9.8 Technological Characteristics
The oxygen concentrator operates by using molecular sieve material to absorb water and nitrogen from filtered air. The resulting gas has an increased concentration of oxygen. Demand flow delivery systems have been in use on portable oxygen sources for many years. These technologies are well established and have been used in other legally marketed products. There are no major technologies differences.
ਰ 'ਤੇ Performance Data
The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device.
9.10 Conclusion
Based on the design, performance specifications and testing and intended use, the Merits Health Products Oxygen Concentrators are substantially equivalent to the currently marketed device.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing the wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 16 2006
Mr. Steve Chao Merits Health Products Company, Limited 9. Road 36. Taichung Industrial Park Taichung, Taiwan R.O.C.
Re: K053230
Trade/Device Name: Merits Health Products Oxygen Concentrator Regulation Number: 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: March 16, 2006 Received: March 21, 2006
Dear Mr. Chao:
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 such 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 -Mr. Chao
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); 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 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sayite y. Michaud
Chiu Lin, Ph.D. 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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Indications for Use
510(k) File Number:
Indications For Use:
Device Name:
Merits Health Products Oxygen Concentrator
The Oxygen Concentrators are indicated for provide supplemental oxygen when the patient is away from their primary home oxygen source. The devices are not intended for life support nor do they provide any patient monitoring capabilities.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 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)
Mishal Vahdat
v. General Huspital. · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·
§ 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).