(77 days)
The Oxygen Concentrator is indicated for the delivery of supplemental oxygen in the home or medical institutions. The device is not intended for life support nor does it provide any patient monitoring capabilities.
The Merits Health Products Oxygen Concentrators are prescription devices designed to provide an inexpensive supply of supplemental oxygen in a home or institution without a continuous source of purified oxygen. They are not lifesupporting 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 93% 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. Other options will include an Oxygen alarm and a pediatric flowmeter.
The provided text is a 510(k) summary for an oxygen concentrator, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices and does not describe acceptance criteria, a detailed study proving performance, or specific AI/algorithm performance metrics. The information requested falls outside the scope of this particular submission for a Class II medical device like an oxygen concentrator, which typically relies on established performance standards for its product category rather than complex efficacy studies with AI components.
Therefore, most of the requested information cannot be extracted from the given text.
Here's a breakdown of what can be inferred or directly stated:
1. Table of acceptance criteria and the reported device performance
The document states: "The Device meets the requirements of the FDA recognized standard of the first The Device meets the requirements of the PDF roosgnitations of the predicate devices."
This implies that the acceptance criteria are based on the FDA-recognized standards applicable to oxygen concentrators and that the device's performance met these standards. However, the specific quantitative criteria (e.g., oxygen purity levels, flow rates) and the exact reported performance values are not detailed in this summary. It only indicates compliance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/Not provided. This submission is for a physical medical device (oxygen concentrator), not a data-driven AI algorithm. There is no "test set" in the context of diagnostic performance. Performance tests would relate to the physical operation of the concentrator itself (e.g., oxygen output, reliability).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. This information is relevant for studies validating diagnostic algorithms, not for the regulatory submission of an oxygen concentrator.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. Similar to point 3, this is for diagnostic studies.
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/Not provided. The device is an oxygen concentrator, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable/Not provided. The device is an oxygen concentrator, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable/Not provided. For an oxygen concentrator, performance "ground truth" would be objective measurements like oxygen concentration, flow rate, noise levels, and durability, measured against established engineering and medical device standards. These specific measurements are not presented in this summary.
8. The sample size for the training set
Not applicable/Not provided. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable/Not provided. There is no "training set" as this is not an AI/machine learning device.
In summary, the provided document is a 510(k) Pre-Market Notification for an oxygen concentrator. Its purpose is to demonstrate "substantial equivalence" to other legally marketed devices, primarily by showing that it has the same intended use, technological characteristics, and performs according to established FDA-recognized standards for its device class. It does not contain the detailed study results, acceptance criteria, or AI-specific information requested, as these are not typically part of a 510(k) submission for this type of device.
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SUMMARY OF SAFETY AND EFFECTIVENESS 9.0
"510(k) SUMMARY"
9.1 Submitter:
P/L Biomedical 7690 Cameron Circle Fort Mvers, FL 33912 Tel - 941-768-1118 Fax - 815-550-0162 Contact - Lee Leichter Prepared - August 7, 2001
| 9.2 | Trade/Proprietary Name: | Merits Health Products OxygenConcentrators |
|---|---|---|
| 9.3 | Common/Usual Name: | Oxygen Concentrator |
| 9.4 | Classification Name: | Portable Oxygen Generator |
Comparison to Currently Marketed Devices 9.5
The Merits Health Products Oxygen Concentrators are substantially equivalent to the OxLife Concentrators (K955549 and K971964), AirSep NewLife Oxygen Concentrators (Last Submission - K960309) and Invacare Oxygen Concentrators (K904087).
9.6 Device Description
The Merits Health Products Oxygen Concentrators are prescription devices designed to provide an inexpensive supply of supplemental oxygen in a home or institution without a continuous source of purified oxygen. They are not lifesupporting 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 93% 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. Other options will include an Oxygen alarm and a pediatric flowmeter.
Indications for Use 9.7
The oxygen concentrators are intended to provide supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring
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capabilities.
Technological Characteristics ರಿ.8
9.6 The Uxygen concentrator operation by assisting gas has an increased water and "httpgen from lifters and "The recularly of the recent in the been used in concentration of oxygen. "This toonnelogy to major technological differences.
Performance Data 9.9
9.9 Performance Data
The Device meets the requirements of the FDA recognized standard of the first The Device meets the requirements of the PDF roosgnitations of the predicate devices.
Conclusion ರಿ.9
9.9 - Conclusion
Based on the design, performance specifications and testing and intended use, the Based on the design, portomianse openies.
Oxygen Concentrators are substantially equivalent to the currently marketed devices.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 8 2001
Mr. Lee Leichter Merits Health Products Co., Ltd. c/o P/L Biomedical 7690 Cameron Circle Fort Myers, FL 33912
Re: K011844
Merits Health Products Oxygen Concentrators Regulation Number: 868.5440 Regulatory Class: II (two) Product Code: 73 CAW Dated: June 4, 2001 Received: June 12, 2001
Dear Mr. Leichter:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this
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Page 2 - Mr. Lee Leichter
response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
James E. Dillard III
Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) File Number:
KO11844
Merits Health Products Oxygen Concentrator
Indications For Use:
Device Name:
The Oxygen Concentrator is indicated for the delivery of supplemental oxygen in the home or medical institutions. The device is not intended for life support nor does it provide any patient monitoring capabilities.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dell
Division of Cardiovascular & Respiratory Devices
510(k) Number K11844
Prescription Use
(Per 21 CFR 801.19)
OR
Over-The-Counter Use
§ 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).