(42 days)
The Oxygen Concentrators are 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 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 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. Options will include an Oxygen alarm and a pediatric flowmeter
The provided text is a 510(k) summary for the Merits Health Products Oxygen Concentrator. It describes the device and claims substantial equivalence to a predicate device. However, it does not contain details about specific acceptance criteria, a study proving the device meets those criteria, or information related to AI/algorithm performance analysis.
Based on the provided text, here's what can be extracted:
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A table of acceptance criteria and the reported device performance
The document states: "The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device." However, it does not provide a table of the specific specifications (acceptance criteria) or the detailed performance results. It generally claims equivalence to the predicate device (K011884). -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the provided text. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not present in the provided text. The device is an oxygen concentrator, not an imaging or diagnostic AI device that would typically involve expert ground truth for a test set in the same way. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the provided text. It is not relevant for this type of device submission. -
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
This information is not present in the provided text. This is a medical device (oxygen concentrator), not an AI-assisted diagnostic tool, so an MRMC study with human readers and AI assistance would not be applicable. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not present in the provided text. This is an oxygen concentrator, not an algorithm, so "standalone algorithm performance" is not applicable. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present in the provided text. For an oxygen concentrator, "ground truth" would likely relate to objective measurements of oxygen concentration, flow rates, and safety parameters, rather than expert consensus on diagnostic images or pathology. -
The sample size for the training set
This information is not present in the provided text. This device is not an AI/ML algorithm that requires a training set in the conventional sense. -
How the ground truth for the training set was established
This information is not present in the provided text, as it's not applicable to this type of device.
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FEB 1 1 2002
SUMMARY OF SAFETY AND EFFECTIVENESS 9.0
"510(k) SUMMARY"
Submitter: 9.1
0.3
P/L Biomedical 7690 Cameron Circle Fort Myers, FL 33912 Tel - 941-768-1118 Fax - 815-550-0162 Contact - Lee Leichter Prepared - December 12, 2001
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Trade/Proprietary Name: 9.2
Merits Health Products Oxygen Concentrators Oxygen Concentrator Portable Oxygen Generator -
Classification Name: 9.4
Common/Usual Name:
Comparison to Currently Marketed Devices 9.5 The modified 3-liter Merits Heatth Products Oxygen Concentrators are substantially equivalent to the currently marketed 5-liter Merits Health Products Oxygen Concentrators (K011884)
Device Description તે છે. દિ
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 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 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. 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 capabilities.
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SUMMARY OF SAFETY AND EFFECTIVENESS (Con't) 9.0
Technological Characteristics ರಿ. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8. 8
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. This technology is well established and has been used in other legally marketed products. There are no major technological differences.
9.9 Performance Data
The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device.
Conclusion 9.10
Based on the design, performance specifications and intended use, the Oxygen Concentrators are substantially equivalent to the currently marketed device.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized abstract design resembling a bird or a human figure in motion. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the central design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2002
Mr. Lee Leichter Merits Health Products Co., Ltd. c/o P/L Biomedical 7690 Cameron Circle Fort Myers, FL 33912
Re: K014301
Oxygen Concentrators Regulation Number: 868.5440 Regulation Name: Generator, Oxygen, Portable Regulatory Class: II (two) Product Code: 73 CAW Dated: January 28, 2002 Received: January 29, 2002
Dear Mr. Leichter:
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. Lee Leichter
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 or uny 1 odetar bather 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 Of It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the qualisms control provisions (Sections 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) I mo lotter watification. 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oivision 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/dsma/dsmamain.html
Sincerely yours,
L. Dake Toth
Tram D. Zuckerman, M.D. Acting 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
1-014301 710(k) File Number: Merits Health Products Oxygen Concentrator Device Name: The Oxygen Concentrators are indicated for the delivery of Indications For Use: 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)
Division of Cardiovascular & Respiratory Devices
510(k) Number K01430
escription 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).