(89 days)
Oxygen generated by a portable oxygen generator is supplemental and should not be considered life-supporting. Supplemental oxygen is non-addictive but should only be used at the specific liter flow and number of hours prescribed by your physician.
This device is intended for home use, in patients requiring supplemental oxygen for the palliative or therapeutic treatment of a variety of respiratory diseases, including emphysema, chronic obstructive pulmonary disease, cardiopulmonary insufficiency and bronchiectasis.
Federal law restricts this device to sale by or on the order of a licensed physician, and is to be prescribed only after appropriate clinical evaluation or oximetry screening tests have been performed on the patient by the prescribing physician.
This unit is not to be used for or with any life-supporting applications. Geriatic, pediatric, or any other patient unable to communicate discomfort while using this machine may require additional monitoring. In the event of an alarm or if you are experiencing any signs of patient discomfort, consult your physician immediately.
OxyPure Portable Oxygen Generator
The provided document is a 510(k) clearance letter from the FDA for a medical device called the "OxyPure Portable Oxygen Generator." This document does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies as requested in the prompt.
The letter explicitly states that the device is determined to be "substantially equivalent" to predicate devices marketed before specific dates. This type of regulatory clearance typically relies on demonstrating equivalence to existing legally marketed devices, rather than comprehensive studies with detailed performance metrics and ground truth establishment as would be required for novel or high-risk devices.
Therefore, I cannot fulfill your request using the provided information. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed analysis of performance metrics from a specific study.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 1997
Blake M. Paterson, M.D. Arbor Research Corporation 806 Airport Boulevard Ann Arbor, Michigan 48108
Re : K971129 OxyPure Portable Oxyqen Generator Regulatory Class: II (two) Product Code: 73 CAW Dated: March 25, 1997 Received: March 27, 1997
Dear Dr. Paterson:
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 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 aqainst 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 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.
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Page 2 - Blake M. Paterson, M.D.
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 leqally 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) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Cal ahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510 (k) Number: K971129
OxyPure Portable Oxygen Generator Device Name:
Indications For Use:
Oxygen generated by a portable oxygen generator is supplemental and should not be considered life-supporting. Supplemental oxygen is non-addictive but should only be used at the specific liter flow and number of hours prescribed by your physician.
This device is intended for home use, in patients requiring supplemental oxygen for the palliative or therapeutic treatment of a variety of respiratory diseases, including emphysema, chronic obstructive pulmonary disease, cardiopulmonary insufficiency and bronchiectasis.
Federal law restricts this device to sale by or on the order of a licensed physician, and is to be prescribed only after appropriate clinical evaluation or oximetry screening tests have been performed on the patient by the prescribing physician.
This unit is not to be used for or with any life-supporting applications. Geriatic, pediatric, or any other patient unable to communicate discomfort while using this machine may require additional monitoring. In the event of an alarm or if you are experiencing any signs of patient discomfort, consult your physician immediately.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Richard N. Phillips
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K971129 510(k) Number _
Prescription Use L (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
§ 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).