(89 days)
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Not Found
No
The document describes a portable oxygen generator and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes.
The device is intended for the palliative or therapeutic treatment of various respiratory diseases, indicating a therapeutic purpose.
No
Explanation: The device is an oxygen generator, intended for providing supplemental oxygen as a treatment. While it mentions that a physician prescribes it after clinical evaluation or oximetry screening tests, the device itself does not perform any diagnostic function. Its purpose is therapeutic, not diagnostic.
No
The device description explicitly states "OxyPure Portable Oxygen Generator," indicating a hardware device that generates oxygen. The intended use also describes the use of oxygen generated by this device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as generating supplemental oxygen for therapeutic treatment of respiratory diseases. This is a therapeutic device, not a diagnostic one.
- Mechanism: The device generates oxygen, which is a physical process delivered to the patient. IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- No mention of specimen analysis: The description does not mention any analysis of biological specimens.
Therefore, the OxyPure Portable Oxygen Generator is a medical device used for treatment, not an IVD.
N/A
Intended Use / 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.
Product codes
73 CAW
Device Description
OxyPure Portable Oxyqen Generator
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Geriatic, pediatric, or any other patient unable to communicate discomfort while using this machine may require additional monitoring.
Intended User / Care Setting
home use, licensed physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three overlapping profiles, symbolizing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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.
1
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)