(90 days)
Not Found
Not Found
No
The summary contains no mention of AI, ML, or related concepts, and the device description is not available to infer such capabilities.
No
Explanation: The device is intended for emergency first aid to provide oxygen, which is a supportive measure, not a treatment for a condition or disease.
No
The device is intended to provide oxygen for emergency first aid, which is a therapeutic rather than a diagnostic function.
No
The device is described as a "Home/Commercial Oxygen Unit," which strongly implies a physical hardware device for delivering oxygen, not a software-only application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to provide oxygen for emergency first aid." This describes a device that provides a therapeutic substance (oxygen) directly to a patient, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
The device appears to be a medical device that delivers oxygen, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Home/Commercial Oxygen Unit by system O2™ is intended to provide oxygen for emergency first aid.
The Home/Commercial Oxygen Unit by system O2™ delivers in excess of 5 liters per minute for more than 15 minutes. Because the unit does not yet exceed 6 liters per minute average flow rate, the packaging will include the following statement:
CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a licensed physician.
Product codes
CAW
Device Description
Home/Commercial Oxygen Unit by System 02
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
emergency first aid
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with outstretched arms, resembling a bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 3 1999
Mr. Lester Ford President 0, Marketing Group Inc. 11285 Elkins Rd. Suite H5 Roswell, GA 30076
Re : K991569 Home/Commercial Oxygen Unit By System 02 Trade Name: Requlatory Class: II Product Code: CAW Dated: April 30, 1999 Received: May 5, 1999
Dear Mr. Ford:
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, Druq, 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, labelinq, 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 Existing major regulations affecting your device additional controls. can be found in the Code of Federal Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 requlations.
1
Page 2 - Mr. Lester Ford
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) 594-4586. 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 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,
Thomas J. Callahon
Thomas J. Callahan, Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K99/569
Indications for Use
The Home/Commercial Oxygen Unit by system O2™ is intended to provide oxygen for emergency first aid.
The Home/Commercial Oxygen Unit by system O2™ delivers in excess of 5 liters per minute for more than 15 minutes. Because the unit does not yet exceed 6 liters per minute average flow rate, the packaging will include the following statement:
Federal Law (USA) restricts this device to sale by or on the order of a CAUTION: licensed physician.
fettbrohm
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number
prescription use
✓
OTc