(121 days)
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No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the device's function of generating oxygen.
Yes
The device is intended for "emergency first aid administration" of oxygen, which is a therapeutic intervention.
No
The device is intended to generate oxygen for emergency first aid administration, which is a therapeutic or supportive function, not a diagnostic one.
No
The device description explicitly states "emOx Portable Oxygen Generator," which implies a physical hardware component for generating oxygen. The summary does not mention any software-only functionality.
Based on the provided information, the emOx device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "generate oxygen... for emergency first aid administration." This describes a device used directly on a patient for therapeutic or supportive purposes, not for testing samples (like blood, urine, etc.) outside the body to diagnose or monitor a condition.
- Device Description: The description "Portable Oxygen Generator" further supports its function as a device for delivering oxygen to a patient.
- Lack of IVD Characteristics: The provided information does not mention any activities typical of IVDs, such as:
- Analyzing biological samples.
- Providing diagnostic information based on sample analysis.
- Using reagents or test kits.
Therefore, the emOx device, as described, falls under the category of a medical device used for direct patient care, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The emOx device is intended to generate oxygen of greater than 99.7% purity for emergency first aid administration.
Product codes
73 CAW
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
emergency first aid administration
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
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Key Metrics
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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 is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is the department's emblem, which consists of a stylized caduceus-like symbol with three wavy lines representing the human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 1999
Mr. Ivor Duncan EmOx 911 cc P.O. Box 79 Somerset West South Africa 7129
Re: K984081 EmOx Regulatory Class: II (two) Product Code: 73 CAW Dated: January 31, 1999 Received: March 12, 1999
Dear Mr. Duncan:
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 requlations affecting your device can be found in the Code of Federal Requlations, 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 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 In addition, FDA may publish further announcements regulatory action. 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 - Mr. Ivor Duncan
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) 594-4648. 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): 984081
Device Name: emOx Portable Oxygen Generator
Indications for use: The emOx device is intended to generate oxygen of greater than 99.7% purity for emergency first aid administration.
Atl A. Ciall.
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use_ (Per 21 CFR 801.109
OR
Over the counter Use
AW.