(121 days)
The emOx device is intended to generate oxygen of greater than 99.7% purity for emergency first aid administration.
emOx Portable Oxygen Generator
The provided document is a 510(k) clearance letter from the FDA for a device called "emOx Portable Oxygen Generator" (K984081). It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed information requested regarding acceptance criteria, study data, sample sizes, expert qualifications, or ground truth establishment.
A 510(k) clearance letter typically references that such information was provided by the manufacturer in their submission, but it does not reproduce the full study report or acceptance criteria within the letter itself. The letter focuses on the FDA's determination of substantial equivalence based on the submitted data.
Therefore, I cannot fulfill your request with the provided text. The requested information about acceptance criteria, study details, sample sizes, and ground truth would be found in the original 510(k) submission documentation, which is not included in this letter.
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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
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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.
§ 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).