(111 days)
The Ox-Sox is designed to fit over and clearly identify "E" Oxygen cylinders, both in healthcare facilities and for home use. The device is for use with gas cylinders containing oxygen.
The Ox-Sox is designed to fit over and clearly identify "E" Oxygen cylinders.
The provided text does not contain information about acceptance criteria, device performance, or any study details that would allow for the construction of such a table or the answering of the subsequent questions. The document is an FDA 510(k) clearance letter for the Ox-Sox device, indicating it is substantially equivalent to legally marketed predicate devices, and outlines its indications for use as a cover to identify "E" Oxygen cylinders. It does not include performance data or study results.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 7 2006
Mr. Erik Stalhandske Patient Safety Innovations, LLP 10051 East Highland Road, Suite 29-202 Howell, Michigan 48843
Re: K062300
Trade/Device Name: Ox-Sox™, Model E Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: ECX Dated: October 24, 2006 Received: October 25, 2006
Dear Mr. Stalhandske:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 ta298. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Stalhandske
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Ox-Sox™ ______________________________________________________________________________________________________________________________________________________________________ Device Name:
Indications for Use: The Ox-Sox is designed to fit over and clearly identify "E" Oxygen cylinders, both in healthcare facilities and for home use. The device is for use with gas cylinders containing oxygen.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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§ 868.2700 Pressure regulator.
(a)
Identification. A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.