Topical oxygen chambers for extremities (TOCEs) would be reclassified as Class II devices under a draft "special control guidance" issued by the FDA April 6. A TOCE is defined as "a device that is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers such as bedsores." The device does not include full-body hyperbaric chambers.
The guidance explains that the "FDA believes that special controls, when combined with the general controls, will be sufficient to provide reasonable assurance of the safety and effectiveness of the TOCE." The specific health risks manufacturers should address, according to the draft, are: infection, to be mitigated by sterility, clinical studies and labeling; fire and explosion, to be mitigated by fire and explosion controls and labeling; local tissue damage, to be mitigated by oxygen pressure control and labeling; adverse tissue reaction, to be dealt with by biocompatibility measures; and electrical shock, to be mitigated by electrical safety testing and labeling.
Addressing these concerns through special controls and combining them with general controls will help a manufacturer receive "a timely 510(k) review" from the FDA, the document notes.
An abbreviated 510(k) submission should contain a description of the device, its intended use and design requirements, identification of the risk analysis method, a discussion of the device characteristics, performance aspects, and a declaration of conformity to any standards the manufacturer relied on in making the TOCE or that will be applied standards testing will be done before the product is marketed.
For more information, access www.fda.gov/cdrh/ode/guidance/1582.html (http://www.fda.gov/cdrh/ode/guidance/1582.html). ()a href="http://www.fdanews.com/ddl/33_15/" target=_blank>