An MD&DI March 1997 Column
With advances in technology emerging every day, manufacturers are constantly presented with the opportunity to update their devices. While such advances promise to improve health care, modifications may affect the safety and effectiveness of a device. Such changes may also require manufacturers to submit 510(k)s to FDA. This month FDA assists the editors in determining whether design changes warrant such a submission.
A manufacturer produces a finished medical device that can be inserted into the body for aspirating body fluids. The device was introduced into commercial distribution prior to the May 28, 1976, Medical Device Amendments and has not undergone any modifications since that date. The manufacturer would now like to make the following changes to the device: the addition of an O-ring to make it leakproof, the use of transparent plastic instead of the original colored plastic, and the addition of a sounding line to gauge the depth of insertion. These are intended to make the device more accurate and easier to use. Is the manufacturer required to submit a 510(k)?
On January 10, 1997, FDA issued in final form a guidance document entitled Deciding When to Submit a 510(k) for a Change to an Existing Device. The following answer is based on that document.
As written, the question does not contain enough information to make an accurate evaluation because it doesn't explain where the device is to be used in the body or whether it is to be used during surgery or dental procedures. Nevertheless, it appears that the changes made as a whole will require the submission of a 510(k).
Because of the risk of HIV transmission, the transfer of body fluids is not an inconsequential procedure. Under section 510(k) of the Federal Food, Drug, and Cosmetic Act, any change that could significantly affect safety and effectiveness requires a new 510(k) submission. Adding an O-ring to prevent leakage would appear to make the device safer to use. Therefore, a 510(k) must be submitted.
In addition, by adding an O-ring the manufacturer is introducing a new material that may require biocompatibility testing. Changes to device design require some level of design evaluation to ensure that the device continues to perform as intended. Occasionally, changes that are meant to be cosmetic produce unexpected results or adversely affect product performance. In such instances, the safety and effectiveness of a device may be affected, so the manufacturer must submit a 510(k).
The second change involves the use of transparent plastic instead of the original colored plastic. A change in a material that comes in contact with body tissue may require additional biocompatibility testing. If such additional testing is required, a 510(k) is usually necessary. Also, if the device is to be sterilized commercially, the manufacturer needs to consider the effect sterilization will have on the plastic.
Finally, the manufacturer wishes to add a sounding line to gauge the depth of insertion. This type of change will require some level of design evaluation to ensure that the device continues to perform as safely and as effectively as the original.
Deciding When to Submit a 510(k) for a Change to an Existing Device is available from FDA's Facts-On-Demand service by calling 800/899-0381, and requesting shelf number 935, or by visiting FDA's web site at http://www.fda.gov/cdrh/ode/510kmod.html.
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Although every effort is made to ensure the accuracy of this column, neither the experts nor the editors can guarantee the accuracy of the solutions offered. They also cannot ensure that the proposed answers will work in every situation.
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