Company: 3TP LLC.
Product: 3TP software
Date: 10/5/04
The Diagnostic Devices Branch (DDB), Office of Compliance (OC), Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA) has reviewed your Internet website for 3TP Software. Based on our review of your website, it appears that your company is marketing 3TP Software for intended uses beyond the scope of your FDA clearance for the product.
3TP Software is a device as defined within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) because it is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or because it is intended to affect the structure or any function of the body.
FDA cleared 3TP Software for the following indications:
The 3TP Software Option is intended to be used as a post processing software package designed to provide a reliable means for visualizing the presence and pattern of contrast induced enhancement on MR datasets. 3TP supports the evaluation of dynamic MR data gathered during the injection of a bolus of contrast media. The resulting time course information can be displayed in a variety of formats, including a parametric image overlaid onto source MR images. In the hands of a trained physician the information provided by the 3TP Software Option could yield information that may assist in the interpretation of dynamic contrast enhanced studies.
Your website demonstrates that 3TP LLC is marketing the 3TP Software for intended uses that do not fall within the existing clearance. For instance, the website states that 3TP Software “facilitates rapid detection of breast cancer.”
“3TP is an innovative software solution that facilitates detection of breast cancer through rapid interpretation of contrast enhanced MRI images.”
Marketing the 3TP Software for indications beyond the scope of your FDA clearance violates the law. Specifically, the device is adulterated under section 501(f)(1)(B) of the Act because you do not have an approved Premarket Approval Application (PMA) to demonstrate that the device is safe and effective for the new intended uses for which you are marketing it. In addition, your device is misbranded under section 502(o) of the Act because you have not submitted a section 510(k) premarket notification to notify the agency of your intent to introduce the device into commercial distribution for these new intended uses. For a product requiring premarket approval, the notification required by section 510(k) of the Act is deemed satisfied when a PMA is pending before the FDA. [21 CFR 807.81(b).]
Issuer: Center for Devices and Radiological Health (CDRH)
