If conflicts arise between the orthopedic patient-matched guide’s indications for use and the implant system’s indication/ contraindications, those conflicts may constitute misbranding
This summer, the U.S. Food and Drug Administration (FDA) issued draft guidance regarding patient-matched guides to orthopedic implants, which are intended to assist in the execution of a pre-surgical plan concurred upon by the patient’s healthcare professional to position an orthopedic implant in a way consistent with the implant’s indicated use. In the draft guidance, FDA recommends information to include in pre-market submissions for patient-matched guides to orthopedic implants. FDA also suggests information for manufacturers to consider when creating the design process for patient-matched guides.
Patient-Matched Guide Indications
First, FDA offers clarity and guidance for orthopedic patient-matched guide indications for use, which, in general, are the descriptions of the disease or condition the device will diagnose, treat, prevent, cure or mitigate, and a description of the patient population for which the device is intended. This requirement is critical for patient-matched guides in order to identify appropriate technical performance testing procedures.
In the draft guidance, FDA notes that when describing the indications for orthopedic patient-matched guide use, manufacturers should evaluate a patient-matched guide’s performance within an implant system to avoid conflicts in approved indications. If conflicts arise between the orthopedic patient-matched guide’s indications for use and the implant system’s indication/contraindications, those conflicts may constitute misbranding. Thus, indication descriptions should include, for example, the specific implant system the guide is intended to support and whether the indicated patient population is a subset of the implant system’s patient population.
Second, FDA also expresses that the device description is critical to development of the appropriate technical performance testing parameters necessary to support the regulatory submission. Because the designs of patient-matched guides differ slightly between patients, a manufacturer should be careful to establish and document the design process that they used to define the range of pre-specified, allowable design parameters.
The device description should describe device components and materials and the process of designing and creating the guide. Accordingly, a device description in a regulatory submission should include description of the following aspects:
- Patient-matched guide (including guide components);
- General design process (such as a flowchart);
- Patient image acquisition for patient pre-operative images used in guide design;
- Image quality control, segmentation and anatomical definitions (to ensure reproducibility of performance testing results);
- Pre-operative planning and healthcare professional concurrence (to assist in the device being used for the purpose for which it is intended);
- Guide design and patient-matched features definition (including the targeted bone/guide interface location and identification of how the resulting guide features correlate with the implant system’s alignment recommendations);
- Guide construction (used during the manufacturing process); and
- Surgical technique (to ensure the device is used for the purpose for which it is intended).
FDA offered recommendations of specific aspects to be included for each of the above categories of the device description.
Third, with respect to software used in the development of patient-matched guides, manufacturers should refer to existing software guidance, “Content of Premarket Submissions for Device Software Functions,” for submission documentation. FDA clarified, however, that changes to already marketed systems should be accompanied by a description of how that change supports pre-operative planning and guide design. Some changes may require a new marketing submission.
Changes Requiring New 510(k) Submissions
Finally, FDA directs manufacturers to consider whether modifications may warrant a new 510(k) submission, pointing to four qualifying changes that would require this:
- Design of patient-contacting regions, guide holes or slots, or critical guide structures;
- Planning process such as automating a manual segmentation step;
- Patient imaging modality; and
- Anatomic contact location.
Notably, FDA makes clear that the following modifications would likely not require a new 510(k):
- Software update to off-the-shelf segmentation software;
- Format of the pre-operative planning report; and
- Nonpatient contacting and noncritical guide structure.
For More Information
If you have any questions about this Alert, please contact Frederick R. Ball, Patrick C. Gallagher, Ph.D., Sean K. Burke, Coleen W. Hill, any of the attorneys in our Life Sciences and Medical Technologies Industry Group, any of the attorneys in our Products Liability and Toxic Torts Group or the attorney in the firm with whom you are regularly in contact.
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