FDA issues final guidance for bone anchor 510(k) submissions
The FDA issued a final guidance for 510(k) submissions for bone anchor devices, also known as suture anchor devices, used for attachment of soft tissue to bone.
The final guidance provides and clarifies the recommended content for a bone anchor 510(k) submission, including descriptive characteristics, labeling and biocompatibility. The guidance also provides recommendations for bench-testing methods for bone anchor devices, including nitinol and absorbable polymeric bone anchors.
The guide recommends bone anchor devices to be submitted under the product codes MAI or MBI.
Under the guidance, descriptions of general bone anchors should include dimensions, descriptions of all components and how the components are assembled, the identity and size of sutures included in the anchor construct using the United States Pharmacopoeia, recommended suture size if it does not include a suture, a description of the anchor attachment mechanism and the method of bone preparation for insertion.
Additional recommendations on descriptive characteristics are included for nitinol suture anchors and polymeric absorbable suture anchors.
Under the guidance, manufacturers must compare their new device to a similar legally marketed predicate device to support its equivalence. The comparison should provide information showing how the device is similar to and different from the predicate, using side-by-side comparisons whenever possible.
The final guide also recommends that 510(k) submissions contain information on the biocompatibility of all patient-contacting materials (using historical examples if applicable), sterility, instructions on how to reprocess a reusable device or a single-use device that is provided to a non-sterile user, the description of the packaging and meet FDA pyrogen limit specifications.
The guide recommends that manufacturers evaluate the performance of their device on suture characterization, insertion, pullout, component interconnection, fatigue, corrosion and degradation. Specific details are included in the guide.
Clinical testing for bone anchors may be requested on devices whose indications for use are dissimilar from legally marketed devices of the same type, include new technology, include cases in which engineering and/or animal testing raises concerns and on devices with lower mechanical properties than predicates.
Under the guide, labeling should include indications and directions for use.
In accordance with 21 CFR 807.81(a)(3), the guidance requires a new 510(k) submission for a device change or modification that affects safety, effectiveness or intended use.
Reference:
www.fda.gov/media/72235/download