(65 days)
Fracture fixation of long bone diaphysis (tibia, humerus, femur) and fracture reduction at metaphyseal and epiphyseal levels.
Pediatric Intramedullary Nail
This FDA letter acknowledges the substantial equivalence of the "MacMed Paediatric Intramedullary Nail" (K991877) to legally marketed predicate devices, thereby allowing its commercialization. However, the provided document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.
The letter is solely a regulatory approval based on the comparison to existing devices, not a review of clinical or performance data as would be found in a study report. Therefore, I cannot provide the requested information from this document.
To answer your questions, you would need access to the original 510(k) submission (K991877) from InnerVision®, Inc., which would have included the technical and performance data supporting their claim of substantial equivalence.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.