(45 days)
This device is intended for use in surgical procedures to repair Pectus Excavation and other sternal deformities.
A stainless steel bar, variable length from 7 to 14 inches, and 0.50 inches wide, with two holes and notches on both ends for sutures to secure the bar to the lateral chest wall (a drawing is included in Attachment I.) . The bar is shaped by the surgeon prior to insertion.
The provided text is a 510(k) premarket notification for the Lorenz Pectus Support Bar. It does not contain information about acceptance criteria, device performance studies, or any of the detailed study analytics requested.
The document primarily focuses on:
- Device Description: A stainless steel bar for repairing Pectus Excavation and other sternal deformities.
- Potential Risks: Standard risks associated with long-term metallic implants (inadequate bone quality, malpositioning, infection, nerve injury, bending/fracture).
- Substantially Equivalent Devices: Mentions two predicate devices: The Adkins Strut and The Strib.
- Regulatory Information: FDA approval of the 510(k) based on substantial equivalence to predicate devices, classification, and general controls.
- Indications For Use: Surgical procedures to repair Pectus Excavation and other sternal deformities.
Therefore, I cannot extract the requested information as it is not present in the provided text. The submission process for this device, being a 510(k), relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials with detailed performance data against acceptance criteria.
§ 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.