(420 days)
The CSCO Forehead Fixation System is intended for use in an endoscopic forehead or brow lift procedure. This procedure is performed endoscopically through several small openings rather than through a trans-coronal incision, resulting in reduced scarring and blood loss for patients. The soft tissue is elevated off the underlying bone endoscopically and fixed in the higher position by tying sutures attached to the tissue of the scalp to the CSCO Forehead Fixation System anchored in the outer table of the skull. The CSCO Forehead Fixation System is attached to the skull through a small incision in the scalp. It is recommended that the CSCO Forehead Fixation System be removed after approximately 10-14 days to allow adherence of the newly elevated soft tissues to the underlying frontal bone.
This submission describes a bone anchor device intended for use in endoscopic forehead or brow lift procedures. The CSCO Forehead Fixation System is a partially threaded bone screw 2.0 mm in diameter and available in either 12, 14 or 16 mm lengths. The distal 4 mm of each screw is threaded. The remainder of the shaft is smooth. The screw head is hexagonal and has a small groove just inferior to it for attachment of the suture. It is recommended that the CSCO Forehead Fixation System be removed after approximately 10-14 days to allow adherence of the newly elevated soft tissues to the underlying frontal bone. The device can be removed without anesthesia in the doctor's office.
The provided text describes a 510(k) submission for a medical device called the "CSCO Forehead Fixation System." This document is a premarket notification to the FDA, demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical study evaluating the device's performance against specific acceptance criteria.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a performance study cannot be extracted from the provided text.
The document focuses on:
- Device Description: What the CSCO Forehead Fixation System is and its intended use.
- Equivalence Claim: How it is similar in intended use, material, design, and operational principle to predicate devices (Zimmer Statak Anchors, Howmedica Mainstay Anchor, Synthes Cortical Bone Screw, Mitek® Threaded 2.0 mm Anchor, Marker System for Stereotaxic Navigation).
- Regulatory Outcome: The FDA's determination of substantial equivalence, allowing the device to be marketed.
No study proving the device meets acceptance criteria is described in this 510(k) summary. The 510(k) pathway often relies on demonstrating substantial equivalence to existing devices that have already been proven safe and effective, rather than requiring new, extensive clinical performance trials for every submission.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.