(268 days)
Bladder Neck Suspension
The Linvatec Bio-Anchor is indicated for bladder neck suspension for female urinary incontinence due to urethral hypermobility.
The Bio-Anchor is a PLLA suture anchoring device. The device is cylindrical in shape with three circular ribs perpendicular to the long axis. The first and second ribs are the same size, with the proximal, third rib wider to allow for a centrally located eyelet running perpendicular to the long axis of the device. Freely passing suture is then threaded onto the Bio-Anchor by the surgeon. The lack of permanent attachment of the suture to the Bio-Anchor allows the use of sliding knots. Once the Bio-Anchor is implanted, the ends of the suture are passed through the soft tissue and tied for reattachment. Synthetic non-absorbable, polyester USP #0, #1, or #2 suture is recommended for use with this device.
The material used for this device is:
Anchor - Poly (L-lactic) acid (PLLA)
The Bio-Anchor Absorbable Suture Anchor is available in sizes ranging from 2.5mm to 5.2mm diameter.
The provided text is a 510(k) Summary of Safety and Effectiveness for a medical device (Bio-Anchor Absorbable Suture Anchor) submitted to the FDA in 1997. This type of document is a premarket notification for demonstrating substantial equivalence to a legally marketed predicate device, not a study designed to prove the device meets specific acceptance criteria based on performance data.
Therefore, the document does not contain the acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC study results, standalone algorithm performance, or details on how ground truth was established for training and test sets as typically found in a clinical study report.
Here's why this information is missing and an explanation based on the document type:
This 510(k) submission focuses on demonstrating substantial equivalence to existing, legally marketed devices. It does this by:
- Describing the device: Its material (PLLA), shape, and mechanism of action.
- Stating its intended use: Bladder neck suspension for female urinary incontinence due to urethral hypermobility.
- Identifying predicate devices: Linvatec Revo/Mini Revo, Mitek GII Anchor and Absorbable Anchor, Zimmer Statak Device, Zimmer Resorbable Soft Tissue Attachment Device, and Vesica Medical, Inc. Bone Anchor System.
- Comparing the new device to predicates: A table highlights similarities and dissimilarities in materials, intended use, sterilization, and sizes. The key similarity emphasized is the material (PLLA) with the Zimmer Resorbable device and the intended use with several predicates.
The FDA's review and approval (as indicated by the letter in Section 4 and 5) signify that they found the device substantially equivalent to predicates and thus determined it to be safe and effective for its stated intended use, based on the information provided and comparisons to established devices. It does not imply that a new clinical study with specific acceptance criteria was performed or reported in this document.
If such a study were conducted, its results would typically be included as part of the submission, detailing methods, endpoints, statistical analyses, and performance metrics. However, for a 510(k) requiring substantial equivalence, extensive comparative performance data against specific acceptance criteria is often not required if equivalence can be demonstrated through other means (e.g., material, design, and intended use similarity to predicate devices).
§ 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.