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510(k) Data Aggregation
(30 days)
Properly used, in the presence of adequate immobilization, absorbable BioCuff CM screw/washer maintains proximity between soft tissue and bone to facilitate the soft tissue reattachment. BioCuff C™ loses its strength over 20 to 50 weeks while the lesion of the tendon is healing. This indication is completely identical with the previously cleared BioCuffM (K001378).
The BioCuff C™ is not intended for use in and is contraindicated for: 1) Insufficient quality or quantity of bone, 2) Foreign body sensitivity to the implant material. Where the material is suspected a test should be made prior to implantation to rule out sensitivity. 3) Patients with active sepsis or infection. 4) Conditions, which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing and rehabilitation period.
BioCuff CTM is composed of poly-L/D-lactide copolymer. This raw material is completely identical with the previously cleared Bionx Implants Inc. BioCuff™ (K001378).
The device description of BioCuff C™ screw and washer combination is as follows:
- Composed of poly-L/D-lactide copolymer
- -Lengths 18, 28 and 36mm.
- Diameter 6.0 mm
- -Cannulation for 1.5mm K-wire
The only modifications that were made are:
- Cannulated design for easier installation of the product
- Increased outer diameter
- Minor design changes in head of the screw and washer accordingly
- Revision of instrument set according to needs of cannulation. This means cannulated screwdriver, cannulated drill, grasper, cannulated bone tap, sterilization tray and K-wire. Instrument set is substantially equivalent to previously cleared Bionx Implants Inc. BioCuff™ screw/washer (K001378) and Cannulated SmartScrew (K974876, K992947).
- Introduction of new reference numbers
- Introduction of new trade name, BioCuff CTM
This 510(k) submission (K013057) for the Bionx Implants Inc. BioCuff CTM is for a bioabsorbable soft tissue fixation fastener. The submission establishes substantial equivalence to a predicate device, the Bionx Implants Inc. BioCuff™ (K001378).
The core of this submission is demonstrating that the BioCuff CTM is substantially equivalent to the predicate device, BioCuff™. This means the acceptance criteria are implicitly those of the predicate device, and the study proves the new device meets these criteria by showing it has the same or very similar performance and safety characteristics.
Here’s an breakdown based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence claim based on minor modifications and identical materials to a predicate, explicit numerical acceptance criteria and a detailed performance study with reported values for the new device (BioCuff CTM) against those criteria are not provided in the document in the format you expect for a novel device. Instead, the "acceptance criteria" are implied to be the performance characteristics of the predicate device, which the new device is claimed to match.
| Acceptance Criteria (Implied from Predicate) | Reported Device Performance (BioCuff CTM) |
|---|---|
| Material Composition: Poly-L/D-lactide copolymer | Identical: Composed of poly-L/D-lactide copolymer |
| Intended Use: Maintains proximity between soft tissue and bone to facilitate reattachment; loses strength over 20-50 weeks during healing. | Identical: "This indication is completely identical with the previously cleared BioCuff™ (K001378)." |
| Contraindications: | Identical: The document explicitly states, "Also, like the predicate devices, the BioCuff Cᵀᴹ is not intended for use in and is contraindicated for...". The list of contraindications is then provided and is assumed to be the same as the predicate. |
| Dimensions (Predicate - BioCuff™): (Not explicitly stated in the provided text for the predicate, but implied by the changes.) | Modified: Lengths 18, 28, and 36mm; Diameter 6.0 mm (These are the new device dimensions, which are noted to be an increase in outer diameter from the predicate. The FDA's clearance implies this modification does not raise new safety or effectiveness concerns.) |
| Design: Non-cannulated | Modified: Cannulated design for easier installation; minor design changes in the head of the screw and washer. |
| Instrument Set: Non-cannulated instruments | Modified: Revision of instrument set to cannulated (screwdriver, drill, grasper, bone tap, sterilization tray, K-wire). Stated to be substantially equivalent to predicate and other cleared cannulated screws. |
| Overall Safety & Effectiveness: No new issues raised by modifications. | Confirmed: "The minor technological differences between BioCuff CTM and the predicate device do not raise any new issues of safety or effectiveness." FDA clearance letter confirms substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not describe an independent clinical or performance study with a test set of patients or devices where data was collected. This 510(k) relies on a declaration of substantial equivalence to a previously cleared device. Therefore, there is no mention of a "test set" and thus no sample size or data provenance in the context of a new performance study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
No new test set was used, and thus no expert ground truth establishment for a new test set is mentioned.
4. Adjudication Method for the Test Set
Not applicable as no new test set and no expert review for a new test set were conducted.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed or mentioned. The device is a physical implant, not an AI or imaging diagnostic tool that would typically involve a MRMC study.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This is a medical device (implant), not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for this submission is effectively the established safety and effectiveness profile of the predicate device (BioCuff™ K001378). The new device's substantial equivalence is argued based on its identical material, intended use, and minor design changes that do not alter its fundamental function or safety profile.
8. Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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