(62 days)
Stabilization of fractures & Osteotomy Bone deformity correction of lower extremities Arthrodesis of the rear foot, mid foot, and ankle joint. Limb lengthening in pediatric and adults.
The Fusion Medical Ring Lock system is a Circular Frame and Footplate system, used in lower extremity Stabilization and Deformity Correction. Wires are placed in the bone and attached to the frame with wire fixation bolts. The wires are then tensioned to support the bone. Rings are made of aluminum 6061 T6. Posts are used to capture wires that are elevated off the frame. Posts are made of 17-4 PH stainless steel. Washers are used to fine tune the elevation, and hinges are used for gradual correction of bone.
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This document describes a 510(k) submission for the "Fusion Medical Ring Lock System", which is an external ring fixation device. The core of the submission is to demonstrate substantial equivalence to a predicate device, the "Vilex Frame (K052196)". The study provided is a comparative analysis, not a clinical trial with acceptance criteria for device performance in a clinical setting.
Description of Acceptance Criteria and Study to Prove Device Meets Criteria
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for Substantial Equivalence:
The primary acceptance criterion for this 510(k) submission is to demonstrate that the new device (Fusion Medical Ring Lock System) is substantially equivalent to a legally marketed predicate device (Vilex Frame K052196) in terms of intended use, technological characteristics, and safety and effectiveness.
| Acceptance Criterion (for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Identical or similar indications. | Identical: The Fusion Medical Ring Lock System is indicated for: Stabilization of fractures & Osteotomy, Bone deformity correction of lower extremities, Arthrodesis of the rear foot, mid foot and ankle joint, and Limb lengthening in pediatric and adults. The predicate Vilex Frame has the "same indication for use." |
| Technological Characteristics: Same or similar technological characteristics (design, materials, sizes). | Similar/Functionally Identical: The technological characteristics are stated to be "identical." The only design difference mentioned is that Fusion's tabs have 3 holes, while Vilex's have 2 holes. Both are made from the "same material, aluminum alloy." Sizes (140mm, 160mm, 180mm, 205mm) for the frame, as well as rod material and length, are reported as "the same." Posts are made of 17-4 PH stainless steel for Fusion, while the predicate's post material isn't explicitly stated but assumed similar due to the claim of identical characteristics. |
| Safety and Effectiveness: No new questions of safety or effectiveness are raised. | Demonstrated through Comparative Analysis: "Cross sectional engineering analysis shows the Fusion Medical Ring Lock system is equivalent to the Vilex Frame. There was no change to the design or size to decrease structural strengths in the rings or components and their material." This analysis implicitly concludes that the minor design difference (3 holes vs. 2 holes on tabs) does not negatively impact structural integrity or raise new safety/effectiveness concerns. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. This submission relies on an "engineering analysis" and comparison to a predicate device, rather than a statistical test set of devices or patient data.
- Data Provenance: The data provenance is from an internal "cross sectional engineering analysis" performed by the submitter (Fusion Medical Corp.). It is not explicitly stated whether this involved physical testing of multiple units or purely computational analysis, but the phrasing "cross sectional engineering analysis shows..." suggests a comparative assessment of design specifications and material properties. It is retrospective in the sense that it evaluates the design against the predicate's known characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable in the context of clinical expert consensus. The "ground truth" here is established by the engineering analysis, which would have been conducted by engineering personnel at Fusion Medical Corp. The specific number or qualifications of these engineers are not provided in the document. For a 510(k) submission, the FDA acts as the ultimate "expert" in determining if substantial equivalence is met based on the presented data.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no clinical test set requiring adjudication of findings. The decision on substantial equivalence is made by the FDA based on the information provided in the submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This submission focuses on demonstrating substantial equivalence of a medical device based on its physical characteristics and intended use, not on user performance or clinical outcomes that would require an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance Study: Not applicable. This device is a mechanical external fixation system, not a software algorithm or AI-driven tool. Therefore, a "standalone algorithm performance" study is not relevant.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this submission is the established characteristics and performance of the legally marketed predicate device (Vilex Frame K052196). The submitted "engineering analysis" serves to compare the new device's characteristics against this established ground truth to argue for equivalence.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. There is no concept of a "training set" as this is not an AI/ML device or a clinical study that would involve such a set.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth: Not applicable, as there is no training set for this type of device submission.
§ 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.