(38 days)
The 450 mm Nancy Nail™ is intended as a temporary implant to aid in the healing of long bone (tibia, humerus, femur, etc.) fractures at diaphyseal, metaphyseal and epiphyseal levels. It is intended for use in children above four years of sge and in any patient below 65 kg. The 100 mm Nancy Nail™ is designed to treat fractures of small long bones with long diaphyses such as carpal or tarsal bones. The 450 mm Nancy Nail™ is also intended for use in upper extremity fractures in all patients.
The Nancy Nail™ is a titanium alloy pin that is implanted to facilitate the fixation of long bone fractures. The Nancy Nail™ is available in two lengths; the 450 mm is available in five diameters (2.0, 2.5, 3.0, 3.5, 4.0 mm), and the 100 mm is available in 1.0 mm diameter. The Nancy Nail™ is a single-use device intended for temporary implantation. It is intended to be removed once the bone has healed.
The provided 510(k) summary for the ACE® Nancy Nail™ (K032687) is a substantial equivalence submission, not a study demonstrating performance against specific acceptance criteria.
In substantial equivalence submissions, the "acceptance criteria" are generally that the new device is as safe and effective as a legally marketed predicate device. The "study" isn't a performance study with numerical results, but rather a comparison to a predicate device.
Therefore, many of the requested fields are not applicable to this type of regulatory submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance / Evidence Provided |
|---|---|
| Design Similarity (ACE® Nancy Nail™ vs. Predicate) | * Materials: Both devices are made of titanium alloy. |
| * Geometric Design: The Nancy Nail™ is a titanium alloy pin, available in two lengths (450mm with 5 diameters, 100mm with 1 diameter). While specific dimensions of the predicate aren't detailed, the overall design type (elastic intramedullary nail) is common. | |
| Mechanisms of Action Similarity | Implicitly, as both are "Elastic Intramedullary Nails" used for long bone fracture fixation, their biomechanical function would be considered similar. |
| Indications for Use Similarity | * Predicate: Synthes Elastic Intramedullary Nail System (K971783) had existing clearance for upper extremity fractures in all patients. |
| * ACE® Nancy Nail™: Original indications included long bone fractures in children above four years of age and patients below 65 kg (450mm nail), and small long bones (100mm nail). This submission adds the indication for use in upper extremity fractures in all patients, aligning it with the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable. This submission is based on a comparison to a predicate device, not on a new performance study with a test set. There are no patient samples or data provenance details provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No test set or ground truth established by experts is mentioned, as this is a substantial equivalence submission.
4. Adjudication Method for the Test Set
- Not applicable. No test set or adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No. An MRMC study was not conducted or presented in this 510(k) summary. This type of study is not typically required for substantial equivalence for a device like an intramedullary nail.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical medical device (intramedullary nail), not an algorithm or AI solution. Therefore, a standalone algorithm performance study is irrelevant.
7. The Type of Ground Truth Used
- Not applicable. No specific "ground truth" in the clinical study sense (e.g., pathology, outcomes data) was used or provided in this submission to demonstrate new device performance. The "ground truth" for the regulatory decision is the established safety and effectiveness of the predicate device.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning or algorithms.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, there is no training set for this type of device.
Summary of the 510(k) Submission:
The DePuy ACE® Nancy Nail™ (K032687) sought to expand its indications for use to include upper extremity fractures in all patients. This was achieved through a substantial equivalence claim to the Synthes Elastic Intramedullary Nail System (K971783), which already had clearance for this specific indication.
The basis for substantial equivalence was "similarities of design, materials, and indications for use." The submission states that the new indication (upper extremity fractures in all patients for the 450 mm Nancy Nail™) had been previously cleared for the Synthes predicate device. The FDA's letter confirmed that the device was found substantially equivalent for the stated indications for use.
Therefore, the "proof" the device meets acceptance criteria is the successful demonstration of its substantial equivalence to a legally marketed predicate device, rather than explicit numerical performance data from a new clinical study.
§ 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.