(87 days)
The Distal Radius Fracture Repair Kit is intended for the fixation of fractures and osteotomies involving the distal radius.
The Distal Radius Fracture Repair System consists of the Distal Volar Fracture Repair System, which was previously cleared under 510(k) No. K002775. The system comprises volar stabilization plate, bone, screws, and fixation pegs. This 510(k) is being submitted as a modification to the original 510(k) No. K002775 to allow for the dorsal fixation of stable fractures of the distal radius. The Distal Dorsal Nail Plate (DNP) (left and right) is an implantable orthopedic nail-plate device used for the fixation of distal radius fractures. This device permits fixation of distal radius fractures with a minimal incision on the dorsal side while avoiding the tendon adhesion problems. The device consists of a plate portion, which offsets into a nail portion, all cut out of a solid piece of titanium (Titanium TI-6AL-4V ELI anodized Type II). The plate portion is narrow (~6mm) and long (~16mm) and has 3 threaded holes for the attachment of pegs with bending load capacity. These holds are appropriately angled so the pegs fan out and support the distal fracture fragment near the articular surface. The nail portion starts thick and tapers into a long, flexible section. At the start of the taper there are 2 crossing holes spaced about 9 mm apart. The holes are sized to fit 2.5 mm screws, which are used to anchor the nail-plate to the radius proximal of the fracture. The pegs, standard or threaded, and the 2.5mm screws are driven with the Peg Driver. The anchor screws and pegs are available in different lengths to accommodate most patient anatomies and fracture morphologies. Other components used in the implantation process are identified as the DNP Jig Set of Stainless Steel SST 17-4. These items consist of the DNP Jig (left or right), drill guide, screw jig and screw quide. A standard awl, which is a manual tool, used to increase the size of a hole or tunnel by scraping in rotation is a standard catalog item manufactured by from K-Medic under catalog no. KM-48-336. The components of this system will be packaged together and will also be available individually. The materials used for the various components in Distal Dorsal Nail Plate and Jig Set include Titanium TI-6AL-4V ELI and Stainless Steel SST 17-4. The components within this system will be provided as non-sterile for steam sterilization by health care professionals prior to use.
This submission, K023007, concerns a modification to an existing device, the Distal Radius Fracture Repair System, specifically adding components for dorsal fixation of distal radius fractures. As such, the study described is a comparison to a predicate device to demonstrate substantial equivalence, rather than a clinical trial proving specific performance criteria in a patient population. Therefore, many of the typical acceptance criteria and study design elements for AI/device performance do not apply in this context.
Here's a breakdown of the information based on the provided text, and where certain requested details are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (metallic bone fixation appliance), acceptance criteria are primarily related to substantial equivalence to a legally marketed predicate device, focusing on intended use, materials, biocompatibility, and overall performance characteristics. Performance is assessed through comparison of features rather than quantitative metrics like sensitivity/specificity.
| Feature Comparison (Acceptance Criteria Implicit) | Distal Radius Fracture Repair Kit (Proposed Device) | Synthes Distal Radius Plate System (Predicate Device) | Outcome (Implied Acceptance) |
|---|---|---|---|
| Manufacturer | Hand Innovations, Inc. | Synthes USA | Different, but not a disqualifier |
| Packaging | Tempered Plastic suitable for steam sterilization | Stainless steel tray suitable for steam sterilization | Different materials, but both suitable for steam sterilization |
| Sterilization Method | Provided non-sterile, recommend steam sterilization | Provided non-sterile, recommend steam sterilization | Equivalent |
| Intended Use | Fixation of fractures and osteotomies involving the distal radius. | Fixation of fractures, osteotomies, including carpal fusions involving the distal radius applied to the volar and dorsal aspects. | Substantially Equivalent (proposed device explicitly adding dorsal fixation, aligning with predicate's broader scope) |
| Implant Period | Permanent | Permanent | Equivalent |
| Material of Construction | Plates: Titanium; Pegs and Screws: Titanium and Stainless Steel | Plates: Stainless Steel and Titanium Alloy; Pegs and Screws: Stainless Steel and Titanium Alloy | Similar (both use titanium and stainless steel), considered equivalent |
| Available Configurations | Right and Left, Volar and Dorsal | Right and Left, Volar and Dorsal | Equivalent |
| No. of Buttress Pegs | 5 each size | 6 maximum | Similar range |
| No. of Cortex Screws | 8 each size | 6 maximum | Similar range |
| Buttress Peg Length (mm) | 16, 18, 20, 22, 24, 26, 28 | Trim to desired length | Different approach but both accommodate length needs |
| Cortex Screw Length (mm) | 10, 12, 14, 16, 18 | 10 to 26 | Similar range |
| Specialized Instruments Included | Bending tool, Drill Guide, Depth Gauge, Peg Driver, Screw Driver, DNP Jig Right & Left | Bending Pliers and Irons, Drill Guide, Depth Gage, Peg Driver, Screw Driver | Similar instruments for similar functions. |
| Tool and Component Separators/Holders in Tray | Yes | Yes | Equivalent |
The FDA's letter (K023007) states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device..." This indicates that the device met the implicit acceptance criteria for substantial equivalence based on the comparison provided.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This is a comparison of device characteristics and intended use to a predicate device, not a performance study involving a test set of data (e.g., patient images or clinical outcomes). The "test set" is effectively the set of characteristics of the proposed device compared feature-by-feature to the predicate.
- Data Provenance: Not applicable for a traditional test set. The data presented is a description of the proposed device's design and materials, and a specification comparison to a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Ground truth, in the sense of expert-established diagnoses or outcomes, is not relevant for this type of submission which focuses on substantial equivalence of a physical medical device. The "ground truth" here is the design and manufacturing specifications of the devices being compared.
4. Adjudication Method for the Test Set
- Not applicable. There is no "adjudication" in the sense of resolving discrepancies between expert readings or device outputs. The comparison is objective based on device specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., AI for image interpretation) to compare human performance with and without AI assistance. This submission describes a physical orthopedic implant.
- Effect Size: Not applicable as no such study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone performance study was not done. This concept applies to AI algorithms operating independently, which is not relevant for an orthopedic implant.
7. The Type of Ground Truth Used
- The "ground truth" used for this submission is the device's design specifications, material composition, intended use, and functional characteristics, as described by the manufacturer, and compared against the established specifications and intended use of the legally marketed predicate device. This is a regulatory "ground truth" for substantial equivalence rather than a clinical ground truth.
8. The Sample Size for the Training Set
- Not applicable. There is no concept of a "training set" for this type of device submission. This is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, there is no ground truth established for one.
§ 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.