(61 days)
The Sterile Kirschner Wires and Steinmann Pins are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implantation through the skin so that traction may be applied to the skeletal system.
This system consists of sterile, smooth and threaded Kirschner wires (K-wires) and Steinmann pins ranging in length from 4 to 9 inches and ranging in diameter from 0.028 to 0.188 inches. All of the K-wires and Steinmann pins except the 6" K-wires are available with four point style options: trocar, bayonet, double end trocar and double end bayonet. The 6" K-wires are available with double end trocar points. All of the K-wires and Steinmann pins are manufactured from 316 LVM stainless steel.
This 510(k) summary describes a medical device, "Sterile Kirschner Wires and Steinmann Pins," which are bone fixation fasteners. The summary focuses on establishing substantial equivalence to a predicate device (DePuy Non-sterile Kirschner Wires and Steinmann Pins) based on design, sizes, material, and intended use. The primary difference highlighted is the sterility of the submitted device.
However, the provided text does not contain any information regarding:
- Acceptance criteria in tabular format or otherwise.
- The reported device performance against any criteria.
- Details about a study conducted to prove the device meets acceptance criteria.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies or their effect sizes.
- Standalone algorithm performance.
- The type or establishment method of ground truth for any set.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is solely a 510(k) summary for substantial equivalence, not a performance study report.
{0}------------------------------------------------
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988 |
|---|---|
| 510(K) CONTACT: | Cheryl HastingsManager, Pre-clinical Device Evaluation |
| TRADE NAME: | Sterile Kirschner Wires and Steinmann Pins |
| COMMON NAME: | Bone Fixation Fasteners |
| CLASSIFICATION: | 888.3040 Smooth or threaded bone fixation fasteners |
| DEVICE PRODUCT CODE: | 87 HTY and 87 JDW |
| SUBSTANTIALLYEQUIVALENT DEVICES: | DePuy Non-sterile Kirschner Wires and Steinmann Pins |
INTENDED USE AND DEVICE DESCRIPTION:
The Sterile Kirschner Wires and Steinmann Pins are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implantation through the skin so that traction may be applied to the skeletal system.
This system consists of sterile, smooth and threaded Kirschner wires (K-wires) and Steinmann pins ranging in length from 4 to 9 inches and ranging in diameter from 0.028 to 0.188 inches. All of the K-wires and Steinmann pins except the 6" K-wires are available with four point style options: trocar, bayonet, double end trocar and double end bayonet. The 6" K-wires are available with double end trocar points. All of the K-wires and Steinmann pins are manufactured from 316 LVM stainless steel.
BASIS OF SUBSTANTIAL EQUIVALENCE:
A comparison of the sterile K-wires and Steinmann pins described in this submission and the non-sterile devices sold prior to 1976 shows that they are very similar or identical in terms of design, sizes, material and intended use. The only significant difference between the two systems is that the system described in this submission is provided sterile while the system sold by DePuy prior to 1976 was non-sterile.
000012
§ 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.