(68 days)
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No
The summary describes a simple mechanical fixation device (threaded pin) and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is a "Threaded Fixation Pin" intended for "internal alignment and fixation for small bones of the hand and foot," which are structural functions, not therapeutic. Therapeutic devices are typically involved in treating or preventing disease, not solely providing mechanical support.
No
The device is a threaded fixation pin used for internal alignment and fixation of small bones. This is a therapeutic function, not a diagnostic one which involves identifying a medical condition.
No
The device description clearly states "Threaded Fixation Pin," which is a hardware component used for internal alignment and fixation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "internal alignment and fixation for small bones of the hand and foot." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "Threaded Fixation Pin." This is a physical implant used in surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with bodily specimens for diagnostic purposes.
Therefore, this device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
The proposed device, the Threaded Fixation Pin claims substantial equivalence to a currently marketed device, Synthes Threaded Kirschner Wires. The Synthes Threaded Kirschner Wires and the proposed device are available in Titanium Alloy. Both function as internal alignment and fixation for small bones of the hand and foot and have no significant design differences.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
small bones of the hand and foot
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
NOV - 6 1996
K963433
Threaded Fixation Pin 510(k)Summary - Safety and Effectiveness
The proposed device, the Threaded Fixation Pin claims substantial equivalence to a currently marketed device, Synthes Threaded Kirschner Wires. The Synthes Threaded Kirschner Wires and the proposed device are available in Titanium Alloy. Both function as internal alignment and fixation for small bones of the hand and foot and have no significant design differences.