(75 days)
Synthes guidewires
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No
The device description and intended use are for a simple mechanical guidewire used in bone surgery, with no mention of any computational or analytical capabilities.
No
The device, guidewires for cannulated screws, is described as an internal fixation device used to temporarily stabilize fractures or osteotomies, which is a supportive role to the overall healing process rather than directly providing a therapeutic effect like curing a disease or restoring function through biological means.
No
The device description indicates that it is a guidewire for cannulated bone screws used as internal fixation. It is designed to assist in the surgical placement of screws for fracture fixation, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a guidewire made of stainless steel or Titanium alloy, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is described as a guidewire used with cannulated bone screws for internal fixation of bones in the hand and foot. This is a surgical device used in vivo (within the body) for structural support and fracture repair.
- Device Description: The description reinforces its use in surgical procedures involving bone fixation.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided description contains none of these elements.
Therefore, this device falls under the category of a surgical implant/instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The proposed device, the guidewires for cannulated screws claims substantial equivalence to a currently marketed device, Synthes guidewires. The Synthes guidew res and the proposed device are available in either stainless steel or Titanium alloy. Both function with a cannuiated bone screw used as internal fixation for the carpel, tarsal, metacarpal, and phalanges of the hand and foot. There are no significant design differences. The tips of the guidewires are pointed with either a trocar or diamond point for starting into the bone. The wires are normally used as temporary fixation of a fracture or osteotomy site until a bone screw can be driven over the wire and the wire removed
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
carpel, tarsal, metacarpal, and phalanges 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Synthes guidewires
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
NOV 13 1995 11 9 6
Guide Wires for Cannulated Screws 510(k)Summary - Safety and Effectiveness
The proposed device, the guidewires for cannulated screws claims substantial equivalence to a currently marketed device, Synthes guidewires. The Synthes guidew res and the proposed device are available in either stainless steel or Titanium alloy. Both function with a cannuiated bone screw used as internal fixation for the carpel, tarsal, metacarpal, and phalanges of the hand and foot. There are no significant design differences. The tips of the guidewires are pointed with either a trocar or diamond point for starting into the bone. The wires are normally used as temporary fixation of a fracture or osteotomy site until a bone screw can be driven over the wire and the wire removed