(137 days)
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No
The description focuses on the mechanical design and materials of a traditional intramedullary nail for fracture fixation, with no mention of AI or ML capabilities.
Yes
The device is intended to stabilize fractures of the femur, which is a therapeutic intervention.
No
This device is a fixation device (intramedullary nail) used to stabilize fractures of the femur. It is a treatment device, not a diagnostic one.
No
The device description clearly describes a physical, implantable medical device made of titanium alloy, including nails, screws, and bolts, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Synthes CFN is intended to "stabilize fractures of the femur." This is a therapeutic purpose, not a diagnostic one.
- Device Description: The description details a physical implant designed to fix bone fractures. It does not describe any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) to diagnose a condition.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening.
The Synthes CFN is a surgical implant used to treat bone fractures.
N/A
Intended Use / Indications for Use
Synthes CFN is intended to stabilize fractures of the femur. Specifically, it is intended for acute femoral diaphyseal fractures, post-isthmic femoral fractures, subtrochanteric femoral fractures, non-unions, and impending pathological fractures. Synthes URFN is intended to stabilize fractures of the femur. Specifically, it is intended for acute femoral diaphyseal fractures, post-isthmic femoral fractures, subtrochanteric femoral fractures, and impending pathological fractures. The Synthes URFN is also intended to stabilize fractures of the femur. Specifically, it is intended for acute femoral diaphyseal fractures and post-isthmic femoral fractures.
Product codes
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Device Description
Synthes CFN is a cannulated locking intramedullary fixation device. It is cannulated throughout the length of the nail which facilitates insection over a guide rod into a reamed or unreamed femur. The nail has a gradual anterior bow with a radius of curvature that is designed to approximate that of the femur. It has proximal and distal locking holes that utilize the same size locking bolts. The most proximal locking hole is elongated. Nail accessories include a Twisted Blade, 5.0 mm Shaft Screws, Locking Sleeves, 4.9 mm Locking Bolts, and End Caps. The accessories are intended to transmit load between the bone and the CFN to prevent rotation and displacement of the nail/fracture when stabilizing subtrochanteric femoral fractures. The device is manufactured from titanium alloy.
The Synthes URFN is also intended to stabilize fractures of the femur. Specifically, it is intended for acute femoral diaphyseal fractures and post-isthmic femoral fractures. The nail has a gradual anterior bow with a radius of curvature that is designed to approximate that of the femur. It has proximal and distal locking holes that utilize the same size locking bolts. The proximal-most locking hole is elongated. It has a solid cross section to facilitate insertion into a non-reamed or minimally reamed femur. The device is manufactured from titanium alloy.
Synthes will provide the device both sterile and non-sterile. Of course, non-sterile devices must be sterilized prior to use; moist heat sterilization is recommended using the Association for the Advancement of Medical Instrumentation (AAMI) guideline "Good Hospital Practice: Steam Sterilization and Sterility Assurance".
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
femur
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)
Based on mechanical test results, the CFN design has been found to be at least equivalent to the URFN.
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.
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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
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§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A small circle with an R inside is located to the right of the word.
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Attachment VII:
Summary of Safety and Effectiveness Information [510(k) Summary]
Synthes (USA) 1690 Russell Road Paoli, PA 19301
(610) 647-9700 Contact: Angela Silvestri October 20, 1995
Device: Synthes Cannulated Femoral Nail (CFN) System is compared to Synthes Unreamed Femoral Nail (URFN).
Synthes CFN is intended to stabilize fractures of the femur. Specifically, it is intended for acute femoral diaphyseal fractures, post-isthmic femoral fractures, subtrochanteric femoral fractures, non-unions, and impending pathological fractures. Synthes CFN is a cannulated locking intramedullary fixation device. It is cannulated throughout the length of the nail which facilitates insection over a guide rod into a reamed or unreamed femur. The nail has a gradual anterior bow with a radius of curvature that is designed to approximate that of the femur. It has proximal and distal locking holes that utilize the same size locking bolts. The most proximal locking hole is elongated. Nail accessories include a Twisted Blade, 5.0 mm Shaft Screws, Locking Sleeves, 4.9 mm Locking Bolts, and End Caps. The accessories are intended to transmit load between the bone and the CFN to prevent rotation and displacement of the nail/fracture when stabilizing subtrochanteric femoral fractures. The device is manufactured from titanium alloy.
Synthes URFN is intended to stabilize fractures of the femur. Specifically, it is intended for acute femoral diaphyseal fractures, post-isthmic femoral fractures, subtrochanteric femoral fractures, and impending pathological fractures. The Synthes URFN is also intended to stabilize fractures of the femur. Specifically, it is intended for acute femoral diaphyseal fractures and post-isthmic femoral fractures. The nail has a gradual anterior bow with a radius of curvature that is designed to approximate that of the femur. It has proximal and distal locking holes that utilize the same size locking bolts. The proximal-most locking hole is elongated. It has a solid cross section to facilitate insertion into a non-reamed or minimally reamed femur. The device is manufactured from titanium alloy.
Synthes will provide the device both sterile and non-sterile. Of course, non-sterile devices must be sterilized prior to use; moist heat sterilization is recommended using the Association for the Advancement of Medical Instrumentation (AAMI) guideline "Good Hospital Practice: Steam Sterilization and Sterility Assurance".
Based on mechanical test results, the CFN design has been found to be at least equivalent to the URFN.
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