(57 days)
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No
The summary describes a mechanical implant (tibial nail) and its physical characteristics, materials, and sterilization parameters. There is no mention of software, algorithms, data processing, or any terms related to AI or ML.
Yes
The device is described as an implantable nail intended to stabilize fractures of the tibia, aligning with the definition of a therapeutic device designed to treat a medical condition.
No
The description indicates the device is an implantable nail used to stabilize fractures, not to diagnose medical conditions.
No
The device description clearly describes a physical implantable medical device (a tibial nail) made of titanium, with specific dimensions and features, and mentions sterilization requirements. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "stabilize fractures of the tibia." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "Synthes Titanium Cannulated Tibial Nail," which is an implantable medical device used to fix bones.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
The description clearly indicates a device used in vivo (within the living body) for a structural purpose, not a test performed in vitro (in a lab setting) on a sample.
N/A
Intended Use / Indications for Use
Both devices mentioned above are intended to stabilize fractures of the tibia. Indications include, but are not limited to, open and closed tibial shaft fractures, certain pre- and post-isthmic fractures, tibial malunions and tibial non-unions.
Product codes
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Device Description
The Synthes Ti CTN is available in sizes ranging from 11 mm in diameter and in lengths ranging from 255 mm to 420 mm. The nail has a cannulated tube with a bend in the sagittal plane which facilitates insertion into the tibia. There are four locking holes proximally and three locking holes distally. All of the locking holes accept 4.9 mm Titanium Locking Bolts.
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
tibia
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
Image /page/0/Picture/0 description: The image shows the Synthes logo. The logo consists of a circular symbol on the left, followed by the word "SYNTHES" in bold, sans-serif font. A registered trademark symbol is located to the right of the word "SYNTHES".
Attachment VII:
Summary of Safety and Effectiveness Information
Synthes (USA) 1690 Russell Road Paoli, PA 19301
(610) 647-9700 Contact: Angela Silvestri May 1996
JUL 2 4 1996
Synthes Titanium Cannulated Tibial Nail (Ti CTN) is compared to Synthes Ti-6Al-7Nb Unreamed Tibial Nail and is an extension to Synthes Titanium Tibial Nail System.
Both devices mentioned above are intended to stabilize fractures of the tibia. Indications include, but are not limited to, open and closed tibial shaft fractures, certain pre- and post-isthmic fractures, tibial malunions and tibial non-unions.
The Synthes Ti CTN is available in sizes ranging from 11 mm in diameter and in lengths ranging from 255 mm to 420 mm. The nail has a cannulated tube with a bend in the sagittal plane which facilitates insertion into the tibia. There are four locking holes proximally and three locking holes distally. All of the locking holes accept 4.9 mm Titanium Locking Bolts.
The devices will be provided both sterile. The non-sterile devices must be sterilized prior to use. The following sterilization parameters are recommended:
| Method | Cycle | Time | Temperature |
|---|---|---|---|
| Steam | Pre-Vacuum | 6 minutes | 132°C - 135°C |
| Steam | Gravity Displacement | 15 minutes | 132°C - 135°C |