(84 days)
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No
The device description and intended use are purely mechanical, and there are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML devices.
Yes
The device is described as stabilizing and providing "treatment for fractures of the hand and foot," which indicates a therapeutic purpose.
No
The device is described as an external fixator used to stabilize and treat fractures, which is a therapeutic function, not a diagnostic one. It does not mention any ability to identify or characterize a disease or condition.
No
The device description explicitly lists physical components made of stainless steel and carbon fiber reinforced epoxy, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "stabilize and provide treatment for fractures of the hand and foot." This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The components are mechanical parts (wires, clamps, rods) used for external fixation. They do not involve the analysis of biological samples (blood, urine, tissue, etc.) which is the hallmark of IVDs.
- No mention of biological samples or analysis: The description focuses on the physical components and their function in stabilizing fractures.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Synthes Mini External Fixator stabilizes and provides treatment for fractures of the hand and foot.
Product codes
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Device Description
Synthes Mini External Fixator includes the following components: Threaded Kirschner Wires, Wire-to-Rod and Rod-to-Rod Clamps, Rods and an Angled Connecting Bar.
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
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
mechanical testing
Key Metrics
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Predicate Device(s)
Howmedica Mini Hoffmann External Fixation System
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
SYNTHES®
JUN 2 8 1996
Attachment B: Summary of Safety and Effectiveness Information [510(k) Summary]
SYNTHES (USA) 1690 Russell Road Paoli, PA 19301
(610) 647-9700 Contact: Angela Silvestri June 1996
Device: Synthes Mini External Fixator is compared to the Howmedica Mini Hoffmann External Fixation System.
The Synthes Mini External Fixator stabilizes and provides treatment for fractures of the hand and foot. Synthes Mini External Fixator includes the following components: Threaded Kirschner Wires, Wire-to-Rod and Rod-to-Rod Clamps, Rods and an Angled Connecting Bar. It is anticipated that the most common use of the device would be as follows:
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- A K-wire is inserted into the proximal and distal fracture with the help of a soft tissue protector.
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- Slide one clamp over each K-wire; slide rod through both clamps.
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- After the fracture is repositioned, securely tighten the nuts for the K-wire and the rod.
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- Place the two remaining K-wires through the two clamp openings.
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- Tighten all clamp nuts.
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- Cut K-wires.
The wires are manufactured from stainless steel; the clamps and angled connecting bar from various grades of stainless steel, the rods from carbon fiber reinforced epoxy.
The Howmedica Mini Hoffmann External Fixation System is also intended for immediate reduction and stabilization of fractures of the hand, wrist, foot and maxillofacial area. It is manufactured from stainless steel.
Based on the results of the mechanical testing, Synthes Mini External Fixator provides fixation that is at least equivalent to or stiffer than the Howmedica Mini Hoffmann External Fixation System.