(45 days)
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No
The summary describes a physical internal wire fixation device and makes no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as an "internal wire fixation device to be used on various types of articular fractures" and is intended for "osteosyntheses of epiphysial fractures with small osteoarticular fragments and for temporary support of dislocations of small articulations," which are therapeutic applications.
No
The device is described as an "internal wire fixation device" intended for osteosyntheses of fractures and temporary support of dislocations. Its function is to fix or support anatomical structures, not to identify or diagnose medical conditions.
No
The device description explicitly states it is an "internal wire fixation device," which is a physical hardware component, not software.
Based on the provided information, the Block Stop Wires device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used in vivo (within the body) for the fixation of fractures and support of dislocations. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to provide information about a person's health.
- Device Description: The description confirms it's an "internal wire fixation device," which is used surgically within the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVDs.
Therefore, the Block Stop Wires device is a surgical implant/device, not an IVD.
N/A
Intended Use / Indications for Use
The Block Stop Wires device is intended for use in the osteosyntheses of epiphysial fractures with small osteoarticular fragments and for temporary support of dislocations of small articulations.
Product codes
Pin, fixation, smooth.
Device Description
The Block Stop Wires device is an internal wire fixation device to be used on various types of articular fractures.
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
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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)
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
Image /page/0/Picture/0 description: The image shows the logo for Ferguson Medical. The logo consists of a stylized letter "M" on the left, followed by the words "FERGUSON" and "MEDICAL" stacked on top of each other on the right. The font is bold and sans-serif, and the entire logo is in black.
916-342-4133 FAX: 916-343-4541
NOV 25 1996
10 September 1996
K964087
510 ( k ) SUMMARY
The 510(k) summary information required by 21 CFR 807.92 is as follows:
- A. Classification name: Pin, fixation, smooth.
Common/usual name: Fixation wire, fixation pin, and others
Proprietary name: Block Stop Wires
- B. Substantial equivalence: Kirschner Medical Wire and Steinman Pins (K831005), and others.
- C. Device description: The Block Stop Wires device is an internal wire fixation device to be used on various types of articular fractures.
- D. Intended use: The Block Stop Wires device is intended for use in the osteosyntheses of epiphysial fractures with small osteoarticular fragments and for temporary support of dislocations of small articulations.
- E. Technological characteristics: The Block Stop Wires device is similar to predicate devices in its design, function, and intended use.