(47 days)
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No
The summary describes a mechanical external fixator and does not mention any software, image processing, AI, or ML capabilities.
No
The device, an external fixator, is used for mechanical support and stabilization of fractures, which is a structural intervention rather than a therapeutic one (i.e., treating a disease or disorder).
No
The device description clearly states it is an external fixator for bones, used for treatment (fixation of fractures and reconstruction), not for diagnosing conditions.
No
The device description explicitly states it is a "unilateral external fixator," which is a physical hardware device used for bone fixation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "external fixation of fractures and/or the reconstruction of small bones." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is an "external fixator designed for use on small bones." This is a physical device used to stabilize bones externally.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. The provided description does not mention any such use or interaction with biological specimens.
Therefore, the MINIFIX is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MINIFIX is intended for use in external fixation of fractures and/or the reconstruction of small bones, including, but not limited to, metacarpal and metatarsal.
Product codes
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Device Description
The MINIFIX is a unilateral external fixator designed for use on small bones such as the metacarpal.
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
small bones such as the metacarpal, metacarpal and metatarsal
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)
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 logo for Ferguson Medical. The logo has a stylized letter 'F' on the left side. To the right of the 'F' is the text 'FERGUSON MEDICAL' stacked on top of each other. The text and the 'F' are in a bold, sans-serif font.
916-342-4133 FAX: 916-343-454
NOV 27 1996
01 September 1996
K964094 510(k) SUMMARY
The 510(k) summary information required by 21 CFR 807.92 is as follows:
- Component, traction, A. Classification name: invasive, or pin, fixation, threaded.
Common/usual name: Unilateral mini-fixator, finger fixator, etc.
MINIFIX Proprietary name:
- equivalence: Howmedica Hoffmann B. Substantial Fixation Pin System (K861766), Lima-LTO SEM External Stabilizer (K880282) and Modular others.
- Device description: The MINIFIX is a unilateral C. . external fixator designed for use on small bones such as the metacarpal.
- The MINIFIX is intended for use in D. Intended use: external fixation of fractures and/or the reconstruction of small bones, including, but not limited to, metacarpal and metatarsal.
- The MINIFIX device E. Technological characteristics:
1
is similar to predicate devices in its design, function, and intended use.
The proposed device is quite simple in its configuration and design, therefore requires a minimum of instrumentation to install.
Submitted, FERGUSON MEDICAL Establishment Registration Number 2937794
Frank Feur
Frank Ferguson Official Correspondent