(88 days)
There are no K/DEN numbers present in the provided text.
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No
The summary describes a titanium fixation system and does not mention any software, image processing, or AI/ML terms.
No
The provided information describes the composition of a fixation system (Bioplate Fixation System) which is a device implanted in the body. While it's used to fix bones, its primary function is structural support and stabilization, not to directly treat a disease or medical condition in a therapeutic manner such as drug delivery or energy application for treatment. Its action is mechanical.
No
Explanation: The device is described as a "Fixation System" made of titanium, which is typically used for surgical implantation rather than diagnosis. There is no mention of diagnostic functions or capabilities.
No
The device description explicitly states it is manufactured of titanium, indicating it is a physical hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro testing: The description focuses on the materials and intended use for fixation within the body (implants). There is no indication that this device is used to test samples (like blood, urine, or tissue) outside of the body.
- Focus on implantation: The description explicitly states the materials are "implanted safely for many years," which is characteristic of an implantable medical device, not an IVD.
- Lack of IVD-related information: The provided sections do not include any information typically associated with IVDs, such as:
- Intended use for diagnosing a condition based on in vitro analysis.
- Mention of reagents, assays, or laboratory procedures.
- Performance metrics relevant to diagnostic accuracy (sensitivity, specificity, etc.).
Therefore, the Bioplate Fixation System, as described, is a medical device intended for implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
The Bioplate Fixation System is manufactured of commercially pure titanium and a titanium 6A1-4V ELI alloy, materials that have been implanted safely for many years.
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
AUG 1 6 1996
BIOMEDICS, INC. 536 South Rimpau Boulevard Los Angeles, California 90020-4832 Tel: (213) 934-4700, FAX: (213) 934-8212
Summary of Safety and Effectiveness
This statement regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The Bioplate Fixation System is manufactured of commercially pure titanium and a titanium 6A1-4V ELI alloy, materials that have been implanted safely for many years. These materials are recognized as acceptable for implantation purposes through device classification (for example, see 21 Code of Federal Regulations, sections 888.3030.)
The plates are substantially equivalent in construction and design to the predicate devices manufactured by Howmedica, Medicon, Inc. , KLS and W.L. Lorenz. The screws are manufactured of a titanium alloy that is substantially equivalent in design to the predicate devices.