(31 days)
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No
The device description and intended use are purely mechanical and do not mention any software, algorithms, or data processing capabilities that would indicate AI/ML.
No
The device is used for fracture fixation, which is a structural support function rather than a therapeutic (treating disease or illness) function.
No
The device description indicates it is a surgical pin used for fracture fixation, not for identifying or diagnosing a condition. Its function is to treat, not to detect.
No
The device description clearly states it is a physical pin made of stainless steel, available in different lengths and diameters, and is provided pre-sterile. This indicates a hardware medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The Acumed Tension Band Pin is a physical implant made of stainless steel, designed to be surgically inserted into the body to fix fractures.
- Intended Use: Its intended use is for fracture fixation in tension band wiring procedures, which is a surgical technique performed inside the body.
The description clearly indicates a surgical implant used for structural support within the body, not a device used for testing biological samples in a lab.
N/A
Intended Use / Indications for Use
The Acumed Tension Band Pin is used in conjunction with orthopedic wire to address malleolar, patella, and oleacranon fracture fixation in tension band wiring procedures. This device is not intended for usage in the spine.
Product codes
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Device Description
The Acumed Tension Band Pin is used in conjunction with orthopedic wire to address malleolar, patella, and oleacranon fracture fixation in tension band wiring procedures. This device is not intended for usage in the spine. This device has a diameter of .0625" and is available in lengths of 35mm, 45mm, and 55mm. The Acumed Tension Band Pin is manufactured from 316L stainless steel and is provided pre-sterile. Sterility is achieved by a minimum dose of 2.5 megarads of gamma radiation. Validation of sterility is maintained on site. Sterility level is10.4. Information regarding packaging and labeling have been provided.
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
malleolar, patella, and oleacranon
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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§ 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
Quality Orthopaedic Instruments and Implants
DEC વે વિવેત
Enclosure D - 510(k) Summary
This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.93.
The Acumed Tension Band Pin is used in conjunction with orthopedic wire to address malleolar, patella, and oleacranon fracture fixation in tension band wiring procedures. This device is not intended for usage in the spine. This device has a diameter of .0625" and is available in lengths of 35mm, 45mm, and 55mm. The Acumed Tension Band Pin is manufactured from 316L stainless steel and is provided pre-sterile. Sterility is achieved by a minimum dose of 2.5 megarads of gamma radiation. Validation of sterility is maintained on site. Sterility level is10.4. Information regarding packaging and labeling have been provided.
The Acumed Tension Band Pin is similar to the Acumed Fixation Pin and the Howmedica Kirschner Wire in material and design. Like Howmedica's Kirschner Wire, the Acumed Tension Band Pin is intended to be used in tension band wiring procedures addressing malleolar, patella, and olecranon fractures.
Based on the similarities between the Acumed Tension Band Pin and both the Acumed Fixation Pin and Howmedica Kirschner Wire, the safety and effectiveness is expected to be similar to the Acumed Fixation Pin and Howmedica Kirschner Wire.