(57 days)
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No
The device description and performance studies focus on the mechanical properties of carbon tubes for external fixation, with no mention of AI or ML.
No
Explanation: The device is described as "connecting elements for use with the Monotube® Clamps for the construction of external fixation frames". These are components of a medical device, not a complete therapeutic device themselves. While part of a therapeutic system (external fixation), the description focuses on their mechanical properties and material changes, indicating they are structural components.
No
The device description clearly states "The Monotube® Carbon Tubes... are connecting elements for use with the Monotube® Clamps for the construction of external fixation frames." This indicates a structural, mechanical function, not one involved in diagnosing a condition.
No
The device description clearly states it is a physical component (tubes) used in external fixation frames, and the performance studies focus on mechanical properties.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The text explicitly states the intended use is for "connecting elements for use with the Monotube® Clamps for the construction of external fixation frames." This describes a surgical or orthopedic device, not a device used to examine specimens from the human body in vitro.
- Device Description: The description focuses on the physical characteristics and function of the tubes as part of an external fixation system.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical characteristics of an IVD.
Therefore, this device falls under the category of a medical device used for external fixation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Monotube® Carbon Tubes, previously cleared in a premarket 510(k) submission, are connecting elements for use with the Monotube® Clamps for the construction of external fixation frames.
Product codes
888.3040
Device Description
The Monotube® Carbon Tubes are connecting elements for use with the Monotube® Clamps for the construction of external fixation frames. The tubes are available in 15mm, 20mm and 25mm diameters and a variety of lengths to accommodate varying anatomical situations. This present submission describes a change in material and manufacturing method to these tubes.
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
Testing of the devices is presented in the submission. Testing was performed to compare the static mechanical properties of the tube and subassemblies using both the existing tubes and the tubes that are the subject of this submission. Static axial compressive frame testing was also performed to determine frame yield strength and stiffness.
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
NOV -6 1996
510(k) Summary
Trade Name: Common Name: Classification Name: Monotube® Carbon Tube External Fixation Tube Smooth or Threaded Metallic Bone Fixation Fastener 888.3040
The Monotube® Carbon Tubes, previously cleared in a premarket 510(k) submission, are connecting elements for use with the Monotube® Clamps for the construction of external fixation The tubes are available in 15mm, 20mm and 25mm diameters frames. and a variety of lengths to accommodate varying anatomical This present submission describes a change in situations. material and manufacturing method to these tubes.
Equivalency of this device is based on similarities in intended use, materials, design and operational principles to the previously cleared Monotube® Carbon Tubes.
Testing of the devices is presented in the submission. Testing was performed to compare the static mechanical properties of the tube and subassemblies using both the existing tubes and the tubes that are the subject of this submission. Static axial compressive frame testing was also performed to determine frame yield strength and stiffness.
For information contact: John Dichiara
Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 (201) 507-7386 Fax: (201) 507-6870