(44 days)
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No
The summary describes a mechanical external fixator and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is used for fracture fixation, limb lengthening, and correction of deformities, which are therapeutic interventions.
No
The device is described as an external fixator used for fracture fixation, limb lengthening, and deformity correction, which are therapeutic rather than diagnostic purposes.
No
The device description explicitly states it is a "modular unilateral, extensible device" with components made of aluminum, stainless steel, cobalt alloy, brass, and nylon, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures involving fracture fixation, limb lengthening, deformity correction, and joint arthrodesis. These are all procedures performed on the patient's body.
- Device Description: The description details a modular external fixator made of materials like aluminum, stainless steel, etc., which are typical for surgical implants and external fixation devices.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information about a patient's health status.
IVDs are devices used to perform tests on samples taken from the human body to diagnose diseases or other conditions. This device is a surgical tool used to treat conditions directly on the patient.
N/A
Intended Use / Indications for Use
Indications for the Heidelberg Fixator include: fracture fixation (open and closed); pseudoarthrosis or nonunion of long bones; limb lengthening, correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Heidelberg External Fixator is a modular unilateral, extensible device used for the indications listed previously. Components are made of aluminum, stainless steel, cobalt alloy, brass, and nylon which are similar to materials used in other unilateral fixators.
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
long bones
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
Summary of Safety and Effectiveness Heidelberg External Fixator
APR | 6 1997
Substantial Equivalence Information
The Heidelberg External Fixator is substantially equivalent to the following:
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- Hex-Fix Field Fixator--K953397
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- Orthofix External Fixator -- K802814
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- Ilizarov External Fixator System -- K870961
All of the devices listed above have similar indications for use, similar materials composition, and similar design. The safety and effectiveness of external fixators is based on the long history of use of these devices in the market place.
Device Description
The Heidelberg External Fixator is a modular unilateral, extensible device used for the indications listed previously. Components are made of aluminum, stainless steel, cobalt alloy, brass, and nylon which are similar to materials used in other unilateral fixators.
Indications for Use
Indications for the Heidelberg Fixator include: fracture fixation (open and closed); pseudoarthrosis or nonunion of long bones; limb lengthening, correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis.