(67 days)
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No
The description focuses on the mechanical components and function of an external fixation system, with no mention of AI or ML.
Yes
The device is described as an external fixation system intended for the treatment of various bone conditions, including leg lengthening, osteotomies, arthrodesis, and fracture fixation, which are therapeutic uses.
No
The device is an external fixation system used for treating bone conditions, not for diagnosing them. Its purpose is to physically stabilize and aid in the healing or lengthening of bone, not to identify or assess medical conditions.
No
The device description explicitly states it consists of physical components like fixator rails, bone screws, and clamps made of aluminum alloy, titanium alloy, and stainless steel. It is a hardware-based external fixation system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The EBI X FIX™ DynaFix® Mini External Fixation System is a physical device that is surgically implanted or attached externally to the bone. It directly interacts with the patient's body for structural support and manipulation of bone.
- Intended Use: The intended uses (leg lengthening, osteotomies, arthrodesis, fracture fixation) are all procedures performed directly on the patient's bone, not on specimens taken from the patient.
The device is a surgical implant/external fixation device, not an IVD.
N/A
Intended Use / Indications for Use
The EBI X FIX™ DynaFix® Mini External Fixation System is a unilateral external fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis. fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. External fixators are recommended for Class II by the Orthopedic Panel (Single/Multiple Component Metallic Bone Fixation Appliance, 21 CFR 888.3030).
Product codes
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Device Description
The EBI X FIX™ DynaFix® Mini External Fixation System consists of fixator components and bone screws. The fixator frame consists of fixator rails which are connected by a central component. The fixator frame attaches to the bone via bone screws which penetrate the patient's skin. The fixator frame secures to the shanks of the bone screws with bone screw clamps. The EBI X FIX™ DynaFix® Mini External Fixation System is capable of providing physicians with capability to lengthen. The EBI X FIX™ DynaFix® Mini External Fixation System frame components are composed of aluminum alloy, titanium alloy and stainless steel. The EBI X FIX™ DynaFix® Mini External Fixation System bone screws are made of 316L stainless steel.
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
Comparative testing of the EBI X FIX™ DynaFix® Mini External Fixation System and the Orthofix® Mini Fixator and Mini Lengthener was performed. The testing included static and fatigue testing. The results demonstrate that in general, the EBI X FIX™ DynaFix® Mini External Fixation System has greater mechanical strength than the Orthofix® Mini Fixator and Mini Lengthener.
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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§ 888.3030 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 Electro Biology, Inc. The logo consists of the letters "EBI" in large, bold, black font, followed by the words "Electro Biology" in a smaller, italicized font. There is a line above the word "Electro" and a small symbol above the "I" in "EBI".
Enhancing Bone Healing through Applied Science
970290
510(k) SUMMARY FOR THE X FIX™ DynaFix® Mini External Fixation System
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The EBI X FIX™ DynaFix® Mini External Fixation System is a unilateral external fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis. fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. External fixators are recommended for Class II by the Orthopedic Panel (Single/Multiple Component Metallic Bone Fixation Appliance, 21 CFR 888.3030).
The EBI X FIX™ DynaFix® Mini External Fixation System is substantially equivalent to the Orthofix® Mini Fixator and Orthofix® Mini Lengthener (Orthofix® S.R.L., Verona Italy) the Synthes Mini External Fixator (Synthes, USA) and the Hoffman Mini External Fixator (Howmedica, Inc.).
The EBI X FIX™ DynaFix® Mini External Fixation System consists of fixator components and bone screws. The fixator frame consists of fixator rails which are connected by a central component. The fixator frame attaches to the bone via bone screws which penetrate the patient's skin. The fixator frame secures to the shanks of the bone screws with bone screw clamps. The EBI X FIX™ DynaFix® Mini External Fixation System is capable of providing physicians with capability to lengthen. The EBI X FIX™ DynaFix® Mini External Fixation System frame components are composed of aluminum alloy, titanium alloy and stainless steel. The EBI X FIX™ DynaFix® Mini External Fixation System bone screws are made of 316L stainless steel.
Comparative testing of the EBI X FIX™ DynaFix® Mini External Fixation System and the Orthofix® Mini Fixator and Mini Lengthener was performed. The testing included static and fatigue testing. The results demonstrate that in general, the EBI X FIX™ DynaFix® Mini External Fixation System has greater mechanical strength than the Orthofix® Mini Fixator and Mini Lengthener.
In summary, the results of the static and fatigue testing and the comparison of the systems' intended uses, components and designs demonstrate that the EBI X FIX™ DynaFix® Mini External Fixation System is substantially equivalent to the Orthofix® Mini Fixator and Orthofix® Mini Lengthener, the Synthes Mini External Fixator and the Hoffman Mini External Fixator.
X. Sarto
Jon Caparolta Manager, Regulatory Affairs Electro-Biology, Inc.
1/23/97
Date
ion with this submission regarding a determination of subs lawfully marketed without pre-market approval or reclassification and is not in ad on he Inter sion or any other type of evidence of infinement litication (Fatablishment Register) Norification Processor. Finel Reminion Programme, August 23, 1977 42 FR 4230 (Tacker N RA-03551