K Number
K961433
Device Name
EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BONE SCREWS
Date Cleared
1996-06-28

(74 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EBI X FIX DynaFix System is intended for 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. The EBI DFS™ Distal Radius Fixator is intended for use in upper extremity applications for the reduction, alignment and stabilization of intra-articular and extra-articular fractures, corrective osteotomies, and soft tissue deformities.
Device Description
The bone screws have a tapered thread diameter and are available in a variety of diameters and lengths in both cortical and cancellous thread patterns. The screws will be available with and without the additional proprietary silver coating which has been shown to significantly reduce bacterial colonization of the surface, and will be sold sterile and nonsterile.
More Information

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Not Found

No
The summary describes a mechanical external fixation system and bone screws, with no mention of AI or ML capabilities.

Yes
The device is described as "intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions" which directly indicates a therapeutic purpose.

No
The provided text describes a device for the treatment of bone conditions and fracture fixation, which are therapeutic procedures, not diagnostic ones.

No

The device description explicitly details physical components like bone screws with varying diameters, lengths, and thread patterns, and mentions a proprietary silver coating. This indicates a hardware-based medical device, not a software-only one.

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 the treatment of bone conditions and fractures through external fixation. This is a therapeutic intervention performed directly on the patient's body.
  • Device Description: The description details bone screws, which are physical implants used in surgery.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment decisions.

IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside or on the body) for surgical treatment.

N/A

Intended Use / Indications for Use

The EBI X FIX DynaFix System is intended for 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. The EBI DFS™ Distal Radius Fixator is intended for use in upper extremity applications for the reduction, alignment and stabilization of intra-articular and extra-articular fractures, corrective osteotomies, and soft tissue deformities.

Product codes

888.3030

Device Description

The bone screws have a tapered thread diameter and are available in a variety of diameters and lengths in both cortical and cancellous thread patterns. The screws will be available with and without the additional proprietary silver coating which has been shown to significantly reduce bacterial colonization of the surface, and will be sold sterile and nonsterile.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

The coated screws underwent biocompatibility, fatigue, and direct inoculation testing.

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.

Not Found

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.

Not Found

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

K961433

JUN 2 8 1996

510(k) Summary of Safety & Effectiveness

This 510(k) Summary of Safety and Effectiveness for the EBI X FIX™ DynaFix™ System and EBI DFS™ Distal Radius Fixator is provided as required per Section 513(1)(3) of the Food, Drug and Cosmetic Act.

    1. Submitter: Electro-Biology, Inc. 6 Upper Pond Road Parsippany, NJ 07054
      Contact Person: Sharon A. Starowicz Telephone: (201) 331-3904

Date prepared: June 26, 1996

| 2. Proprietary Name: | EBI X FIXT™ DynaFix™ System - SC Bone Screws
EBI DFST™ Distal Radius Fixator - SC Bone Screws |
|----------------------|--------------------------------------------------------------------------------------------------|
| Common Name: | External Fixation Bone Screws |
| Classification Name: | Single/Multiple Component Metallic Bone Fixation Appliances and
Accessories (888.3030) |

    1. Predicate or legally marketed devices that are substantially equivalent:
    • EBI X FIX™ DynaFix™ System and DFS™ Distal Radius Fixator Bone Screws
    • · Vitaphore SilverFoam Wound Dressing
    • " Genetic Laboratories E-Z DERM™ Temporary Skin Substitute with Silver
    • · Arrow Antimicrobial Multi-Lumen Central Venous Catheter
    • · Vitaphore Pin Protection Device
  • বঁ Description of the device: The bone screws have a tapered thread diameter and are available in a variety of diameters and lengths in both cortical and cancellous thread patterns. The screws will be available with and without the additional proprietary silver coating which has been shown to significantly reduce bacterial colonization of the surface, and will be sold sterile and nonsterile.

Intended Use: The EBI X FIX DynaFix System is intended for 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. The EBI DFS™ Distal Radius Fixator is intended for use in upper extremity applications for the reduction, alignment and stabilization of intra-articular and extra-articular fractures, corrective osteotomies, and soft tissue deformities.

    1. Materials: The SC bone screws are manufactured from stainless steel, 316L per ASTM F138. The silver coating is applied by a proprietary process according to Device Master File MAF-480.
    1. Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the SC bone screws and other currently marketed bone screws. The addition of the silver coating will not adversely affect the use of the bone screws. The coated screws underwent biocompatibility, fatigue, and direct inoculation testing. They are substantially equivalent* to the predicate devices in design and function.

*Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully market approval or reclassification and is not intended to be interpreted as an admission or any other in patent infringement lingulon. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.))