(71 days)
Not Found
Not Found
No
The summary describes a mechanical external fixation system with no mention of AI or ML components or functionality.
Yes
The device is described as an external fixation device "intended for use in the treatment of bone conditions including limb lengthening, corrective osteotomies, arthrodesis, fracture fixation, acute or gradual multiplanar correction and other bone conditions." This directly indicates a therapeutic purpose.
No
Explanation: The EBI XFIX DFS® Rail System is described as an external fixation device used for treating bone conditions, including limb lengthening, corrective osteotomies, and fracture fixation. Its function is to provide physical support and stabilization for therapy, not to diagnose a condition.
No
The device description explicitly states it consists of "fixation components and implantable bone screws," which are hardware components, not software.
Based on the provided information, the EBI XFIX DFS® Rail System 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, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the EBI XFIX DFS® Rail System is an external fixation device used for treating bone conditions by being attached to bone screws inserted into the patient. This is a surgical device used directly on the patient's body, not for analyzing samples taken from the body.
Therefore, the EBI XFIX DFS® Rail System falls under the category of a surgical or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The EBI XFIX DFS® Rail System is a unilateral external fixation device intended for use in the treatment of bone conditions including limb lengthening, corrective osteotomies, arthrodesis, fracture fixation, acute or gradual multiplanar correction and other bone conditions amenable to treatment by use of the external fixation modality.
Product codes
KTT
Device Description
The system consists of fixation components and implantable bone screws. The EBI XFIX DFS Rail System is utilized in the following manner: bone screws are inserted through the patient skin and soft tissue and into the bone. The fixator frame of the EBI XFIX DFS Rail System is attached to the shanks of the bone screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
EBI XFIX DynaFix Fixation System, The Adult Limb Reconstruction System Orthofix. Inc., Heidelberg External Fixator Smith and Nephew, Inc.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
K99/94)
10Fa
510(k) Summary of Safety & Effectiveness
This 510(k) Summary of Safety and Effectiveness for the EBI XFIX DFS® Rail System is provided as required per Section 513(1)(3) of the Federal Food, Drug and Cosmetic Act.
Electro-Biology, Inc. Contact Person: Jonas Wilf 1. Sponsor: 100 Interpace Parkway Telephone: (973) 299-9022 Parsippany, NJ 07054
Date prepared: June 8, 1999
| 2. Proprietary Name: | EBI XFIX DFS® Rail System |
|---|---|
| Common Name: | External Fixation Device |
| Classification Names: | Single Multiple Component Metallic Bone |
| Fixation Appliances and Accessories, 21 CFR 888.3030. |
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- Predicate or legally marketed devices that are substantially equivalent:
- 으 EBI XFIX DynaFix Fixation System - Electro-Biology, Inc.
- The Adult Limb Reconstruction System Orthofix. Inc. t
- Heidelberg External Fixator Smith and Nephew, Inc. .
- Description of the device: The system consists of fixation components and 4. implantable bone screws. The EBI XFIX DFS Rail System is utilized in the following manner: bone screws are inserted through the patient skin and soft tissue and into the bone. The fixator frame of the EBI XFIX DFS Rail System is attached to the shanks of the bone screws.
- Intended Use: The EBI XFIX DFS® Rail System is a unilateral external fixation ડ. device intended for use in the treatment of bone conditions including limb lengthening, corrective osteotomies, arthrodesis, fracture fixation, acute or gradual multiplanar correction and other bone conditions amenable to treatment by use of the external fixation modality.
- Materials: The components of the system may be manufactured from materials such 6. as Aluminum, Stainless Steel, Pyromet® 718, and Ti-6Al-4V ELI,
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- Comparison of the technological characteristics of the device to predicate devices:
The EBI XFIX DFS Rail System is substantially equivalent to the following predicate EBI and competitive devices. The components of the EBI XFIX DFS
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K 99 1941
2 of 2
Rail System are fabricated from the same materials as the components of the currently marketed EBI XFIX DynaFix Fixation System.
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The bone screw clamps of the EBI XFIX DFS Rail System, like the bone screw . clamps currently marketed competitive Adult Limb Reconstruction System -Orthofix, Inc. and EBI XFIX DynaFix Fixation System, are designed for attachment
to the bone screws. In addition the bone screw clamps of the EBI XFIX DFS Rail System and the competitive Adult Limb Reconstruction System - Orthofix, Inc are designed to track along the length of the rail. -
The Compression Distraction Clicker of the design of the EBI XFIX DFS Rail . System, like the currently marketed competitive Adult Limb Reconstruction System - Orthofix, Inc. and Heidelberg External Fixator-Smith & Nephew, is designed to provide the surgeon the ability to compress or distract the bone of the patient postoperatively for optimal treatment.
The EBI XFIX DFS Rail System like the currently marketed EBI XFIX DynaFix Fixation System and competitive Adult Limb Reconstruction System - Orthofix, Inc. and Heidelberg External Fixator-Smith & Nephew, is provided non-sterile. There are no significant differences between the EBI SpineLink™ System and other currently marketed spinal systems. It is substantially equivalent* to the predicate devices in regards to intended use, materials 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 the product can be lawfully market without pre-market approval or reclassification and is not interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premation Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved lines that resemble a human figure in profile, with the lines representing the head, body, and legs. The overall design is simple and conveys a sense of health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1999
Mr. Jon Caparotta Manager, Regulatory Affairs Electro-Biology, Incorporated 100 Interpace Parkway Parsippany, New Jersey 07054
Re: K991941
Trade Name: EBI XFIX DFS® Rail System Regulatory Class: II Product Code: KTT Dated: June 8, 1999 Received: June 9, 1999
Dear Mr. Caparotta:
We have reviewed your Section 510(k) notification of intent to market the device referenced above, and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the Act. The general control provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, EDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Jon Caparotta
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Russell S. Rogers
Sa~Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
×991941
Statement of Indications for Use:
The EBI XFIX DFS® Rail System is a unilateral external fixation device intended for use in the treatment of bone conditions including limb lengthening, corrective osteotomies, arthrodesis, fracture fixation, acute or gradual multiplanar correction and other bone conditions amenable to treatment by use of the external fixation modality.
Russell H. Vayner Su, Jr.
ivision Sign-Off) of General icos 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
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