(28 days)
The EBI XFIX® Vision™ 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.
The EBI XFIX Vision Fixation System has not changed the Indications for Use or fundamental scientific technology of the previous cleared system. The system consists of external fixation components and implantable bone screws. The EBI XFIX Vision Fixation 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 Vision Fixation System is attached to the shanks of the bone screws. This submission is for additional components.
The provided text is a 510(k) Summary of Safety & Effectiveness for the EBI XFIX® Vision™ Fixation System, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study.
Therefore, the document does not contain the information requested regarding acceptance criteria, reported device performance, sample sizes for test or training sets, expert qualifications, ground truth establishment, or specific study designs (like MRMC or standalone performance).
Instead, the submission states:
- "The EBI XFIX Vision Fixation System has not changed the 4. Indications for Use or fundamental scientific technology of the previous cleared system."
- "The components of the EBI XFIX Vision Fixation System are fabricated from the same types of materials as the components of the currently marketed EBI XFIX DFS System and Howmedica External Fixation System."
- "The bone screw clamps of the EBI XFIX Vision Fixation System, like the bone screw . clamps currently marketed EBI XFIX DFS System, are designed for attachment to the bone screws."
- "The EBI XFIX Vision Fixation System like the currently marketed EBI XFIX DFS System is provided non-sterile."
- "There are no significant differences between the EBI XFIX Vision Fixation System and other currently marketed external fixation systems. It is substantially equivalent* to the predicate devices in regards to intended use, materials and function."
This type of submission relies on the prior clearance of predicate devices and highlights the similarities in intended use, materials, and function to argue for its safety and effectiveness, rather than presenting a de novo study with explicit acceptance criteria and performance metrics.
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510(k) Summary of Safety & Effectiveness
This 510(k) Summary of Safety and Effectiveness for the EBI XFIX® Vision™ Fixation System is provided as required per Section 513(1)(3) of the Federal Food, Drug and Cosmetic Act.
| 1. Sponsor: | EBI, L.P. |
|---|---|
| 100 Interpace Parkway | |
| Parsippany, NJ 07054 | |
| Contact Person: | Jonas Wilf |
| Telephone: | (973) 299-9022 |
Date prepared: November 12, 1999
| 2. Proprietary Name: | EBI XFIX® Vision™ Fixation System |
|---|---|
| Common Name: | External Fixation Device |
| Classification Names: | Single Multiple Component MetallicBone Fixation Appliances andAccessories, 21 CFR 888.3030. |
Predicate or legally marketed devices that are substantially equivalent: 3.
- EBI XFIX® DFS® System Electro-Biology, Inc. 피
- 트 Hoffmann II External Fixation System - Howmedica Corporation
- Description of the device: The EBI XFIX Vision Fixation System has not changed the 4. Indications for Use or fundamental scientific technology of the previous cleared system. The system consists of external fixation components and implantable bone screws. The EBI XFIX Vision Fixation 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 Vision Fixation System is attached to the shanks of the bone screws. This submission is for additional components.
- Intended Use: The EBI XFIX Vision Fixation System is a unilateral external fixation ધં 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.
- Materials: The components of the system may be manufactured from materials such as 6. Aluminum, Stainless Steel, Pvromet® 718, Carbon Fiber, and Ti-6A1-4V ELI.
-
- Comparison of the technological characteristics of the device to predicate devices:
- The EBI XFIX Vision Fixation System is substantially equivalent to the following . predicate EBI and competitive devices. The components of the EBI XFIX Vision
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Fixation System are fabricated from the same types of materials as the components of the currently marketed EBI XFIX DFS System and Howmedica External Fixation System.
- The bone screw clamps of the EBI XFIX Vision Fixation System, like the bone screw . clamps currently marketed EBI XFIX DFS System, are designed for attachment to the bone screws.
The EBI XFIX Vision Fixation System like the currently marketed EBI XFIX DFS System is provided non-sterile. There are no significant differences between the EBI XFIX Vision Fixation System and other currently marketed external fixation 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 to whether the product can be lawfully markets approval or reclassification and is not intended to be interpreted as an admission or any other type of evidence infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.))
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC I 4 1999
Mr. Jon Caparotta Manager, Regulatory Affairs EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054-1079
Re: K993886 Trade Name: EBI XFIX Vision Fixation System Regulatory Class: II Product Code: KTT Dated: November 12, 1999 Received: November 16, 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 legally marketed predicate 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 controls provisions of the Act. The general controls 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 requirements, 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, FDA 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) 594-4559. 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use:
The EBI XFIX® Vision™ 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.
Prescription Use
(Per 21 CFR 801.109)
brace
(Division Sign-Off)
Division of General Restorative Devices K993886
Number
§ 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.