(25 days)
Not Found
Not Found
No
The summary describes a mechanical external fixation system and explicitly states that the fundamental scientific technology has not changed from the previously cleared system. There are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML devices.
Yes
The device is used for the treatment of bone conditions such as leg lengthening, osteotomies, arthrodesis, and fracture fixation, which implies a therapeutic purpose.
No
The device is an external fixation system used for treating bone conditions, not for diagnosing them. Its purpose is to physically stabilize and correct bone structures.
No
The device description explicitly states that the system consists of "external fixation components and implantable bone screws," which are hardware components.
No, this device 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. This testing is done outside of the body (in vitro).
- Device Description: The EBI XFIX® DFS® Metaphyseal Correction System is an external fixation system with implantable bone screws. It is used directly on the patient's bone to treat conditions like fractures, osteotomies, and leg lengthening. This is an in vivo (within the living body) application.
- Intended Use: The intended use clearly describes a surgical procedure involving the direct application of the device to the bone for structural support and correction. It does not involve the analysis of biological specimens.
Therefore, based on the provided information, the EBI XFIX® DFS® Metaphyseal Correction System is a surgical device used for external fixation, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The EBI XFIX® DFS® Metaphyseal Correction System is 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.
Product codes (comma separated list FDA assigned to the subject device)
KTT
Device Description
The EBI XFIX® DFS® Metaphyseal Correction System has not changed the Indications for Use or fundamental scientific technology of the previously cleared system. The system consists of external fixation components and implantable bone screws. The EBI XFIX® DFS® Metaphyseal Correction System is utilized in the following manner: bone screws are inserted through the patient's skin and soft tissue and into the bone. The fixator frame of the EBI XFIX® DFS® Metaphyseal Correction System is attached to the shanks of the bone screws. This submission is for additional components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
Indicated Patient Age Range
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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): 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.
EBI XFIX® DFS® System EBI, L.P.
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).
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
510(k) Summary of Safety & Effectiveness
This 510(k) Summary of Safety and Effectiveness for the EBI XFIX® DFS® Metaphyseal Correction System is provided as required per Section 513(3) of the Food, Drug and Cosmetic Act.
| 1. Submitter: EBI, L.P.
100 Interpace Parkway
Parsippany, NJ 07054 | Contact Person: Jon Caparotta
Telephone: (973) 299-9022 |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Date prepared: April 27, 2000 | |
| 2. Proprietary Name: | EBI XFIX® DFS® Metaphyseal Correction
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:
- EBI XFIX® DFS® System EBI, L.P. �
-
- Description of the device: The EBI XFIX® DFS® Metaphyseal Correction System has not changed the Indications for Use or fundamental scientific technology of the previously cleared system. The system consists of external fixation components and implantable bone screws. The EBI XFIX® DFS® Metaphyseal Correction System is utilized in the following manner: bone screws are inserted through the patient's skin and soft tissue and into the bone. The fixator frame of the EBI XFIX® DFS® Metaphyseal Correction System is
1
attached to the shanks of the bone screws. This submission is for additional components.
-
- Intended Use: The EBI XFIX® DFS® Metaphyseal Correction System is 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 titanium, stainless steel, and aluminum.
-
- Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the EBI XFIX® DFS® Metaphyseal Correction 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 marketed without pre-market approval or reclassification and is not intended to be interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with three wing-like shapes. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2000
Mr. Jon Caparotta Manager, Regulatory Affairs EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054-1079
Re: K001358
Trade Name: EBI XFIX® DFS® Metaphyseal Correction System Regulatory Class: II Product Code: KTT Dated: April 27, 2000 Received: April 28, 2000
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, 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.
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.
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Page 2 - Mr. Jon Caparotta
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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Dona R. Lochner
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
1_of_1 Page
510(k) Number (if known): との01ろ58
Device Name: EBI XFIX® DFS® Metaphyseal Correction System
Indications For Use:
The EBI XFIX® DFS® Metaphyseal Correction 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Dune R. Lochner
vision Sign-Off Division of General Restorative Devices 510(k) Number K 001358
G
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