(16 days)
Not Found
No
The summary describes a mechanical external fixation system and explicitly states the submission is only for modified bone screws, with no mention of AI/ML or related concepts.
Yes
The device is described as an "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," which clearly indicates a therapeutic purpose.
No
Explanation: The device is an external fixation system used for treating bone conditions, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states that the system consists of fixation components and implantable bone screws, which are hardware components. The submission is for modifications to these hardware components (self-drilling and blunt-tipped bone screws).
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, such as blood, urine, or tissue, to provide information about a person's health. They are used outside the body (in vitro).
- Device Description: The EBI® XFIX® DFS® System is an external fixation device that is applied directly to the patient's bone through the skin. It is used for structural support and manipulation of bone, not for analyzing biological samples.
- Intended Use: The intended uses listed (leg lengthening, osteotomies, arthrodesis, fracture fixation) are all surgical procedures involving the musculoskeletal system, not diagnostic tests performed on biological specimens.
The device description clearly indicates it's a physical device used to stabilize and manipulate bone in vivo (within the living body), which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The EBI® XFIX® DFS® 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.
Product codes (comma separated list FDA assigned to the subject device)
KTT
Device Description
The System consists of fixation components and implantable bone screws. The EBI® XFIX® DFS® 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® System is attached to the shanks of the bone screws. The intended use and fundamental scientific technology have not changed from the previously cleared submission. This submission is only for the addition of modified self-drilling and blunt-tipped bone screws to the System.
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): 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 (K953406)
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 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
OCT 2 5 2002
Special 510(k) Device Modification: EBI® XFIX® DFS® Fixation System
KC23349
page 1 of 2
510(k) Summary of Safety and Effectiveness
This 510(k) Summary of Safety and Effectiveness for the EBI® XFIX® DFS® System is provided as required per Section 513(1)(3) of the Federal Food. Drug and Cosmetic Act.
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- Sponsor: Contact Person: Frederic Testa, RAC EBI, L.P. Telephone: (973) 299-9300, ext.2208 100 Interpace Parkway Parsippany, NJ 07054
Date Prepared: October 7, 2002
- Sponsor: Contact Person: Frederic Testa, RAC EBI, L.P. Telephone: (973) 299-9300, ext.2208 100 Interpace Parkway Parsippany, NJ 07054
| 2. Proprietary Name: | EBI® XFIX® DFS® System |
|---|---|
| Common Name: | External Fixation Device |
| Classification Name: | Single Multiple Component Metallic Bone Fixation |
| Appliances and Accessories, 21 CFR 888.3030. |
3. Predicate or Legally Marketed Device:
- EBI® XFIX® DFS® System (K953406) .
4. Description of Device:
The System consists of fixation components and implantable bone screws. The EBI® XFIX® DFS® 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® System is attached to the shanks of the bone screws. The intended use and fundamental scientific technology have not changed from the previously cleared submission. This submission is only for the addition of modified self-drilling and blunt-tipped bone screws to the System
5. Intended Use:
The EBI® XFIX® DFS® 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.
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Red Book
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6. Materials:
The components of the System may be manufactured from materials such as Aluminum, Stainless Steel, Cobalt Chrome, Carbon Fiber, and Titanium Alloy.
7. Comparison of the technological characteristics of the device to predicate devices:
The modified EBI® XFIX® DFS® System is substantially equivalent to the following predicate device:
EBI® XFIX® DFS® System (K953406)
- The modified EBI® XFIX® DFS® System is fabricated from . the same materials as the components of the currently marketed EBI® XFIX® DFS® Fixation System.
- The modified EBI XFIX® DFS® System and the currently marketed EBI® . XFIX® DFS® System are both indicated 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 bone screw clamps of the modified EBI® XFIX® DFS® System, like . the bone screw clamps currently marketed in the EBI® XFIX® DFS® System, are designed for attachment to the bone screws.
- The additional component of the EBI® XFIX® DFS® System, like the ● components of the currently marketed EBI® XFIX® DFS® System, is provided non-sterile.
- There are no significant differences between the modified EBI® XFIX® ● DFS® System and the currently marketed EBI® XFIX® DFS® System. It is substantially equivalent* to the predicate device with regard 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 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three abstract human figures, possibly representing people or families, with flowing lines suggesting movement or connection.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 2 5 2002
EBI. L.P. Frederic Testa, RAC Regulatory Affairs Specialist 100 Interpace Parkway Parsippany, New Jersey 07054
Re: K023399
Trade/Device Name: EBI® XFIX® DFS® System Regulation Number: 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: KTT Dated: October 8, 2002 Received: October 9, 2002
Dear Mr. Testa:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -- Mr. Frederic Testa
This Jetter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Sincerely yours,
K-Mark A. Millbex
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
4
STATEMENT OF INDICATIONS FOR USE
Page
510(k) Number (if known): 112359 Device Name: EBI® XFIX® DFS® System
Indications For Use:
The EBI® XFIX® DFS® 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 (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
Mark A. Milliman
Division Sign. Of Divis : in rative and Neurological Devices
510(k) Number _K023399