(29 days)
No
The summary describes a mechanical external fixation system and explicitly states that the fundamental scientific technology has not changed from previously cleared submissions. There is no mention 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 including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality," which falls under therapeutic uses.
No
Explanation: The device is an external fixation system used for treating bone conditions, not for diagnosing them. It is a therapeutic device that physically supports and stabilizes bones.
No
The device description explicitly states that the system consists of "external fixation components and implantable bone screws," which are hardware. The submission is for additional rod sizes, which are also hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The EBI® XFIX® Vision® Fixation System is a physical device that is implanted into the body (bone screws) and attached externally (fixator frame) to treat bone conditions. It directly interacts with the patient's anatomy.
- Intended Use: The intended use is for the treatment of bone conditions, not for analyzing specimens to provide diagnostic information.
The description clearly indicates a surgical/orthopedic device used for mechanical support and manipulation of bone, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes
KTT
Device Description
The System consists of external fixation components and implantable bone screws. The EBI® XFIX® Vision 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® Vision® Fixation System is attached to the shanks of the bone screws. This submission is for the additional rod sizes to the existing System. The intended use and fundamental scientific technology have not changed from the previously cleared submission.
The components of the System may be manufactured from materials such as Aluminum Alloy, Stainless Steel, Pyromet® 718, Carbon Fiber, and Titanium Alloy.
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)
K993886, K011711, K014194, K033635
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
K040833
page 1 of 2
Special 510(k) Device Modification: EBI® XFIX® Vision® Fixation System
510(k) Summary
This 510(k) Summary for the EBI® XFIX® Vision® Fixation System is provided as required per Section 513(1)(3) of the Federal Food, Drug and Cosmetic Act.
Contact Person: Frederic Testa, RAC 1. Sponsor: (973) 299-9300, ext.2208 Telephone: EBI. L.P. 100 Interpace Parkway Parsippany, NJ 07054
Date Prepared: March 23, 2004
2. Proprietary Name: | EBI® XFIX® Vision® Fixation 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:
4. Description of Device:
The System consists of external fixation components and implantable bone screws. The EBI® XFIX® Vision 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® Vision® Fixation System is attached to the shanks of the bone screws. This submission is for the additional rod sizes to the existing System. The intended use and fundamental scientific technology have not changed from the previously cleared submission.
5. Intended 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.
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040833
page 2 of 2
6. Materials:
The components of the System may be manufactured from materials such as Aluminum Alloy, Stainless Steel, Pyromet® 718, Carbon Fiber, and Titanium Alloy.
7. Comparison of the technological characteristics of the device to predicate devices:
The modified EBI® XFIX® Vision® Fixation System is substantially equivalent to the following predicate device:
EBI® XFIX® Vision® Fixation System (K993886, K011711, K014194, K033635)
- The additional EBI® XFIX® Vision® Fixation System components are . fabricated from the same materials as the components of the currently marketed EBI® XFIX® Vision® Fixation System.
- The modified EBI XFIX® Vision® Fixation System and the currently . marketed EBI® XFIX® Vision® Fixation 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® Vision® Fixation . System, like the bone screw clamps currently marketed in the EBI® XFIX® Vision® Fixation System, are designed for attachment to the bone screws.
- The modified EBI® XFIX® Vision® Fixation System like the currently . marketed EBI® XFIX® Vision® Fixation System, is provided non-sterile.
There are no significant differences between the modified EBI® XFIX® Vision® Fixation System and the currently marketed EBI® XFIX® Vision® Fixation System. It is substantially equivalent* to the predicate device with regard to intended use, materials, and function.
- pry 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 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.)]
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 2004
Mr. Frederic Testa, RAC Regulatory Affairs Specialist EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054
Re: K040833 Trade/Device Name: EBI® XFIX® Vision® Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: March 23, 2004 Received: March 31, 2004
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 complics 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, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yours of substantial equivalence of your device 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mixtimational 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,
Martin A Mulheran
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 1 of 1
510(k) Number (if known):
Device Name: EBI® XFIX® Vision® Fixation System
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.
(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. Melkeum
Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number