(25 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on mechanical components for external fixation.
Yes
The device is intended for use in the treatment of bone conditions, which is a therapeutic purpose.
No
The device description clearly states it is an external fixation device used for treatment of bone conditions, not for diagnosis.
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.
- Device Description: The EBI® XFIX® Vision® Fixation System is a physical device that is surgically implanted into the bone and attached externally. It is used to mechanically stabilize and manipulate bone for treatment.
- Intended Use: The intended use is for treating bone conditions through external fixation, which is a mechanical process, not a diagnostic test performed on a specimen.
The description clearly indicates a device used for surgical intervention and mechanical support of bone, not for analyzing biological samples for diagnostic purposes.
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 (comma separated list FDA assigned to the subject device)
KTT
Device Description
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'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 addition of components to the existing System. The intended use and fundamental scientific technology have not changed from the previously cleared submission.
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.
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
11711 Special 510(k) Device Modification: EBI® XFIX® Vision™ Fixation System
6/29/01
510(k) Summary of Safety and Effectiveness
This 510(k) Summary of Safety and Effectiveness for the EBI® XFIX® Vision® Fixation System is provided as required per Section 513(I)(3) of the Federal Food, Drug and Cosmetic Act.
- Sponsor: EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054
Contact Person: Patricia Flood, RAC (973) 299-9300, ext.3318 Telephone:
June 1, 2001 Date Prepared:
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:
EBI® XFIX® Vision® Fixation System (K993886)
4. Description of Device:
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'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 addition of components 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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6. Materials:
The components of the System may be manufactured from materials such as The components of the System may be manager, 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)
- 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® YFIX® 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.
- Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other " Ally statement made in confinent and servilly marketed without pre-market approval or reclassification and is not interpreted as an admission or any other type of evidence in patent infingement litigation. [Establishment Registration and 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2001
Ms. Patricia Flood, RAC Senior Regulatory Affairs Specialist EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054
Re: K011711
Trade Name: Modification to EBI® EFIX® Vision Fixation System Regulatory Number: 888.3030 Regulatory Class: II Product Code: KTT Dated: June 1, 2001 Received: June 4, 2001
Dear Ms. Flood:
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 - Ms. Patricia Flood
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for invitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, (201) 594-4639. Addinesian) (201) 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.
Dmitchell runs
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
ದಿ
Enclosure
4
STATEMENT OF INDICATIONS FOR USE
11711 510(k) Number (if known): C EBI® XFIX® Vision® Fixation System Device Name: 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)
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Page
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Mitchell Ref for cuuu
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K010711