(14 days)
Not Found
No
The document 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 for training/testing.
Yes
The device is described as an external fixation device for treating bone conditions, which directly implies a therapeutic purpose.
No
Explanation: The device description states it is an external fixation device used for treating bone conditions, not for diagnosing them. It is used to fix bones, not to provide diagnostic information.
No
The device description explicitly states it consists of "external fixation components and implantable bone screws," which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the treatment of bone conditions through external fixation. This is a therapeutic intervention, not a diagnostic one.
- Device Description: The description details the physical components (external fixation components and bone screws) and how they are used to stabilize and manipulate bone. This aligns with a surgical or therapeutic device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
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® 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 modification of the SL Rapid Clamps and the addition of a 'MRI Safe' labeling claim to the existing System when the newly modified SL Rapid Clamps are utilized. 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)
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
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(I)(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: November 18, 2003
| 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® 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 modification of the SL Rapid Clamps and the addition of a 'MRI Safe' labeling claim to the existing System when the newly modified SL Rapid Clamps are utilized. 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.
1
6. Materials:
KO 33635
page 2 of 2
The components of the System may be manufactured from materials such as The Components of the Bystern in Jyromete 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)
- The modified EBI® XFIX® Vision® Fixation System and the currently . marketed EBI® XFIX® Vision® Fixation System are fabricated from the same materials.
- 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.
*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 infingement ticlassineanon and is not menter 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 Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 2003
Mr. Frederic Testa, RAC Regulatory Affairs Specialist EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054
Re: K033635 K033635
Trade/Device Name: EBI® XFIX® Vision® Fixation System Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: November 18 Received: November 19, 2003
Dear Mr. Testa:
We have reviewed your Section 510(k) premarket notification of intent to market the review we nave reviewed your becamined the device is substantially equivalent (for the indications referenced above and nave decemblied the arrest are are as a marketed in interstate for use stated in the encrosule) to tegary maneted province Amendments, or to
commerce prior to May 28, 1976, the enactment date of the fiederal Food. Drug commerce provide to May 20, 1977, the enated and the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of explication (RMA) devices that have been recials.ned in accerany al of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premiers of the Act, "PM and Cosment Act (Act) that do not require spare the general controls provisions of the Act. The Act. The Act. The You may, therefore, market the device, books of the more
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the free houses and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see aboro) als. Existing major regulations affecting your device EDA mex may be subject to such additional controller withouts. Title 21, Parts 800 to 898. In addition, FDA may nc found in the Code of Pouchal Ing
Please be advised that FDA's issuance of a substantial equivalence determination does not nean Please be advised that FDA s issuation of a badeained with other requirements of the Act
that FDA has made a determination that your device complies with on You must that FDA has made a decemmanon that Jour sered by other Federal agencies. You must or any rederal statutes and regulations daminders. by a not limited to: registration and fisting (21 l comply with an the Act 3 regartements, news 801 ); good manufacturing practice requirements as scheeller the alogtrea CFR Part 607), fabeling (21 CFR Part 800), good manager, and if applicable, the clectronic forth in the quality systems (Sections (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 icter will anow yourse ough finding of substantial equivalence of your device to a legally premaince hotification. The are and on and on 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 If you desire specific acrios is 1 your as 1) 594-4659. Also, please note the regulation entitled, Contact the Office of Crice of Cremarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miormational 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,
Mark A. Milken
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) |
| -------------------------------------------- | ---- | -------------------------------------------------- |
|---|
f Mark N Millman
Restorative
K0 33635