(20 days)
No
The document describes a mechanical external fixation system and explicitly states that the intended use and fundamental scientific technology have not changed from previously cleared submissions. There is no mention of AI, ML, image processing, or any data-driven components.
Yes
The device is an external fixation system used for the treatment of bone conditions, which directly relates to therapy for physical ailments.
No
The device is described as an external fixation system used for treating bone conditions, not for diagnosing them. It's a therapeutic device.
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 "adapters" to connect to existing fixators, also hardware components.
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 by physically fixing bones externally. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details external fixation components and implantable bone screws that are physically attached to the patient's bone. This is consistent with a surgical/orthopedic device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. 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 addition of "adapters" to the existing System, which allow connection to various EBI® XFIX® System Fixators. 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 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.
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page 1 of 2
FEB 0 5 2002
Special 510(k) Device Modification: EBI® XFIX® Vision® Fixation System
510(k) Summary
020141
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.
-
- Sponsor: Contact Person: Patricia Flood, RAC EBI, L.P. Telephone: (973) 299-9300, ext.3318 100 Interpace Parkway Parsippany, NJ 07054
Date Prepared: January 15, 2002
- Sponsor: Contact Person: Patricia Flood, RAC EBI, L.P. Telephone: (973) 299-9300, ext.3318 100 Interpace Parkway Parsippany, NJ 07054
| 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 addition of "adapters" to the existing System, which allow connection to various EBI® XFIX® System Fixators. 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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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)
- 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.
- 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.)]
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 5 2002
Jon Caparotta Manager, Regulatory Affairs EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054
Re: K020141 Trade/Device Name: EBI EFIX Vision Fixation System Regulatory Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: January 15, 2002 Received: January 16, 2002
Dear Mr. Caparotta:
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. Jon Caparotta
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse of substantial equivalence of your device to a legally premarket notification. The Pro Print and ssification 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 additionally 21 OF IC For Car (301) 594-4659. Additionally, for questions on the promotion and advertising of Compination at (301) 091-1009 office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner general mistmational 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 vours,
Sincerely yours,
Q. Mark N. Millenn
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 -
62014 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 N Millikin
of General, Restorative and Neurological Devices
510(k) Number K020141