(35 days)
Not Found
Not Found
No
The summary describes a mechanical external fixation device and does not mention any AI/ML terms, image processing, or data sets typically associated with AI/ML development.
Yes
The device is described for "treatment of the HDP by na in and other osteotomies, arthrodesis, fracture fixation, and other bone bond tone able to treatment by the use of the external fixation modality," which clearly indicates a therapeutic purpose.
No
Explanation: The device is an external fixation system used for treating HDP by na in and other osteotomies, arthrodesis, and fracture fixation. It is a treatment device, not a diagnostic one.
No
The device description explicitly states "External Fixation Device," which is a hardware component used for bone stabilization. The performance studies also focus on mechanical testing of the "FootPlate System," further indicating a physical device.
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 surgical treatment of bone conditions in the foot (osteotomies, arthrodesis, fracture fixation). This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: It is described as an "External Fixation Device," which is a surgical tool used to stabilize bones.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information. The focus is entirely on mechanical support and stabilization of bone.
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
Intended for use in the treatment of bone conditions including osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by the use of the external fixation modality.
Product codes (comma separated list FDA assigned to the subject device)
KTT
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing of the FootPlate System was conducted which demonstrates that the FootPlate System conforms to its design specifications. Additionally, an Engineering Rationale was written to demonstrate that the mechanical testing conducted represented the worst case construct and why further testing on the additional sizes of FootPlate System components is unnecessary. Mechanical testing was performed on the FootPlate System to verify the static and fatigue design specifications. In all instances, the FootPlate System functioned as intended and the test results obtained were as expected.
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.
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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
SEP 2 1 2005
510(k) SUMMARY
EBI, L.P.'s
EBI® DynaFix® Vision® FootPlate System
| SUBMITTER: | EBI, L.P. |
|---|---|
| ADDRESS: | 100 Interpace Parkway |
| Parsippany, NJ 07054 | |
| PHONE: | (973) 299-9300 |
| FAX: | (973) 257-0232 |
| CONTACT PERSON: | Peter Allan |
| DATE PREPARED: | August 16, 2005 |
| TRADE NAME: | EBI® DynaFix® Vision® FootPlate System |
| COMMON NAME: | External Fixation Device |
| CLASSIFICATION NAME: | Single/Multiple Component Metallic Bone Fixation |
| Appliances and Accessories, 21 CFR 888.3030 | |
| CLASSIFICATION #: | Class II |
| PREDICATE DEVICES: | EBI® XFIX® DFS® System, EBI® XFIX® Vision® |
| Fixation System, Howmedica Osteonics | |
| Corporation Hoffmann® II Foot Ring |
INTENDED/INDICATIONS FOR USE:
Intended for use in the treatment of bone conditions including osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by the use of the external fixation modality.
1
TECHNOLOGICAL CHARACTERISTICS:
Performance Data
Mechanical testing of the FootPlate System was conducted which demonstrates that the FootPlate System conforms to its design specifications. Additionally, an Engineering Rationale was written to demonstrate that the mechanical testing conducted represented the worst case construct and why further testing on the additional sizes of FootPlate System components is unnecessary. Mechanical testing was performed on the FootPlate System to verify the static and fatigue design specifications. In all instances, the FootPlate System functioned as intended and the test results obtained were as expected.
Substantial Equivalence
The FootPlate System is as safe and effective as the DFS and Vision Systems and has the same intended uses and similar indications, technological characteristics and principles of operation as its EBI® predicate device. The minor technological differences between the FootPlate System and its EBI® predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the FootPlate System is as safe and effective as the DFS System and Vision System. Thus, the FootPlate System is substantially equivalent. Additionally, the FootPlate System has the same intended anatomical use as the Hoffmann® II Foot Ring predicate device.
6²/₂ 14
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Image /page/2/Picture/1 description: The image is a logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" written around it. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health and Human Services.
Public Health Service
SEP 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Peter Allan EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054
Re: K052239 Trade/Device Name: EBI® DynaFix® Vision® FootPlate 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: August 16, 2005 Received: August 17, 2005
Dear Mr. Allan:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Peter Allan
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to begin mailteing your device of your device to a legally premarket nother in the PDF Intellig of basification 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 If you desire specific advice for your don't to the news note the regulation entitled, a Contact the Office of Complance in (21 trip Part 807.97). You may obtain MISofanding by reference to premailters under the Act from the Division of Small other general information on your response 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 N. Malkerson
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
. Enclosure
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Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: EBI® DynaFix® Vision® FootPlate System
Indications for Use:
The EBI® DynaFix® Vision® FootPlate System intended for use in the treatment of the HDP by na in and other osteotomies, arthrodesis, fracture fixation, and other bone bond tone able to treatment by the use of the external fixation modality.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 C.F.R. 801 Subpart D) AND/OR
Over The Counter Use_ (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
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