(49 days)
Not Found
No
The summary describes a mechanical external fixation device and its components, with no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is described as an external fixation device intended for the treatment of bone conditions like leg lengthening, osteotomies, and fracture fixation, all of which are medical treatments for conditions.
No
Explanation: The device is described as an "external fixation device" intended for "treatment of bone conditions" such as "leg lengthening, osteotomies, arthrodesis, fracture fixation." This indicates a therapeutic, not diagnostic, purpose.
No
The device description explicitly states it is an "external fixation device" and describes "additional modular components," indicating it is a hardware-based medical device. The performance studies also focus on mechanical testing of the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "treatment of bone conditions" using an "external fixation treatment modality." This describes a therapeutic device used directly on the patient's body to treat a physical condition.
- Device Description: The device is described as an "external fixation device" and "modular components" for a "FootRing System." This further reinforces its nature as a physical device used externally for treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a therapeutic device used to physically treat a bone condition.
N/A
Intended Use / Indications for Use
The Biomet® Vision® FootRing System is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by the use of the external fixation treatment modality.
Product codes (comma separated list FDA assigned to the subject device)
KTT
Device Description
The Biomet® Vision® FootRing System is an external fixation device. The devices in this 510(k) are additional modular components to the predicate Biomet® Vision® FootRing System, which is based upon the FootRing component as the frame for a construct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Non-Clinical Testing: Mechanical testing of the Biomet® Vision® FootRing System was conducted to verify the static and fatique design specifications and to determine performance with respect to the predicate. Mechanical Testing was also conducted to verify static design specifications for new connection components. The test results were as expected and demonstrate that the FootRing System is functional within its intended use, conforms to its design specifications and is substantially equivalent to the predicate device in performance characteristics. The minor technological differences between the Biomet® Vision® FootRing System and its predicate devices raise no new issues of safety and effectiveness. Performance data indicate that the Biomet® Vision® FootRing System is as safe and effective as the EBI® DynaFix® Vision® FootPlate System, K052239. Thus, the FootRing System is substantially equivalent.
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
K071395 Page 1/1
JUL - 9 2007
510(k) Summary
| Preparation Date: | July 7, 2007 |
|---|---|
| Applicant/Sponsor: | Biomet Trauma (formerly known as EBI, L.P.) |
| 100 Interpace Parkway | |
| Parsippany, NJ 07054 | |
| Contact Person: | Debra L. Bing |
| Director, Regulatory Affairs | |
| Biomet Trauma | |
| 973-299-9300 | |
| Proprietary Name: | Biomet® Vision® FootRing System |
| Common Name: | External Fixation Device |
| Classification Name: | Single/multiple component metallic bone fixation appliances and accessories, 2 |
| CFR 888.3030, KTT |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: EBI® DynaFix® Vision® FootPlate System, K052239 (Biomet Trauma), Sheffield Ring Fixator, K944092, K955848 and/or subsequent (Orthofix, Inc.)
Device Description: The Biomet® Vision® FootRing System is an external fixation device. The devices in this 510(k) are additional modular components to the predicate Biomet® Vision® FootRing System, which is based upon the FootRing component as the frame for a construct.
Intended Use: The Biomet® Vision® FootRing System is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by the use of the external fixation treatment modality.
Summary of Technologies: The intented use is identical to the predicate Biom® FootRing System. The new modular components are geometrically similar or identical to components in the predicate device. The new components incorporate similar or identical connection mechanisms to the predicates. Finally the new components are made from the same materials and finishes, conforming to the same standards as the predicate device.
Non-Clinical Testing: Mechanical testing of the Biomet® Vision® FootRing System was conducted to verify the static and fatique design specifications and to determine performance with respect to the predicate. Mechanical Testing was also conducted to verify static design specifications for new connection components. The test results were as expected and demonstrate that the FootRing System is functional within its intended use, conforms to its design specifications and is substantially equivalent to the predicate device in performance characteristics. The minor technological differences between the Biomet® Vision® FootRing System and its predicate devices raise no new issues of safety and effectiveness. Performance
1
data indicate that the Biomet® Vision® FootRing System is as safe and effective as the EBI® DynaFix® Vision® FootPlate System, K052239. Thus, the FootRing System is substantially equivalent.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or other bird in flight. The symbol is composed of three curved lines that converge at the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet Manufacturing Corp. % Mr. Robert Friddle Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
JUL - 9 2007
K071395 Trade/Device Name: Vision® FootRing System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: May 18, 2007 Received: May 21, 2007
Dear Mr. Friddle:
Re:
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
3
Page 2 - Mr. Robert Friddle
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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Beehup
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K671395 510(k) Number (if known):_
Device Name: Biomet® Vision® FootRing System
Indications for Use:
The Biomet® Vision® FootRing System is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by the use of the external fixation treatment modality.
Prescription Use Yes (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Boelus
Division of Ge and Neurological De
510(k) Number K071395
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