(41 days)
The system is intended for fixation of fractures, malunions and osteotomies involving the distal radius.
The Distal Radius Volar Rim Plating System consists of a series of plates utilizing non-locking, locking and variable angle screws manufactured from Titanium alloy and CoCr used in bone fixation and the management of fractures and reconstructive surgeries in narrow to standard head widths.
The provided text is a 510(k) summary for a medical device (Distal Radius Volar Rim Plating System). It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance metrics, or any studies using a test set of data (clinical or otherwise) to demonstrate a specific level of performance.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.
Specifically, the document lacks the following information required to answer your questions:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set or data provenance.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication method for a test set.
- Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results from a standalone algorithm performance study.
- Type of ground truth used (clinical outcomes, pathology, expert consensus, etc.).
- Sample size for a training set.
- How ground truth for a training set was established.
The "Summary of Substantial Equivalence" section only mentions "pre-clinical data including axial load construct testing, evaluation of galvanic corrosion potential, tab bending and function" to demonstrate similarity to predicate devices, but these are general engineering tests, not studies assessing diagnostic or clinical performance against acceptance criteria using patient data or expert consensus.
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K132704 page 1 of 1
Section 5 - 510(k) Summary
| Submitted by: | Biomet Trauma56 East Bell DrivePO Box 587Warsaw, IN 46581Phone: (305) 269-6386Fax: (305) 269-6400 | OCT 0 9 2013 |
|---|---|---|
| Contact Person: | Suzana Otaño, Global Project Manager, Regulatory Affairs | |
| Date Prepared: | August 27, 2013 | |
| Proprietary Name: | Distal Radius Volar Rim Plating System | |
| Common Name: | Plate, Fixation, Bone | |
| Classification Name: | Single/multiple component metallic bone fixation appliances andaccessories (21 CFR § 888.3030) | |
| Predicate Devices: | The Distal Radius Volar Rim Plating System is substantiallyequivalent to currently marketed Distal Volar Radius Plating System(K112345). | |
| Device Description: | The Distal Radius Volar Rim Plating System consists of a series ofplates utilizing non-locking, locking and variable angle screwsmanufactured from Titanium alloy and CoCr used in bone fixationand the management of fractures and reconstructive surgeries innarrow to standard head widths. | |
| Indications for Use: | The system is intended for fixation of fractures, malunions andosteotomies involving the distal radius. | |
| TechnologicalCharacteristics: | The technological characteristics of the Distal Radius Volar RimPlating System are similar to the predicate devices including design,dimensions and material. | |
| Summary ofSubstantialEquivalence: | The Distal Radius Volar Rim Plating System is substantiallyequivalent to currently marketed devices as demonstrated with pre-clinical data including axial load construct testing, evaluation ofgalvanic corrosion potential, tab bending and function. No newissues of safety or efficacy have been raised. |
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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing a bird, which is the department's official symbol.
Public Heatth Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 9, 2013
Biomet, Inc. Ms. Suzana Otaño Global Project Manager, Regulatory Affairs P.O. Box 587 Warsaw, Indiana 46581
Re: K132704
Trade/Device Name: Distal Radius Volar Rim Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: LXT Date: August 27, 2013 Received: August 29, 2013
Dear Ms. Otaño:
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 advises, good mease note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 or any i with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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Page 2 – Ms. Suzana Otaño
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
ErinIDKeith
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosurc
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Section 4 - Indications for Use Statement
| 510(k) Number: | K132704 |
|---|---|
| Device Name: | Distal Radius Volar Rim Plating System |
| Indications For Use: | The system is intended for fixation of fractures, malunions and osteotomies involving the distal radius. |
| scription Use | X | AND/OR | Over-the-Counter |
|---|---|---|---|
| --------------- | --- | -------- | ------------------ |
Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D)
Over-the-Counter AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth L. Frank -S
Division of Orthopedic Devices
Page 1 of 1
Distal Radius Volar Rim System · Traditional 510(k) Biomet Trauma
Page 45 of 133
§ 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.