(178 days)
Not Found
No
The description mentions "IntelliFIT Technology" which uses "contour analysis to map patterns in complex bone" to determine pre-defined plate sizes. While this involves data analysis, it is described as a process used during the development of the device's sizes, not as a real-time or adaptive AI/ML function within the marketed device itself. There is no indication of the device using AI/ML for diagnosis, treatment planning, or any other function during clinical use.
Yes
Explanation: The device is indicated for medical conditions such as fractures, fracture dislocations, osteotomies, and non-unions of the proximal radius, and is used to treat or alleviate these conditions.
No
The device description clearly states it is a "Plating System" comprised of plates and screws used for fractures, dislocations, osteotomies, and non-unions of the proximal radius. This indicates it is an implantable device used for treatment, not for diagnosis.
No
The device description explicitly states the system is comprised of physical components (plates and screws), which are hardware. While software (IntelliFIT Technology) was used in the design process, the final product is a physical medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The ExploR® Radial Head Plating System is a surgical implant used to fix fractures and other issues in the proximal radius bone. It is a physical device implanted into the body.
- Intended Use: The intended use is for treating fractures, dislocations, osteotomies, and non-unions of the proximal radius. This is a surgical intervention, not a diagnostic test performed on a sample.
The information provided clearly describes a surgical implant system, not a diagnostic test.
N/A
Intended Use / Indications for Use
The ExploR® Radial Head Plating System is indicated for fractures, fracture dislocations, osteotomies and non-unions of the proximal radius.
Product codes
HRS, HWC
Device Description
The Explor® Radial Head Plating System is comprised of 3 styles of plates (neck plates, rim plates and rim long plates) in two sizes (small and standard) each and locking and non-locking screws in multiple lengths. Plate sizing and contouring was developed through the use of Biomet's IntelliFIT Technology which uses contour analysis to map patterns in complex bone on cadaveric specimens to determine plate sizing. (Note, the software was used to determine a set of pre-defined plate sizes and is not used to create individual, patient matched plates.)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal radius
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
Not Found
Key Metrics
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
Image /page/0/Picture/0 description: The image shows the logo for Biomet Manufacturing Corp. The logo consists of the word "BIOMET" in a stylized font, with the words "MANUFACTURING CORP." printed below. The logo is black and white and appears to be a scan of a document.
JUL 2 1 2011
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| Submitter Information | |
|---|---|
| Name | Biomet Manufacturing Corp. |
| Address | 56 East Bell Drive |
| Warsaw, IN 46581-0857 | |
| Phone number | (574) 267-6639 |
| Fax number | (574) 371-1027 |
| Establishment Registration | |
| Number | 1825034 |
| Name of contact person | Patricia Sandborn Beres |
| Senior Regulatory Specialist | |
| Date prepared | January 3, 2011 |
| Name of device | |
| Trade or proprietary | |
| name | Explor® Radial Head Plating System |
| Common or usual | |
| name | plate, fixation, bonescrew, fixation, bone |
| Classification name | Single/multiple component metallic bone fixation appliances and accessoriesSmooth or threaded metallic bone fixation fastener |
| Classification panel | Orthopedics |
| Regulation | 21 CFR 888.303021 CFR 888.3040 |
| Product Code(s) | HRSHWC |
| Legally marketed device(s) to | |
| which equivalence is claimed | K062494 - EBI OptiLock® Upper Extremity Plating System |
| K033456 - EVOLVE® Radial Plate | |
| K040777 - Synthes (USA) LCP Radial Head Plating System | |
| Reason for 510(k) submission | New device |
| Device description | The Explor® Radial Head Plating System is comprised of 3 styles of |
| plates (neck plates, rim plates and rim long plates) in two sizes (small | |
| and standard) each and locking and non-locking screws in multiple | |
| lengths. Plate sizing and contouring was developed through the use | |
| of Biomet's IntelliFIT Technology which uses contour analysis to map | |
| patterns in complex bone on cadaveric specimens to determine plate | |
| sizing. (Note, the software was used to determine a set of pre-defined | |
| plate sizes and is not used to create individual, patient matched | |
| plates.) | |
| Intended use of the device | Bone fixation |
Mailing Address:
Walling Address: 0587
Worldw.com (107.0687)
World Posts (100.000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
Shipping Address:
56 East Bell Drive
Warsaw, IN 46582
F
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p. 1 of 2
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510(k) Summary ExploR® Radial Head Plating System Page 2 of 2
| Indications for use | The ExploR® Radial Head Plating System is indicated for fractures, fracture dislocations, osteotomies and non-unions of the proximal radius. | ||
|---|---|---|---|
| Summary of the technological characteristics of the device compared to the predicate | |||
| Characteristic | New Device | Predicate Device* | |
| Plate Design | Neck, Rim and Long Rim | K062494 | |
| K033456 | |||
| K040777 | |||
| Plate Material | Stainless Steel ASTM F138 or F139 | K062494 | |
| Plate Dimensions | Length: 18.2mm to 26.2mm | ||
| Width: 15.2 mm - 16.7mm | K062494 | ||
| K033456 | |||
| K040777 | |||
| Screw Design | Locking and Non-Locking | K062494 | |
| K033456 | |||
| K040777 | |||
| Screw Material | Stainless Steel ASTM F138 or F139 | K062494 | |
| Screw Dimensions | Diameter: 2.0mm | ||
| Length: 10-30mm | K033456 | ||
| K040777 | |||
| PERFORMANCE DATA | |||
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL | |||
| EQUIVALENCE | |||
| Performance Test Summary-New Device | |||
| Characteristic | Standard/Test/FDA Guidance | Results Summary | |
| Plate Strength | Engineering Analysis | Meet or exceed predicate | |
| Comparative Performance Information Summary | |||
| Characteristic | Requirement | New Device | Predicate Device* |
| Plate Strength | Meet or exceed predicate | Meet | K062494 |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL | |||
| EQUIVALENCE AND/OR OF CLINICAL INFORMATION | |||
| Clinical Performance Data/Information: None | |||
| MAGNETIC RESONANCE (MR) ENVIROMENT | |||
| Biomet® has performed non-clinical Magnetic Resonance Imaging (MRI) studies on Plating Systems manufactured of 316L Stainless Steel per ASTM F138. These Plating Systems are determined to be MR Conditional in accordance to ASTM F2503-08 Standard Practice for Marking Devices and Other Items for Safety in the Magnetic Resonance Environment. MR Conditional refers to an item that has been demonstrated to pose no known hazards in a specified MR environment with specified conditions of use. | |||
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA | |||
| No mechanical or clinical testing was necessary for a determination of substantial equivalence. The results of engineering analysis indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices. | |||
| * Any statement made in conjunction with this submission regarding and/or a determination of substantial equivalence to any other |
product is intended only to relate to whether the product can be lawfully market approval or redassification and is not intended to be interpreted as an admission or any other type of evident infingenent litigation. [Establishment
Registration and Pernarket Notification Procedures, Final R
, 2f2
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" which is arranged in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biomet Manufacturing Corp. % Ms. Patricia Beres Senior Regulatory Specialist 56 East Bell Drive, P.O. Box 587 Warsaw, Indiana 46581-0587
JUL 2 1 2011
Re: K110201
Trade/Device Name: ExploR® Radial Head 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: HRS, HWC Dated: June 22, 2011 Received: June 24, 2011
Dear Ms. Beres:
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. Please 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
3
Page 2 - Ms. Patricia Beres
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); medical device reporting (reporting of medical 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Eric L. Keith
For Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: ExploR® Radial Head Plating System
Indications For Use:
:: .....
The ExploR® Radial Head Plating System is indicated for fractures, fracture dislocations, osteotomies and non-unions of the proximal radius.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ NO (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)
for M. Multerm
(Division Sign Oft) (Division Sigiron of Surgical, Orthopedic, Division of Suices
Page 1 of 1
510(k) Number K110201