(85 days)
Not Found
No
The device description and intended use clearly define it as a metallic bone fixation system, with no mention of AI or ML capabilities. The lack of information regarding image processing, AI/ML terms, training/test sets, performance studies, and key metrics further supports this conclusion.
Yes
The device is a metallic bone fixation appliance used for fracture fixation and correction of deformity, which are therapeutic interventions.
No
The device is described as a "bone fixation appliance" intended for "long bone fracture fixation" and correction of bone deformities, malunions, non-unions, or arthrodesis. It is a treatment device, not one that gathers or analyzes data to determine the nature or cause of a condition.
No
The device description explicitly states it is a "Single/multiple metallic bone fixation appliances and accessories," which are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided information clearly describes the SMPle™ Pediatric Submuscular Plating System as a "metallic bone fixation appliance" intended for the surgical fixation of bone fractures and deformities. This is a device used within the body during surgery, not for testing samples outside the body.
The information provided aligns with a surgical implant or orthopedic device, not an IVD.
N/A
Intended Use / Indications for Use
The SMPle™ Pediatric Submuscular Plating System is intended for adult or pediatric patients as indicated for long bone fracture fixation of bones that have been surgically prepared (osteotomy) for correction of deformity, malunions, non-union or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, and radius.
In pediatric femoral applications, the SMPle® Pediatric Submuscular Plating System is intended for use in the treatment of femoral fractures, malunions or non-unions, femoral osteotomies required for the correction of deformity, and arthrodesis. Indications for buttressing multi-fragmentary distal femoral fractures include: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, non-unions and mal-unions, and osteotomies of the femur.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The technological characteristics of the SMPle™ Pediatric Submuscular Plating System are the same, or similar to, other legally marketed predicate devices.
This plating system may be placed via a standard open surgical technique or via a submuscular technique. These plates may be used in conjunction with other devices and treatment modalities for deformity correction at the discretion of the treating physician.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tibia, fibula, femur, humerus, ulna, and radius
Indicated Patient Age Range
adult or pediatric patients
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): 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.
K082807, K083286, K020221, K061098
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
Biomet Trauma Traditional 510(k) Premarket Notification
h093983 (pg 1/2)
Image /page/0/Figure/22 description: The image shows the logo for Biomet Trauma. The logo is in black and white and features the word "BIOMET" in a bold, sans-serif font. Below the word "BIOMET" is the word "TRAUMA" in a smaller, sans-serif font.
MAR 1 9 2010
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93
Submitter:
Biomet Trauma 100 Interpace Parkway Parsippany, NJ 07054
2242816
Establishment Registration Number:
Contact:
Margaret F. Crowe Regulatory Affairs Project Manager Biomet Trauma 100 Interpace Parkway Parsippany, NJ 070654 Tel .: 973-299-9300, ext. 2260 Fax: 973-257-0232 E-mail: margaret.crowe@biomet.com
Date Prepared:
December 22, 2009
SMPle" Pediatric Submuscular Plating System Trade/Proprietary Name:
Common/Usual Name: Plates/Screws
Single/multiple metallic bone fixation appliances and Classification Name: accessories (21 CFR 888.3030)
Device Panel/Product Code: Orthopedics HRS/HWC
Device Description:
Indications for Use:
The SMPle" Pediatric Submuscular Plating System is intended for adult or pediatric patients as indicated for long bone fracture fixation of bones that have been surgically prepared (osteotomy) for correction of deformity, malunions, non-union or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, and radius.
1
Biomet Trauma Traditional 510(k) Premarket Notification
In pediatric femoral applications, the SMPle™ Pediatric Submuscular Plating System is intended for use in the treatment of femoral fractures, malunions or non-unions, femoral osteotomies required for the correction of deformity, and arthrodesis. Indications for buttressing multi-fragmentary distal femoral fractures include: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, non-unions and mal-unions, and osteotomies of the femur.
Summary of Technologies:
The technological characteristics of the SMPle™ Pediatric Submuscular Plating System are the same, or similar to, other legally marketed predicate devices.
This plating system may be placed via a standard open surgical technique or via a submuscular technique. These plates may be used in conjunction with other devices and treatment modalities for deformity correction at the discretion of the treating physician.
Substantial Equivalence:
The SMPle™ Pediatric Submuscular Plating System is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics, and principles of operation and does not present any new issues of safety or effectiveness. Examples of predicates include: Synthes 3.5 and 4.5 Locking Compression Plates for expanded indications (K082807); Orthopediatrics PediLoc™ Plating Systems (K083286) and the Biomet IQL Plating System (K020221), and the Biomet OptiLock® Periarticular Plating System (K061098). Based upon the engineering analysis and the other information presented in this premarket notification, the SMPle" Pediatric Submuscular Plating System is equivalent for its intended use to other legally marketed plate and screw systems.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle's head and neck, depicted with three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Biomet Trauma (aka EBI, LP) % Ms. Margaret Crowe Regulatory Affairs Project Manager 100 Interpace Parkway Parsippany, NJ 070654
MAR 1 9 2010
Re: K093983
Trade/Device Name: SMPle™ Pediatric Submuscular Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS. HWC Dated: December 23, 2009 Received: December 24, 2009
Dear Ms. Crowe:
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 mav 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); medical device reporting (reporting of medical
3
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
for
Mark N. Malle
Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Biomet Trauma Traditional 510(k) Premarket Notification
Indications for Use
510(k) Number (if known): _in093983 (pa 1/1 )
Device Name: SMPle™ Pediatric Submuscular Plating System
The SMPle™ Pediatric Submuscular Plating System is intended for adult or pediatric patients as indicated for long bone fracture fixation of bones that have been surgically prepared (osteotomy) for correction of deformity, malunions, non-union or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, and radius.
In pediatric femoral applications, the SMPle® Pediatric Submuscular Plating System is intended for use in the treatment of femoral fractures, malunions or non-unions, femoral osteotomies required for the correction of deformity, and arthrodesis. Indications for buttressing multi-fragmentary distal femoral fractures include: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, non-unions and mal-unions, and osteotomies of the femur.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Temperature
Sonta
mxm
(Division Sign-Off)
Division of Surgica!, Orthopedic, and Restorative Devices
510(k) Number K693983
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