(68 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and predicate device comparison of a titanium plating system, with no mention of AI or ML.
No
The device is a plating system engineered to provide mechanical support for fracture fixation and non-union cases. It acts as a static structural support and does not actively participate in or facilitate the healing process.
No
The device is a titanium plating system intended for fixation of fractures and non-unions, which is a therapeutic purpose, not a diagnostic one.
No
The device description clearly states it is a titanium plating system comprised of physical plates and screws, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the MBD Plate System is for the "fixation of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula." This describes a surgical implant used to stabilize bones.
- Device Description: The description details a "titanium plating system comprised of various length plates and screws." This is consistent with a surgical implant, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does none of those things. It is a physical implant used in surgery.
The information provided strongly indicates that this is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MBD Plate System is intended for fixation of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.
Product codes
HRS, HWC
Device Description
The MBD Plate System is a titanium plating system comprised of various length plates and screws. The plates are low profile straight plates ranging in length from 72mm to 136mm. The plate thickness and width are 3mm and 11mm, respectively. Plate sizes are from 6 to 11 holes and each plate hole and/or slot accepts 4.0mm non-locking bone screws. Bone screws range from 12 to 24mm in length. Additionally, the system comprises low-profile 2.5mm diameter fragment screws in lengths from 10 to 24mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.
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
The MBD Plate System has been evaluated through non-clinical performance testing for fatigue and static The testing demonstrated that the MBD Plate system components met four-point bend testing. performance requirements and are as safe and effective as their predicate devices.
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
Section 5: 510(k) Summary
The following information is provided as required by 21 CFR § 807.87 for MBD Medical's 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
The safety and effectiveness of the MBD Plate System is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate device(s).
| Sponsor: | MBD Medical, LLC
84 Honeck Street
Englewood, NJ 07631 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jennifer A. Daudelin
M Squared Associates, Inc.
575 Eighth Avenue, Suite 1212
New York, NY 10018
Ph: 703-562-9800 x251
Fax: 703-562-9797
Email: jdaudelin@msquaredassociates.com |
| Date Prepared: | April 8, 2014 |
| Proposed Class: | II |
| Proprietary Name: | MBD Plate System |
| Common Name: | Plate, Fixation, Bone |
| Classification Name: | Plate, Fixation, Bone |
| Regulation Number: | 21 CFR 888.3030 |
| Product Codes: | HRS, HWC |
| Predicate Device(s): | |
| Manufacturer | Device Name | Procode | 510(k) Number | Common Name | Class |
|---|---|---|---|---|---|
| Synthes | |||||
| (USA) | Synthes One-Third | ||||
| Tubular DCL Plate | HRS | K011335 | Plate, Fixation Bone | II | |
| Howmedica | |||||
| Osteonics | |||||
| Corp. | Variax Clavicle | ||||
| System | HRS, | ||||
| HWC | K113760 | Plate, Fixation Bone | II |
Indication for Use
The MBD Plate System is intended for fixation of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.
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Device Description
The MBD Plate System is a titanium plating system comprised of various length plates and screws. The plates are low profile straight plates ranging in length from 72mm to 136mm. The plate thickness and width are 3mm and 11mm, respectively. Plate sizes are from 6 to 11 holes and each plate hole and/or slot accepts 4.0mm non-locking bone screws. Bone screws range from 12 to 24mm in length. Additionally, the system comprises low-profile 2.5mm diameter fragment screws in lengths from 10 to 24mm.
Performance Data
The MBD Plate System has been evaluated through non-clinical performance testing for fatigue and static The testing demonstrated that the MBD Plate system components met four-point bend testing. performance requirements and are as safe and effective as their predicate devices.
Technological Characteristics and Substantial Equivalence
The MBD Plate System has the same indications for use, materials, and similar design features as compared with the predicate systems. The bench testing demonstrates that the performance characteristics of the MBD Plate System are equivalent to those of other legally marketed plate/screw systems, and therefore supports a determination of Substantial Equivalence for the proposed indications for use. Any differences between the subject and predicate devices would not render the device NSE, affect the safety or effectiveness, or raise different questions of safety and effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 30, 2014
MBD Medical, LLC % Jennifer A. Daudelin Regulatory Consultant III M Squared Associates, Inc. 575 Eighth Avenue, Suite 1212 New York, New York 10018
Re: K141045
Trade/Device Name: MBD Plate 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: May 9, 2014 Received: May 13, 2014
Dear Ms. Daudelin:
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 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
Page 2 - Ms. Jennifer A. Daudelin
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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Lori A. Wiggins
- for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4: Indications for Use Statement
K141045 510(k) Number: Device Name: MBD Plate System Indications for Use:
The MBD Plate System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
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Elizabet标秘厨Frank -S
Division of Orthopedic Devices