(98 days)
No
The device description and performance studies focus on the mechanical properties and design of bone plates and screws, with no mention of AI or ML technologies.
No
Explanation: A therapeutic device is designed to treat or alleviate a medical condition. While this device aids in the healing of fractures, it is an internal fixation system, not something that actively treats through intervention like medication delivery or energy application. Its primary function is mechanical stabilization and support rather than direct therapeutic action.
No
Explanation: The device is an internal fixation system (plates, screws, and locking caps) used for the treatment of distal radius fractures, which is a therapeutic function, not diagnostic.
No
The device description explicitly states it consists of plates, screws, and locking caps made of Ti-6A1-4V ELI alloy, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "internal fixation of fractures of the distal radius." This describes a surgical procedure to stabilize a bone fracture.
- Device Description: The device consists of "plates, screws, and locking caps" made of a titanium alloy. These are physical implants used in surgery.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze samples (like blood, urine, or tissue), or provide information about a patient's health status through in vitro testing.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used for treatment.
N/A
Intended Use / Indications for Use
The MDS Distal Radius Plating System is internal fixation of fractures of the distal radius.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Distal Radius Plating System is an internal fixation system to be used for the treatment of distal radius fractures. The system consists of plates, screws, and locking caps. The Distal Radius Plates are bilateral and available in two different models; standard or with a multi-directional oblong hole (MDOH) feature. Each model comes in two sizes, 5 hole and 6 hole. The Distal Radius Plating System Screws are 2.7mm in diameter and available in various lengths.
The MDS device is single-use ONLY.
Materials: Ti-6A1-4V ELI alloy conforming to ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance and Conclusions: The results of non-clinical (laboratory/performance) testing demonstrate that the subject and predicate devices have similar performance properties. Substantial equivalence was demonstrated in the performance testing section of the submission by comparing the design and testing according to ASTM F382-99, Standard Test Metallic Medical Bone Plates and ASTM F543-07, Standard Specification and Test Method for Metallic Bone Screws, which show that the Distal Radius Plating System performs as well as the predicate devices. Comparison of the design, intended use, and testing demonstrate that the Distal Radius Plating System performs as well as the predicate devices and should thereby be considered substantially equivalent.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
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.
Synthes Locking Distal Radius Plate System – K012114, Variax Distal Radius Plating System - K141430, Proximal Humerus Plating System – K141493
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.
Paragon 28, Inc.; The Monster Screw System: Instrument Reprocessing Instructions for Reusable Instruments - K151418
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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 15, 2016
Miami Device Solutions, LLC Ms. Michelle Montesino Regulatory Affairs Associate 7620 North West 25th Street, Unit 3 Miami, Florida 33122
Re: K161292
Trade/Device Name: Distal Radius 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: July 7, 2016 Received: July 8, 2016
Dear Ms. Montesino:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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" (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 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161292
Device Name Distal Radius Plating System
Indications for Use (Describe)
The MDS Distal Radius Plating System is internal fixation of fractures of the distal radius.
Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
| Submitter Name: | Miami Device Solutions, LLC |
|---|---|
| Submitter Address: | 7620 NWth 25 Street, Unit 3; Miami, FL |
| 33122 | |
| Contact Person: | Michelle Montesino |
| Phone: (786) 422-1400 Ext. 106 | |
| Fax: (786) 422-1401 | |
| Date of Submission: | August 5, 2016 |
| Manufacturer Name: | Miami Device Solutions, LLC |
| Manufacturer Address: | 7620 NWth 25 Street, Unit 3; Miami, FL 33122 |
| Registration Number: | 3009222247 |
| Contact Name: | Markku Biedermann |
| Title: | President |
| Device Trade Name: | Distal Radius Plating System |
| Device Common Name: | Distal Radius Plating System |
| Classification Names: | Plate, fixation, bone; and screw, fixation, bone |
| Classification Code: | HRS; and HWC - Class II |
| Classification Panel: | Orthopedic |
| Regulation Number: | 21 CFR section 888.3030; and 888.3040 |
| Predicate Devices: | Synthes Locking Distal Radius Plate System – K012114 |
| Variax Distal Radius Plating System - K141430 | |
| Proximal Humerus Plating System – K141493 | |
| Reference Devices: | Paragon 28, Inc.; The Monster Screw System: Instrument |
| Reprocessing Instructions for Reusable Instruments - K151418 |
Device Description:
The Distal Radius Plating System is an internal fixation system to be used for the treatment of distal radius fractures. The system consists of plates, screws, and locking caps. The Distal Radius Plates are bilateral and available in two different models; standard or with a multi-directional oblong hole (MDOH) feature. Each model comes in two sizes, 5 hole and 6 hole. The Distal Radius Plating System Screws are 2.7mm in diameter and available in various lengths.
The MDS device is single-use ONLY.
Materials: Ti-6A1-4V ELI alloy conforming to ASTM F136.
Intended Use:
The MDS Distal Radius Plating System is internal fixation of fractures of the distal radius.
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Summary of Technologies:
The Distal Radius Plating System has the same intended use, similar performance characteristics, and is similar in design and materials to the Synthes (K012114) and Stryker (K141430) predicate devices listed above; with the exception of the Miami Device Solutions predicate (K141493) which is indicated for the proximal humerus. The Miami Device Solutions Proximal Humerus Plating System (K141493) is considered a predicate because it utilizes the same locking technology as the subject device. Additionally, the subject device provides the option of a multi-directional oblong hole (MDOH) that the listed predicates do not.
Performance Data:
Non-Clinical Performance and Conclusions:
The results of non-clinical (laboratory/performance) testing demonstrate that the subject and predicate devices have similar performance properties. Substantial equivalence was demonstrated in the performance testing section of the submission by comparing the design and testing according to ASTM F382-99, Standard Test Metallic Medical Bone Plates and ASTM F543-07, Standard Specification and Test Method for Metallic Bone Screws, which show that the Distal Radius Plating System performs as well as the predicate devices. Comparison of the design, intended use, and testing demonstrate that the Distal Radius Plating System performs as well as the predicate devices and should thereby be considered substantially equivalent.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
Conclusion
The Miami Device Solutions Distal Radius Plating System is substantially equivalent to the predicate devices.