(288 days)
The MDS Proximal Humerus Plating System is intended to provide internal fixation of fractures of the proximal humerus.
The Proximal Humerus Plating System is an internal fixation plate system to be used for proximal humerus fractures. The system consists of plates, screws, and locking caps. The Proximal Humerus Plates are available in two lengths, and are side-specific. The Proximal Humerus Plating System Screws are 3.5mm in diameter and available in various lengths.
This document describes a 510(k) premarket notification for the "Proximal Humerus Plating System," a metallic bone fixation device. The submission primarily relies on non-clinical performance testing to establish substantial equivalence, common for Class II devices of this nature.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance (Conclusion) |
|---|---|
| ASTM F382-99: Standard Test Method for Metallic Medical Bone Plates | The Proximal Humerus Plating System performs as well as the predicate devices. |
| ASTM F543-07: Standard Specification and Test Method for Metallic Bone Screws | The Proximal Humerus Plating System performs as well as the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes (number of plates/screws tested) for mechanical testing. It mentions "non-clinical (laboratory/performance) testing." The data provenance is laboratory testing, not from human subjects or patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The ground truth for this device is based on compliance with engineering standards (ASTM F382-99 and ASTM F543-07) and mechanical testing data, not expert human interpretation of medical images or conditions.
4. Adjudication Method for the Test Set:
Not applicable. There was no human expert adjudication involved in establishing the "ground truth" for the mechanical performance of this device.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. The device is a surgical implant, and its effectiveness is determined by its mechanical properties and surgical outcomes, not by reader performance in interpreting imaging data.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done:
Not applicable. This device is a physical medical implant, not an algorithm or AI-powered system, so the concept of standalone algorithm performance does not apply.
7. The Type of Ground Truth Used:
The ground truth used is based on engineering standards and mechanical testing data. Specifically, the device's performance was compared against the requirements and methodologies outlined in ASTM F382-99 for bone plates and ASTM F543-07 for bone screws.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical implant; therefore, it does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
Image /page/0/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" arranged around the perimeter. Inside the circle is an emblem featuring a stylized image of three human profiles facing to the right, stacked one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 20, 2015
Miami Device Solutions. LLC % Mr. Peter J. Mincieli HealthLink Associates, Incorporated 631 South East 11th Street Pompano Beach, Florida 33060
Re: K141493
Trade/Device Name: Proximal Humerus 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: December 23, 2014 Received: December 29, 2014
Dear Mr. Mincieli:
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
{1}------------------------------------------------
Page 2 - Mr. Peter J. Mincieli
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/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 yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
| 510(k) Number (if known) | K141493 |
|---|---|
| -------------------------- | --------- |
Device Name: Proximal Humerus Plating System
The MDS Proximal Humerus Plating System is intended to provide internal fixation of fractures of the proximal humerus.
Prescription Use X (Per 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
{3}------------------------------------------------
510(k) Summary
| Name of Applicant: | Miami Device Solutions, LLCMarkku Biedermann7620 NW 25th Street, Unit 3Miami, FL 33122Phone: (786) 422-1400Fax: (786) 422-1401 |
|---|---|
| 510(k) Contact: | Healthlink Associates, Inc.Peter J Mincieli631 SE 11th StreetPompano Beach, FL 33060Phone: (954) 818-9204Fax: (800) 215-9489 |
| Date: | 02-19-2015 |
| Trade Name: | Proximal Humerus Plating System |
| Common Name: | Single/Multiple component metallic bone fixation appliances and accessoriesSmooth or threaded metallic bone fixation fastener |
| Classification: | Class II per 21 CFR 888.3030 |
| Device Product Code: | HRS / HWC |
| Predicate Devices: | Arthrex Humeral Fracture Plates and Screws - K041965Smith and Nephew Inc. Peri-Loc Locking Bone Plates and Locking Bone Screws for theUpper -Extremity - K051735Zimmer Universal Locking System, 3.5mm - K081759 |
| Device Description: | The Proximal Humerus Plating System is an internal fixation plate system to be used forproximal humerus fractures. The system consists of plates, screws, and locking caps. ThProximal Humerus Plates are available in two lengths, and are side-specific.The Proximal Humerus Plating System Screws are 3.5mm in diameter and available invarious lengths. |
| Intended Use: | The Proximal Humerus Plating System is indicated for internal fixation of fractures ofthe proximal humerus. |
| Comparison to Predicate Device: | The Proximal Humerus Plating System has the same intended use, similar performancecharacteristics, and is similar in design and materials to the predicate devices listedabove, with the exception of the Smith and Nephew Self-Tapping Locking Screw which |
{4}------------------------------------------------
Non-Clinical Performance and Conclusions:
The results of non-clinical (laboratory/performance) testing demonstrate that the device is safe and effective.
Substantial equivalence was demonstrated in the performance testing section of the submission by comparing the design and testing according to ASTMF382-99, Standard Test Method for Metallic Medical Bone Plates and ASTM F543-07, Standard Specification and Test Method for Metallic Bone Screws which shows that the Proximal Humerus Plating System performs as well as the predicate devices. Comparison of the design, intended use, and testing demonstrate that the Proximal Humerus 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.
§ 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.