(288 days)
Not Found
No
The device description and performance studies focus on mechanical properties and comparison to predicate devices based on standard test methods for bone plates and screws. There is no mention of AI, ML, image processing, or data sets for training/testing algorithms.
Yes
Explanation: The device is an internal fixation system used for fractures, which directly treats a medical condition.
No
The device is described as an internal fixation system for fractures, which is a treatment rather than a diagnostic function.
No
The device description explicitly states it is an "internal fixation plate system" consisting of "plates, screws, and locking caps," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to provide internal fixation of fractures of the proximal humerus." This describes a surgical implant used to stabilize bone fractures.
- Device Description: The description details plates, screws, and locking caps, which are all components of a surgical implant system.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with bodily specimens in this way.
This device is a surgical implant used for internal fixation of bone fractures.
N/A
Intended Use / Indications for Use
The MDS Proximal Humerus Plating System is intended to provide internal fixation of fractures of the proximal humerus.
The Proximal Humerus Plating System is indicated for internal fixation of fractures of the proximal humerus.
Product codes
HRS, HWC
Device Description
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. Th 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal humerus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Per 21 CFR 801 Subpart D)
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)
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 data and conclusions were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Arthrex Humeral Fracture Plates and Screws - K041965, Smith and Nephew Inc. Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper -Extremity - K051735, Zimmer Universal Locking System, 3.5mm - K081759
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/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
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510(k) Summary
| Name of Applicant: | Miami Device Solutions, LLC
Markku Biedermann
7620 NW 25th Street, Unit 3
Miami, FL 33122
Phone: (786) 422-1400
Fax: (786) 422-1401 |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Healthlink Associates, Inc.
Peter J Mincieli
631 SE 11th Street
Pompano Beach, FL 33060
Phone: (954) 818-9204
Fax: (800) 215-9489 |
| Date: | 02-19-2015 |
| Trade Name: | Proximal Humerus Plating System |
| Common Name: | Single/Multiple component metallic bone fixation appliances and accessories
Smooth 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 - K041965
Smith and Nephew Inc. Peri-Loc Locking Bone Plates and Locking Bone Screws for the
Upper -Extremity - K051735
Zimmer Universal Locking System, 3.5mm - K081759 |
| Device Description: | 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. Th
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. |
| Intended Use: | The Proximal Humerus Plating System is indicated for internal fixation of fractures of
the proximal humerus. |
| Comparison to Predicate Device: | The Proximal Humerus Plating System has the same intended use, similar performance
characteristics, and is similar in design and materials to the predicate devices listed
above, 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.