(68 days)
No
The summary describes a traditional mechanical implant system for bone fixation and does not mention any AI or ML components or functionalities.
Yes
The device is described as an "internal fixation system" for treating "fractures of the distal radius," which is a therapeutic intervention.
No
This device is an internal fixation system (plates, screws, pegs, and locking caps) used for treating fractures, which is a therapeutic purpose rather than a diagnostic one.
No
The device description explicitly states it consists of plates, screws, pegs, and locking caps made of Ti-6Al-4V ELI alloy, which are physical hardware components for internal fixation.
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 bone fractures, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device consists of "plates, screws, pegs, and locking caps" made of a metallic alloy. These are implants used in surgery, not reagents, instruments, or software used for in vitro testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a disease or condition
The device is clearly an orthopedic implant used for surgical treatment of bone fractures.
N/A
Intended Use / Indications for Use
The MDS Distal Radius Plating System is internal fixation of fractures of the distal radius.
Product codes
HRS, HWC
Device Description
This special 510(k) submission is intended to add new plate designs, screw diameter options and lengths, pegs, and accompanying instrumentation to the Miami Device Solutions Distal Radius Plating System cleared through K161292/K162635.
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, pegs, and locking caps. The Distal Radius Plates are available in bilateral and side-specific designs to accommodate different anatomies and fracture patterns. The addition of new devices through this special 510(k) provides the user with more options for fixation.
Materials: Ti-6Al-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
Prescription Use
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
Non-Clinical Performance and Conclusions: The results of non-clinical (laboratory/performance) testing as well as engineering analysis for subject devices demonstrate that the device is as safe and as effective as the predicates. Substantial equivalence is demonstrated in the performance testing section of the submission by comparing subject and predicate designs, as well as testing according to ASTM F543-07, Standard Specification and Test Method for Metallic Bone Screws. Comparison of the design, intended use, and testing support substantial equivalence of the subject device to the predicate.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
Key Metrics
Not Found
Predicate Device(s)
K161292, K162635, K071092, K133246
Reference Device(s)
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
December 10, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
Miami Device Solutions, LLC Michelle Montesino Regulatory Affairs Specialist 7620 NW 25th Street, Unit 3 & 4 Miami, Florida 33122
Re: K182810
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: November 16, 2018 Received: November 19, 2018
Dear Michelle 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali -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)
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K182810 PAGE 1 OF 2
510(k) SUMMARY
| Submitter Name: | Miami Device Solutions, LLC | ||
|---|---|---|---|
| Submitter Address: | 7620 NW 25th Street, Unit 3 & 4; Miami, FL 33122 | ||
| Contact Person: | Michelle Montesino | ||
| Phone: (786) 422-1400 Ext. 106 | |||
| Fax: (786) 422-1401 | |||
| Anderson Giraldo | |||
| Phone: (786) 422-1400 Ext. 115 | |||
| Fax: (786) 422-1401 | |||
| Date of Submission: | October 2, 2018 | ||
| Manufacturer Name: | Miami Device Solutions, LLC | ||
| Manufacturer Address: | 7620 NW 25th Street, Unit 3 & 4; 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: | |||
| K161292, | |||
| K162635, | Primary | Miami Device Solutions Distal | |
| Radius Plating System | |||
| K071092, | Secondary | Stryker Asnis Micro Cannulated | |
| Screw |
Secondary
Reference Devices:
K041461 Kinetikos Medical Inc. Distal Volar Radius Plate System (Viper Plate)
System
Zimmer Distal Radius Plating
4
| K151418 | The Monster Screw System: Instrument
Reprocessing Instructions for Reusable Instruments |
| --------- | -------------------------------------------------------------------------------------------- |
|---|
Device Description:
This special 510(k) submission is intended to add new plate designs, screw diameter options and lengths, pegs, and accompanying instrumentation to the Miami Device Solutions Distal Radius Plating System cleared through K161292/K162635.
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, pegs, and locking caps. The Distal Radius Plates are available in bilateral and side-specific designs to accommodate different anatomies and fracture patterns. The addition of new devices through this special 510(k) provides the user with more options for fixation.
Materials: Ti-6Al-4V ELI alloy conforming to ASTM F136.
Intended Use:
The addition of devices through this special 510(k) does not alter the intended use of the predicate system as cleared in K161292/K162635, Distal Radius Plating System. The indications for use for the subject device are provided below.
Indications for Use
The MDS Distal Radius Plating System is internal fixation of fractures of the distal radius.
Summary of Technologies:
The proposed device is substantially equivalent in intended use, materials, and performance characteristics to the predicate device. The addition of devices to the plating system through this special 510(k) does not alter the fundamental technology and operating principles of the Distal Radius Plating System.
Performance Data:
Non-Clinical Performance and Conclusions:
The results of non-clinical (laboratory/performance) testing as well as engineering analysis for subject devices demonstrate that the device is as safe and as effective as the predicates. Substantial equivalence is demonstrated in the performance testing section of the submission by comparing subject and predicate designs, as well as testing according to ASTM F543-07, Standard Specification and Test Method for Metallic Bone Screws. Comparison of the design, intended use, and testing support substantial equivalence of the subject device to the predicate.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
Conclusion
The Miami Device Solutions Distal Radius Plating System with the addition of devices through this special 510(k) is substantially equivalent to the predicate device.