(30 days)
Not Found
No
The device description focuses on mechanical components (plates, screws, instruments, caddy) for surgical fixation and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
Yes
The device is described as an "internal fixation system to be used for the treatment of distal radius fractures," which is a therapeutic intervention.
No.
The device is a surgical plating system and related instruments intended for internal fixation of fractures, not for diagnosing medical conditions.
No
The device description clearly outlines physical instruments (drill guides, sleeves, caddy) and implants (plates, screws, locking caps), indicating it is a hardware-based medical device system.
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 repair a bone fracture, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The device consists of plates, screws, locking caps, drill guides, sleeves, and a caddy. These are all surgical instruments and implants used directly on the patient during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device clearly falls under the category of a surgical implant and associated instruments.
N/A
Intended Use / Indications for Use
The MDS Distal Radius Plating System is intended for internal fixation of fractures of the distal radius.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
This special 510(k) submission is intended to add the following device instruments and caddy as accessories to the Miami Device Solutions Distal Radius Plating System which was cleared in K161292:
-
- Polyaxial Drill Guide
-
- Polyaxial Drill Guide Sleeve for K-Wire
-
- Polyaxial Drill Guide Caddy
The polyaxial drill guide caddy holds polyaxial drill guides and polyaxial drill guide sleeves for Kwires. The polyaxial drill guide and the polyaxial drill guide sleeve for K-wire helps the user during drill and K-wire insertion. 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.
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 additional instruments and caddy were shown to be compatible with applicable implants and instruments. Verification testing showed that the system is biocompatible and can be cleaned and sterilized.
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.
Miami Device Solutions Distal Radius Plating System – K161292
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.
Not Found
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 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 a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 21, 2016
Miami Device Solutions, LLC Ms. Michelle Montesino Regulatory Affairs Associate 7620 N.W. 25th Street, Unit 3 Miami, Florida 33122
Re: K162635
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: September 20, 2016 Received: September 21, 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,
Image /page/1/Picture/8 description: The image shows the name "Mark N. Melkerson -S" in a simple, sans-serif font. The text is horizontally aligned and appears to be part of a document or label. The letters are clear and legible, with consistent spacing between them.
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) K162635 (Page 1 of 1)
Device Name Distal Radius Plating System
Indications for Use (Describe) The MDS Distal Radius Plating System is intended for 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Device Solutions, LLC
3
510(k) SUMMARY
Special 510(k) Application
| Submitter Name: | Miami Device Solutions, LLC |
|---|---|
| Submitter Address: | 7620 NW 25th Street, Unit 3; Miami, FL 33122 |
| Contact Person: | Michelle Montesino |
| Phone: (786) 422-1400 Ext. 106 | |
| Fax: (786) 422-1401 | |
| Date of Submission: | September 20, 2016 |
| Manufacturer Name: | Miami Device Solutions, LLC |
| Manufacturer Address: | 7620 NW 25th 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: | Miami Device Solutions Distal Radius Plating System – |
| K161292 |
Device Description:
This special 510(k) submission is intended to add the following device instruments and caddy as accessories to the Miami Device Solutions Distal Radius Plating System which was cleared in K161292:
-
- Polyaxial Drill Guide
-
- Polyaxial Drill Guide Sleeve for K-Wire
-
- Polyaxial Drill Guide Caddy
The polyaxial drill guide caddy holds polyaxial drill guides and polyaxial drill guide sleeves for Kwires. The polyaxial drill guide and the polyaxial drill guide sleeve for K-wire helps the user during drill and K-wire insertion. 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.
4
Materials: Ti-6Al-4V ELI alloy conforming to ASTM F136.
Intended Use:
The addition of the polyaxial drill guide caddy, polyaxial drill guides, and polyaxial drill guide sleeves for K-wire does not alter the intended use of the predicate system as cleared in K161292 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 intended for 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 the following instruments as accessories to the plating system does not alter the technology.
Performance Data:
Non-Clinical Performance and Conclusions:
The additional instruments and caddy were shown to be compatible with applicable implants and instruments. Verification testing showed that the system is biocompatible and can be cleaned and sterilized.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
Conclusion
The Miami Device Solutions Distal Radius Plating System and the addition polyaxial drill guides, polyaxial drill guide sleeves for K-wire, and the polyaxial drill guide caddy is substantially equivalent to the predicate device.