(59 days)
No
The summary describes a mechanical plating system for bone fixation and does not mention any AI or ML components or functionalities.
No
The device is a wrist plating system indicated for fixation of fractures, malunions, and osteotomies, which is a structural support device rather than a therapeutic one that directly treats or cures a disease.
No
Explanation: The device is a plating system for bone fixation, used in the treatment of fractures and other bone conditions. Its purpose is therapeutic (fixation), not diagnostic.
No
The device description clearly describes physical bone plates and screws, which are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of fractures, malunions, and osteotomies involving the radius and ulna. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a plating system consisting of plates and screws designed to be implanted into bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze biological samples. This device is an implantable surgical device.
No.
The provided FDA clearance letter does not contain any mention of a Predetermined Change Control Plan (PCCP) or language indicating that the device is authorized under such a program.
Intended Use / Indications for Use
The EVOS Wrist Plating System is indicated for adult and pediatric patients with osteopenic bone. It is indicated for fixation of fractures, malunions, and osteotomies involving the radius and ulna.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
Subject of this premarket notification is the EVOS Wrist Fragment Plating System. The proposed devices incorporate design features that are currently incorporated on previously cleared Smith & Nephew bone plate and screw systems. Like their previously cleared counterparts, the proposed plates feature a screw-to-plate locking feature that permits their use with the proposed and compatibility designed locking and non-locking cortex screws described in this premarket notification. Each screw hole contains five separate tabs that engage with the threads of the locking screw. The locking screws can be angled and locked up to fifteen degrees in any direction, allowing for custom, multi-directional locked plating constructs. The subject plates can be used with screws previously cleared via K161665, K132296, K993106, K162078, K140814 and K132886 and pegs subject of this premarket notification. Refer to Section 11 Device Description for greater detail.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radius and ulna
Indicated Patient Age Range
adult and pediatric patients
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)
- Finite element analysis (FEA) was conducted on the proposed plate designs to determine the worst case plates for further mechanical testing. Plates were separated into groups for evaluation based upon similar designs or anatomical application.
- Bending performance was evaluated through static or cantilever bend testing for the worst case plate designs identified through FEA. Results of the testing determined that the subject plates performed similar or superior to the predicate plates tested, when evaluated under the same conditions.
- Packaging verification testing was conducted for the proposed packaging configurations and the results of this testing demonstrated that the product will not be damaged during shipment and will adequately maintain sterility post shipment.
- Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance , "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.
- EVOS Wrist Fracture Plating System Biocompatibility Testing
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.
K161665, K132296, K993106, K162078, K043185, K140814, K132886
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
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Smith & Nephew, Inc. Bryan Cowell Senior Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116
August 9, 2018
Re: K181533
Trade/Device Name: EVOS Wrist Fracture 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 Dated: June 7, 2018 Received: June 11, 2018
Dear Bryan Cowell:
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/cdrl/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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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,
Mark N. Melkerson -S
Mark Melkerson Division Director Division of Orthopedics Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181533
Device Name EVOS Wrist Fracture Plating System
Indications for Use (Describe)
The EVOS Wrist Plating System is indicated for adult and pediatric patients with osteopenic bone. It is indicated for fixation of fractures, malunions, and osteotomies involving the radius and ulna.
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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| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Date of Summary: | April 20, 2018
Bryan Cowell
Senior Regulatory Affairs Specialist
T 978-749-1093
F 978-749-1443 |
| Name of Device: | EVOS Wrist Fragment Plating System |
| Common Name: | Bone Plates |
| Device Classification Name and
Reference: | 21 CFR 888.3030 Single/multiple component metallic bone
fixation appliances and accessories |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | HRS |
Predicates
| Manufacturer | Description | Submission
Number | Clearance Date |
|----------------------|-------------------------------------------------------------|----------------------|----------------------|
| Smith & Nephew, Inc. | VLP Wrist Fracture System
(primary predicate) | K161665 | November 15,
2016 |
| Smith & Nephew, Inc. | D-RAD SMARTPACK | K132296 | January 7, 2014 |
| Smith & Nephew, Inc. | Bone Plate System | K993106 | December 9,
1999 |
| Smith & Nephew, Inc. | EVOS Small Fragment
Plating System | K162078 | November 18,
2016 |
| Smith & Nephew, Inc. | Synthes 3.5mm Cortex
Screws | K043185 | February 3,
2005 |
| Smith & Nephew, Inc. | EVOS Mini Fragment Plating
System | K140814 | May 7, 2014 |
| Smith & Nephew, Inc. | Variable - Angle Locking
Mini Fragment Plating
System | K132886 | February 4,
2014 |
Device Description
Subject of this premarket notification is the EVOS Wrist Fragment Plating System. The proposed devices incorporate design features that are currently incorporated on previously cleared Smith & Nephew bone plate and screw systems. Like their previously cleared counterparts, the proposed plates feature a screw-to-plate locking feature that permits their use with the proposed and compatibility designed locking and non-locking cortex screws described in this premarket notification. Each screw hole contains five separate tabs that engage with the threads of the locking screw. The
4
locking screws can be angled and locked up to fifteen degrees in any direction, allowing for custom, multi-directional locked plating constructs. The subject plates can be used with screws previously cleared via K161665, K132296, K993106, K162078, K140814 and K132886 and pegs subject of this premarket notification. Refer to Section 11 Device Description for greater detail.
Indications for Use
The EVOS Wrist Plating System is indicated for adult and pediatric patients, as well as patients with osteopenic bone. It is indicated for fixation of fractures, malunions, and osteotomies involving the radius and ulna.
Technological Characteristics
Device comparisons described in this premarket notification demonstrated that the proposed devices are substantially equivalent to legally marketed predicates with respect to intended use, indications, and performance characteristics. The subject devices include plates with both locking and non-locking holes similar to the previously cleared predicate devices K161665, K132296, K993106, K162078, K043185, K140814 and K132886.
Summary of Pre-clinical Testing
- . Finite element analysis (FEA) was conducted on the proposed plate designs to determine the worst case plates for further mechanical testing. Plates were separated into groups for evaluation based upon similar designs or anatomical application.
- Bending performance was evaluated through static or cantilever bend testing for the worst case plate ● designs identified through FEA. Results of the testing determined that the subject plates performed similar or superior to the predicate plates tested, when evaluated under the same conditions.
- Packaging verification testing was conducted for the proposed packaging configurations and the . results of this testing demonstrated that the product will not be damaged during shipment and will adequately maintain sterility post shipment.
- Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance , "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.
- EVOS Wrist Fracture Plating System Biocompatibility Testing o
Conclusion
This Traditional 510(k) premarket notification is being submitted to request clearance for the EVOS Wrist Fracture Plating System. Based on similarities to the predicate plating systems and a review of the mechanical testing performed, the subject devices are substantially equivalent to the predicate devices.