(386 days)
No
The summary describes a mechanical implant (wrist plating system) and its performance testing, with no mention of AI or ML.
Yes
The device is indicated for fixation of fractures, malunions, and osteotomies involving the radius and ulna, which are all conditions that require therapeutic intervention.
No
The device is described as a plating system intended for fixation of fractures, malunions, and osteotomies, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is comprised of physical components like plates, pegs, and screws, which are hardware.
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 comprised of plates, pegs, and screws. These are physical implants used to stabilize 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 in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
The EVOS Wrist Plating System is indicated for adult and pediatic patients, as well as 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
The subject of this premarket notification is the EVOS Wrist Spanning Plate. The proposed device has identical indications to those previously cleared Smith & Nephew EVOS Wrist Fracture Plating system K181533 i.e. primary predicate. The proposed device incorporates design features similar to those currently incorporated on previously cleared Smith& Nephew Bone Plate System TC -100 (K993106). Like their previously cleared counterparts, the proposed plate features a screw-to-plate locking feature that permits their use with the proposed and compatibility designed locking and cortex screws described in this premarket notification. It is comprised of EVOS Wrist Spanning plate 13H, 1.8mm locking pegs, 2.4 and 3.5mm locking and cortex screws.
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)
. Bending performance was evaluated using a four-point bend fatigue test identified through FEA as the worst-case scenario in accordance with the guidelines of ASTM F382. The acceptance criterion was met in that the subject plates that were tested showed similar or superior (higher) bending fatigue performance compared to the predicates.
. 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.
. Master Biological Evaluation of Titanium Plate Implant Devices
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.
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.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left 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 is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 18, 2022
Smith & Nephew, Inc. Jyothsna Baravatula Regulatory Affairs Specialist 1450 E Brooks Rd Memphis, Tennessee 38116
Re: K213123
Trade/Device Name: EVOS Wrist Spanning Plate 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: September 13, 2022 Received: September 14, 2022
Dear Jyothsna Baravatula:
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.
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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213123
Device Name EVOS Wrist Spanning plate
Indications for Use (Describe)
The EVOS Wrist Plating System is indicated for adult and pediatic patients, as well as 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) | |
|---|---|
X 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: | 17 November 2021 |
| Name of Device: | EVOS Wrist Spanning Plate |
| 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. | EVOS Wrist Fracture Plating
System
(Primary Predicate) | K181533 | August 09, 2018 |
| Smith & Nephew, Inc. | Smith & Nephew Bone Plate
System (TC-100) | K993106 | December 09,
1999 |
Device Description
The subject of this premarket notification is the EVOS Wrist Spanning Plate. The proposed device has identical indications to those previously cleared Smith & Nephew EVOS Wrist Fracture Plating system K181533 i.e. primary predicate. The proposed device incorporates design features similar to those currently incorporated on previously cleared Smith& Nephew Bone Plate System TC -100 (K993106). Like their previously cleared counterparts, the proposed plate features a screw-to-plate locking feature that permits their use with the proposed and compatibility designed locking and cortex screws described in this premarket notification. It is comprised of EVOS Wrist Spanning plate 13H, 1.8mm locking pegs, 2.4 and 3.5mm locking and cortex screws.
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 device EVOS Wrist Spanning plate and the Smith & Nephew Bone Plating System (K993106) have similar design. Both devices have same operating principle i.e. they
4
mith Neph
use pegs and screws to be attached to bone. The subject device includes EVOS Wrist Spanning plate along with locking pegs, locking and cortex screws (K132886, K181533). Screw holes in the EVOS Wrist Spanning plate can either be threaded holes or variable angle holes. The subject screws feature a hex drive and are similar to existing Smith & Nephew predicate screws with respect to thread form and major and minor diameter.
Summary of Pre-Clinical Testing
- . Bending performance was evaluated using a four-point bend fatigue test identified through FEA as the worst-case scenario in accordance with the guidelines of ASTM F382. The acceptance criterion was met in that the subject plates that were tested showed similar or superior (higher) bending fatigue performance compared to the predicates.
- . 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.
- . Master Biological Evaluation of Titanium Plate Implant Devices
Conclusion
This Traditional 510(k) premarket notification is being submitted to request clearance for the EVOS Wrist Spanning Plate. Based on similarities to the predicate plating systems and a review ofthe mechanical testing performed, the subject devices are substantially equivalent to the predicate device.