(196 days)
No
The document describes a mechanical plating system for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are based on mechanical testing and finite element analysis.
Yes
The device aids in fracture fixation and stabilization of bone fragments, which are therapeutic interventions.
No
The device is a plating system for fracture fixation and reduction of bones, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states the device consists of "bone plates" manufactured from "implantgrade 316L Stainless Steel material," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fracture fixation or reduction of small bones and small bone fragments" and "non-load bearing stabilization of bone fragments in long bones," as well as "fixation of patellar fractures." These are all surgical procedures performed directly on the patient's body.
- Device Description: The device is described as "bone plates" and "screws," which are implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the body, not to be implanted within the body for structural support or fixation.
N/A
Intended Use / Indications for Use
The EVOS Mini Plating System, excluding EVOS Patella Plates, is indicated for patients 12 – 21 and those over 21 years of age, as well as patients with osteopenic bone. The Smith & Nephew EVOS Mini Plating System is indicated for fracture fixation or reduction of small bones and small bone fragments. This system is also indicated for non-load bearing stabilization of bone fragments in long bones.
The EVOS Patella Plates are indicated for the fixation of patellar fractures for patients over 21 years of age.
Product codes
HRS, HWC
Device Description
The subject EVOS Patella Plates are an extension to the EVOS Mini Fragment system previously cleared under K140814 (S.E. 5/7/2014). The subject bone plates consist of a Staggered Patella Plate, and a Small and Large Mesh Patella Plate. The subject plates are compatible with the previously cleared EVOS 2.7mm locking screws, and partially and fully threaded 4.0mm osteopenia screws (K140814). The proposed plates feature a variable angle locking screw hole feature, are manufactured from implantgrade 316L Stainless Steel material and will be available in a sterile packaged condition.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bones, small bone fragments, long bones, patellar fractures.
Indicated Patient Age Range
The EVOS Mini Plating System, excluding EVOS Patella Plates, is indicated for patients 12 – 21 and those over 21 years of age.
The EVOS Patella Plates are indicated for patients over 21 years of age.
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)
The following nonclinical tests were used to determine substantial equivalence:
- Finite element analysis (FEA) and predicate clinical data were leveraged to support device performance.
- Four Point Bend Fatigue performance evaluation was done for the subject plates.
- Magnetic resonance imaging (MR) compatibility evaluation was done per ASTM F2213, ASTM F2182, and ASTM F2119.
- Packaging verification testing was conducted on the subject devices per ASTM F2096 and ASTM F88.
The testing detailed in this premarket notification demonstrates that the subject EVOS Patella Plates are substantially equivalent in performance to the predicate EVOS Mini-Fragment system (K140814, S.E. 5/7/2014).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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September 3, 2024
Smith & Nephew Mandy Coe Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116
Re: K240487
Trade/Device Name: EVOS Patella Plates 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: June 17, 2024 Received: June 21, 2024
Dear Mandy Coe:
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 (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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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
2
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-S
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
EVOS Mini-Fragment System
Indications for Use (Describe)
The EVOS Mini Plating System, excluding EVOS Patella Plates, is indicated for patients 12 - 21 and those over 21 years of age, as well as patients with osteopenic bone. The Smith & Nephew EVOS Mini Plating System is indicated for fracture fixation of small bones and small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.
The EVOS Patella Plates are indicated for the fixation and stabilization of patellar fractures for patients over 21 years of age.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
ver-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) #: | K240487 | 510(k) Summary | K240487 | ||
|---|---|---|---|---|---|
| Prepared on: | 2024-09-03 | ||||
| Contact Details | 21 CFR 807.92(a)(1) | ||||
| Applicant Name | Smith & Nephew | ||||
| Applicant Address | 1450 Brooks Road Memphis TN 38116 United States | ||||
| Applicant Contact Telephone | 901-949-3344 | ||||
| Applicant Contact | Mrs. Mandy Coe | ||||
| Applicant Contact Email | mandy.coe@smith-nephew.com | ||||
| Device Name | 21 CFR 807.92(a)(2) | ||||
| Device Trade Name | EVOS Mini-Fragment System | ||||
| Common Name | Single/multiple component metallic bone fixation appliances and accessories | ||||
| Classification Name | Plate, Fixation, Bone | ||||
| Regulation Number | 888.3030 | ||||
| Product Code(s) | HRS, HWC | ||||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |||
| K140814 | EVOS Mini-Fragment Plating System | HRS | |||
| K210408 | Depuy Synthes Variable Angle Locking Patella Plating System | HRS | |||
| K203834 | Arthrex Patella Sutureplates | HRS | |||
| Device Description Summary | 21 CFR 807.92(a)(4) |
Device Description Summary
The subject EVOS Patella Plates are an extension to the EVOS Mini Fragment system previously cleared under K140814 (S.E. 5/7/2014). The subject bone plates consist of a Staggered Patella Plate, and a Small and Large Mesh Patella Plate. The subject plates are compatible with the previously cleared EVOS 2.7mm locking screws, and partially and fully threaded 4.0mm osteopenia screws (K140814). The proposed plates feature a variable angle locking screw hole feature, are manufactured from implantgrade 316L Stainless Steel material and will be available in a sterile packaged condition.
Intended Use/Indications for Use
The EVOS Mini Plating System, excluding EVOS Patella Plates, is indicated for patients 12 – 21 and those over 21 years of age, as well as patients with osteopenic bone. The Smith & Nephew EVOS Mini Plating System is indicated for fracture fixation or reduction of small bones and small bone fragments. This system is also indicated for non-load bearing stabilization of bone fragments in long bones.
The EVOS Patella Plates are indicated for the fixation of patellar fractures for patients over 21 years of age.
21 CFR 807.92(a)(5)
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Indications for Use Comparison
The indications for use of the subject devices are substantially equivalent to the indications for the cleared predicates.
Technological Comparison
21 CFR 807.92(a)(6)
Device comparisons described in this premarket notification demonstrated that the proposed bone plates are substantially equivalent to legally marketed predicates with respect to indications, and performance characteristics. Both the subject and predicate devices have same operating principle, material, and technological characteristics such as variable angle locking screw holes.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following nonclinical tests were used to determine substantial equivalence:
- · Finite element analysis (FEA) and predicate clinical data were leveraged to support device performance.
- · Four Point Bend Fatigue performance evaluation was done for the subject plates.
- · Magnetic resonance imaging (MR) compatibility evaluation was done per ASTM F2213, ASTM F2182, and ASTM F2119. • Packaging verification testing was conducted on the subject devices per ASTM F2096 and ASTM F88.
The testing detailed in this premarket not the subject EVOS Patella Plates are substantially equivalent in performance to the predicate EVOS Mini-Fragment system (K140814, S.E. 57/2014).