The EVOS Small Fragment Plating System is indicated for adult and pediatric patients with osteopenic bone. It is indicated for fixation of small and long bone fractures, including, but not limited to, those of the tibia, fibula, femur, humerus, ulna, radius, pelvis, acctabulum, metacarpals, metatarsals, and clavicle.

Device Description

The subject of this special premarket notification are minor modifications to the 3.5mm nonlocking cortex screws and 4.7mm non-locking osteopenia screws (fully and partially threaded) previously cleared for market via Traditional 510(k), K162078. Design modifications described in this submission include minor updates to the tip of the cortex screw design and an increase in the screw head diameter for both the cortex and osteopenia screws.

The subject EVOS Small Fragment non-locking screws are intended to be used with existing Smith & Nephew implants and instruments that have been previously cleared for market for use with the EVOS Small Fragment Plating System.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device, the EVOS Small Fragment Plating System, specifically concerning minor modifications to existing non-locking screws. This document outlines the regulatory submission process and the justification for substantial equivalence to a predicate device.

It's important to understand that a 510(k) notification for a Class II medical device like this typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than performing a clinical study to prove the device meets specific acceptance criteria in a patient population. The "acceptance criteria" here refer to mechanical performance tests to show that the minor design changes do not negatively impact the device's safety and effectiveness compared to the predicate.

Therefore, the requested information elements related to clinical study design, such as sample size for test sets, data provenance, expert ground truth, MRMC studies, or standalone algorithm performance, are not applicable to this type of submission. This document describes a pre-clinical mechanical testing study.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Device: EVOS Small Fragment Plating System (modified 3.5mm non-locking cortex screws and 4.7mm non-locking osteopenia screws)

Acceptance Criteria Category	Specific Test/Metric	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance	Screw Insertion (Cortex Screws)	Performance similar or superior to existing EVOS screw design.	"Results of the testing demonstrated that screws manufactured with the modified tip performed similar or superior to the existing EVOS screw design."
Mechanical Performance	Maximum Stripping Torque (Modified Head Screws)	Significantly different (specifically, an increase) in maximum stripping torque compared to the current EVOS screw design to ensure adequate strength.	"Results of the testing demonstrated that the proposed head design modification met the acceptance criteria in that they were significantly different compared to the current EVOS screw design (increase in maximum stripping torque)." (This implies a higher stripping torque is desirable for improved performance/security).
Biocompatibility/Safety	Pyrogenicity	Not a new worst-case device for pyrogenicity compared to existing cleared products.	"Pyrogen testing was previously conducted for EVOS screws to support clearance of K162078. Existing results... as well as other implants cleaned using the same cleaning system that are considered more worst-case in terms of features, were reviewed and it was determined that the subject devices do not represent a new worst-case device."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact number of screws or test replicates used for the screw insertion and maximum stripping torque tests. This level of detail is typically found in the full test reports, which are not included in this summary.
Data Provenance: The studies were pre-clinical mechanical tests performed by the manufacturer (Smith & Nephew, Inc.). The data would be internally generated from laboratory testing. It is not patient or human subject data, so concepts like "country of origin" or "retrospective/prospective" in a clinical sense do not apply.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not Applicable. This was a pre-clinical mechanical testing study, not a study involving human interpretation of data where "ground truth" would be established by medical experts (e.g., radiologists). The "ground truth" is derived from direct physical measurements and engineering standards.

4. Adjudication Method for the Test Set

Not Applicable. As this was a pre-clinical mechanical testing study, there was no need for adjudication by multiple experts. The results are quantitative measurements from lab equipment.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is a type of clinical study evaluating diagnostic accuracy (e.g., of an imaging algorithm) with multiple readers and cases. This submission is for a bone fixation system and involves pre-clinical mechanical testing, not a diagnostic or clinical comparative effectiveness study of human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not Applicable. This device is a physical medical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the mechanical tests (screw insertion, stripping torque), the "ground truth" is based on engineering measurements and material science principles. The performance is compared against established benchmarks or the performance of the predicate device to ensure equivalence or improvement.
For pyrogenicity, the "ground truth" is based on established testing methodologies and safety standards for medical device biocompatibility.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of this pre-clinical mechanical testing for a physical implant. The concept of a training set applies to AI/ML algorithms.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. (See #8)

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 23, 2017

Smith & Nephew, Inc. Ms. Samantha Staubach Regulatory Affairs Specialist 1450 East Brooks Road Memphis, TN 38116

Re: K172262

Trade/Device Name: EVOS Small Fragment 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: July 26, 2017 Received: July 27, 2017

Dear Ms. Staubach:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 (DICE) 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" (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 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 (DICE) 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, Katherine D. Kavlock

-5

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K172262

Device Name EVOS Small Fragment Plating System

Indications for Use (Describe)

			------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-------
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)

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.

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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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FORM FDA 3881 (8/14)

PSC Publishing Services (301) 443-6740

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Image /page/3/Picture/1 description: The image contains the Smith & Nephew logo. The logo features a stylized orange flower-like symbol on the left. To the right of the symbol, the text "We are smith&nephew" is displayed, with "We are" in gray and "smith&nephew" in orange.

Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	August 18, 2017Samantha StaubachRegulatory Affairs SpecialistT 901-399-6132F 901-566-7596
Name of Device:	EVOS Small Fragment Plating System
Common Name:	Bone Screws
Device Classification Name andReference:	21CFR 888.3030 Single/multiple component metallic bonefixation appliances and accessories21 CFR 888.3040 Smooth or threaded metallic bone fixationfastener
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	HRS/HWC

Predicates

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew, Inc.	Smith & Nephew, Inc. EVOSSmall Fragment Plating System	K162078	November 18,2016

Device Description

Indications for Use

The EVOS Small Fragment Plating System is indicated for adult and pediatric patients, as well as patients with osteopenic bone. It is indicated for fixation of small and long bone fractures, including, but not limited to, those of the tibia, fibula, femur, humerus, ulna, radius, pelvis, acetabulum, metacarpals, metatarsals, and clavicle.

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Technological Characteristics

The subject devices are very similar to existing Smith & Nephew Plating System 3.5mm nonlocking cortex screws and 4.7mm non-locking osteopenia screws cleared via K162078. The minor modifications to the tip of the cortex screw and the head of the cortex and osteopenia screws are not expected to impact device safety or effectiveness, as demonstrated through mechanical testing. Device comparisons described in this premarket notification demonstrated that the proposed devices are identical to the predicate EVOS Small Fragment Plating System non-locking screws with respect to intended use, indications, materials, methods of manufacture, sterility, and packaging.

Summary of Pre-Clinical Testing

Screw insertion testing Insertion testing was conducted for the cortex screws with . modified tips and was compared to the existing EVOS design. Results of the testing demonstrated that screws manufactured with the modified tip performed similar or superior to the existing EVOS screw design.
Maximum stripping torque testing EVOS screws with modified screw head . diameters were compared against the existing EVOS screw design. Results of the testing demonstrated that the proposed head design modification met the acceptance criteria in that they were significantly different compared to the current EVOS screw design (increase in maximum stripping torque).
Engineering rationale Pyrogen testing was previously conducted for EVOS screws to ● support clearance of K162078. Existing results for the EVOS implants, as well as other implants cleaned using the same cleaning system that are considered more worstcase in terms of features, were reviewed and it was determined that the subject devices do not represent a new worst-case device.

Conclusion

This Special 510(k) premarket notification is being submitted to request clearance for the modified non-locking screws intended to be used with the EVOS Small Fragment Plating System. Based on similarities to the predicate components and a review of the mechanical testing performed, the subject modified screws are substantially equivalent to the predicate screws cleared via K162078.

Regulation Number and Section

§ 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.