The EVOS Small Fragment Plating System is indicated for adult and adolescent (greater than 12-21 years of age) 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, metatarsals, and clavicle.

Device Description

The subject of this Traditional 510k is the EVOS Straight Proximal Humerus 7-15 hole plates (137-225mm). The EVOS Straight Proximal Humerus Plate are a line extension to the existing 3 and 5 holes EVOS Straight Proximal Humerus Plates (93-114mm). The EVOS Straight Proximal Humerus Plates were previously cleared for market via premarket notification K173293. The lengths of the subject EVOS Straight Proximal Humerus Plates are being extended to include 7-15 hole plates (137-225mm). The EVOS Straight Proximal Humerus Plates are for single use only. Similar plate lengths have been cleared on EVOS Curved Proximal Humerus 6-18 hole plates (114-246mm) via premarket notification K173293.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

Summary of Acceptance Criteria and Device Performance for EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)

Based on the provided document, the device described is a bone fixation plate, not an AI or diagnostic device. Therefore, the typical "acceptance criteria" and "device performance" metrics associated with AI-powered diagnostic tools (like sensitivity, specificity, accuracy, etc.) are not applicable here. Instead, the "acceptance criteria" for this type of medical device relate to substantial equivalence to a predicate device, demonstrated through engineering analysis, material properties, and performance testing relevant to mechanical functionality and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit from document)	Reported Device Performance
Substantial Equivalence	Equivalence in intended use, indications for use, design, material, and performance characteristics to predicate device.	The subject device is deemed "substantially equivalent" to predicate devices (K173293) based on engineering analysis.
Biocompatibility/Safety	Acceptable endotoxin limits.	Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in relevant FDA guidance and standards (ANSI/AAMI ST72).
Mechanical Performance	Mechanical performance comparable to predicate device.	An engineering analysis (specifically, a finite element analysis, as mentioned in the conclusion) was conducted, and its review indicates substantial equivalence in performance to the predicate devices.

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

Sample Size for Test Set: Not applicable in the context of an engineering analysis of a bone plate. There isn't a "test set" of patient data or images in the way an AI study would have. The "testing" refers to mechanical and material characterization of the device itself.
Data Provenance: Not applicable. The "data" comes from engineering analysis and laboratory testing of the device, not from patient populations.

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

Not applicable. The "ground truth" for a mechanical device is established through engineering principles, material science, and regulatory standards, not expert consensus on patient cases.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" requiring adjudication in this context.

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

No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating human performance, often in diagnostic tasks, with and without AI assistance. This document describes a medical implant.

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

Not applicable. This device is a physical bone plate, not an algorithm.

7. The Type of Ground Truth Used

For mechanical performance: The "ground truth" is based on established engineering principles, material properties, and validated computational models (finite element analysis). Compliance with validated engineering standards and comparison to a legally marketed predicate device forms the basis of performance evaluation.
For biocompatibility: The "ground truth" is defined by established regulatory limits for endotoxins as detailed in FDA guidance and ANSI/AAMI ST72.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for this type of medical device.

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

Not applicable.

Summary

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July 22, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The Department of Health & Human Services logo is a stylized depiction of a human figure, while the FDA acronym and name are written in blue, with the acronym in a square and the name in a sans-serif font.

Smith & Nephew, Inc. Kayla Franklin Regulatory Affairs Specialist 1 7135 Goodlett Farms Parkway Cordova, Tennessee 38016

Re: K201527

Trade/Device Name: EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm) 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 5, 2020 Received: June 8, 2020

Dear Kayla Franklin:

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.

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

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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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201527

Device Name

EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)

Indications for Use (Describe)

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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510(k) Summary

Submitted by:	Smith & Nephew, Inc.
	Advanced Surgical Devices Division
	7135 Goodlett Farms Parkway
	Cordova, Tennessee 38016
Date of Submission:	July 22, 2020
Contact Person:	Kayla Franklin, Regulatory Affairs Specialist I
	T (901) 800-3398
	M (901) 325-2471
Name of Device:	EVOS Straight Proximal Humerus 7-15 hole Plates
	(137-225mm)
Common Name:	Plate, Fixation, Bone
Device Classification Name	21 CFR 888.3030 – Single/Multiple Component
and Reference:	Metallic Bone Fixation Appliances and Accessories
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	HRS
Predicate Device:	EVOS Straight Proximal Humerus Plates – K173293

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Device Description:

Indications for Use

Technoloqical Characteristics

Device comparisons described in this premarket notification demonstrate that the subject device EVOS Straight Proximal Humerus 7-15 hole plates (137-225mm) are substantially equivalent to the below listed legally marketed predicate devices with regard to intended use, indications for use, design, material and performance characteristics.

Substantial Equivalence Information

The overall design, materials, and indications for the EVOS Straight Proximal Humerus 7-15 hole plates (137-225mm) are substantially equivalent to the following commercially available predicate devices.

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Table 6.1: Predicate Devices

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew, Inc.	72466903 EVOS3.5mm StraightProximal HumerusPlate 3H 93mm & 5H114mm	K173293	01/08/2018

Performance Testing

To further support a determination of substantial equivalence, an engineering analysis was conducted on the EVOS Straight Proximal Humerus 7-15 hole plates (137-225mm). A review of the testing indicates that the EVOS Straight Proximal Humerus 7-15 hole plates (137-225mm) are substantially equivalent to predicate devices listed in the Table 6.1 above.

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.

Conclusion

As previously noted, this 510(k) Premarket Notification is being submitted to request clearance for the EVOS Straight Proximal Humerus 7-15 hole plates (137-225mm). Based on the similarities to the predicate devices and a review of the finite element analysis testing, the subject device is substantially equivalent to the commercially available predicate devices listed above.

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.