The CONQUEST FN system is comprised of contoured locking bone plates and compatible locking and non-locking bone screws. The subject premarket notification describes additional sizes of the bone plates to the Smith & Nephew CONQUEST FN system. The subject devices are manufactured from the same implant-grade stainless steel (316L) and designed for singleuse. They will be provided in a sterile packaged option and will be sterilized via Gamma irradiation.

AI/ML Overview

This document, K193029, is a 510(k) premarket notification for a medical device called CONQUEST FN, specifically an additional size of the bone plate (CONQUEST FN 3 Hole Small Stature Plate). The FDA letter confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain information about studies involving AI or human readers, expert ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies. The acceptance criteria discussed refer to engineering and biocompatibility testing for a physical implant, not an AI/software device.

Therefore, I cannot provide a response filling in the requested information about AI device acceptance criteria and performance studies. The document describes a traditional medical device (metallic bone fixation appliance) and its mechanical and material testing.

The "Summary of Pre-Clinical Testing" section discusses:

Construct Fatigue Testing: This is a mechanical test to assess the device's durability under repeated stress.
Bacterial Endotoxin Testing: This is a biocompatibility test to ensure the device is safe from endotoxin contamination.

The acceptance criteria for these tests are described in terms of meeting specific standards and showing similar stability to the predicate device.

If your request was based on the assumption that this document detailed an AI/software device, please note that it does not.

Summary

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February 28, 2020

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K193029 Smith & Nephew, Inc. 1450 E Brooks Rd, Memphis, TN 38116 US Trade/Device Name: CONQUEST FN Contact Name: Thomas Fearnley Senior Regulatory Affairs Specialist

Re: K193029

Trade/Device Name: CONQUEST FN Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDO, KTT Dated: January 24, 2020 Received: January 27, 2020

Dear Thomas Fearnley:

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 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

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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 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 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.

Vesa Vuniqi, MS Assistant Director DHT6A: Division of Joint Arthroplasty 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) K193029

Device Name CONQUEST FN

Indications for Use (Describe)

The Smith & Nephew CONQUEST FN is indicated for displaced intracapsular femoral neck fractures.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/2 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew" in black and orange. The words "We are" are in black, while "smith&nephew" is in orange.

Submitted by:	Smith & Nephew, Inc.Advance Surgical Devices Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	October 29, 2019
Contact Person and Address:	Thomas FearnleySenior Regulatory Affairs SpecialistT (901) 399-1224F (901) 566-7022
Name of Device:	CONQUEST FN
Common Name:	Internal Fracture Fixation Device
Device Classification Name andReference:	21 CFR 888.3030 Single/multiple component metallic bonefixation appliances and accessoriesClass II
Panel Code:	Orthopedics/87
Product Code:	JDO,KTT

Device Description

Intended Use

The Smith & Nephew CONQUEST FN is intended for use in internal fixation of femoral neck fractures.

Indications for Use

The Smith & Nephew CONQUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures.

Comparison to Technological Characteristics with Predicate Device

Device comparisons described in this premarket notification demonstrated that the proposed CONQUEST FN bone plates are substantially equivalent to the legally marketed predicate devices listed below with regard to intended use, indications for use, and performance characteristics.

The subject bone plates feature characteristics very similar to the CONQUEST FN system bone plates cleared via K152686, with the primary differences being the elimination of the plate shaft and distal screw holes. All other design aspects, indications for use, intended use, material and fundamental scientific technology remain the same as those in K152686.

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Substantial Equivalence Information

The substantial equivalence of the CONQUEST FN 3 Hole Small Stature Plate is based on its similarities in indications for use, design features, sterilization methods, and materials to the predicate systems listed in the following table.

Manufacturer	Description	SubmissionNumber	ClearanceDate
Smith & Nephew	CONQUEST FN (Primary Predicate)	K152686	3/17/2016
Smith & Nephew	Smith & Nephew Cannulated Screws andWashers	K111994	10/11/2011

Table 5.1: Substantially Equivalent Predicates to CONQUEST FN 3 Hole Small Stature Plate

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A comparison of the subject device to the predicate device is described in the following table. Table 5.2 Summary of Comparison to Predicate Devices

Design AspectReviewed	CONQUEST FN 3Hole Small StaturePlate	CONQUEST FN(primary predicate)	Cannulated Screws andWashers
Predicate Type	N/A	Primary	Reference
510(k) Number	Subject 510(k)	K152686	K111994
Same intendeduse	Yes	Yes	Yes
SameIndications forUse	The Smith & NephewCONQUEST FN isindicated fordisplaced andundisplacedintracapsular femoralneck fractures	The Smith & NephewCONQUEST FN isindicated fordisplaced andundisplacedintracapsular femoralneck fractures	The Smith & NephewCannulated Screws andWashers are used foradult and pediatricpatients as indicated forpelvic, small, and longbone fracture fixation.
SimilarOperatingPrinciple	Yes	Yes	No
Raw materialtype	316L Stainless Steel	316L Stainless Steel	316L Stainless Steel
Similar designfeatures.function andintended use	Yes	Yes	No
Anatomicallybased FemoralLocking Plate	Yes	Yes	No
Screws	7.5 and 8.5mmLocking Screws(based on POGOScrew designK080649, up to 3)	7.5 and 8.5mmLocking Screws(based on POGOScrew designK080649, up to 3)4.5mm locking andnon-locking screws	4.0mm, 5.5mm,6.5mm, 7.0mm and8.0mm CannulatedScrews

Summary of Pre-Clinical Testing

Construct Fatigue Testing was conducted on the CONQUEST FN 3 Hole Small Stature . Plate. Results of the test concluded that the CONQUEST FN 3 Hole Small Stature Plate met the acceptance criteria and is expected to have similar construct stability during bending fatigue as compared to the predicate.
Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in FDA Guidance , "Submission and Review of Sterility Information in Premarket Notification

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(510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxin Testing: Questions and Answers," and ANSI/AAMI ST72.

Conclusion

The proposed additional sizes of CONQUEST FN plates are substantially equivalent to the previously cleared CONQUEST FN plates cleared with the CONQUEST FN system in K152686 in that the indications for use and fundamental scientific technology for the subject devices are identical.

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.