Candidates for total or unicompartmental knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant. In candidates for unicompartmental knee arthroplasty, only one side of the medial or lateral compartment) is affected.

The Sigma® C/R Porocoat® Femoral Components are intended for cementless use as the femoral component of a Total Knee Replacement system.

In the US, all other porous coated components have been cleared for CEMENTED USE ONL Y. Any Non-Porous coated components are intended for CEMENTED USE ONLY.

Device Description

A total knee prosthesis is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant, with or without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial tray with or without porous coating, and a polyethylene insert and locking components. Some metal components have modular stems, sleeves and/or modular wedges. The patella component may be of an all polyethylene design or may be a metal backed polyethylene component.

AI/ML Overview

This 510(k) submission is to provide MRI compatibility labeling for the PFC SIGMA Knee System. No clinical studies were conducted as the submission is based on non-clinical testing for MRI compatibility.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria	Reported Device Performance
Magnetically Induced Displacement Force (ASTM F2052-14)	No excessive movement or dislodgement of the device in the MR environment. (Implied by safety concerns addressed in the FDA guidance and ASTM standards)	Testing concluded no safety issues related to magnetic field interactions under specific conditions.
Torque (ASTM F2213-06)	No excessive rotation or twisting of the device in the MR environment. (Implied by safety concerns addressed in the FDA guidance and ASTM standards)	Testing concluded no safety issues related to magnetic field interactions under specific conditions.
Radiofrequency (RF) Heating (ASTM F2182-11a)	No unsafe temperature increase in the device due to RF energy from the MR scanner that could impact patient safety. (Implied by safety concerns addressed in the FDA guidance and ASTM standards)	Testing concluded no safety issues related to magnetic field interactions under specific conditions.
Image Artifacts (ASTM F2219-07)	Image quality should not be unacceptably degraded by device-induced artifacts, or the effects assessed and characterized. (Implied by concerns about imaging)	Effects of the implants on image quality were evaluated.
MR Conditional Labeling (ASTM F2503-13)	The device should meet criteria to be labeled as "MR Conditional," meaning it can be safely used in a specified MR environment under defined conditions.	Testing supports an MR conditional label as described in FDA Guidance Document and ASTM F2503-13.

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

Sample Size for Test Set: The document states that "worst-case components and constructs" were evaluated for RF Heating and image artifacts. However, a specific numerical sample size for the devices tested is not provided.
Data Provenance: The data is non-clinical, originating from laboratory testing (often referred to as ex-vivo or in-vitro when applicable to medical devices). The country of origin for the testing itself is not explicitly stated, but it follows US FDA guidance and ASTM standards. The study is retrospective in the sense that the device design already existed and was being evaluated for an additional claim.

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

This section is not applicable. The ground truth for MRI compatibility is established through standardized physical tests and measurements, not through expert consensus on interpretations of images or clinical outcomes. The "ground truth" is whether the device physically behaves safely and predictably in an MR environment according to predefined engineering standards.

4. Adjudication Method for the Test Set

This section is not applicable. As the evaluation involved physical measurements and adherence to engineering standards, there was no need for expert adjudication in the traditional sense of clinical trial data interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission is for MRI compatibility labeling based on non-clinical testing.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

A standalone performance study of an algorithm was not done. This submission pertains to the physical properties of a knee implant system and its interaction with MRI, not an algorithm.

7. Type of Ground Truth Used

The ground truth used was based on results from standardized non-clinical physical and engineering tests (magnetically induced displacement force, torque, RF heating, image artifacts) as defined by FDA guidance and ASTM standards (e.g., ASTM F2052-14, ASTM F2213-06, ASTM F2182-11a, ASTM F2219-07, ASTM F2503-13).

8. Sample Size for the Training Set

This section is not applicable. There was no "training set" as this was not a machine learning or AI-based study.

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

This section is not applicable.

Summary

{0}------------------------------------------------

November 8, 2019

Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

DePuy Orthopaedics, Inc. Mr. Brian Kincaid Associate Director, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46582

Re: K182301

Trade/Device Name: PFC SIGMA Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, MBH Dated: November 1, 2019 Received: November 4, 2019

Dear Mr. Kincaid:

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.

{1}------------------------------------------------

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.

Ting Song, PhD Assistant Director (Acting) DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K182301

Device Name PFC SIGMA Knee System

Indications for Use (Describe)

The Sigma® C/R Porocoat® Femoral Components are intended for cementless use as the femoral component of a Total Knee Replacement system.

In the US, all other porous coated components have been cleared for CEMENTED USE ONL Y. Any Non-Porous coated components are intended for CEMENTED USE ONLY.

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.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Section 5: 510 (k) Summary

(As required by 21 CFR 807.92)

Submitter Information
Name	DePuy Orthopaedics
Address	700 Orthopedic DriveWarsaw, IN 46582
Phone number	574-372-7337
Fax number	574- 371-4987
Establishment Registration Number	1818910
Name of contact person	Brian Kincaid
Date prepared	May 23, 2019
Name of device
Trade or proprietary name	PFC SIGMA Knee System
Common or usual name	Total Knee Replacement Prothesis
Classification name	Knee joint patellofemorotibial polymer/metal/polymer semi-contrainedcemented prosthesisKnee joint patellofemorotibial metal/polymer porous-coateduncemented prosthesis
Class	II
Classification panel	87 Orthopedics
Regulation	21 CFR 888.3560, 21 CFR 888.3565
Product Code(s)	JWH, MBH
Legally marketed device(s)to which equivalence isclaimed.	K882234, K884796, K952830, K961685,K971189PFC SIGMA Knee System, Tibial Tray
	K952830PFC SIGMA Knee System, Fluted Tibial Rod
Note: The primary predicatedevice is K032115. Allothers are additionalpredicate devices.	K882234PFC SIGMA Knee System, Taper Femoral Stem
	K063633PFC SIGMA Knee System, Universal Stem
	K943462, K961685, K062654PFC SIGMA Cruciate Knee System
	K950010, K952830, K971189PFC SIGMA Knee System
	K952830, K060515PFC SIGMA Knee System, adaptors and bolts
	K991106PFC SIGMA Porous Modular Keel Tray
	K984158PFC SIGMA Plus Offset Tibial Tray
	K032115 (Primary)PFC SIGMA Co-Cr Tibial Tray

{4}------------------------------------------------

Reason for 510(k) submission	The subject of this submission is to provide magnetic resonance imaging(MRI) compatibility labeling for the PFC SIGMA Knee System. There areno proposed changes to the indications for use, the design of the product,the materials that comprise the product, or the use of the product.
Device description	A total knee prosthesis is composed of individually packaged femoral, tibialand patellar components designed to replace the natural articular surface ofthe knee joint. The femoral component is a metal implant, with or withouta porous coating. The tibial component may be an all polyethylenecomponent or comprised of a metal tibial tray with or without porouscoating, and a polyethylene insert and locking components. Some metalcomponents have modular stems, sleeves and/or modular wedges. Thepatella component may be of an all polyethylene design or may be a metalbacked polyethylene component.
Intended use of the device	Total knee arthroplasty is intended to provide increased patient mobility andreduced pain by replacing the damaged knee joint articulation in patientswhere there is evidence of sufficient sound bone to seat and support thecomponents. Total knee replacement may be considered for youngerpatients if, in the opinion of the surgeon, an unequivocal indication for totalknee replacement outweighs the risks associated with the age of the patient,and if limited demands regarding activity and knee joint loading can beassured. This includes severely crippled patients with multiple jointinvolvement for whom a gain in knee mobility may lead to an expectationof significant improvement in the quality of their lives.
Indications for use	Candidates for total or unicompartmental knee replacement include patientswith a severely painful and/or severely disabled joint resulting fromosteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failedprevious implant. In candidates for unicompartmental knee arthroplasty,only one side of the joint (the medial or lateral compartment) is affected.The SIGMA® C/R Porocoat® Femoral Components are intended forcemented or cementless use as the femoral component of a Total KneeReplacement system.In the US, all other porous coated components have been cleared forCEMENTED USE ONLY. Any Non-Porous coated components areintended for CEMENTED USE ONLY.
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPAREDTO THE PREDICATE DEVICE

The purpose of this submission is to change the device labeling to include information for safety and compatibility of the subject devices in the MR environment. The design features and materials of the subject devices are identical to those of the predicate devices. The indications for use are identical to the predicate devices. The safety and effectiveness of the subject devices are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this submission.

{5}------------------------------------------------

PERFORMANCE DATA

SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The purpose of the submission is to add MR compatibility to the device labeling for the PFC SIGMA Knee System. There are no changes to the intended use, design, materials, sterilization, packaging, shelf life, or manufacturing methods for the PFC SIGMA Knee System.

The MR environment could potentially interact with the subject devices that may impact patient safety and imaging, including movement or dislodgement of the device due to magnetically induced displacement force and/or torque, radiofrequency (RF) induced heating, and image artifacts. Methods used to evaluate MR compatibility included the Food and Drug Administration (FDA) guidance document entitled "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment', as well as the following standards from the American Society for testing and Materials (ASTM):

Magnetically induced displacement force (ASTM F2052-14*) ●
Torque (ASTM F2213-06)
Radio frequency (RF) heating (ASTM F2182-11a)
Image Artifacts (ASTM F2219-07)
Standard Practice for marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment ● (F2503-13)

The tests determined the effects of the implants, and the effects of the implants on the image quality. The tests evaluated the worst-case components and constructs for RF Heating, and image artifacts. The testing concluded that there are no safety issues related to magnetic field interactions under specific conditions identified in the labeling.

As a result, the testing supports a MR conditional label as described within the FDA's Guidance Document and the ASTM standard, F2503-13.

*Note: External test reports have been written in compliance to ASTM F2052-14. However, a single change has been made to ASTM F2052-15 to voluntarily include the determination of the maximum allowable spatial gradient of the magnetic field. This has been incorporated in the respective reports. Henceforth, all references to the standard will be ASTM F2052-14.

SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION

No clinical tests were conducted to demonstrate substantial equivalence.

CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The subject devices are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.