(441 days)
Not Found
No
The document describes a knee replacement implant and its MR compatibility testing. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is a total knee prosthesis, which is a medical implant designed to replace a severely painful and/or disabled joint, thereby restoring function and alleviating symptoms. This fits the definition of a therapeutic device as it treats a condition.
No
The device described is a total knee prosthesis, which is an implant used for joint replacement, not a device that provides diagnostic information. Its purpose is therapeutic, replacing a damaged joint, rather than identifying or characterizing a medical condition.
No
The device description clearly states it is a total knee prosthesis composed of physical components (femoral, tibial, and patellar components) made of metal and polyethylene. The performance studies also focus on the physical properties of these implants in an MRI environment.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for total or unicompartmental knee replacement, which is a surgical procedure to replace a damaged joint. This is a therapeutic intervention, not a diagnostic test performed in vitro (outside the body).
- Device Description: The device is described as a total knee prosthesis composed of physical components (femoral, tibial, and patellar) designed to replace the natural joint surface. This is a medical device used in vivo (inside the body).
- No mention of diagnostic testing: There is no indication that this device is used to diagnose a condition, analyze samples (blood, tissue, etc.), or provide information about a patient's health status through in vitro methods.
- Focus on MR compatibility: The performance studies focus on the device's safety and compatibility within an MRI environment, which is relevant to its use as an implant, not as a diagnostic tool.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JWH, MBH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
Indicated Patient Age Range
Not Found
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 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.
No clinical tests were conducted to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K032115, K882234, K884796, K952830, K961685, K971189
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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)
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.
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) |
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
Section 5: 510 (k) Summary
(As required by 21 CFR 807.92)
| Submitter Information | |
|---|---|
| Name | DePuy Orthopaedics |
| Address | 700 Orthopedic Drive |
| Warsaw, 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-contrained |
| cemented prosthesis | |
| Knee joint patellofemorotibial metal/polymer porous-coated | |
| uncemented 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 is | |
| claimed. | K882234, K884796, K952830, K961685, |
| K971189 | |
| PFC SIGMA Knee System, Tibial Tray | |
| K952830 | |
| PFC SIGMA Knee System, Fluted Tibial Rod | |
| Note: The primary predicate | |
| device is K032115. All | |
| others are additional | |
| predicate devices. | K882234 |
| PFC SIGMA Knee System, Taper Femoral Stem | |
| K063633 | |
| PFC SIGMA Knee System, Universal Stem | |
| K943462, K961685, K062654 | |
| PFC SIGMA Cruciate Knee System | |
| K950010, K952830, K971189 | |
| PFC SIGMA Knee System | |
| K952830, K060515 | |
| PFC SIGMA Knee System, adaptors and bolts | |
| K991106 | |
| PFC SIGMA Porous Modular Keel Tray | |
| K984158 | |
| PFC 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 are
no 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, 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. |
| Intended use of the device | Total knee arthroplasty is intended to provide increased patient mobility and
reduced pain by replacing the damaged knee joint articulation in patients
where there is evidence of sufficient sound bone to seat and support the
components. Total knee replacement may be considered for younger
patients if, in the opinion of the surgeon, an unequivocal indication for total
knee replacement outweighs the risks associated with the age of the patient,
and if limited demands regarding activity and knee joint loading can be
assured. This includes severely crippled patients with multiple joint
involvement for whom a gain in knee mobility may lead to an expectation
of significant improvement in the quality of their lives. |
| Indications for use | Candidates for total or unicompartmental knee replacement include patients
with a severely painful and/or severely disabled joint resulting from
osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed
previous 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 for
cemented or 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 ONLY. Any Non-Porous coated components are
intended for CEMENTED USE ONLY. |
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED
TO 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.