(81 days)
The DePuy Sigma CR-F femoral component is intended for cemented use only. Candidates for total 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.
The Sigma CR-F femoral component is part of the PFC Sigma Total Knee Replacement System. It is a Co-Cr-Mo femoral component with an asymmetric trochlear groove, available in sizes 1.5 - 6, in right and left versions. The fixation surface is textured. It incorporates two pegs to provide additional stability and recessed cement pockets for enhanced cement fixation. These features have not changed from those on the predicate PFC Sigma CR femoral component.
Here's an analysis of the provided text regarding the DePuy Sigma CR-F femoral component, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (PFC Sigma CR femoral component) | Demonstrated through: - Same indications, materials, manufacturing process, sterilization, and packaging. - Non-clinical testing: Comparisons of tibiofemoral contact area and pressure, range of motion analysis, and constraint testing showed equivalence. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable. The submission explicitly states "Clinical testing was not necessary to determine substantial equivalence between the subject Sigma CR-F femoral components and the predicate devices."
- Data Provenance: Not applicable, as no clinical testing was performed. Non-clinical testing data (e.g., biomechanical testing) would typically be generated in a lab setting, likely in the country of manufacture (USA, given the applicant is DePuy Orthopaedics Inc. in Warsaw, Indiana). The nature of the non-clinical tests suggests a prospective approach to data generation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable, as no clinical testing with a "test set" and "ground truth" was conducted in the human-in-the-loop sense. The ground truth for non-clinical testing is typically defined by engineering specifications, biomechanical principles, and established testing standards.
4. Adjudication Method for the Test Set:
- Not applicable, as no clinical human-reader-based test set was used.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical knee implant, not an AI software/device that would assist human readers in interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of AI algorithms. However, "standalone" in a broader sense refers to the device's inherent mechanical performance. The non-clinical testing (tibiofemoral contact area, pressure, range of motion, constraint testing) demonstrates the standalone performance of the implant itself, comparing it to the predicate device.
7. The Type of Ground Truth Used:
- The "ground truth" for demonstrating substantial equivalence was based on engineering and biomechanical performance metrics established for the predicate device. These include:
- Material specifications
- Manufacturing processes
- Sterilization methods
- Packaging
- Biomechanical properties: tibiofemoral contact area and pressure, range of motion, and constraint characteristics.
The ground truth here is derived from the established and proven performance of the predicate device, not clinical outcomes or pathology from a patient population related to the new device itself.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI device that requires a training set of data.
9. How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no "training set" for this type of medical device submission.
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KD82500 * 1/2
510(k) Summary
NOV 1 8 2008
| Applicant / Sponsor: | DePuy Orthopaedics Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988Establishment Registration No.: 1818910 |
|---|---|
| Contact Person: | Nancy FriddleProject Leader, Regulatory AffairsTel: (574) 371-4923Fax: (574) 371-4987 |
| Proprietary Name: | DePuy Sigma CR-F femoral component |
| Common Name: | Total Knee Replacement Prosthesis |
| Classification Name: | 21 CFR 888.3560: Knee joint patellofemorotibial,polymer/metal/polymer semi-constrained cementedprosthesis, Class II |
| Product Code: | JWH |
| SubstantiallyEquivalent Devices: | PFC Sigma® Knee System (cleared as Darwin KneeSystem), K943462 |
| PFC Cruciate Retaining Knee System, Size 1.5, K96168 |
Device Description:
The Sigma CR-F femoral component is part of the PFC Sigma Total Knee Replacement System. It is a Co-Cr-Mo femoral component with an asymmetric trochlear groove, available in sizes 1.5 - 6, in right and left versions. The fixation surface is textured. It incorporates two pegs to provide additional stability and recessed cement pockets for enhanced cement fixation. These features have not changed from those on the predicate PFC Sigma CR femoral component.
Intended Use:
Total Knee Replacement 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.
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Image /page/1/Picture/0 description: The image shows handwritten text that appears to be a combination of letters and numbers. On the left side, the text reads 'K082500'. To the right of this, there is another set of characters that look like '#2/2'. The handwriting is somewhat stylized, with some characters more clearly formed than others.
Total knee replacement may be considered for younger patients if, in the opinion of the surgeon, an uncquivocal 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 significant improvement in their quality of life.
The Sigma CR-F femoral component is intended to accommodate knee flexion to 150 degrees in those patients able to attain a high degree of knec flexion.
Indications:
The DePuy Sigma CR-F femoral component is intended for cemented use only.
Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, theumatoid arthritis, or a failed previous implant.
Summary of Technologies/Substantial Equivalence:
The Sigma CR-F femoral component has the same indications, materials, manufacturing process, sterilization and packaging as the previously cleared PFC Sigma CR femoral components. The design of the implant has been modified to provide more congruent articulation with the tibial insert during high flexion.
Non-Clinical Testing:
Comparisons of tibiofemoral contact area and pressure, range of motion analysis and constraint testing were performed to demonstrate the substantial equivalence of the Sigma CR-F femoral components to the predicate PFC Sigma CR femoral components.
Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence between the subject Sigma CR-F femoral components and the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in providing health and human services to the people of the United States.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Orthopaedics, Inc. % Ms. Nancy Friddle Project Leader, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
NOV 1 8 2008
K082500 Trade/Device Name: DePuy Sigma Cr-F Femoral Component Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: August 28, 2008 Received: August 29, 2008
Dear Ms. Friddle:
Re:
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, Or to 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your devise can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, TDA0000 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 af 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); good manufacturing practice requirements as set
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Page 2 - Ms. Nancy Friddle
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliary, pat (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Protmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark M. Mulhausen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): _ (082500
Device Name: DePuy Sigma CR-F Femoral Component
Indications for Use:
The DePuy Sigma CR-F femoral component is intended for cemented use only.
Candidates for total 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Division of General, Restorative, and Neurological Devices
510(k) Number K682500
§ 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.