(22 days)
The Sigma Cruciate Retaining Porocoat Femoral Components are intended for cemented or cementless use as the femoral components of a Total Knee Replacement system.
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.
Candidates for total knee replacement include elderly patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. 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 significant improvement in their quality of life.
The Sigma C/R Porocoat Femoral Components are part of the Sigma Total Knee Replacement System. They are porous coated Co-Cr femoral components with an asymmetric trochlear groove, available in sizes 1.5- 6, in right and left versions. Fixation of the femoral component to the femur is achieved using either bone cement or by biologic fixation via tissue ingrowth into the porous coating.
The provided text is a 510(k) summary for the DePuy Sigma Cruciate Retaining (C/R) Porocoat® Femoral Components. This document focuses on demonstrating substantial equivalence to previously cleared devices, rather than presenting a study with specific acceptance criteria and performance metrics for a novel technology.
Therefore, many of the requested elements (acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, etc.) are not applicable or not present in this type of submission.
Here's why and what information can be extracted:
- This is a 510(k) submission for substantial equivalence. In a 510(k) pathway, the primary goal is to show that a new device is as safe and effective as a legally marketed predicate device. This is often done by demonstrating similarity in design, materials, indications for use, and technological characteristics. It does not typically involve extensive clinical performance studies with acceptance criteria in the same way a PMA or a novel AI/software device would.
- The device is an orthopedic implant (Total Knee Replacement Prosthesis). For such devices, substantial equivalence is commonly established through a comparison of physical and mechanical properties, sterilization methods, biocompatibility, and intended use, often leveraging existing data from the predicate device.
- The key argument for substantial equivalence is based on existing, cleared components. The DePuy Sigma C/R Porocoat Femoral Components are described as:
- "identical in design to the Sigma Femoral Components cleared for cemented use only in K943462 and K961685." (Predicate 1 & 2 for design)
- "The Porocoat porous coating... is identical to the Porocoat porous coating used on the LCS Knee Femoral Components, which were approved for cementless use in P830055 and on the AML Proximally Coated Hip cleared for cementless use in K933787." (Predicate 3 & 4 for the Porocoat feature and cementless use).
Given this context, here's an attempt to address your points, indicating where information is not available:
Acceptance Criteria and Study Overview
This 510(k) submission does not present a study with specific, quantifiable "acceptance criteria" and "reported device performance" in the way one would see for a diagnostic device or an AI algorithm. Instead, the "study" is a comparative analysis demonstrating substantial equivalence to predicate devices, focusing on design, materials, and technological characteristics. The "acceptance criteria" are implied by the FDA's decision to clear the device based on the submission's arguments for similarity to existing devices.
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable. This submission does not provide a table of acceptance criteria and reported device performance metrics because it's a substantial equivalence argument, not a performance study against novel criteria. The "performance" is inferred to be equivalent to the predicate devices due to identical design and materials.
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable. No explicit "test set" or human subject data is described for this specific submission. Substantial equivalence for this type of device relies on engineering comparisons, material analysis, and referencing existing predicate device data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable. Ground truth, in the context of device performance studies, is not applicable here as no clinical "test set" requiring expert evaluation is mentioned. The "truth" for substantial equivalence is based on the technical specifications and regulatory history of the predicate devices.
4. Adjudication Method for the Test Set
Not Applicable. No multi-expert adjudication method is described as there is no "test set" requiring such evaluation.
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
Not Applicable. This device is a passive implant (knee component), not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical orthopedic implant, not an algorithm.
7. The Type of Ground Truth Used
"Ground truth" for this 510(k) is implicitly based on the established safety and effectiveness of the legally marketed predicate devices. The submission argues that because the new device's design (K943462, K961685) and surface coating (P830055, K933787) are identical to components already cleared by the FDA, its safety and effectiveness are also equivalent.
8. The Sample Size for the Training Set
Not Applicable. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. This is not an AI/ML device requiring a ground truth for a training set.
In summary, the K062654 submission is a classic example of a 510(k) premarket notification for demonstrating substantial equivalence of a medical device (a knee implant component) to existing predicate devices. It relies on direct comparison of design, materials, and indications for use, rather than presenting de novo clinical performance studies with acceptance criteria commonly seen for diagnostic or AI-driven devices.
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SEP 2 9 2006
510(k) SUMMARY
| NAME OF FIRM: | DePuy Orthopaedics Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988Establishment Registration No.: 1818910 |
|---|---|
| 510(k) CONTACT: | Nancy FriddleTeam Leader, Regulatory AffairsTel: (574) 371-4923Email: nfriddle@dpyus.jnj.com |
| TRADE NAME: | DePuy Sigma Cruciate Retaining (C/R)Porocoat® Femoral Components |
| COMMON NAME: | Total Knee Replacement Prosthesis |
| CLASSIFICATIONS: | 888.3560 Knee joint patellofemorotibialpolymer/metal/polymer semi-constrainedcemented prosthesis; Class II888.3565 Knee joint patellofemorotibialpolymer/metal porous coated uncementedprosthesis; Class II |
| DEVICE PRODUCT CODES: | JWH, MBH |
| SUBSTANTIALLY EQUIVALENTDEVICES: | PFC Sigma® Knee System (cleared as DarwinKnee System), K943462PFC Cruciate Retaining Knee System, Size 1.5K961685AML® Proximally Coated Hip, K933787 |
DEVICE DESCRIPTION:
The Sigma C/R Porocoat Femoral Components are part of the Sigma Total Knee Replacement System. They are porous coated Co-Cr femoral components with an asymmetric trochlear groove, available in sizes 1.5- 6, in right and left versions. Fixation of the femoral component to the femur is achieved using either bone cement or by biologic fixation via tissue ingrowth into the porous coating.
INDICATIONS FOR USE:
The Sigma C/R Porocoat Femoral Components are intended for cemented or cementless use as the femoral components of a Total Knee Replacement system.
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Total Knee Replacement is intended to provide increased patient mobility and reduced pain bv replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
Candidates for total knee replacement include elderly patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. 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 significant improvement in their quality of life.
SUBSTANTIAL EQUIVALENCE
The Sigma C/R Porocoat Femoral Components are identical in design to the Sigma Femoral Components cleared for cemented use only in K943462 and K961685. The Porocoat porous coating of the Sigma C/R Porocoat Femoral Components is identical to the Porocoat porous coating used on the LCS Knee Femoral Components, which were approved for cementless use in P830055 and on the AML Proximally Coated Hip cleared for cementless use in K933787.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle-like symbol with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
SEP 2 9 2006
DePuy Orthopaedics, Inc. % Ms. Nancy Friddle Team Leader, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K062654
Trade/Device Name: "DePay Sigma Cruciate Retaining Porocoat" Femoral Components Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: September 6, 2006 Received: September 7, 2006
Dear Ms. Friddle:
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 for about in 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. 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 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); good manufacturing practice requirements as set 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.
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Page 2 -- Ms. Nancy Friddle
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its will ber (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
f
Mark N. Mulkerson
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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K062654 510(k) Number (if known):
Device Name: DePuy Sigma Cruciate Retaining Porocoat® Femoral Components
Indications for Use:
The Sigma Cruciate Retaining Porocoat Femoral Components are intended for cemented or cementless use as the femoral components of a Total Knee Replacement system.
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.
Candidates for total knee replacement include elderly patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. 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 significant improvement in their quality of life.
| 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)
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and Neurslogica
510(k) Number K062654
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§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.