(58 days)
The EVOLUTION® MP Revision Femoral System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
- Inflammatory degenerative joint disease, including rheumatoid arthritis;
- Correction of functional deformity
- Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
The EVOLUTION® MP Revision Femoral System is for cemented use only.
The EVOLUTION® MP Revision Femoral System is a line extension of the EVOLUTION® MP Total Knee System product line. The device is a stemmed distal femoral knee joint replacement implant for use in revision or a complicated primary total knee arthroplasty. The design features are summarized below:
- Manufactured from Cobalt Chrome Alloy
- Available in CS and PS design, sizes 3-7, left and right
- Compatible with 510(k) cleared EVOLUTION® Tibial Inserts, EVOLUTION® Adaptive Tibial Inserts, ADVANCE® Patellae and ADVANCE® Stem Extensions
- System includes 4, 8 and 12 mm augments to fill bone voids in distal and/or posterior bone geometry
This document is a 510(k) Pre-Market Notification from the FDA for the EVOLUTION® MP Revision Femoral System. It is a regulatory approval document and, as such, does not contain the information requested in your prompt regarding acceptance criteria and study particulars for an AI/device performance study.
The device detailed in this document is a knee joint replacement implant. The document focuses on demonstrating substantial equivalence to a predicate device based on design features, materials, and nonclinical (mechanical) testing, not on the performance of a diagnostic AI algorithm.
Specifically, the document states:
- "E. Clinical Testing: Clinical data was not provided for the subject devices." This explicitly indicates that no clinical performance study, let alone one involving AI or diagnostic accuracy, was conducted or submitted.
Therefore, I cannot provide an answer to your detailed questions (acceptance criteria, sample sizes, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set details) because this document does not describe the kind of study you are asking about.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 7, 2014
MicroPort Orthopedics Incorporated Ms. Caroline Fryar Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002
Re: K142550 Trade/Device Name: EVOLUTION® MP Revision Femoral System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: September 8, 2014 Received: September 10, 2014
Dear Ms. Fryar:
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. 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); good manufacturing practice requirements as set
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Page 2 - Ms. Caroline Fryar
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Expiration Date: January 31, 2017
See PRA Statement below.
Form Approved: OMB No. 0910-0120
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
EVOLUTION® MP Revision Femoral System
Indications for Use (Describe)
The EVOLUTION® MP Revision Femoral System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
-
Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
-
Inflammatory degenerative joint disease, including rheumatoid arthritis:
-
Correction of functional deformity
-
Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
The EVOLUTION® MP Revision Femoral System is for cemented use only.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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EVOLUTION® MP Revision Femoral System Traditional 510(k) Tab 006: 510(k) Summary of Safety and Effectiveness
Image /page/3/Picture/2 description: The image shows the logo for MicroPort Orthopedics Inc. The logo features the company name in blue and red text, with a red star-like symbol in the upper left corner. Below the logo is the company's address, which is 5677 Airline Road, Arlington, TN 38002, and their website, ortho.microport.com.
510(k) Summary of Safety and Effectiveness
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for the EVOLUTION® MP Revision Femoral System
| Submitted by: | MicroPort Orthopedics Inc. |
|---|---|
| 5677 Airline Rd, Arlington TN, 38002 | |
| Phone: 866-872-0211 | |
| Fax: 855-446-2247 | |
| Date: | November 3, 2014 |
| Contact Person: | Caroline Fryar |
| Regulatory Affairs Specialist | |
| Proprietary Name: | EVOLUTION® MP Revision Femoral System |
| Common Name: | Stemmed Femoral System |
| Classification Name and Reference: | 21 CFR 888.3560 Knee joint patellofemorotibial |
| polymer/metal/polymer semi-constrained cemented prosthesisClass II | |
| Subject Product Code and Panel Code: | Orthopedics/87/JWH |
| Predicate Device: | AXIOM® Stemmed Femoral Component (K932677) |
| Reference Devices: | ADVANCE® Femoral Augments (K990030) |
| ADVANCE® Stemmed Porous Femur (K061223) | |
| EVOLUTION® MP CS/CR Non-Porous Femur (K093552, K102380) | |
| EVOLUTION® MP CS/CR Porous Femur (K140735) |
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DEVICE INFORMATION
A. Intended Use
The EVOLUTION® MP Revision Femoral System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic 1. arthritis, or avascular necrosis
-
- Inflammatory degenerative joint disease, including rheumatoid arthritis;
-
- Correction of functional deformity
-
- Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
The EVOLUTION® MP Revision Femoral System is for cemented use only.
B. Device Description
The EVOLUTION® MP Revision Femoral System is a line extension of the EVOLUTION® MP Total Knee System product line. The device is a stemmed distal femoral knee joint replacement implant for use in revision or a complicated primary total knee arthroplasty. The design features are summarized below:
- Manufactured from Cobalt Chrome Alloy
- Available in CS and PS design, sizes 3-7, left and right
- Compatible with 510(k) cleared EVOLUTION® Tibial Inserts, EVOLUTION® ● Adaptive Tibial Inserts, ADVANCE® Patellae and ADVANCE® Stem Extensions
- . System includes 4, 8 and 12 mm augments to fill bone voids in distal and/or posterior bone geometry
C. Substantial Equivalence Information
The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The indications for use are identical to the predicate devices. The fundamental scientific technology of the modified devices has not changed relative to the predicate device, as well. The safety and effectiveness of the subject devices are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
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D. Nonclinical Testing
The subject EVOLUTION® MP Revision Femur was evaluated for fatigue strength, which concluded that the subject stemmed femoral component performs as well or better than the predicate device.
E. Clinical Testing
Clinical data was not provided for the subject devices.
F. Conclusion
The design features, materials information, predicate testing and analysis date provided in this premarket notification adequately support the substantial equivalence of the EVOLUTION® MP Revision Femoral System.
§ 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.