(88 days)
No
The device description and testing focus solely on the MR compatibility of passive implants, with no mention of AI/ML capabilities or data processing beyond standard MR image artifact evaluation.
Yes
The device is a knee arthroplasty system, which is used to treat various knee conditions and correct deformities; these are therapeutic interventions.
No
This device is a knee arthroplasty system intended for surgical implantation, not for diagnosing medical conditions.
No
The device description explicitly lists multiple hardware components made of various materials (metal, titanium alloy, UHMWPE) that are implanted in the body. The submission focuses on testing the compatibility of these physical implants with an MR environment.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this device is a knee arthroplasty system, consisting of implants (femoral components, tibial bases, etc.) designed to be surgically implanted into the knee joint. The intended use is for treating various knee conditions through surgical replacement.
- No Mention of Samples or Testing: There is no mention of the device being used to test samples from the body or to diagnose conditions based on such testing.
- Focus on Implantation and MR Compatibility: The information focuses on the physical components of the implant, their materials, and their compatibility with Magnetic Resonance (MR) imaging after implantation.
Therefore, this device falls under the category of a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EVOLUTION® BIOFOAM® Tibial, EVOLUTION® Revision Tibial, and EVOLUTION® Revision CCK Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
-
Non-inflammatory degenerative joint disease: including osteoarthritis, 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® BIOFOAM® Tibial System implants are for cementless use only.
The EVOLUTION® Revision Tibial and EVOLUTION® Revision CCK Systems are for cemented use only.
Product codes
MBH, JWH
Device Description
A labeling change is taking place to include MR Conditional language and symbols to the implant components of the predicate device systems identified above. The changes only apply to the device labeling; therefore, the subject devices are identical to the predicate devices.
The non-clinical testing provided establishes the conditional safety and compatibility of the passive implants in a magnetic resonance (MR) environment. The subject devices include the following components and basic design features:
- . Metal femoral components manufactured from cobalt chrome alloy
- . Femoral revision accessories, including augments, manufactured from titanium alloy
- . CCK tibial inserts manufactured from UHMWPE with locking screws and posts manufactured from titanium alloy
- . Tibial bases manufactured from titanium alloy available in porous and non-porous versions
- Tibial revision accessories, including keels, augments, stem extensions, and adapters, . manufactured from titanium alloy.
- . Patellae manufactured from UHMWPE and cobalt chrome alloy
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Knee
Indicated Patient Age Range
skeletally mature patients
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
Nonclinical testing was conducted to establish the conditional safety and compatibility of the passive implants in a magnetic resonance (MR) environment according to the recommendations provided in the Guidance for Industry and Food and Drug Administration Staff entitled "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", issued by the US FDA on December 11, 2014. Testing was also conducted according to the following standards:
- . NEMA MS 8-2008 Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems
- . ASTM F2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- . ASTM F2119-07(2013) Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
- . ASTM F2182-11a Standard Test Method For Measurement of Radio Frequency Induced Heating On Or Near Passive Implants During Magnetic Resonance Imaging
- . ASTM F2213-06(2011) Standard Test Method For Measurement Of Magnetically Induced Torque On Medical Devices In The Magnetic Resonance Environment
- ASTM F2503-13 Standard Practice For Marking Medical Devices And Other Items For Safety In The Magnetic Resonance Environment
The test determined the effects of MRI on the implants and the effects of the implants on the MR image quality. The tests evaluated the worst case components and constructs for RF heating, field interactions, and image artifacts. The testing concluded that there are no safety issues related to magnetic field interactions under the specific conditions identified in the labeling.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" stacked on top of each other.
MicroPort Orthopedics, Inc. Grace Johnson-Bann Sr. Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002
May 4, 2018
Re: K180317
Trade/Device Name: EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System 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: February 1, 2018 Received: February 5, 2018
Dear Ms. Johnson-Bann:
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 forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K180317
Device Name
EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System
Indications for Use (Describe)
The EVOLUTION® BIOFOAM® Tibial, EVOLUTION® Revision Tibial, and EVOLUTION® Revision CCK Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
-
Non-inflammatory degenerative joint disease: including osteoarthritis, 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® BIOFOAM® Tibial System implants are for cementless use only.
The EVOLUTION® Revision Tibial and EVOLUTION® Revision CCK Systems are 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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Image /page/3/Picture/0 description: The image shows the logo for MicroPort Orthopedics. The logo consists of a blue square with rounded corners, inside of which is a white circle containing a red diamond shape. To the right of the square is the word "MicroPort" in blue, with the word "Orthopedics" underneath in red. Below that is the phrase "Full Function. Faster." in blue.
510(K) SUMMARY
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® Knee Systems MR Labeling.
| Submitted by: | MicroPort Orthopedics Inc.
5677 Airline Rd, Arlington TN, 38002
Phone: 866-872-0211
Fax: 855-446-2247 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | May 2, 2018 |
| Contact Person: | Grace Johnson-Bann
Sr. Regulatory Affairs Specialist |
| Proprietary Name of Modified Device: | EVOLUTION® Knee Systems – MR Labeling
EVOLUTION® BIOFOAM® Tibial System
EVOLUTION® Revision Tibial System
EVOLUTION® Revision CCK System |
| Common Name: | Cementless Knee Systems, Cemented Revision Knee Systems, MR Labeling |
| Classification Name and Reference: | 21 CFR 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis
Class II
21 CFR 888.3560 – Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
Class II |
| Subject Product Code and Panel Code: | Orthopedics/87/MBH, JWH |
| Predicate Devices: | EVOLUTION® BIOFOAM® Tibial System (K152298)
EVOLUTION® Revision Tibial System (K162026)
EVOLUTION® Revision CCK System (K171389) |
| Reference Device: | MPO Total Knee Systems MR Labeling (K152631) |
MicroPort Orthopedics BV Hoogoorddreef 5, 1101 BA Amsterdam, The Netherlands +31 20 545 01 00
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Image /page/4/Picture/1 description: The image is a logo for MicroPort Orthopedics. The logo features a blue square with rounded corners on the left side, inside of which is a white circle with a red diamond shape in the center. To the right of the square is the word "MicroPort" in blue, with the word "Orthopedics" in red underneath. Below the words is the phrase "Full Function, Faster" in blue.
DEVICE INFORMATION
A. Intended Use
The EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, and EVOLUTION® Revision CCK System are 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® BIOFOAM® Tibial System is for use without bone cement.
The EVOLUTION® Revision Tibial and CCK Systems are for cemented use only.
B. Device Description
A labeling change is taking place to include MR Conditional language and symbols to the implant components of the predicate device systems identified above. The changes only apply to the device labeling; therefore, the subject devices are identical to the predicate devices.
The non-clinical testing provided establishes the conditional safety and compatibility of the passive implants in a magnetic resonance (MR) environment. The subject devices include the following components and basic design features:
- . Metal femoral components manufactured from cobalt chrome alloy
- . Femoral revision accessories, including augments, manufactured from titanium alloy
- . CCK tibial inserts manufactured from UHMWPE with locking screws and posts manufactured from titanium alloy
- . Tibial bases manufactured from titanium alloy available in porous and non-porous versions
- Tibial revision accessories, including keels, augments, stem extensions, and adapters, . manufactured from titanium alloy.
- . Patellae manufactured from UHMWPE and cobalt chrome alloy
C. Substantial Equivalence Information
The scope of this Premarket Notification only includes labeling changes for the subject devices. The design features and materials of the subject devices are identical to those of the predicate devices. The indications for use of the subject devices are also identical those of 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
Premarket Notification.
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Image /page/5/Picture/1 description: The image contains the logo for MicroPort Orthopedics. The logo features a blue square with rounded corners, inside of which is a white circle containing a red star-like shape. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" in red below it. Underneath "Orthopedics" is the tagline "Full Function. Faster."
D. Nonclinical Testing
Nonclincal testing was conducted to establish the conditional safety and compatibility of the passive implants in a magnetic resonance (MR) environment according to the recommendations provided in the Guidance for Industry and Food and Drug Administration Staff entitled "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", issued by the US FDA on December 11, 2014. Testing was also conducted according to the following standards:
- . NEMA MS 8-2008 Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems
- . ASTM F2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- . ASTM F2119-07(2013) Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
- . ASTM F2182-11a Standard Test Method For Measurement of Radio Frequency Induced Heating On Or Near Passive Implants During Magnetic Resonance Imaging
- . ASTM F2213-06(2011) Standard Test Method For Measurement Of Magnetically Induced Torque On Medical Devices In The Magnetic Resonance Environment
- ASTM F2503-13 Standard Practice For Marking Medical Devices And Other Items For Safety In The Magnetic Resonance Environment
The test determined the effects of MRI on the implants and the effects of the implants on the MR image quality. The tests evaluated the worst case components and constructs for RF heating, field interactions, and image artifacts. The testing concluded that there are no safety issues related to magnetic field interactions under the specific conditions identified in the labeling.
E. Clinical Testing
Clinical data was not provided for the subject devices.
F. Conclusion
The information provided in this Premarket Notification adequately supports the labeling change for the subject devices and the substantial equivalence of the subject devices to the predicate devices.