(126 days)
No
The summary describes patient-specific surgical guides based on imaging, but there is no mention of AI or ML in the device description, intended use, or performance studies. The validation focuses on non-clinical and cadaver testing, not AI/ML model performance metrics.
No.
The device is described as a surgical instrument and patient-specific medical device intended to assist in positioning total knee replacement components and guiding bone marking, rather than directly treating a disease or condition.
No
Explanation: The Materialise TKA Guide System is described as a surgical instrument and patient-specific medical device intended to assist in the positioning of knee replacement components and guiding bone marking intra-operatively. It is not described as providing a diagnosis or diagnostic information.
No
The device description explicitly states that the Materialise TKA Guides are "an instrument set containing a femur and/or tibia template(s)," which are physical components, not software.
Based on the provided information, the Materialise TKA Guide System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a "surgical instrument to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting." This describes a device used during a surgical procedure on a patient's body, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description reinforces that these are "patient-specific medical devices that are designed to implant the following knee prostheses." Again, this points to a surgical tool used directly on the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, tissue, etc.) or to provide diagnostic information about a patient's condition.
IVD devices are typically used to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Materialise TKA Guide System's function is purely as a surgical aid for positioning implants during a knee replacement surgery.
N/A
Intended Use / Indications for Use
The Materialise TKA Guide System is intended to be used as a surgical instrument to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Materialise TKA Guide System is to be used with Zimmer NexGen CR-Flex fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-Flex fixed bearing, Zimmer NexGen LPS fixed bearing, Zimmer Gender Solutions Natural - Knee Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persona™ PS fixed bearing, Zimmer Persona™ Trabecular Metal™, Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, and AGC® Complete Knee system, and Consensus Knee System prostheses families only.
The Materialise TKA Guides are intended for single use only.
Product codes
JWH, OIY, OOG, MBH
Device Description
Materialise TKA Guides are patient-specific medical devices that are designed to implant the following knee prostheses:
Zimmer NexGen CR-Flex fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-Flex fixed bearing, Zimmer NexGen LPS fixed bearing, Zimmer Gender Solutions Natural - Knee Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persona™ PS fixed bearing, Zimmer Persona ™ Trabecular Metal ™, Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, and AGC® Complete Knee system, and Consensus Knee System.
The Materialise TKA Guides must only be used in conjunction with the implants listed above. Consult the prosthesis labeling and instructions for use for specific patient indications, associated risks, information for use, warnings and precautions. Materialise TKA Guides is an instrument set containing a femur and/or tibia template(s).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI images
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified surgeon / Intra-operatively
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
Non-clinical tests: The system was validated using saw bones to verify it is adequate to perform as intended and to determine substantial equivalence. Testing verified that the accuracy and performance of the system is adequate to perform as intended.
Cadaver testing: Validated the use of the subject device for use in total knee replacement and demonstrated equivalent product performance as the existing predicate devices (K102795 and K133162).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K945589, K932837, K143725, K110950, K102927, K001456, K983004, K962215, K954818
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 10, 2015
Materialise N.V. Laurel Berzanskis Regulatory Affairs Officer Technologielann 15 3001 Leuven Belgium
Re: K150928
Trade/Device Name: Materialise TKA Guide System (Materialise TKA Planner, Materialise TKA Guides) Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, OIY, OOG, MBH Dated: July 6, 2015 Received: July 10, 2014
Dear Laurel Berzanskis:
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
1
Page 2 - Laurel Berzanskis
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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If vou 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/ResourcesforYou/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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K150928
Device Name: Materialise TKA Guide System (Materialise TKA Planner, Materialise TKA Guides)
Indications for Use:
The Materialise TKA Guide System is intended to be used as a surgical instrument to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Materialise TKA Guide System is to be used with Zimmer NexGen CR-Flex fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-Flex fixed bearing, Zimmer NexGen LPS fixed bearing, Zimmer Gender Solutions Natural - Knee Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persona™ PS fixed bearing, Zimmer Persona™ Trabecular Metal™, Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, and AGC® Complete Knee system, and Consensus Knee System prostheses families only.
The Materialise TKA Guides are intended for single use only.
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
3
510(k) Summary
The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92
| Company name | Materialise N.V. |
|---|---|
| Establishment registration number | 3003998208 |
| Street Address | Technologielaan 15 |
| City | Leuven |
| Postal code | 3001 |
| Country | Belgium |
| Phone number | +32 16 74 45 37 |
| Fax number | +32 16 39 66 06 |
| Principal Contact person | Laurel Berzanskis |
| Contact title | Regulatory Affairs Officer |
| Contact e-mail address | Regulatory.Affairs@materialise.be |
| Additional contact person | Wim Claassen |
| Contact title | Product Manager |
| Contact e-mail address | Wim.Claassen@materialise.be |
Submission date
The date of the Traditional 510(k) submission is April 3, 2015.
Submission information
| Trade Name | Materialise TKA Planner
Materialise TKA Guide |
|--------------------------|-------------------------------------------------------------------------------------------------|
| Common Name | Knee prosthesis |
| Classification Name | Knee joint patellofemorotibial polymer /metal /polymer semi-
constrained cemented prosthesis |
| Primary product code | JWH (21 CFR 888.3560) |
| Subsequent product codes | OIY, OOG, MBH |
Predicate Devices
The primary predicate devices to which substantial equivalence is claimed:
| Trade or proprietary or model name | Zimmer Patient Specific Instruments System 5.4 |
|---|---|
| 510(k) number | K133162 |
| Decision date | February 25th, 2014 |
4
| Classification product code | JWH (21 CFR 888.3560) |
|---|---|
| Subsequent product codes | MBH, OIY, OOG |
| Manufacturer | Materialise N.V. |
The secondary predicate device to which substantial equivalence is claimed:
| Trade or proprietary or model name | Signature Personalized Patient Care System (Signature
Planner; Signature guides) |
|------------------------------------|-------------------------------------------------------------------------------------|
| 510(k) number | K102795 |
| Decision date | February 2nd, 2011 |
| Classification product code | JWH (21 CFR 888.3560) |
| Subsequent product codes | MBH, OIY, OOG |
| Manufacturer | Materialise N.V. |
Device Description
Materialise TKA Guides are patient-specific medical devices that are designed to implant the following knee prostheses:
Zimmer NexGen CR-Flex fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-Flex fixed bearing, Zimmer NexGen LPS fixed bearing, Zimmer Gender Solutions Natural - Knee Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persona™ PS fixed bearing, Zimmer Persona ™ Trabecular Metal ™, Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, and AGC® Complete Knee system, and Consensus Knee System.
The Materialise TKA Guides must only be used in conjunction with the implants listed above. Consult the prosthesis labeling and instructions for use for specific patient indications, associated risks, information for use, warnings and precautions. Materialise TKA Guides is an instrument set containing a femur and/or tibia template(s).
Intended Use
The Materialise TKA Guide System is intended to be used as a surgical instrument to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Materialise TKA Guide System is to be used with Zimmer NexGen CR-Flex fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-Flex fixed bearing, Zimmer NexGen LPS fixed bearing, Zimmer Gender Solutions Natural - Knee Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persona™ PS fixed bearing, Zimmer Persona ™ Trabecular Metal ™, Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty Tibial Systems,
5
Maxim® Complete Knee System, Ascent™ Total Knee System, and AGC® Complete Knee system, and Consensus Knee System prostheses families only.
The Materialise TKA Guides are intended for single use only.
Functioning of the Device
The Materialise TKA Guide System generates a pre-surgical plan based on MRI images using the Materialise TKA Planner. The software device then is used pre-operatively by a qualified surgeon to inspect, fine-tune and approve the pre-surgical plan. Next, Materialise TKA Guides are designed and manufactured based on the approved pre-surgical plan. Materialise TKA Guides are patient specific templates which transfer the preoperatively determined positioning of the chosen total knee replacement components to the patient intraoperatively, assisting the surgeon in positioning the actual total knee replacement components by guiding and marking drill locations.
Technological Characteristics
A detailed comparison shows the subject device is substantially equivalent in intended use, design, functionality, operating principles, materials and performance characteristics to the primary predicate and secondary predicate devices, however offers a web based software application rather than a desktop application, and extends the compatible implant families to Consensus implants cleared under K945589, K932837, K143725, K110950, K102927, K001456, K983004, K962215, and K954818.
Performance Data
Materialise TKA Guide System was validated though non-clinical tests using saw bones to verify the system is adequate to perform as intended and to determine substantial equivalence. Previous testing for biocompatibility, sterility, cleaning, debris, dimensional stability and packaging are applicable to the subject device and demonstrate substantial equivalence with the predicate device. Testing verified that the accuracy and performance of the system is adequate to perform as intended. Cadaver testing validated the use of the subject device for use in total knee replacement and demonstrated equivalent product performance as the existing predicate devices (K102795 and K133162).
Summary
The characteristics that determine the functionality and performance of the Materialise TKA Guide System are substantially equivalent to the devices cleared under K133162 and K102795. The non-clinical testing indicates that the subject device is as safe, as effective, and performs as well as the predicates. The Materialise TKA Guide System will be manufactured in compliance with FDA (CFR 820 & Part 11) and ISO quality system (9000 and 13485) requirements.