(189 days)
P010014
No
The summary describes patient-specific surgical guides based on MRI images, but there is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on patient-specific design and traditional validation methods.
No
The device is described as a surgical instrument used to assist in the positioning of partial knee replacement components and guide bone marking and cutting, not to treat a disease or condition itself.
No
Explanation: The device is described as a surgical instrument and patient-specific medical device intended to assist in the positioning of knee replacement components, guide bone marking, and guide bone cutting. It is used intra-operatively by a qualified surgeon for implantation, not for diagnosis.
No
The device description explicitly states that the Materialise PKA Guides are "patient-specific medical devices" and an "instrument set containing a femur and/or tibia template(s) and bone models," indicating physical components.
Based on the provided information, the Materialise PKA Guide System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "surgical instrument to assist in the positioning of Partial Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone." This describes a surgical tool used during a procedure, not a device used to perform tests on samples taken from the body to diagnose or monitor a condition.
- Device Description: It's described as "patient-specific medical devices that are designed to implant partial knee prosthesis." This further reinforces its role as a surgical aid.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Materialise PKA Guide System is used in vivo (within the body) during surgery.
N/A
Intended Use / Indications for Use
The Materialise PKA Guide System is intended to be used as a surgical instrument to assist in the positioning of Partial Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone.
The Materialise PKA Guide System is to be used with ZUK UNI, JOURNEY™ UNI, JOURNEY II UNI, JZ (Hybrid) UNI knee systems. Vanguard™ M Unicompartmental Knee System and Oxford® Partial Knee System prostheses families only.
The Zimmer Biomet Patient Specific Instruments are compatible for use with the Oxford® Partial Knee System as approved in P010014.
The Materialise PKA Guides are intended for single use only.
Product codes
HSX, OOG
Device Description
Materialise PKA Guides are patient-specific medical devices that are designed to implant partial knee prosthesis.
The Materialise PKA Guides must only be used in conjunction with the 510(k) cleared, legally marketed prosthesis. Consult the prosthesis labeling and instructions for specific patient indications, contraindications, associated risks, information for use, warnings and precautions. Motorialise PKA Guides is an instrument set containing a femur and/or tibia template(s) and bone models.
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
No new testing of the Materialise PKA Guides was done in support of this pre-market notification. Previous testing for biocompatibility, sterility, cleaning, debris and dimensional stability 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. The stability of the device placement, surgical technique, intended use and functional elements of the subject device are the same as that of the predicate Signature Personalized Patient Care System (K110415) and therefore previous cadaver testing on predicate device K110415 is considered applicable to the subject device. New software validation/verification testing of the Materialise PKA Planner was done in support of this pre-market notification in the form of usability evaluations.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
P010014
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
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July 6, 2018
Materialise NV Oliver Clemens Regulatory Officer Technologielaan 15 Leuven, 3001 Be
Re: K173970
Trade/Device Name: Materialise PKA Guide System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee Joint Femorotibial Metal/Polymer Non-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSX, OOG Dated: December 29, 2017 Received: December 29, 2017
Dear Oliver Clemens:
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. Iisting 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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 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, Vincent J. Devlin -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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Indications for Use
510(k) Number (if known) K173970
Device Name Materialise PKA Guide System
Indications for Use (Describe)
The Materialise PKA Guide System is intended to be used as a surgical instrument to assist in the positioning of Partial Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone.
The Materialise PKA Guide System is to be used with ZUK UNI, JOURNEY™ UNI, JOURNEY II UNI, JZ (Hybrid) UNI knee systems. Vanguard™ M Unicompartmental Knee System and Oxford® Partial Knee System prostheses families only.
The Zimmer Biomet Patient Specific Instruments are compatible for use with the Oxford® Partial Knee System as approved in P010014.
The Materialise PKA Guides are intended for single use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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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 39 62 80 |
| Fax number | +32 16 39 66 06 |
| Principal Contact person | Oliver Clemens |
| Contact title | Regulatory Affairs Officer |
| Contact e-mail address | Regulatory.Affairs@materialise.be |
| Additional contact person | Wim Claassen |
| Contact title | Portfolio Manager |
| Contact e-mail address | Wim.Claassen@materialise.be |
Submission date
The date of the Traditional 510(k) submission is December 21, 2017.
Submission information
| Device name | Materialise PKA Guide System |
|---|---|
| Trade Name | Materialise PKA Planner |
| Materialise PKA Guide | |
| SurgiCase Planner | |
| Visionaire UNI cutting guides | |
| Signature Planner | |
| Signature Guides | |
| Zimmer Patient Specific Instruments Planner | |
| Zimmer Patient Specific Instruments | |
| Common Name | Knee prosthesis |
| Classification Name | Knee joint patellofemorotibial polymer /metal /polymer semi- |
| constrained cemented prosthesis | |
| Primary product code | HSX (21 CFR 888.3520) |
| Subsequent product codes | OOG |
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Predicate Devices
The predicate devices to which substantial equivalence is claimed:
| Trade or proprietary or model name | Materialise PKA Guide System |
|---|---|
| 510(k) number | K172650 |
| Decision date | November 20, 2017 |
| Classification product code | HSX (21 CFR 888.3520) |
| Subsequent product codes | OOG |
| Manufacturer | Materialise N.V. |
| Trade or proprietary or model name | Signature Personalized Patient Care System |
|---|---|
| 510(k) number | K110415 |
| Decision date | May 16, 2011 |
| Classification product code | HRY (21 CFR 888.3530) |
| Subsequent product codes | JWH, MBH, OIY, OOG |
| Manufacturer | Materialise N.V. |
| Trade or proprietary or model name | Materialise TKA Guide System |
|---|---|
| 510(k) number | K173445 |
| Decision date | February 2, 2018 |
| Classification product code | JWH (21 CFR 888.3560) |
| Subsequent product codes | MBH, OIY, OOG |
| Manufacturer | Materialise N.V. |
Device Description
Materialise PKA Guides are patient-specific medical devices that are designed to implant partial knee prosthesis.
The Materialise PKA Guides must only be used in conjunction with the 510(k) cleared, legally marketed prosthesis. Consult the prosthesis labeling and instructions for specific patient indications, contraindications, associated
5
risks, information for use, warnings and precautions. Moterialise PKA Guides is an instrument set containing a femur and/or tibia template(s) and bone models.
Intended Use
The Materialise PKA Guide System is intended to be used as a surgical instrument to assist in the positioning of Partial Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone.
The Materialise PKA Guide System is to be used with ZUK UNI, JOURNEY II UNI, JZ (Hybrid) UNI knee systems, Vanguard™ M Unicompartmental Knee System and Oxford® Partial Knee System prostheses families only.
The Zimmer Biomet Patient Specific Instruments are compatible for use with the Oxford® Partial Knee System as approved in P010014.
The Materialise PKA Guides are intended for single use only.
Functioning of the Device
The Materialise PKA Guide System generates a pre-surgical plan based on MRI images using the Materialise PKA 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 PKA Guides are designed based on the approved presurgical plan. Materialise PKA Guides are patient specific templates which transfer the pre-operatively determined positioning of the chosen partial knee replacement components to the patient intra-operatively, assisting the surgeon in positioning and aligning the actual partial knee replacement components by guiding the marking of bone before cutting and to guide cutting of the bone.
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 main difference between the subject device and previously cleared predicate device K172650 is the Oxford and Vanguard M implants in the Planner software for the surgeon to select during stage. The software algorithm was extended with an Oxford specific planning algorithm which was previously cleared as part of the software component of predicate device K110415. Furthermore, the medical coordinate system and clinical relevant landmarks for the PKA Oxford specific planning algorithm were aligned with those of the TKA procedure as cleared in predicate device K173445. The changes do not affect the safety and effectiveness of the devices.
Performance Data
No new testing of the Materialise PKA Guides was done in support of this pre-market notification. Previous testing for biocompatibility, sterility, cleaning, debris and dimensional stability 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. The stability of the device placement, surgical technique, intended use and functional elements of the subject device are the same as that of the predicate Signature Personalized Patient Care System (K110415) and therefore previous cadaver testing on predicate device K110415 is considered applicable to the subject device. New software validation/verification testing of the Materialise PKA Planner was done in support of this pre-market notification in the form of usability evaluations.
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Summary
The characteristics that determine the functionality and performance of the Materialise PKA Guide System are substantially equivalent to the devices cleared under K172650 and K110415. The non-clinical testing indicates that the subject device is as safe, as effective, and performs as well as the predicates. The Materialise PKA Guide System will be manufactured in compliance with FDA (CFR 820 & Part 11) and ISO quality system (9000 and 13485) requirements.