(147 days)
No
The summary describes a software planning tool and patient-specific hardware for surgical guidance, but there is no mention of AI or ML in the intended use, device description, or performance studies. The software focuses on visualization, measurement, and planning based on CT scans, which are standard functions for surgical planning software and do not inherently require AI/ML.
No
The device is a surgical instrument and planning tool used to assist in the positioning of glenoid components during shoulder arthroplasty, not for treating a disease or condition itself.
No
The device is intended for pre-surgical planning and intraoperative surgical guidance for glenoid component positioning, not for diagnosing a medical condition.
No
The device description explicitly states that the system is composed of both a software component (SurgiCase Shoulder Planner) and a hardware component (Materialise Glenoid Positioning System Guide and Models).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a surgical instrument and a pre-surgical planner used to assist in the intraoperative positioning of glenoid components during shoulder surgery. It references anatomical landmarks identifiable on preoperative CT scans.
- Device Description: The device description reinforces that it's a patient-specific medical device designed to assist the surgeon in the placement of glenoid components. It involves software for planning and hardware (guides and models) for transferring the plan to surgery.
- Lack of IVD Characteristics: An In Vitro Diagnostic device is typically used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens. It's a tool used in conjunction with surgical procedures and medical imaging.
The device is a surgical planning and guidance system, which falls under the category of medical devices used in surgical procedures, not IVDs.
N/A
Intended Use / Indications for Use
Hardware: The Materialise Glenoid Positioning System is intended to be used as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans. The Materialise Glenoid Positioning System can be used in conjunction with Stryker's following total and reverse shoulder implants systems and their respective compatible components: ReUnion RSA Reverse Shoulder System (K183039) and Reunion TSA Total Shoulder Arthroplasty System (K183039), with DJO's following total and reverse shoulder implant systems and their respective components: Reverse® Shoulder Prosthesis (K051075, K111629, K092873), Turon® Shoulder System (K080402) and AltiVate™ Anatomic Shoulder System (K162024), with Lima's following total and reverse shoulder implant systems and their respective compatible components: SMR Shoulder System (K100858), SMR Reverse Shoulder System (K110598), SMR Modular Glenoid (K113254), SMR 3-Pegs Glenoid (K130642), SMR TT Metal Back Glenoid (K133349), SMR 40mm Glenosphere (K142139) and SMR Modular Glenoid (K143256), and with Depuy Synthes' following total and reverse shoulder implant systems and their respective compatible components: GLOBAL® APG+ Shoulder System (K052472), DELTA XTEND™ Reverse Shoulder System (K120174, K062250, K183077) and GLOBAL® STEPTECH® APG Shoulder System (K092122). The Materialise Glenoid Positioning System Guide and Models are single use only.
Software: SurgiCase Shoulder Planner is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder orthopedic surgery. The software is used to assist in the positioning of glenoid components. SurgiCase Shoulder Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Materialise Glenoid Positioning Guide and Models.
Product codes
KWS
Device Description
Materialise Glenoid Positioning System is a patient-specific medical device that is designed to assist the surgeon in the placement of glenoid components. This can be done by generating a pre-surgical plan or by generating a pre-surgical plan and manufacturing a patientspecific guide and models to transfer the plan to surgery. The device is a system composed of the following:
- a software component, branded as SurgiCase Shoulder Planner. This software is a planning tool used to ● generate a pre-surgical plan for a specific patient.
- a hardware component, branded as the Materialise Glenoid Positioning System™ Guide and Models, which is a patient specific guide and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Patient-specific guide and models will be manufactured if the surgeon requests patient-specific guides to transfer the plan to surgery. The Materialise Glenoid Positioning System Guide is designed and manufactured to fit the anatomy of a specific patient. A bone model of the scapula is delivered with the Materialise Glenoid Positioning System Guide. A graft model can be delivered with the Materialise Glenoid Positioning System Guide.
The Materialise Glenoid Positioning Guide and Models must only be used within the intended use of the compatible components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
preoperative CT-imaging scans
Anatomical Site
shoulder
Indicated Patient Age Range
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Previous testing for biocompatibility, 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. The stability of the device placement, surgical technique, intended use and functional elements of the same as that of the predicate Materialise Glenoid Positioning System K172054 and previously cleared devices K170893, K1536559, and therefore previous cadaver testing on previously cleared devices K153602 and K131559 is considered applicable to the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K183039, K183039, K051075, K111629, K092873, K080402, K162024, K100858, K110598, K113254, K130642, K133349, K142139, K143256, K052472, K120174, K062250, K183077, K092122, K170893, K1536559, K153602, K131559
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
Image /page/0/Picture/0 description: The image shows 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 ADMINISTRATION" in a smaller font.
July 8, 2019
Materialise NV Mieke Janssen Regulatory Affairs Manager Technologielaan 15 3001 Leuven Belgium
Re: K190286
Trade/Device Name: Materialise Glenoid Positioning System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS Dated: June 4, 2019 Received: June 6, 2019
Dear Mieke Janssen:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CAPT Raquel Peat, PhD, MPH, USPHS Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190286
Device Name Materialise Glenoid Positioning System
Indications for Use (Describe)
Hardware
The Materialise Glenoid Positioning System is intended to be used as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans.
The Materialise Glenoid Positioning System can be used in conjunction with Stryker's following total and reverse shoulder implants systems and their respective compatible components: ReUnion RSA Reverse Shoulder System (K183039) and Reunion TSA Total Shoulder Arthroplasty System (K183039), with DJO's following total and reverse shoulder implant systems and their respective components: Reverse® Shoulder Prosthesis (K051075, K111629, K092873), Turon® Shoulder System (K080402) and AltiVate™ Anatomic Shoulder System (K162024), with Lima's following total and reverse shoulder implant systems and their respective compatible components: SMR Shoulder System (K100858), SMR Reverse Shoulder System (K110598), SMR Modular Glenoid (K113254), SMR 3-Pegs Glenoid (K130642), SMR TT Metal Back Glenoid (K133349), SMR 40mm Glenosphere (K142139) and SMR Modular Glenoid (K143256), and with Depuy Synthes' following total and reverse shoulder implant systems and their respective compatible components: GLOBAL® APG+ Shoulder System (K052472), DELTA XTEND™ Reverse Shoulder System (K120174, K062250, K183077) and GLOBAL® STEPTECH® APG Shoulder System (K092122). The Materialise Glenoid Positioning System Guide and Models are single use only.
Software
SurgiCase Shoulder Planner is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder orthopedic surgery. The software is used to assist in the positioning of glenoid components. SurgiCase Shoulder Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Materialise Glenoid Positioning Guide and Models.
| 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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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 71 |
| Fax number | +32 16 39 66 06 |
| Principal Contact person | Mieke Janssen |
| Contact title | Regulatory Affairs Manager |
| Contact e-mail address | Regulatory.Affairs@materialise.be |
| Additional contact person | Ilke Vanhaelen |
| Contact title | Medical Device Development Engineer |
| Contact e-mail address | ilke.vanhaelen@materialise.be |
Submission date
The date of the Traditional 510(k) submission is February 8, 2019.
Submission information
| Trade Name | Materialise Glenoid Positioning System |
|---|---|
| Common Name | Patient specific instrumentation for shoulder arthroplasty + 3D |
| planning software | |
| Classification Name | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer |
| Cemented | |
| Primary product code | KWS (21 CFR 888.3660) |
Predicate Device
The predicate device to which substantial equivalence is claimed:
4
| Materialise Glenoid Positioning System | |
|---|---|
| Trade or proprietary or model name | Materialise Glenoid Positioning System Guide and |
| Models | |
| SurgiCase Shoulder Planner | |
| 510(k) number | K172054 |
| Decision date | November 3, 2017 |
| Classification product code | KWS (21 CFR 888.3660) |
| Manufacturer | Materialise N.V. |
Device Description
Materialise Glenoid Positioning System is a patient-specific medical device that is designed to assist the surgeon in the placement of glenoid components.
This can be done by generating a pre-surgical plan or by generating a pre-surgical plan and manufacturing a patientspecific guide and models to transfer the plan to surgery. The device is a system composed of the following:
- a software component, branded as SurgiCase Shoulder Planner. This software is a planning tool used to ● generate a pre-surgical plan for a specific patient.
- a hardware component, branded as the Materialise Glenoid Positioning System™ Guide and Models, which is a patient specific guide and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Patient-specific guide and models will be manufactured if the surgeon requests patient-specific guides to transfer the plan to surgery. The Materialise Glenoid Positioning System Guide is designed and manufactured to fit the anatomy of a specific patient. A bone model of the scapula is delivered with the Materialise Glenoid Positioning System Guide. A graft model can be delivered with the Materialise Glenoid Positioning System Guide.
The Materialise Glenoid Positioning Guide and Models must only be used within the intended use of the compatible components.
Indications for Use
Hardware
The Materialise Glenoid Positioning System is intended to be used as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans.
The Materialise Glenoid Positioning System can be used in conjunction with Stryker's following total and reverse shoulder implants systems and their respective compatible components: ReUnion RSA Reverse Shoulder System (K183039) and Reunion TSA Total Shoulder Arthroplasty System (K183039), with DJO's following total and reverse shoulder implant systems and their respective compatible components: Reverse®
5
Shoulder Prosthesis (K051075, K111629, K092873), Turon® Shoulder System (K080402) and AltiVate™ Anatomic Shoulder System (K162024), with Lima's following total and reverse shoulder implant systems and their respective compatible components: SMR Shoulder System (K100858), SMR Reverse Shoulder System (K110598), SMR Modular Glenoid (K113254), SMR 3-Pegs Glenoid (K130642), SMR TT Metal Back Glenoid (K133349), SMR 40mm Glenosphere (K142139) and SMR Modular Glenoid (K143256), and with Depuy Synthes' following total and reverse shoulder implant systems and their respective compatible components: GLOBAL® APG+ Shoulder System (K052472), DELTA XTEND™ Reverse Shoulder System (K120174, K062250, K183077) and GLOBAL® STEPTECH® APG Shoulder System (K092122).
The Materialise Glenoid Positioning System Guide and Models are single use only.
Software
SurgiCase Shoulder Planner is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder orthopedic surgery. The software is used to assist in the positioning of glenoid components. SurgiCase Shoulder Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Materialise Glenoid Positioning Guide and Models.
Functioning of the Device
The Materialise Glenoid Positioning System generates a pre-surgical plan based on medical imaging data using the SurgiCase Shoulder Planner. The software device then is used pre-operatively by a qualified surgeon to inspect, finetune and approve the pre-surgical plan. If requested by the surgeon, Materialise Glenoid Positioning System Guide and models are designed and manufactured based on the approved pre-surgical plan. Materialise Glenoid Positioning System Guide and Models are patient specific templates which transfer the pre-operatively determined pin positioning to the patient intra-operatively, assisting the surgeon in positioning glenoid components used with total and reverse shoulder arthroplasty procedures.
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 predicate device, however extends the functionality of the SurgiCase Shoulder Planner to include showing of DICOM images, graft model visualization and a humerus visualization with subluxation index.
Performance Data
Previous testing for biocompatibility, 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. The stability of the device placement, surgical technique, intended use and functional elements of the same as that of the predicate Materialise Glenoid Positioning System K172054 and previously cleared devices K170893, K1536559, and therefore previous cadaver testing on previously cleared devices K153602 and K131559 is considered applicable to the subject device.
Summary
The characteristics that determine the functionality and performance of the subject device are substantially equivalent to the predicate device cleared under K172054. The non-clinical testing indicates that the subject device
6
is as safe, as effective, and performs as well as the predicates. The Materialise Glenoid Positioning System will be manufactured in compliance with FDA (CFR 820 & Part 11) and ISO quality system (9000 and 13485) requirements.