(88 days)
No
The document describes a software planning tool and patient-specific guides/models based on CT scans and surgeon planning, with no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a surgical instrument and planning software used to assist in the positioning of glenoid components for shoulder arthroplasty, not to provide therapy itself.
No
Explanation: The device is described as a "surgical instrument" and a "patient-specific medical device" intended to "assist in the intraoperative positioning of glenoid components" and "transfer the glenoid plan to surgery." While it uses pre-operative CT imaging for planning, its primary function is aiding in surgical placement rather than diagnosing a condition or disease.
No
The device description explicitly states that the system is composed of both a software component (SurgiCase Shoulder Planner) and hardware components (Materialise Shoulder Guide and Models).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Materialise Shoulder Guide and Models, along with the SurgiCase Shoulder Planner software, are used during surgery to assist the surgeon in positioning implants based on preoperative imaging of the patient's anatomy. They are surgical instruments and planning tools, not devices that analyze biological specimens.
- Intended Use: The intended use clearly states the device is a "surgical instrument to assist in the intraoperative positioning of glenoid components" and a "pre-surgical planner for simulation of surgical interventions." This is a surgical aid, not a diagnostic test.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological samples from the patient. Its input is imaging data (CT scans) and its output is a surgical guide and models.
Therefore, the Materialise Shoulder System falls under the category of surgical planning and guidance systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Materialise Shoulder Guide and Models are 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 Shoulder Guide and Models are single use only.
The Materialise Shoulder Guide and Models can be used in conjunction with the following total and reverse shoulder implants systems and their respective compatible components:
- Depuy Synthes'
- DJO's
- Integra's
- Lima's
- Stryker's
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 shoulder 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 Shoulder Guide and Models.
Product codes (comma separated list FDA assigned to the subject device)
QHE, KWS, PHX
Device Description
Materialise Shoulder System is a patient-specific medical device that is designed to be used to assist the surgeon in the placement of shoulder components during total anatomic and reverse shoulder replacement surgery. This can be done by generating a pre-surgical shoulder plan and, if requested by the surgeon, by manufacturing a patient-specific glenoid guide and models to transfer the glenoid 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.
- Materialise Shoulder Guide and Models, which are 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 glenoid guide and models will be manufactured if the surgeon requests patient-specific guides to transfer the glenoid plan to surgery. The Materialise Shoulder Guide is designed and manufactured to fit the anatomy of a specific patient. A bone model of the scapula is delivered with the Materialise Shoulder Guide. A graft model can be delivered with the Materialise Shoulder Guide. The graft model visualizes the graft-space between implant and bone, based on the pre-operative planning of the surgeon. The graft serves as a visual reference for the surgeon in the OR.
The Materialise Shoulder 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
CT-imaging scans
Anatomical Site
Shoulder, glenoid, humeral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, intraoperative, orthopedic surgery
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)
Hardware:
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 subject device are the same as that of the predicate Materialise Glenoid Positioning System K190286 and previously cleared devices K172054, K170893, K153602 and K131559, and therefore previous simulated surgeries using rapid prototyped bone models and previous cadaver testing on previously cleared devices K153602 and K131559 are considered applicable to the subject device.
Software:
Software verification and validation were performed and documentation was provided following the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This includes verification against defined requirements, and validation against user needs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
March 20, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Materialise NV Veerle Vanderheyden Regulatory Affairs Officer Technologielaan 15 3001 Leuven Belgium
Re: K193560
Trade/Device Name: Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: QHE, KWS, PHX Dated: December 20, 2019 Received: December 23, 2019
Dear Veerle Vanderheyden:
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 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
1
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 mediation-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,
Michael C. Owens Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193560
Device Name Materialise Shoulder System
Indications for Use (Describe)
Hardware:
The Materialise Shoulder Guide and Models are 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 Shoulder Guide and Models are single use only.
The Materialise Shoulder Guide and Models can be used in conjunction with the following total and reverse shoulder implants systems and their respective compatible components:
· Depuy Synthes'
- o GLOBAL® APG+ Shoulder System (K052472),
- o DELTA XTEND™ Reverse Shoulder System (K120174, K062250, K183077)
- o GLOBAL® STEPTECH® APG Shoulder System (K092122).
• DJO's
- o Reverse® Shoulder Prosthesis (K051075, K111629, K092873).
- o Turon® Shoulder System (K080402)
- o AltiVate™ Anatomic Shoulder System (K162024)
- · Integra's
o Titan™ Total Shoulder System (K100448, K112438, K142413, K152047)
· Stryker's
- o ReUnion RSA Reverse Shoulder System (K183039)
- o Reunion TSA Total Shoulder Arthroplasty System (K183039).
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 shoulder 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 Shoulder 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
Materialise Shoulder System 510(k) Premarket Notification
510(k) Summary
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 | Veerle Vanderheyden |
| Contact title | Regulatory Affairs Officer |
| Contact e-mail address | Regulatory.Affairs@materialise.be |
| Additional contact person | Sanne Willekens |
| Contact title | Technical product manager |
| Contact e-mail address | Sanne.willekens@materialise.be |
Submission date
The date of the Traditional 510(k) submission is December 20, 2019.
Submission information
| Trade Name | Materialise Shoulder System
Materialise Shoulder Guide and Models
SurgiCase Shoulder Planner |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Patient specific instrumentation for shoulder arthroplasty + 3D
planning software |
| Classification Name | Shoulder joint metal/polymer semi-constrained cemented
prosthesis |
| Primary product code | QHE (21 CFR 888.3660); Shoulder Arthroplasty Implantation
System |
| Additional product codes | KWS (21 CFR 888.3660); Prosthesis, Shoulder, Semi-
Constrained, Metal/Polymer Cemented;
PHX (21 CFR 888.3660); Shoulder Prosthesis, Reverse
Configuration |
5
Predicate Device
The predicate device to which substantial equivalence is claimed:
| Trade or proprietary or model name | Materialise Glenoid Positioning System
Materialise Glenoid Positioning System Guide and
Models
SurgiCase Shoulder Planner |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K190286 |
| Decision date | July 8, 2019 |
| Classification product code | KWS (21 CFR 888.3660) |
| Manufacturer | Materialise N.V. |
Reference Device
| Trade or proprietary or model name | BLUEPRINT ™ Patient Specific Instrumentation |
|---|---|
| 510(k) number | K162800 |
| Decision date | February 22, 2017 |
| Classification product code | KWS (21 CFR 888.3660) |
| Manufacturer | Tornier SAS |
6
Device Description
Materialise Shoulder System is a patient-specific medical device that is designed to be used to assist the surgeon in the placement of shoulder components during total anatomic and reverse shoulder replacement surgery. This can be done by generating a pre-surgical shoulder plan and, if requested by the surgeon, by manufacturing a patient-specific glenoid guide and models to transfer the glenoid 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.
- Materialise Shoulder Guide and Models, which are 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 glenoid guide and models will be manufactured if the surgeon requests patient-specific guides to transfer the glenoid plan to surgery. The Materialise Shoulder Guide is designed and manufactured to fit the anatomy of a specific patient. A bone model of the scapula is delivered with the Materialise Shoulder Guide. A graft model can be delivered with the Materialise Shoulder Guide. The graft model visualizes the graft-space between implant and bone, based on the pre-operative planning of the surgeon. The graft serves as a visual reference for the surgeon in the OR.
The Materialise Shoulder Guide and Models must only be used within the intended use of the compatible components.
Intended Use
Hardware
The Materialise Shoulder Guide and Models are 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 Shoulder Guide and Models are single use only.
The Materialise Shoulder Guide and Models can be used in conjunction with the following total and reverse shoulder implants systems and their respective compatible components:
- . Depuy Synthes'
- DJO's
- Integra's
- Lima's
7
510(k) Summary
- SMR™ Modular Glenoid (K113254) (K143256), O
- SMR™ 3-Pegs Glenoid (K130642), o
- SMR™ TT Metal Back Glenoid (K133349), O
- o SMR™ 40mm Glenosphere (K142139).
- Stryker's
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 shoulder 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 Shoulder Guide and Models.
Functioning of the Device
The Materialise Shoulder System generates a pre-surgical plan based on medical imaging data using the SurgiCase Shoulder Planner. The SurgiCase Shoulder Planner allows a qualified surgeon to visualize, measure, reconstruct, annotate, edit and approve pre-surgical plan data, which leads to the generation of a case planning report. The SurgiCase Shoulder Planner (SCSP) allows for the creation of a glenoid and/or humeral pre-operative plan. If requested by the surgeon, Materialise Shoulder Guide and Models are designed and manufactured based on the approved glenoid pre-surgical plan. Materialise Shoulder Guide and Models are patient specific templates which transfer the pre-operatively determined pin positioning to the patient intraoperatively assisting the surgeon in positioning glenoid components used with total and reverse shoulder arthroplasty procedures. The Materialise Shoulder Guide and Models are available for glenoid components only.
Technological Characteristics
The Materialise Shoulder System has an equivalent intended use and the same fundamental scientific technology as the predicate and reference devices. The subject device's software is intended for positioning shoulder components, i.e. glenoid components (same as the predicate device) and humeral components. The subject device's hardware is intended for positioning shoulder glenoid components only (same as the predicate device).
Software
The subject software device employs similar fundamental technologies as the predicate software device. Technological similarities include:
- Device functionality: The planning functionality, visualization options and planning features are exactly the same for the glenoid planning of the subject device as for the predicate device
- . Software technology: The subject device has the same code base as the predicate device and uses exactly the same methods for design and verification and validation as the predicate device.
8
Following technological differences exist between the subject device software and the predicate device software:
- . The subject device software includes humeral planning, range of motion assessment, defect quantification and bone removal tool. However, the positioning options and visualization options available for humeral planning are technologically the same as for glenoid planning in the predicate device, only applied to a humeral component instead of a glenoid component. The humeral planning feature, range of motion functionality and bone removal tool are present in the reference device: BLUEPRINT™ Patient Specific Instrumentation (K162800).
The subject software technology differences have been demonstrated to not affect safety or effectiveness or raise new issues of safety or effectiveness compared to the predicate device.
Hardware
The subject hardware device is substantially equivalent in intended use, design, functionality, operating principles, materials and performance characteristics to the predicate device.
Performance Data (non-clinical)
Hardware:
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 subject device are the same as that of the predicate Materialise Glenoid Positioning System K190286 and previously cleared devices K172054, K170893, K153602 and K131559, and therefore previous simulated surgeries using rapid prototyped bone models and previous cadaver testing on previously cleared devices K153602 and K131559 are considered applicable to the subject device.
Software:
Software verification and validation were performed and documentation was provided following the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This includes verification against defined requirements, and validation against user needs.
Summary
The non-clinical performance testing indicates that the subject device is as safe, as effective, and performs as well as the predicate device. Therefore it can be concluded that the Materialise Shoulder System is substantial equivalent to the predicate device. The Materialise Shoulder System will be manufactured in compliance with FDA (CFR 820 & Part 11) and ISO quality system (13485) requirements.