(131 days)
No
The document does not mention AI, ML, or related concepts like deep learning, neural networks, or training/test sets for algorithmic models. The description focuses on software for planning and a patient-specific guide based on CT scans and anatomical landmarks.
No
This device is described as a surgical instrument and guide used to assist in the intraoperative positioning of glenoid components, not to directly treat a disease or condition.
No
The device is described as a surgical instrument and patient-specific guide to assist in the intraoperative positioning of glenoid components, not to diagnose a condition.
No
The device description explicitly states that the Materialise Glenoid Positioning System consists of both a software component (SurgiCase Planner) and a hardware component (Materialise Glenoid Positioning System™ guide).
Based on the provided information, the Materialise Glenoid Positioning 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 intraoperative positioning of glenoid components." This describes a tool used during surgery on a patient's body.
- Device Description: The device consists of software and a hardware guide designed to assist the surgeon in placement. This aligns with a surgical aid, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body, not to be used within the body during a surgical procedure. The Materialise Glenoid Positioning System is a surgical planning and guidance tool used in the operating room.
N/A
Intended Use / Indications for Use
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 ReUnion RSA Reverse Shoulder System (K130895) and its respective components, with DJO's Encore Shoulder System (K051075), Turon™ to RSP Conversion Shell (K111629), Turon™ Shoulder System (K080402) and Reverse® Shoulder prosthesis (K092873) and their respective components, and Lima's 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 their respective components.
The Materialise Glenoid Positioning System guide is single use only.
Product codes (comma separated list FDA assigned to the subject device)
KWS
Device Description
The Materialise Glenoid Positioning System™ consists of a software component, SurgiCase Planner and a hardware component, Materialise Glenoid Positioning System™ guide, and is designed to assist the surgeon in the placement of glenoid components.
Materialise Glenoid Positioning Guides are patient-specific medical devices that are designed to assist the surgeon in the placement of glenoid components.
The Materialise Glenoid Positioning Guides 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
surgeon / intraoperative
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. Materialise Glenoid Positioning System was validated through non-clinical tests using rapid prototyped bone models to verify the system is adequate to perform as intended and to determine substantial equivalence. Cadaver testing validated the use of the subject device for use in total and reverse shoulder arthroplasty and demonstrated equivalent product performance as the existing predicate device (K131559).
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.
K130895, K051075, K111629, K080402, K092873, K100858, K110598, K113254, K130642, K133349, K142139, K143256
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, representing the department's focus on health and human well-being. The profiles are depicted in a simple, abstract manner.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 26, 2016
Materialise NV Mr. Oliver Clemens Regulatory Officer Technologielaan 15, Leuven 3001 BELGIUM
Re: K153602
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: March 22, 2016 Received: March 28, 2016
Dear Mr. 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, 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 you 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)
Device Name
Materialise Glenoid Positioning System
Indications for Use (Describe)
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 ReUnion RSA Reverse Shoulder System (K130895) and its respective components, with DJO's Encore Shoulder System (K051075), Turon™ to RSP Conversion Shell (K111629), Turon™ Shoulder System (K080402) and Reverse® Shoulder prosthesis (K092873) and their respective components, and Lima's 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 their respective components.
The Materialise Glenoid Positioning System guide is 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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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 39 62 80 |
| Fax number | +32 16 39 66 06 |
| Principal Contact person | Oliver Clemens |
| Contact title | Regulatory Officer |
| Contact e-mail address | Regulatory.Affairs@materialise.be |
| Additional contact person | Filip Jonkergouw |
| Contact title | Product Manager |
| Contact e-mail address | Filip.Jonkergouw@materialise.be |
Submission date
The date of the Traditional 510(k) submission is December 15, 2015.
Submission information
| Trade Name | Materialise Glenoid Positioning System |
|---|---|
| Common Name | Patient specific instrumentation for shoulder arthroplasty |
| 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
| Trade or proprietary or model name | Match Point System™, Match Point System™ guide,
SurgiCase Connect |
|------------------------------------|----------------------------------------------------------------------|
| 510(k) number | K131559 |
| Decision date | September 27th, 2013 |
| Classification product code | KWS (21 CFR 888.3660) |
| Manufacturer | Materialise N.V. |
Device Description
The Materialise Glenoid Positioning System™ consists of a software component, SurgiCase Planner and a hardware component, Materialise Glenoid Positioning System™ guide, and is designed to assist the surgeon in the placement of glenoid components.
Materialise Glenoid Positioning Guides are patient-specific medical devices that are designed to assist the surgeon in the placement of glenoid components.
The Materialise Glenoid Positioning Guides must only be used within the intended use of the compatible components.
Intended Use
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 ReUnion RSA Reverse Shoulder System (K130895) and its respective components, with DJO's Encore Shoulder System (K051075), Turon™ to RSP Conversion Shell (K11629), Turon™ Shoulder System (K080402) and Reverse® Shoulder prosthesis (K092873) and their respective components, and Lima's 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 their respective components.
The Materialise Glenoid Positioning System guide is single use only.
Functioning of the Device
The Materialise Glenoid Positioning System generates a pre-surgical plan based on medical imaging data using the SurgiCase 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 Glenoid Positioning System guides are designed and manufactured
5
based on the approved pre-surgical plan. Materialise Glenoid Positioning System guides 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 offers a web-based software application rather than a desktop application, extends the implant families to Stryker implants cleared under K130895 and Lima implants cleared under K100858, K13254, K130642, K133349, K142139 and K143256 and includes an additional drill cylinder on the guide when used with K111629 and K080402, and expands the borders of use by replacing the anatomy based contraindication in K131559 with a contraindication based on a software restriction. The SurgiCase Shoulder Planner may restrict use for the Materialise Glenoid Positioning System when placement of the pilot wire (drill bit) is not optimal for implant placement. To ensure safety and effectiveness of the Materialise Glenoid Positioning System guides, the SurgiCase Shoulder Planner restricts the placement of the pilot wire (drill bit) within the intersection of two cones – a 45° cone from the neutral axis and a 60° cone from the normal of the glenoid face.
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. Materialise Glenoid Positioning System was validated through non-clinical tests using rapid prototyped bone models to verify the system is adequate to perform as intended and to determine substantial equivalence. Cadaver testing validated the use of the subject device for use in total and reverse shoulder arthroplasty and demonstrated equivalent product performance as the existing predicate device (K131559).
Summary
The characteristics that determine the functionality and performance of the subject device are substantially equivalent to the predicate device cleared under K131559. The non-clinical testing indicates that the subject device 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.