(120 days)
No
The summary describes a system that uses software and hardware guides based on preoperative imaging and anatomical landmarks for surgical assistance, with no mention of AI or ML in the device description, performance studies, or key metrics.
No.
The device is described as a "surgical instrument" and "guide" to assist in the intraoperative positioning of glenoid components for shoulder arthroplasty, which means it aids in surgery rather than providing a direct therapeutic effect.
No
The device is described as a surgical instrument and guide for assisting in the intraoperative positioning of glenoid components during shoulder arthroplasty procedures. It does not state that it diagnoses medical conditions or diseases.
No
The device description explicitly states that the Match Point System™ consists of both a software component and a hardware component (Match Point System™ guide).
Based on the provided information, the Match Point System™ is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is a "surgical instrument to assist in the intraoperative positioning of glenoid components." This describes a device used during a surgical procedure to guide the placement of implants, not a device used to test samples (like blood, urine, or tissue) outside the body to diagnose or monitor a medical condition.
- Device Description: The description reinforces its role as a surgical aid, consisting of software and a guide to assist in placement.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
The Match Point System™ falls under the category of a surgical planning and guidance system, which is a type of medical device used in surgical procedures.
N/A
Intended Use / Indications for Use
The Match Point 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 procedures which utilize anatomic landmarks that are identifiable on preoperative CT or MRI medical images.
The Match Point System™ can be used with the following total and reverse shoulder implant systems and their respective compatible components: Encore Shoulder System (K051075), Turon™ to RSP Conversion Shell (K111629), Turon™ Shoulder System (K080402) and. Reverse® Shoulder prosthesis (K092873).
The Match Point System™ guides are intended for single use only.
Product codes
KWS
Device Description
The Match Point System™ consists of a software component, SurgiCase Connect and a hardware component, Match Point System™ guide, and is designed to assist the surgeon in the placement of glenoid components.
The Match Point System is for use 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 or MRI medical images.
Anatomical Site
glenoid components used with total and reverse shoulder arthroplasty procedures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical instrument
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)
Accuracy performance testing was performed in a cadaveric setting to determine substantial equivalence. Testing verified that the accuracy and performance of the system is adequate to perform as intended. Accuracy performance testing was performed on rapid prototyped models to verify guide use, positioning, and accuracy of the shoulder system at its borders for use.
Non-clinical testing was sufficient to demonstrate safety and effectiveness of the device as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K111863, K051075, K080402, K111629, K092873
Reference Device(s)
Not Found
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
SEP 27 2013
510(k) Summary
Submitter information
| 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 |
| Contact name | Alexandra Razzhivina |
| Contact title | Regulatory Officer |
| Contact e-mail address | regulatory.affairs@materialise.be |
| Additional contact person | Mieke Janssen |
| Contact title | Director Quality and Regulatory Affairs |
| Contact e-mail address | mieke.janssen@materialise.be |
| Additional contact person | Johan Ex |
| Contact title | Brand manager |
| Contact e-mail address | johan.ex@materialise.be |
Submission date
The date of the Traditional 510(k) submission is May 27th, 2013.
Submission information
| Trade Name | Match Point System™, Match Point System™ guide, SurgiCase Connect |
|---|---|
| Common Name | Patient specific instrumentation for shoulder arthroplasty |
| Classification Name | Shoulder joint metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3660) |
| Product codes | KWS |
Predicate devices
| Trade or proprietary or model
name | Signature Personalized Patient Care System - Acetabular
Guide System | |
|---------------------------------------|-------------------------------------------------------------------------|--|
| 510(k) number | K111863 | |
| Decision date | 06/15/2012 | |
| Product codes | JDI, KWY, KWZ, LPH, LZO, MAY, MEH | |
| Manufacturer | Materialise NV | |
1
| 510(k)
number | Decision
date | Product
code | Trade or proprietary
or model name | Manufacturer |
|------------------|------------------|-----------------|---------------------------------------|----------------------|
| K051075 | 05/27/2005 | KWS | Encore Shoulder
System | Encore Medical, L.P. |
| K080402 | 03/28/2008 | KWS | Turon™ Shoulder
System | Encore Medical, L.P. |
| K111629 | 09/16/2011 | KWS | Turon™ to RSP
Conversion Shell | Encore Medical, L.P. |
| K092873 | 10/27/2009 | KWS | Reverse® Shoulder
prosthesis | DJO Surgical |
Conventional instrumentation for shoulder arthroplasty (central drill guide) predicate:
Device Information
Description of the device
The Match Point System™ consists of a software component, SurgiCase Connect and a hardware component, Match Point System™ guide, and is designed to assist the surgeon in the placement of glenoid components.
The Match Point System is for use within the intended use of the compatible components.
Functioning of the device
The Match Point System generates a preoperative plan based on medical imaging data using SurgiCase Connect, the software component. This software is used pre-operatively by a qualified surgeon to inspect, fine-tune and approve the preoperative plan. The preoperative plan displays a virtual 3D model of the patient's scapula, a glenoid implant for either reverse or total shoulder replacement positioned onto the glenoid surface, and the central pin which corresponds to the glenoid implant's position. The implant and pin are initially displayed in a default location according to the surgical technique of the respective implant system. The surgeon modifies the default position by rotating and translating the pin and implant Once the implant is in the desired position, the surgeon approves the orientation. preoperative plan.
Once approved, a Match Point System guides is designed and manufactured based on the preoperative plan. Match Point System guides are patient specific templates that transfer the preoperatively approved pin positioning to the patient intraoperatively. The guide consists of a patient specific baseplate which conforms to the patient's anatomy. The drill cylinder's position corresponds to the planned drill position. This drill cylinder's inner diameter matches the corresponding instrumentation's diameter. A Kirschner wire may be optionally used to help stabilize the guide's position while drilling.
Intended use
The Match Point 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 procedures which utilize anatomic landmarks that are identifiable on preoperative CT or MRI medical images.
2
The Match Point System™ can be used with the following total and reverse shoulder implant systems and their respective compatible components: Encore Shoulder System (K051075), Turon™ to RSP Conversion Shell (K111629), Turon™ Shoulder System (K080402) and. Reverse® Shoulder prosthesis (K092873).
The Match Point System™ guides are intended for single use only.
Summary of technological characteristics
Device comparison analysis showed that the proposed device is substantially equivalent to the predicate devices in:
- design, intended use, functionality, technology, material and performance . characteristics for the Signature Personalized Patient Care System ~ Acetabular Guide System;
- intended use and functionality for the conventional instrumentation for shoulder . arthroplasty (central drill guide).
Performance data
Non-clinical tests
Accuracy performance testing was performed in a cadaveric setting to determine substantial equivalence. Testing verified that the accuracy and performance of the system is adequate to perform as intended. Accuracy performance testing was performed on rapid prototyped models to verify guide use, positioning, and accuracy of the shoulder system at its borders for use.
Clinical data
Non-clinical testing was sufficient to demonstrate safety and effectiveness of the device as intended.
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3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure embracing or protecting another smaller figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 27, 2013
Materialise N.V. Ms. Alexandra Razzhivina Regulatory Officer Technologielaan 15 Leuven 3001 Belgium
Re: K131559
Trade/Device Name: Match Point System™ (Match Point System™ Guides, SurgiCase Connect) Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: K WS Dated: September 16, 2013 Received: September 18, 2013
Dear Ms. Razzhivina:
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
4
Page 2 - Ms. Alexandra Razzhivina
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 clectronic 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/McdicalDcvices/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 Small Manufacturers, International and Consumer Assistance 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
5
Indications for Use
KI 31559 510(k) Number (if known): นทหาอพก
Device Name: Match Point System™ (Match Point System™ Guides, SurgiCase Connect)
Indications for Use:
The Match Point 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 procedures which utilize anatomic landmarks that are identifiable on preoperative CT or MRI medical images.
The Match Point System™ can be used with the following total and reverse shoulder implant systems and their respective compatible components: Encore Shoulder System (K051075), Turon™ to RSP Conversion Shell (K111629), Turon™ Shoulder System (K080402) and Reverse® Shoulder prosthesis (K092873).
The Match Point System™ Guides are intended for single use only.
Page 1 of 1
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)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices