(58 days)
Pin Placement Guides: Signature Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The Signature Personalized Patient Care System can be used with the following Biomet® Knee Systems and their respective components: Vanguard™ Complete Knee System, Vanguard™ SSK 360, Vanguard™ SSK Revision Knee System, Regenerex™ Primary Tibial System, Offset & . Microplasty™ Tibial Systems, Maxim™ Complete Knee System, Ascent™ Total Knee System, AGC™ Complete Knee system and Vanguard™ XP Knee system. Cut-Through Guides: Signature Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total and partial knee replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The Signature Personalized Patient Care System can be used with the following Biomet® Knee Systems and their respective components: Vanguard™ Complete Knee System, Vanguard M1™ Unicompartmental Knee System, Vanguard™ SSK 360, Vanguard™ SSK Revision Knee System, Regenerex™ Primary Tibial System, Offset & Microplasty™ Tibial Systems, Maxim™ Complete Knee System, Ascent™ Total Knee System, AGC™ Complete Knee system and Vanguard™ XP Knee system. The Signature Personalized Patient Care System is compatible for use with the Oxford® Partial Knee System as approved in P010014/S31. The Signature guides are intended for single use only.
The Signature Personalized Patient Care System consists of a software component, Signature Planner and a hardware component, Signature guides and is designed to assist the surgeon in the placement of Biomet total knee replacement components. The Signature guides are patient specific devices that are based on a pre-operative plan which is generated using the Signature Planner software. The Signature guides are produced based on the pre-operative plan and are manufactured to fit a specific patient. The Signature Planner software functions essentially the same as in K102795 and K110415, but is adapted to allow the use of Biomet Vanguard™ XP Knee system (K122160) for total knee arthroplasty procedures. The subject guides are intended for the total knee arthroplasty procedures and represent a combination of design and functionality of those in K102795 and K110415. The Vanguard XP-CR tibial tray will utilize the guides cleared in K102795/K110415 as they have the same profile/bone interface as the predicates. The Vanguard XP-XP tibia guide have similar vertical cut slots as partial tibia guide in K110415. The vertical cut-through slots allow for preliminary cuts of the bone, before final cuts are made and the implant is placed.
Here's a breakdown of the acceptance criteria and the study information for the Signature Personalized Patient Care System, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Software validation for its intended use to determine substantial equivalence. | The Signature Planner software has been validated for its intended use to determine substantial equivalence to the predicate devices. |
| Accuracy performance of the system. | Accuracy performance testing by means of two cadaveric trials was performed. Testing verified that the accuracy and performance of the system is adequate to perform as intended. |
| Guide deformation verification after sterilization. | Guide deformation verification after sterilization was performed. Testing verified that the accuracy and performance of the system is adequate to perform as intended. |
| Debris rationale to illustrate substantial equivalence with predicate devices. | A debris rationale is provided to illustrate substantial equivalence with the predicate devices. |
Study Information
-
Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Two cadaveric trials were used for accuracy performance testing.
- Data Provenance: The document does not specify the country of origin for the cadaveric trials. It's a non-clinical study, so "retrospective or prospective" designation isn't directly applicable in the same way it would be for patient data.
-
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document does not specify the number of experts or their qualifications for establishing ground truth in the cadaveric trials. Given that the study involves "accuracy performance testing," the ground truth would likely be based on precise physical measurements of instrument placement, rather than expert interpretation of images.
-
Adjudication Method for the Test Set:
- The document does not describe an adjudication method. For cadaveric accuracy testing, the "ground truth" would be established through direct measurement and comparison to the pre-operative plan, rather than expert consensus on interpretations.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The performance data focuses on non-clinical testing (software validation, cadaveric trials for accuracy, guide deformation, and debris rationale). The submission states "Clinical data: Not applicable."
-
Standalone (Algorithm Only) Performance Study:
- Yes, a standalone performance study was done for the software compomenent, though not described in detail. The "Signature Planner software has been validated for its intended use" indicates a standalone assessment of the software's capabilities to generate a pre-operative plan. The subsequent cadaveric trials would then integrate this software's output with the physical guides.
-
Type of Ground Truth Used:
- For the software validation, the ground truth would likely be based on predefined anatomical landmarks and measurements.
- For the cadaveric trials, the ground truth for accuracy would be based on direct physical measurements (e.g., using a coordinate measuring machine or similar precision tools) to compare the actual placement of the guides/cuts with the pre-operative plan generated by the Signature Planner software.
-
Sample Size for the Training Set:
- The document does not specify a sample size for a training set. The device is described as inheriting functionality from previously cleared devices (K102795 and K110415) and adapting for new implant systems. Software validation often involves internal testing against specifications rather than a separate "training set" in the machine learning sense, especially for earlier medical device software.
-
How the Ground Truth for the Training Set Was Established:
- Not applicable, as a distinct training set (in the machine learning context) with established ground truth is not described in the document. Software validation typically involves testing against predefined output specifications and adherence to design requirements, rather than a separate training process for an algorithm that learns from data.
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510(k) Summary
APR 0 2 2014
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 74 45 37 |
| Fax number | +32 16 39 66 06 |
| Contact name | Oliver Clemens |
| Contact title | Quality and Regulatory Officer |
| Contact e-mail address | regulatory.affairs@materialise.be |
Submission date
The date of the Traditional 510(k) submission is , January 29th 2014.
Submission information
| Trade Name | Signature PlannerSignature guides |
|---|---|
| Common Name | Patient specific instrumentation for knee arthroplasty |
| Classification Name | - Knee joint patellofemorotibial polymer/metal/polymersemi-constrained cemented prosthesis- Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. |
| Primary product code | MBH (21 CFR § 888.3565) |
| Subsequent product codes | OOG, JWH, OIY and MBV |
Predicate devices
| Predicate Device | |
|---|---|
| Trade or proprietary or model name | Signature Personalized Patient Care System |
| 510(k) number | K102795 |
| Decision date | 2 February 2011 |
| Product code | JWH/OIY, MBH, OOG |
| Manufacturer | Materialise N.V. |
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| Trade or proprietary or model name | Signature Personalized Patient Care System |
|---|---|
| 510(k) number | K110415 |
| Decision date | 16 May 2011 |
| Product code | HRY, JWH, OIY, MBH, OOG |
| Manufacturer | Materialise N.V. |
| Predicate Device | ||
|---|---|---|
| Trade or proprietary or model name | Vanguard XP Knee System | |
| 510(k) number | K122160 | |
| Decision date | 20 March 2013 | |
| Product code | MBH, JWH, MBV, OIY | |
| Manufacturer | Biomet Manufacturing, Corp. |
Device Information
Description of the device
The Signature Personalized Patient Care System consists of a software component, Signature Planner and a hardware component, Signature guides and is designed to assist the surgeon in the placement of Biomet total knee replacement components.
Functioning of the device
The Signature guides are patient specific devices that are based on a pre-operative plan which is generated using the Signature Planner software. The Signature guides are produced based on the pre-operative plan and are manufactured to fit a specific patient. The Signature Planner software functions essentially the same as in K102795 and K110415, but is adapted to allow the use of Biomet Vanguard™ XP Knee system (K122160) for total knee arthroplasty procedures.
The subject guides are intended for the total knee arthroplasty procedures and represent a combination of design and functionality of those in K102795 and K110415. The Vanguard XP-CR tibial tray will utilize the guides cleared in K102795/K110415 as they have the same profile/bone interface as the predicates. The Vanguard XP-XP tibia guide have similar vertical cut slots as partial tibia guide in K110415. The vertical cut-through slots allow for preliminary cuts of the bone, before final cuts are made and the implant is placed.
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Intended use
Pin Placement Guides
Signature Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Signature Personalized Patient Care System can be used with the following Biomet® Knee Systems and their respective components: Vanguard™ Complete Knee System, Vanguard™ SSK 360, Vanguard™ SSK Revision Knee System, Regenerex™ Primary Tibial System, Offset & Microplasty™ Tibial Systems, Maxim™ Complete Knee System, Ascent™ Total Knee System, AGC™ Complete Knee system and Vanguard™ XP Knee system.
Cut-Through Guides
Signature Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total and partial knee replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Signature Personalized Patient Care System can be used with the following Biomet® Knee Systems and their respective components: Vanguard™ Complete Knee System, Vanguard M™ Unicompartmental Knee System, Vanguard™ SSK 360, Vanguard™ SSK Revision Knee System, Regenerex™ Primary Tibial System, Offset & Microplasty™ Tibial Systems, Maxim™ Complete Knee System, Ascent™ Total Knee System, AGC™ Complete Knee system and Vanguard™ XP Knee system.
The Signature Personalized Patient Care System is compatible for use with the Oxford® Partial Knee System as approved in P010014/S31.
The Signature guides are intended for single use only.
Summary of technological characteristics
Device comparison showed that the proposed device is substantially equivalent to the Signature Personalized Patient Care System in K102795 and the Signature Personalized Patient Care System in K110415 in terms of intended use, design; functionality, materials, fundamental technology and performance characteristics.
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Performance data
Non-clinical tests
The Signature Planner software has been validated for its intended use to determine substantial equivalence to the predicate devices.
Accuracy performance testing by means of two cadaveric trials, and guide deformation verification after sterilization was performed to determine substantial equivalence. Testing verified that the accuracy and performance of the system is adequate to perform as intended. A debris rationale is provided to illustrate substantial equivalence with the predicate devices.
Clinical data
Not applicable.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white and appears to be a scanned image.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
April 2, 2014
Materialise N.V. Mr. Oliver Clemens Quality and Regulatory Officer Technologielaan 15 Leuven, Belgium 3001
Re: K140257
Trade/Device Name: Signature Personalized Patient Care System (Signature Guides, Signature Planner 8.0)
Regulation Number: 21 CFR 888.3565
Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, OOG, JWH, OIY, MBV
Dated: January 29, 2014
Received: February 3, 2014
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 Part 801); medical device reporting (reporting of medical
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Page 2 - Mr. Oliver Clemens
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.
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/McdicalDevices/5afctv/ReportalProblem/defiult.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/Resourcesfor You/Industry/default.htm.
Sincerely yours, Lori A. Wigqins
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): K140257
Device Name: Signature Personalized Patient Care System (Signature Guides, Signature Planner 8.0)
Indications for Use:
Pin Placement Guides
Signature Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Signature Personalized Patient Care System can be used with the following Biomet® Knee Systems and their respective components: Vanguard™ Complete Knee System, Vanguard™ SSK 360, Vanguard™ SSK Revision Knee System, Regenerex™ Primary Tibial System, Offset & . Microplasty™ Tibial Systems, Maxim™ Complete Knee System, Ascent™ Total Knee System, AGC™ Complete Knee system and Vanguard™ XP Knee system.
Cut-Through Guides
Signature Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total and partial knee replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Signature Personalized Patient Care System can be used with the following Biomet® Knee Systems and their respective components: Vanguard™ Complete Knee System, Vanguard M1™ Unicompartmental Knee System, Vanguard™ SSK 360, Vanguard™ SSK Revision Knee System, Regenerex™ Primary Tibial System, Offset & Microplasty™ Tibial Systems, Maxim™ Complete Knee System, Ascent™ Total Knee System, AGC™ Complete Knee system and Vanguard™ XP Knee system.
The Signature Personalized Patient Care System is compatible for use with the Oxford® Partial Knee System as approved in P010014/S31.
The Signature guides are intended for single use only.
Page 1 of 2
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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)
Page 2 of 2
Casey L. Hanley, Ph.D.
Di
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.