(128 days)
No
The summary describes a software and hardware system for surgical planning and guiding based on patient imaging, but there is no mention of AI or ML in the device description, intended use, or performance studies. The system appears to rely on traditional image processing and planning algorithms rather than AI/ML for its functionality.
No.
A therapeutic device is one that treats or prevents a disease or condition. This device is a surgical instrument used to assist in the positioning of knee replacement components, which is an interventional procedure rather than a therapeutic treatment in itself.
No
The device is described as a "surgical instrument" and a "guide" to assist in the positioning of total knee replacement components and guiding the marking of bone before cutting. It is used intra-operatively by the surgeon. While it uses imaging data, its primary function is not to diagnose a condition or disease, but rather to aid in a surgical procedure based on pre-existing imaging.
No
The device description explicitly states that the Signature™ Personalized Patient Care System consists of both a software component (Signature™ Planner) and a hardware component (Signature™ guides).
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 system is a "surgical instrument to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting." This describes a device used during a surgical procedure on a patient, not a device used to examine specimens in vitro (outside the body).
- Device Description: The description confirms it's a system consisting of software and hardware (guides) designed to assist the surgeon in placing knee replacement components.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. The input is imaging data (MRI or CT), which is used for surgical planning and guidance, not for in vitro diagnosis.
Therefore, the Signature™ Personalized Patient Care System falls under the category of a surgical planning and guidance system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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, and AGC® Complete Knee system.
The Signature™ guides are intended for single use only.
Product codes
JWH, OIY, MBH, OOG
Device Description
Signature тм 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 total knee replacement components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI or CT imaging data
Anatomical Site
knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified surgeon / intra-operatively
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)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
K102795 (1/3)
FEB - 2 2011
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 affairs officer |
| Contact e-mail address | alexandra.razzhivina@materialise.be |
Submission date
The date of the Traditional 510(k) submission is 24th September 2010.
Submission information
| Trade Name | Signature™ Planner
Signature™ guides |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | knee prosthesis |
| Classification Name | - Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained
cemented prosthesis
-Knee joint patellofemorotibial
metal/polymer porous-coated uncemented
prosthesis |
| Product code | JWH/OIY (21 CFR § 888.3560), MBH (21 CFR
§ 888.3565), OOG |
Predicate devices
| Predicate Device | |
|---|---|
| Trade or proprietary or model name | SurgiCase |
| 510(k) number | K073449 |
| Decision date | 04/16/2008 |
| Product code | LLZ |
| Manufacturer | Materialise N.V. |
1
| Predicate Device | |
|---|---|
| Trade or proprietary or model name | Zimmer Patient Specific Instruments |
| System 2.0 | |
| 510(k) number | K093533 |
| Decision date | 02/17/2010 |
| Product code | JWH, MBH |
| Manufacturer | Materialise N.V. |
Device Information
Description of the device
Signature тм 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 total knee replacement components.
Functioning of the device
Signature ти Personalized Patient Care System generates a pre-surgical plan based on MRI or CT imaging data using the Signature™ Planner (software component). The software is then used preoperatively by a qualified surgeon to inspect, fine-tune and approve the pre-surgical plan. Next, Signature™ guides are designed and manufactured based on the approved pre-surgical plan. Signature™ guides are patient specific templates that transfer the pre-operatively determined pin locations for positioning of the total knee replacement components to the patient intra-operatively. The surgical guides are used to accurately place the guide pins used to position the cutting blocks.
Intended use
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, and AGC® Complete Knee system.
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 predicate devices, in that the device materials are identical to the predicate; and, like the predicate device, the subject device is matched to the patient using software.
2
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 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.
Clinical data
Not applicable.
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Materialise N.V. % Ms. Alexandra Razzhivina Technologielaan 15 3001 Leuven, Belgium
FEB - 2 2011
Re: K102795
Trade/Device Name: Signature™ Personalized Patient Care System (Signature™ Guides, Signature™ Planner) Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, OIY, MBH, OOG Dated: December 23, 2010 Received: December 27, 2010
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 indivions for use stated in the enclosure) to legally marketed predicate devices marketed in intestate 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 I.c. The general controls provisions of the Act include requirements for annual registration, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contractly and warranties. We remind you; however, that device labeling must be truthful and not michery
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 (1 h 1 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.
4
Page 2 - Ms. Alexandra Razzhivina
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 liusing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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 economic 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1118001/jp/dfast the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (215FR Paul 807.97). For questions regarding the reporting of adverse events under the MIR 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 Small Manufacturers, International and Consumer Assistance at its toll-freen mber (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
A.j. B. rita
for.
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number K102795:
Device Name: Signature™ Personalized Patient Care System (Signature™ guides, Signature™ Planner)
Indications for Use:
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, and AGC® Complete Knee system.
The Signature™ guides are intended for single use only.
Prescription Use X _ AND/OR Over-The-Counter Use _____________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (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)
Ar. M. Melkersm
Page 1
ical, Orthopedic, Division of Surg and Restorative Devices
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