(97 days)
Not Found
No
The document describes a system for patient-specific surgical instruments based on imaging data, but there is no mention of AI or ML in the intended use, device description, or performance studies. The system appears to be based on pre-operative planning and the creation of custom guides, not on adaptive or learning algorithms.
No.
This device is a surgical instrument designed to assist in the positioning of total knee replacement components and guide bone marking, rather than directly treating or preventing a disease, or affecting the structure or function of the body.
No
The device is described 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. It is used in conjunction with patient imaging scans to aid in surgical procedures, not to diagnose a condition or disease.
No
The device description explicitly states that the system consists of both a software device (ZPSIP) and a hardware component (ZPSI).
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 device 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 surgical aid used during a procedure, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The description reinforces that it's a system consisting of software and hardware designed to "assist a surgeon in the placement of total knee replacement components."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), diagnosing diseases, or providing information about a patient's health status based on in vitro testing.
The device utilizes imaging data (CT scans) to create patient-specific guides for surgery, which falls under the category of medical devices used for surgical planning and execution, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Zimmer Patient Specific Instruments 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 Zimmer Patient Specific Instruments System is to be used with Zimmer NexGen CR-FLEX fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-FLEX fixed bearing, Zimmer NexGen LPS fixed bearing and Zimmer Gender Solutions Natural - Knee Flex fixed bearing prostheses families only.
The Zimmer Patient Specific Instruments are intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH, MBH, OOG
Device Description
The subject device Zimmer Patient Specific Instruments System 4.0 is an upgrade of the predicate device Zimmer Patient Specific Instruments System 2.5 and is designed to assist a surgeon in the placement of total knee replacement components for Zimmer NexGen CR-FLEX fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-FLEX fixed bearing, Zimmer NexGen LPS fixed bearing and Zimmer Gender Solutions Natural - Knee Flex fixed bearing prostheses. The system consists of a software device, branded as Zimmer Patient Specific Instruments Planner (ZPSIP) and a hardware component, branded as Zimmer Patient Specific Instruments (ZPSI). Use of Zimmer Patient Specific Instruments is limited to the treaticular deformities only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computed tomography (CT) image data sets
Anatomical Site
total knee replacement components
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical instrument to assist in the positioning of total knee replacement components 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 have been performed to assess the safety and effectiveness of the subject device. 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): 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.
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
K1i3829
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510(k) Summary
The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92
Submitter's 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 |
| Principal Contact person | Alexandra Razzhivina |
| Contact title | Regulatory Officer |
| Contact e-mail address | Regulatory. Affairs@materialise.be |
| Additional contact person | Karl vom Berge |
| Contact title | Product Manager |
| Contact e-mail address | Karl.Vomberge@materialise.be |
| Additional contact person | Wim Claassen |
| Contact title | Project Manager |
| Contact e-mail address | Wim.Claassen@materialise.be |
Submission date
The date of the Traditional 510(k) submission is December 230, 2011.
Submission information
| Trade Name | Zimmer Patient Specific Instruments
Zimmer Patient Specific Instruments Planner |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 (21 CFR 888.3560)
MBH (21 CFR 888.3565)
OOG (21 CFR 888.3560) |
Predicate Devices
ﭘﺎ ﺗ
The predicate device to which substantial equivalence is claimed to:
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K113829
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| Trade or proprietary or model name | Zimmer Patient Specific Instrument System 2.5 |
|---|---|
| 510(k) number | K111492 |
| Decision date | 17/02/2010 |
| Product code | JWH (21 CFR 888.3560) |
| MBH (21 CFR 888.3565) | |
| Manufacturer | Materialise N.V. |
| Trade or proprietary or model name | SignatureTM Personalized Patient Care System |
| 510(k) number | K102795 |
| Decision date | 02/02/2011 |
| Product code | JWH (21 CFR 888.3560) |
| OIY (21 CFR 888.3560) | |
| MBH (21 CFR 888.3565) | |
| OOG (21 CFR 888.3565) | |
| Manufacturer | Materialise N.V. |
Device Description
The subject device Zimmer Patient Specific Instruments System 4.0 is an upgrade of the predicate device Zimmer Patient Specific Instruments System 2.5 and is designed to assist a surgeon in the placement of total knee replacement components for Zimmer NexGen CR-FLEX fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-FLEX fixed bearing, Zimmer NexGen LPS fixed bearing and Zimmer Gender Solutions Natural - Knee Flex fixed bearing prostheses. The system consists of a software device, branded as Zimmer Patient Specific Instruments Planner (ZPSIP) and a hardware component, branded as Zimmer Patient Specific Instruments (ZPSI). Use of Zimmer Patient Specific Instruments is limited to the treaticular deformities only.
Intended Use
The Zimmer Patient Specific Instruments 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 Zimmer Patient Specific Instruments System is to be used with Zimmer NexGen CR-Flex fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-Flex fixed bearing, Zimmer NexGen LPS fixed bearing and Zimmer Gender Solutions Natural - Knee Flex fixed bearing prostheses families only.
The Zimmer Patient Specific Instruments are intended for single use only.
Functioning of the Device
The Zimmer Patient Specific Instruments System 4.0 generates a pre-surgical plan based on computed tomography (CT) image data sets using the Zimmer Patient Specific Instruments Planner. The software device then is used pre-operatively by a qualified surgeon to inspect, fine-tune and approve the pre-surgical plan. Next, Zimmer Patient Specific Instruments are designed and manufactured based on the approved pre-surgical plan. Zimmer Patient Specific Instruments are patient specific templates which transfer the pre-operatively determined positioning of the chosen total knee replacement components to the patient intra-operatively, assisting the surgeon in positioning and aligning the actual total knee replacement components by guiding and marking drill locations.
Technological Characteristics
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K 11 3829
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A detailed comparison shows the subject device is substantially equivalent in intended use, materials and performance characteristics to the proposed predicate devices.
Performance Data
Non-clinical tests have been performed to assess the safety and effectiveness of the subject device. Testing verified that the accuracy and performance of the system is adequate to perform as intended.
Summary
The characteristics that determine the functionality and performance of the subject device, the Zimmer Patient Specific Instruments System 4.0, are substantially equivalent to those cleared under K111492 and K102795. The Zimmer Patient Specific Instrument System will be manufactured in compliance with FDA and ISO quality system requirements.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.
Public Health Service
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. Leuven, Belgium 3001
APR - 2 2012
Re: K113829
Trade/Device Name: Zimmer Patient Specific Instrument System 4.0 Regulation Number: 21 CFR 888.3560
Regulation Name: Knee joint patellofemorotibial metal/polymer semi-constrained cemented prosthesis.
Regulatory Class: Class II Product Code: JWH, MBH, OOG Dated: March 21, 2012 Received: March 23, 2012
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 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 – Ms. Alexandra Razzhivina
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/ucm115809.htm for 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" (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 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, ·
Mark N. Melkerson Director
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Dage II
Indications for Use
510(k) Number (if known):
Device Name: Zimmer Patient Specific Instruments System 4.0 (Zimmer Patient Specific Instruments Planner, Zimmer Patient Specific Instruments)
Indications for Use:
The Zimmer Patient Specific Instruments 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 Zimmer Patient Specific Instruments System is to be used with Zimmer NexGen CR-FLEX fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-FLEX fixed bearing, Zimmer NexGen LPS fixed bearing and Zimmer Gender Solutions Natural - Knee Flex fixed bearing prostheses families only.
The Zimmer Patient Specific Instruments are intended for single use only.
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)
signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of
510(k) Number K113829