(203 days)
Not Found
No
The summary describes a software and hardware system for surgical planning and guidance based on MRI data, but there is no mention of AI, ML, or related concepts like deep learning, neural networks, or training/test sets for algorithmic performance evaluation. The focus is on patient-specific instrumentation derived from imaging, which is a common practice in orthopedic surgery and does not inherently require AI/ML.
No
The device is described as a surgical instrument to assist in component positioning and bone marking during knee replacement surgery, not a device that directly treats a medical condition or ailment.
No
Explanation: The device is a surgical instrument system used during knee replacement surgery to assist in positioning components and guiding bone marking. It does not diagnose an illness or condition.
No
The device description explicitly states that the system consists of both a software component and a hardware component.
No, 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 intraoperatively and in guiding the marking of bone before cutting." This describes a device used during surgery on a patient, not a device used to test samples outside of the body (in vitro).
- Device Description: The description reinforces that it's a system designed to "assist the surgeon in the placement of total knee replacement components."
- Anatomical Site: The device is used on the "Knee," which is a part of the patient's body.
- Intended User / Care Setting: The device is used by a "Qualified surgeon / Intraoperatively," again indicating use during surgery.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such testing on biological samples. It is a surgical planning and guidance tool.
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 intraoperatively and in guiding the marking of bone before cutting. The Zimmer Patient Specific Instruments System is to be used with Zimmer NEXGEN CR-FLEX fixed bearing and Zimmer NEXGEN LPS-FLEX fixed bearing prostheses families only.
The Zimmer Patient Specific Instruments are intended for single use only.
Product codes
JWH, MBH, OOG
Device Description
The Zimmer Patient Specific Instruments System consists of a software component, Zimmer Patient Specific Instruments Planner and a hardware component, Zimmer Patient Specific Instruments and is designed to assist the surgeon in the placement of total knee replacement components for Zimmer NEXGEN CR-FLEX fixed bearing and Zimmer NEXGEN LPS-FLEX fixed bearing prostheses families.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI imaging data
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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 were performed to assess the safety and effectiveness of the 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K091263
P 1/2
11,
510(k) Summary
..
NOV 1 9 2009
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 66 75 |
| Fax number | +32 16 39 66 06 |
| Contact name | Karl vom Berge |
| Contact title | Product Manager |
| Contact e-mail address | karl.vomberge@materialise.be |
Submission date
The date of the Traditional 510(k) submission is April 29th, 2009. The date of the Additional Information request submission is August 4th 2009.
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) and MBH (21 CFR § 888.3565) |
Predicate device
| Predicate Device | |
|---|---|
| Trade or proprietary or model | |
| name | Patient Matched Cutting Blocks |
| 510(k) number | K082358 |
| Decision date | 11/25/2008 |
| Product code | JWH, MBH |
| Manufacturer | Smith and Nephew, Inc. |
Device Information
Description of the device
The Zimmer Patient Specific Instruments System consists of a software component, Zimmer Patient Specific Instruments Planner and a hardware component, Zimmer Patient Specific Instruments and is designed to assist the surgeon in the placement of total knee
. 4
1
replacement components for Zimmer NEXGEN CR-FLEX fixed bearing and Zimmer NEXGEN LPS-FLEX fixed bearing prostheses families.
Functioning of the device
The Zimmer Patient Specific Instruments System generates a pre-surgical plan based on MRI imaging data using the Zimmer Patient Specific Instruments Planner (software component). The software is then 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 that transfer the pre-operatively determined positioning of the 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.
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 intraoperatively and in guiding the marking of bone before cutting. The Zimmer Patient Specific Instruments System is to be used with Zimmer NEXGEN CR-FLEX fixed bearing and Zimmer NEXGEN LPS-FLEX fixed bearing prostheses families only.
The Zimmer Patient Specific Instruments are intended for single use only.
Summary of technological characteristics
Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the predicate device.
Performance data
Non-clinical tests
Non-clinical tests were performed to assess the safety and effectiveness of the device. Testing verified that the accuracy and performance of the system is adequate to perform as intended.
Clinical data
Not applicable.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 1 5 2011
Materialise N.V. % Mr. Karl vom Berge Technologielaan 15 3001 Leuven Belgium
Re: K091263
Trade/Device Name: Zimmer Patient Specific Instruments System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: OOG, JWH Dated: October 22, 2009 Received: October 26, 2009
Dear Mr. vom Berge:
This letter corrects our substantially equivalent letter of November 19, 2009.
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 (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.
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.
3
Page 2 - Mr. Karl vom Berge
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.
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,
Hy B. Rake
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K091263
Device Name: Zimmer Patient Specific Instruments System (Zimmer Patient Specific Instruments, Zimmer Patient Specific Instruments Planner)
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 intraoperatively and in guiding the marking of bone before cutting. The Zimmer Patient Specific Instruments System is to be used with Zimmer NEXGEN CR-FLEX fixed bearing and Zimmer NEXGEN LPS-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)
Nil R.P. Ozhe for mxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number: K091263