(136 days)
No
The summary does not mention AI or ML, and the device description focuses on software and hardware for surgical guidance based on pre-operative imaging and anatomical landmarks, which is typical of traditional image-guided surgery systems.
No.
This device is a surgical instrument system designed to assist in the positioning of knee replacement components and guiding bone marking/cutting during surgery, not to directly treat a disease or condition itself.
No
The device is described as a "surgical instrument" and assists in the "positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting." Its primary function is to aid in surgery and instrument placement, not to diagnose a medical condition.
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 intraoperatively 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 details a software and hardware system used to assist a surgeon in placing knee replacement components. This aligns with a surgical aid, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting diseases or conditions, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to guide surgical procedures based on imaging data, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
Total Knee Replacement
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 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, Zimmer Gender Solutions Natural - Knee Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persono™ PS fixed bearing and Zimmer Persona™ Trabecular Metal™ prostheses families only.
Unicompartmental Knee Replacement
The Zimmer® Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Unicompartmental Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone 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 Unicompartmental High Flex Knee System 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, OIY
Device Description
The subject device Zimmer® Patient Specific Instruments System 6.0 is a modification to the predicate device Zimmer® Patient Specific Instruments System 4.0 (K113829) to accommodate the new compatible implant system Zimmer® Persona'' components, cleared via 510(k)s K113369, K122745 and K121771. A similar change was done for Zimmer® Patient Specific Instruments System 5.0 (K121640) where the Zimmer® Personal™ components, cleared via 510(k) K113369, were added to MRI image based system. Zimmer® Patient Specific Instruments System 6.0 is designed to assist a surgeon in the placement of total knee replacement components for Zimmer® Persona'" components. 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT image data sets
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)
Results of software verification and validation testing demonstrated the device's safety and effectiveness is substantially equivalent to the predicate device.
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.
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
Zimmer Patient Specific Instruments System 6.0 510(k) Premarket Notification
K140027
510(k) Summary
510(k) Summary
The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92
| 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 |
| Principal Contact person | Oliver Clemens |
| Contact title | Quality and Regulatory Officer |
| Contact e-mail address | Regulatory.Affairs@materialise.be |
| Additional contact person | Wim Claassen |
| Contact title | Product Manager |
| Contact e-mail address | Wim.Claassen@materialise.be |
Submission date
The date of the Traditional 510(k) submission is January 20d 2014
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 |
| Primary product code | JWH (21 CFR 888.3560) |
| Subsequent product codes | MBH, OOG and OIY |
Predicate Devices
The predicate device to which substantial equivalence is claimed to:
| Trade or property or model name | Zimmer® Patient Specific Instruments System 4.0 |
|---|---|
| 510(k) number | K113829 |
| Decision date | April 2nd 2012 |
| Product code | JWH, OOG (21 CFR 888.3560) |
| MBH (21 CFR 888.3565) | |
| Manufacturer | Materialise NV |
| Materialise USA, LLC |
Materialise N.V.
1
510(k) Summary
Zimmer Patient Specific Instruments System 6.0 510(k) Premarket Notification
| Trade or property or model name | Zimmer® Patient Specific Instruments System 5.0 |
|---|---|
| 510(k) number | K121640 |
| Decision date | December 5th 2012 |
| Product code | JWH, OOG (21 CFR 888.3560) |
| Manufacturer | Materialise NV |
| Materialise USA, LLC |
Device Description
The subject device Zimmer® Patient Specific Instruments System 6.0 is a modification to the predicate device Zimmer® Patient Specific Instruments System 4.0 (K113829) to accommodate the new compatible implant system Zimmer® Persona'''' components, cleared via 510(k)s K113369, K122745 and K121771. A similar change was done for Zimmer® Patient Specific Instruments System 5.0 (K121640) where the Zimmer® Personal™ components, cleared via 510(k) K113369, were added to MRI image based system. Zimmer® Patient Specific Instruments System 6.0 is designed to assist a surgeon in the placement of total knee replacement components for Zimmer® Persona'" components. 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).
Intended Use
Total Knee Replacement
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, Zimmer Gender Solutions Natural - Knee Flex fixed bearing, Zimmer Persona" CR fixed bearing, Zimmer Persona™ PS fixed bearing and Zimmer Persona™ Trabecular Metal™ prostheses families only.
Unicompartmental Knee Replacement
The Zimmer® Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Unicompartmental Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone 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 Unicompartmental High Flex Knee System prostheses families only.
The Zimmer® Patient Specific Instruments are intended for single use only.
Functioning of the Device
The Zimmer® Patient Specific Instruments System 6.0 generates a pre-surgical plan based on 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
2
Zimmer Patient Specific Instruments System 6.0 510(k) Premarket Notification
510(k) Summary
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
Device comparison showed that the subject device is substantially equivalent to the Zimmer Patient Specific Instruments System in K113829 and the Zimmer Patient Specific Instruments System in K121640 in terms of intended use, design, functionality, materials, fundamental technology and performance characteristics.
- Both subject device and predicate device are 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.
- . The guides of the subject and predicate devices are designed and manufactured from reconstructed three-dimensional models of the patient's anatomy.
- . The guides of the subject and predicate devices are made of the same material and follow the same manufacturing process.
- . The guide performance of subject and predicate device is guaranteed once the fit of the guide on the patient's anatomy is obtained.
- . The software component of the subject and predicate device are intended for use as medical device
- . The software component of the subject device is the same software component of the predicate device, only updated with new implants, user interface improvements and minor functional additions.
- . The software component of the subject and predicate device functions exactly the same.
- . The software component of the subject and predicate device utilized the same programming language and operating system.
- . The guides and software of the subject and predicate device have been developed by the same manufacturing company (Materialise NV), based on the same fundamental technology and inhouse knowledge
- . The guides and software of the subject and predicate device follow the same internal quality procedures and work instructions for design, development, testing and validation.
Performance Data
Results of software verification and validation testing demonstrated the device's safety and effectiveness is substantially equivalent to the predicate device.
Summarv
The characteristics that determine the functionality and performance of the Zimmer Patient Specific Instruments System 6.0, are substantially equivalent to the devices cleared under K113829 and K121640. The Zimmer Patient Specific Instrument System will be manufactured in compliance with FDA and ISO quality system requirements.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the symbol. The text is in all caps and is in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 22, 2014
Matcrialise NV Mr. Oliver Clemens Quality and Regulatory Officer Technologielaan 15 3001 Leuven Belgium
Re: K140027
Trade/Device Name: Zimmer Patient Specific Instruments System 6.0 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. MBH, OOG. OIY Dated: April 10, 2014 Received: April 14, 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 10 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 - Mr. Oliver Clemens
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Lori A. Wiggins
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K140027
Device Name: Zimmer Patient Specific Instruments System 6.0 (Zimmer Patient Specific Instruments Planner, Zimmer Patient Specific Instruments)
Indications for Use:
Total Knee Replacement
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 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, Zimmer Gender Solutions Natural - Knee Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persono™ PS fixed bearing and Zimmer Persona™ Trabecular Metal™ prostheses families only.
Unicompartmental Knee Replacement
The Zimmer® Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Unicompartmental Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone 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 Unicompartmental High Flex Knee System prostheses families only.
The Zimmer® Patient Specific Instruments 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.
;; .
Division of Orthopedic Devices
.
く