(149 days)
No
The summary describes a software and hardware system for patient-specific surgical guides based on imaging, but there is no mention of AI or ML in the description, intended use, or performance studies. The focus is on planning and physical guides, not algorithmic learning or prediction.
No
The device is described as a surgical instrument to assist in the positioning of knee replacement components and guiding bone cutting, rather than directly treating a medical condition.
No
The device is described as a surgical instrument system used intra-operatively to assist in the positioning of knee replacement components and guide bone cutting, rather than to diagnose a medical condition.
No
The device description explicitly states that the system consists of both a software component and a hardware component.
Based on the provided information, the Zimmer Patient Specific Instruments System 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 Unicompartmental Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone". This describes a surgical aid used during a procedure, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description reinforces its role as a "surgical instrument" and a "hardware component" designed to assist in the placement of knee replacement components.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
The system utilizes imaging data (MRI) to create patient-specific guides for surgery, which is a common application in medical devices, but it doesn't fit the definition of an in vitro diagnostic device.
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 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
HSX/OOG, HSX, HRY, JWH/OIY, MBH, OOG, JWH, MBH
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 unicompartmental knee replacement components for Unicompartmental High Flex Knee System prosthesis.
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
qualified 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)
Software validation and accuracy performance testing by means of saw bone models, cadaveric trials and guide deformation verification after sterilization were performed to assess the safety and effectiveness of the device.
These tests verified that the accuracy and performance of the device is adequate to perform as intended.
Non-clinical laboratory testing was performed to determine substantial equivalence. Testing verified that the accuracy and performance of the device 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
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
KILZZOI(113)
JAN - 6 2012
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 |
| Principal contact person | Alexandra Razzhivina |
| Contact title | Regulatory Officer |
| Contact e-mail address | regulatory.affairs@materialise.be |
| Additional contact person | Li Cher Chan |
| Contact title | Quality responsible |
| Contact e-mail address | licher.chan@materialise.com.my |
| Additional contact person | 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 8th of August.
Submission information
| Trade Name | Zimmer Patient Specific Instruments Planner
Zimmer Patient Specific Instruments |
|---------------------|------------------------------------------------------------------------------------|
| Common Name | Knee prosthesis |
| Classification Name | Knee joint femorotibial metal/polymer non-constrained
cemented prosthesis |
| Product code | HSX/OOG (21 CFR § 888.3520) |
Predicate devices
| Predicate Device | |
|---|---|
| Trade or proprietary or model name | Zimmer Unicompartmental Knee System |
| 510(k) number | K033363 |
| Decision date | 01/16/2004 |
| Product code | HSX |
| Manufacturer | Zimmer, INC. |
Predicate Device
Signature™ Personalized Patient Care System Trade or proprietary or model name
1
| 510(k) number | K110415 |
|---|---|
| Decision date | 05/16/2011 |
| Product code | HRY, JWH/OIY, MBH, OOG |
| Manufacturer | Materialise N.V. |
| Predicate Device | |
|---|---|
| Trade or proprietary or model name | Zimmer Patient Specific Instrument 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
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 unicompartmental knee replacement components for Unicompartmental High Flex Knee System prosthesis.
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. 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 Unicompartmental Knee Replacement components to the patient intra-operatively, assisting the surgeon in positioning and aligning the actual Unicompartmental Knee Replacement components by guiding and marking cut locations.
Intended use
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.
Summary of technological characteristics
Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the predicate devices.
2
Performance data
Non-clinical tests
Software validation and accuracy performance testing by means of saw bone models, cadaveric trials and guide deformation verification after sterilization were performed to assess the safety and effectiveness of the device.
These tests verified that the accuracy and performance of the device is adequate to perform as intended.
Clinical data
Non-clinical laboratory testing was performed to determine substantial equivalence. Testing verified that the accuracy and performance of the device is adequate to perform as intended.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN - 6 2012
Materialise N.V. % Ms. Alexandra Razzhivina 15 Technologielaan Leuven, 3001 Belgium
Re: K112301
Trade/Device Name: The Zimmer Patient Specific Instruments System 3.0 Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prothesis Regulatory Class: Class II Product Code: HSX, OOG Dated: December 16, 2011 Received: December 19, 2011
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
4
Page 2 – Ms. Alexandra Razzhivina
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,
. /Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and - - Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K112301
Device Name: The Zimmer Patient Specific Instruments System 3.0
Indications for Use:
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.
Prescription Use × (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)
B.P. Ramilh for
(Division Sign-Off) Division of Surgical, Orthopedic. and Restorative Devices
Page 1 of 1
510(k) Number K112301