(198 days)
Not Found
No
The summary describes image processing, 3D modeling, and simulation based on anatomical data, but it does not mention or imply the use of AI or ML algorithms for these processes. The segmentation and editing are performed by trained operators.
No
This device is an online image analysis service that provides 3D motion simulation reports for diagnostic and pre/post-operative planning purposes, not for direct therapeutic intervention.
No.
The device is described as an image analysis service for "simulating/evaluating hip preservation surgical treatment options and historical case review." There is no indication that it is used to specifically identify or diagnose a disease or condition for the first time. Instead, it provides calculated intersection zones, simulates range of motion, and calculates morphological shape parameters, which are functions that aid in surgical planning and evaluation rather than primary diagnosis.
Yes
The device is described as an "online image analysis service" and "software" that processes image data and generates reports. While it relies on external image data (CT or MR), the core functionality and output are purely software-based. There is no mention of accompanying hardware provided by Zimmer Biomet as part of the device itself.
Based on the provided information, the Zimmer Biomet Move Forward 3D Motion Simulation Service is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Move Forward's Function: The Move Forward service analyzes medical images (CT or MR) of the hip joint. It does not analyze specimens taken from the body. Its purpose is to create 3D models and simulate motion based on the anatomical structures visualized in the images.
- Intended Use: The intended use is for pre-operative or post-operative simulation/evaluation of hip preservation surgical treatment options and historical case review. This is a planning and evaluation tool based on imaging, not a diagnostic test performed on biological samples.
Therefore, the Move Forward 3D Motion Simulation Service falls under the category of medical imaging software or a medical device that processes imaging data, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Move Forward 3D Motion Simulation Service is an online image analysis service indicated for skeletally mature individuals that enables clinicians to obtain 3D motion simulation reports based on CT or MR image data.
The service can be used by uploading either CT or MR image data of hip joints. The image data is processed by Zimmer Biomet to create 3D anatomy models. These 3D models are then used to perform 3D motion simulations of the hip joint. The report also provides several calculated intersection zones that may improve the simulated range of motion. Move Forward also calculates several morphological shape parameters for each of the 3D anatomy models.
The software generates an interactive report as output. Clinicians do not interact with the image analysis software directly. The image analysis software is only operated by Zimmer Biomet operators who have been specifically trained for this purpose. End users of the generated Move Forward reports are trained medical professionals, including radiologists and orthopedic surgeons.
The Move Forward 3D Motion Service is intended as pre-operative or post-operative software for simulating/evaluating hip preservation surgical treatment options and historical case review, respectively.
Product codes
LLZ
Device Description
The Move Forward 3D Motion Simulation Service is an online image analysis service that enables clinicians to obtain 3D motion simulation reports based on CT or MR image data. This service consists of three modules: CGOnline, Arbiter, and Articulis.
During the segmentation process, 3D bone models of the pelvis and femur bones are created from the image data. Any required editing of the segmentation images are performed by Zimmer Biomet operators. These 3D bone models are then used to perform 3D motion simulations of the hip joint. The 3D motion simulations can be used to visualize rigid shapes such as bones that come into contact with one another, thus potentially limiting range of motion. The system includes several calculated intersection zones that each individually improve the simulated range of motion. The system also calculates several morphological shape parameters for each of the 3D bone models.
The software generates an interactive PDF report as output, which Zimmer Biomet delivers to clinicians on a per case basis through the CGOnline module. In particular, the report that is generated provides information to the clinicians associated with femoroacetabular impingement (FAI). Clinicians do not interact with the image analysis software directly. The Articulis and Arbiter modules are only operated by Zimmer Biomet operators who have been specifically trained for this purpose. End users of the generated Move Forward reports are trained medical professionals, including radiologists and orthopedic surgeons.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR image data
Anatomical Site
Hip joints
Indicated Patient Age Range
Skeletally mature individuals
Intended User / Care Setting
Trained medical professionals, including radiologists and orthopedic surgeons / Online image analysis service
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:
Software Verification and Validation activities demonstrate that the Move Forward 3D Motion Simulation Service does not raise any new issues of safety and effectiveness as compared to the predicate device.
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2017
Biomet, Inc. % Mr. Paul Hardy Regulatory Affairs Senior Specialist 56 East Bell Drive PO Box 587 WARSAW IN 46581
Re: K162559
Trade/Device Name: Move Forward 3D Motion Simulation Service Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 23, 2017 Received: February 24, 2017
Dear Mr. Hardy:
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.
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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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Michael D.'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162559
Device Name
Move Forward 3D Motion Simulation Service
Indications for Use (Describe)
Zimmer Biomet's Move Forward 3D Motion Simulation Service is an online image analysis service indicated for skeletally mature individuals that enables clinicians to obtain 3D motion simulation reports based on CT or MR image data.
The service can be used by uploading either CT or MR image data of hip joints. The image data is processed by Zimmer Biomet to create 3D anatomy models. These 3D models are then used to perform 3D motion simulations of the hip joint. The report also provides several calculated intersection zones that may improve the simulated range of motion. Move Forward also calculates several morphological shape parameters for each of the 3D anatomy models.
The software generates an interactive report as output. Clinicians do not interact with the image analysis software directly. The image analysis software is only operated by Zimmer Biomet operators who have been specifically trained for this purpose. End users of the generated Move Forward reports are trained medical professionals, including radiologists and orthopedic surgeons.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Move Forward 3D Motion Simulation Service 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Biomet, Inc.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Paul Hardy
Regulatory Affairs Senior Specialist
574-372-6799 |
| Date: | February 22, 2017 |
| Subject Device: | Trade Name: Move Forward 3D Motion Simulation Service
Common Name: Hip impingement image analysis system
Classification Name:
• LLZ- Picture Archive and Communications System (PACS) (21 CFR
892.2050) |
Legally marketed devices to which substantial equivalence is claimed:
- Dyonics Plan Hip Impingement Planning Software manufacturered by Smith & Nephew (K132636)
Device Description
The Move Forward 3D Motion Simulation Service is an online image analysis service that enables clinicians to obtain 3D motion simulation reports based on CT or MR image data. This service consists of three modules: CGOnline, Arbiter, and Articulis.
During the segmentation process, 3D bone models of the pelvis and femur bones are created from the image data. Any required editing of the segmentation images are performed by Zimmer Biomet operators. These 3D bone models are then used to perform 3D motion simulations of the hip joint. The 3D motion simulations can be used to visualize rigid shapes such as bones that come into contact with one another, thus potentially limiting range of motion. The system includes several calculated intersection zones that each individually improve the simulated range of motion. The system also calculates several morphological shape parameters for each of the 3D bone models.
4
The software generates an interactive PDF report as output, which Zimmer Biomet delivers to clinicians on a per case basis through the CGOnline module. In particular, the report that is generated provides information to the clinicians associated with femoroacetabular impingement (FAI). Clinicians do not interact with the image analysis software directly. The Articulis and Arbiter modules are only operated by Zimmer Biomet operators who have been specifically trained for this purpose. End users of the generated Move Forward reports are trained medical professionals, including radiologists and orthopedic surgeons.
Indications for Use
Zimmer Biomet's Move Forward 3D Motion Simulation Service is an online image analysis service indicated for skeletally mature individuals that enables clinicians to obtain 3D motion simulation reports based on CT or MR image data.
The service can be used by uploading either CT or MR image data of hip joints. The image data is processed by Zimmer Biomet to create 3D anatomy models. These 3D models are then used to perform 3D motion simulations of the hip joint. The report also provides several calculated intersection zones that may improve the simulated range of motion. Move Forward also calculates several morphological shape parameters for each of the 3D anatomy models.
The software generates an interactive report as an output. Clinicians do not interact with the image analysis software directly. The image analysis software is only operated by Zimmer Biomet operators who have been specifically trained for this purpose. End users of the generated Move Forward reports are trained medical professionals, including radiologists and orthopedic surgeons.
Intended Use
The Move Forward 3D Motion Service is intended as pre-operative or post-operative software for simulating/evaluating hip preservation surgical treatment options and historical case review, respectively.
Summary of Technological Characteristics
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Indications for Use: The Dyonics Plan Hip Impingement Planning System software is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative or post-operative software for simulating/evaluating hip preservation surgical treatment options and historical case review, respectively.
- . Intended Use: The Dyonics Plan is intended as a pre-operative or post-operative software for simulating/evaluating hip preservation surgical treatment options and historical case review respectively.
- Design Features: Stand-alone software packages that have the following features:
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- Input files consist of DICOM files from CTs for Dyonics and CTs and MRIs for 3D O Move Forward Simulation Service
- o The proposed and predicate device both provide image processing tools including image segmentation and 3D rendering tools
- The proposed and predicate device both have tools for surgical simulation and O planning
- The proposed device allows for the display of anatomical parameters which the o predicate device also provides for anatomical parameters.
- The proposed and predicate device provide an output report which can be O referenced pre-operatively, post-operatively, and inter-operatively
- The proposed and predicate device provide range of motion simulations o
Summary of Performance Data (Nonclinical and/or Clinical)
- . Non-Clinical Tests
- o Software Verification and Validation activities demonstrate that the Move Forward 3D Motion Simulation Service does not raise any new issues of safety and effectiveness as compared to the predicate device.
Substantial Equivalence Conclusion
The differences between the proposed and predicate device do not introduce new types of safety and effectiveness questions. The Move Forward 3D Motion Simulation Service is substantially equivalent to the Dyonics Plan software and the intended uses are identical.