(149 days)
No
The summary describes image processing and virtual planning tools but does not mention AI, ML, or related concepts like deep learning, neural networks, or training/test sets for algorithmic models.
No.
The IPS CaseDesigner is a software tool for surgical planning and visualization, not a device directly used in treatment of a disease or condition.
No
Explanation: While the device can "support the diagnostic and treatment planning process," its primary function is virtual surgical planning and image segmentation. It isn't explicitly stated that the device itself performs a diagnosis or is solely used for diagnostic purposes. Its use is focused on surgical aid and planning based on existing diagnostic imaging.
Yes
The device description explicitly states "The IPS CaseDesigner software is a tool..." and details its function as a software for virtual planning and simulation based on imaging data. While it interacts with imaging scanners and facilitates the creation of physical surgical aids, the core device being described and regulated is the software itself. The performance studies section also specifically mentions "Software verification and validation testing".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body (in vitro).
- IPS CaseDesigner Functionality: The description clearly states that IPS CaseDesigner is a software tool for virtual planning of orthognathic surgery. It uses imaging data (CT/CBCT) to create a 3D model of the patient's anatomy and allows the surgeon to plan bone cuts and visualize the results. It also facilitates the creation of surgical aids like splints.
- No Sample Testing: There is no mention of the software performing any tests on biological samples from the patient. Its function is based on processing and visualizing medical imaging data.
- Intended Use: The intended use is to support the diagnostic and treatment planning process of cranio-maxillofacial procedures and facilitate the service offering of individualized surgical aids. This is a surgical planning and visualization tool, not a diagnostic test performed on a sample.
In summary, IPS CaseDesigner is a medical device, but it falls under the category of surgical planning software or medical image processing software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
IPS CaseDesigner is indicated for use as a software and image segmentation system for the transfer of imaging information from a scanner such as a CT scanner. It is also indicated to support the diagnostic and treatment planning process of cranio-maxillofacial procedures. IPS CaseDesigner facilitates the service offering of individualized surgical aids.
Product codes
LLZ
Device Description
The IPS CaseDesigner software is a tool for the virtual planning of orthognathic surgery. The user is a (oral and maxillofacial) surgeon who needs to plan an orthognathic surgery, and will use the software to plan the osteotomy (bone cutting). This allows the surgeon to re-position the digitally cut pieces in the desired alignment and allows the visualization of how the patient aspect will look like, through soft tissue simulation. The software supports various types of osteotomy procedures (Le Fort I, Sagittal Split, Ramus and Chin).The selection of the appropriate osteotomy procedure for each patient case is at the discretion of the clinician.
The IPS CaseDesigner is a 3D image-based environment that allows the clinician to visualize a patient's anatomy. The creation of the 3D augmented patient model is derived from CBCT (Cone-Beam CT) data (DICOM). This allows the clinician virtually plan and simulate a craniomaxillofacial surgery. The IPS CaseDesigner software has the capability to save a surgical splint file that the clinician can send to the manufacturing facility for surgical splint creation based on the CBCT Data. The software does not have any functionality for designing.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM data format from CT/CBCT scanner
Anatomical Site
cranio-maxillofacial regions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
(oral and maxillofacial) 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 verification and validation testing was conducted on the subject device and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Maxilim, Medicim NV, K052424, Surgicase Orthognathic Software Wizard, Materialise N.V., K111641
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with 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 Center - WO66-G609 Silver Spring, MD 20993-0002
November 10, 2016
Nobel Biocare Ab % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K161634
Trade/Device Name: IPS CaseDesigner Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: LLZ Dated: October 19, 2016 Received: October 20, 2016
Dear Charlemagne Chua:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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" (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,
Robert Oals
Robert Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
| Indications for Use |
| Form Approved: OMB No. 0910-0120 |
|---|
| Expiration Date: January 31, 2017 |
| See PRA Statement below. |
| 510(k) Number (if known) | K161634 |
|---|---|
| Device Name | IPS CaseDesigner |
| Indications for Use (Describe) | IPS CaseDesigner is indicated for use as a software and image segmentation system for the transfer of imaging information from a scanner such as a CT scanner. It is also indicated to support the diagnostic and treatment planning process of cranio-maxillofacial procedures. IPS CaseDesigner facilitates the service offering of individualized surgical aids. |
| 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) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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information unless it displays a currently valid OMB number."
| FORM FDA 3881 (1/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
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1. 510(k) Summary
I. Submitter
Submitted by: Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887
Contact Person: Charlemagne Chua, Senior Regulatory Affairs Manager Phone: (714) 282-4800 x7830 Fax: (714) 998-9348
Submitted for: Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden
Date Prepared : October 19, 2016
II. Device
Name of Device: IPS CaseDesigner Common or Usual Name: Picture Archiving and Communications System Classification Name: System, Image Processing, Radiological (21 CFR 892.2050) Regulatory Class: II Product Code: LLZ
III. Predicate Device
Substantial equivalence is claimed to the following devices:
Primary Predicate
-
Maxilim, Medicim NV, K052424 ●
Additional Predicates -
Surgicase Orthognathic Software Wizard, Materialise N.V., K111641 ●
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IV. Device Description
The IPS CaseDesigner software is a tool for the virtual planning of orthognathic surgery. The user is a (oral and maxillofacial) surgeon who needs to plan an orthognathic surgery, and will use the software to plan the osteotomy (bone cutting). This allows the surgeon to re-position the digitally cut pieces in the desired alignment and allows the visualization of how the patient aspect will look like, through soft tissue simulation. The software supports various types of osteotomy procedures (Le Fort I, Sagittal Split, Ramus and Chin).The selection of the appropriate osteotomy procedure for each patient case is at the discretion of the clinician.
The IPS CaseDesigner is a 3D image-based environment that allows the clinician to visualize a patient's anatomy. The creation of the 3D augmented patient model is derived from CBCT (Cone-Beam CT) data (DICOM). This allows the clinician virtually plan and simulate a craniomaxillofacial surgery. The IPS CaseDesigner software has the capability to save a surgical splint file that the clinician can send to the manufacturing facility for surgical splint creation based on the CBCT Data. The software does not have any functionality for designing.
V. Indications for Use
IPS CaseDesigner is indicated for use as a software and image segmentation system for the transfer of imaging information from a scanner such as a CT scanner. It is also indicated to support the diagnostic and treatment planning process of cranio-maxillofacial procedures. IPS CaseDesigner facilitates the service offering of individualized surgical aids.
Discussion
The Indications for Use statement between the subject and predicate devices are equivalent; minor differences in wording do not alter the intended therapeutic use of the subject device nor do they affect the safety and effectiveness of the subject device relative to the predicate. Both the subject and predicate devices are software devices intended for the transfer of medical images and to support diagnostics and treatment planning of cranio-maxillofacial procedures.
VI. Comparison of Technological Characteristics
The subject and predicate devices are software based surgical planning tools which allow for transfer of medical images, and creation of 3D models.
A comparison of the subject and predicate devices is provided in the table below.
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| | SUBJECT DEVICE | PRIMARY PREDICATE | ADDITIONAL
PREDICATE |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | IPS CaseDesigner | Maxilim
(K052424) | SurgiCase, SurgiCase CMF,
ProPlan CMF
(K111641) |
| Indications
for Use
Statement | IPS CaseDesigner is
indicated for use as a
software and image
segmentation system for the
transfer of imaging
information from a scanner
such as a CT scanner. It is
also indicated to support the
diagnostic and treatment
planning process of cranio-
maxillofacial procedures.
IPS CaseDesigner facilitates
the service offering of
individualized surgical aids. | Maxilim is indicated 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. It is also indicated
for use as a planning and
simulation software for
surgical treatment,
specifically maxillofacial
procedures. | SurgiCase contains software
module for pre-operative
simulation of orthognathic
surgical treatment options,
based on imaging
information from a medical
scanner such as a CT scanner
or a Magnetic Resonance
Imaging (MRI) scanner. |
| Intended use | IPS CaseDesigner is a
software for the transfer and
visualization of imaging
information from equipment
such as a CT scanner to
support the diagnostic and
treatment planning process
in cranio-maxillofacial
regions. IPS CaseDesigner
facilitates the service
offering of individualised
surgical aids. | Maxilim is indicated 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. It is also indicated
for use as a planning and
simulation software for
surgical treatment,
specifically maxillofacial
procedures. | Information not available |
| Clinical Use | Cranio-maxillofacial and
orthognathic treatment | Maxillofacial treatment | Cranio-maxillofacial and
Orthognathic treatment |
| Image Import | DICOM data format from
CT/ CBCT scanner
3D models in generic open
file format (STL) | DICOM data format from
CT/ CBCT scanner | CT/CBCT or MRI scan data |
| Software
Functions | 2D and 3D Visualization
Measuring tool,
Distance and angle | 2D and 3D Visualization
Measuring tool,
Distance and angle | 2D and 3D Visualization
Measuring tool |
| | SUBJECT DEVICE | PRIMARY PREDICATE | ADDITIONAL
PREDICATE |
| | IPS CaseDesigner | Maxilim
(K052424) | SurgiCase, SurgiCase CMF,
ProPlan CMF
(K111641) |
| | Bone fragments can be
moved in the 3D space
(translations and rotations) in
order to plan the ideal post-
operative position of each
fragment. | Bone fragments can be
moved in the 3D space
(translations and rotations) in
order to plan the desired
post-operative position of
each fragment. | Information not available |
| | 3D Surgical Model creation | 3D Surgical Model creation | 3D objects from medical
image data |
| | Soft tissue simulation | Soft tissue simulation and
3D photo mapping | Soft tissue simulation and
3D photo mapping |
| | Based on the created
orthognathic plan the user
can export surgical splint
order files. These files can
be used to calculate and
produce orthognathic splints
in the production backend | No | Patient-specific surgical
splints can be generated to
transfer the planned dental
occlusion to surgery. |
| Computer
System
Requirements | Windows 64bit,
Mac | Windows 32 or 64 bit. | Windows 64 bit. |
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Performance Data VII.
The following performance data were provided or relied upon in support of the substantial equivalence determination.
Software Validation
Software verification and validation testing was conducted on the subject device and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
7
VIII. Conclusion
Although there are minor differences in the indications for use statements and technological features of the subject and predicate devices, the testing supports that these differences do not raise any new questions of safety and effectiveness. Therefore, it is concluded that the subject device is substantially equivalent to the cited predicate devices.