(252 days)
Not Found
No
The document describes image segmentation and pre-operative planning software, but there is no mention of AI, ML, or related technologies in the provided text. The focus is on standard software verification and validation processes.
No
The device is described as pre-planning software for dental implant placement and surgical treatment, and it does not have patient contact. It assists in planning but does not directly treat or diagnose a disease or condition.
No
Explanation: The device is described as pre-planning software for dental implant placement and surgical treatment, transferring imaging information and creating a dental plan. It does not perform diagnosis or identify disease.
Yes
The device description explicitly states it is "stand-alone software" and its function is pre-operative planning based on image data, without patient contact. The verification and validation focus solely on software testing.
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 SIMPLANT is for "pre-planning software for dental implant placement and surgical treatment." This is a planning tool for a surgical procedure, not a diagnostic test performed on biological samples.
- Device Description: The description reinforces this by stating it's "stand-alone software intended for pre-operative planning of dental implant placement and surgical treatment options, without patient contact." IVDs typically involve analyzing samples from the patient (blood, urine, tissue, etc.) to diagnose a condition or provide information about a patient's health status.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its input is imaging information from a medical scanner.
In summary, SIMPLANT is a software tool for surgical planning based on medical imaging, not a diagnostic test performed on biological samples. Therefore, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SIMPLANT 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. It is also intended as pre-planning software for dental implant placement and surgical treatment.
Product codes
LLZ
Device Description
The proposed device SIMPLANT 18 is stand-alone software intended for pre-operative planning of dental implant placement and surgical treatment options, without patient contact.
A SIMPLANT project file is created from patient image data, patient information, and implants data which are aggregated together. The SIMPLANT project file is the basis for continued implant surgical planning by dental professionals.
The dental plan, which is the result of the dental implant planning process, can be used for manufacturing of a surgical guide or for evaluation of treatment options during the implant surgery procedure.
The purpose of this premarket notification is to gain clearance for new features implemented in the latest software version, clarification of the indications for use, as well as to document iterative changes to the software that have been implemented since the original clearance under K0110300.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
medical scanner such as a CT scanner.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medically trained people.
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
Software verification and validation was conducted to ensure the functionality and have been included to support the substantial equivalence of the subject SIMPLANT 18 software.
In principle, the software testing has consisted of testing of the software functionality containing the changes introduced since the approved predicate device SimPlant 2011 (K110300). . Software testing has been conducted in accordance with the software life cycle processes, as defined in IEC 62304.
The verification and validation testing has consisted of the following activities:
- Peer Code Review
- Integration test
- Internal release test
- Smoke test
- Formal system test
- Acceptance test
- Beta test
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of verification and validation confirm that all user needs and performance requirements according to the design inputs are fulfilled. Test data to verify the performance of the proposed SIMPLANT 18 have been included and the results of this testing confirmed the functionality and support the substantial equivalence of the proposed device SIMPLANT 18.
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.
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
§ 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
April 4, 2018
Image /page/0/Picture/1 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Dentsply Sirona % Mr. Karl Nittinger Senior Manager, Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60W YORK PA 17401
Re: K172239
Trade/Device Name: SIMPLANT 18 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 20, 2018 Received: February 26, 2018
Dear Mr. Nittinger:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.
1
Page 2 - Mr. Karl Nittinger
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name SIMPLANT 18
Indications for Use (Describe)
SIMPLANT 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. It is also intended as pre-planning software for dental implant placement and surgical treatment.
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) |
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 *
CONTINUE ON A SEPARATE PAGE IF NEEDED.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
Image /page/3/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized leaf-like shape on the left, followed by the words "Dentsply" on the top line and "Sirona" on the bottom line. The text is in a simple, sans-serif font and is aligned to the right of the leaf-like shape.
510(k) SUMMARY For S1MPLANT 18
-
- Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
- Submitter Information:
| Contact Person: | Karl Nittinger |
|---|---|
| Telephone Number: | 717-849-4424 |
| Fax Number: | 717-849-4343 |
February 22, 2018 Date Prepared:
-
- Device Name:
| • Proprietary Name: | Simplant 18 |
|---|---|
| • Classification Name: | Picture archiving and communications system |
| • CFR Number: | 892.2050 |
| • Device Class: | II |
| • Product Code: | LLZ |
-
- Predicate Device:
| Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| SimPlant 2011 | K110300 | Materialise Dental NV |
-
- Description of Device:
The proposed device SIMPLANT 18 is stand-alone software intended for pre-operative planning of dental implant placement and surgical treatment options, without patient contact.
- Description of Device:
A SIMPLANT project file is created from patient image data, patient information, and implants data which are aggregated together. The SIMPLANT project file is the basis for continued implant surgical planning by dental professionals.
The dental plan, which is the result of the dental implant planning process, can be used for manufacturing of a surgical guide or for evaluation of treatment options during the implant surgery procedure.
The purpose of this premarket notification is to gain clearance for new features implemented in the latest software version, clarification of the indications for use, as well as to document iterative changes to the software that have been implemented since the original clearance under K0110300.
4
-
ર. Indications for Use:
SIMPLANT 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. It is also intended as pre-planning software for dental implant placement and surgical treatment. -
б. Substantial Equivalence:
Technological Characteristics:
The proposed SIMPLANT 18 is stand-alone medical device software, used without patient contact.
| Element | Proposed device
SIMPLANT 18 | Predicate device
SimPlant 2011
K110300 | Difference |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer | DENTSPLY Implants NV
(formerly Materialise Dental
NV) | Materialise Dental NV | No |
| Indications for use | SIMPLANT 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.
It is also intended as pre-
planning software for dental
implant placement and
surgical treatment. | SimPlant 2011 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 or a Magnetic
Resonance scanner.
It is also intended as pre-
planning software for
dental implant placement
and surgical treatment. | Yes |
| User | Medically trained people. | Medically trained people. | No |
| Functions | File open/save tools | | |
| | (CB)CT images import | (CB)CT images import | No |
| | Open project | Open project | No |
| | Save project | Save project | No |
| Visualization tools | | | |
| | 2D gray value images | 2D gray value images | No |
| | 3D viewing | 3D viewing | No |
| | Navigation
(Zoom/Pan/Rotate) | Navigation
(Zoom/Pan/Rotate) | No |
| Element | Proposed device
SIMPLANT 18 | Predicate device
SimPlant 2011
K110300 | Difference |
| | Volume rendering | Volume rendering | No |
| | Segmentation tools | | |
| | Segmentation wizard | Segmentation wizard | No |
| | Measurement tools | | |
| | Distance | Distance | No |
| | Angle | Angle | No |
| | Density | Density | No |
| | Preparation tools | | |
| | Dual scan registration
- Soft tissue creation
possibility | Dual scan registration - No soft tissue
creation possibility | Yes |
| | Optical scan registration - Intraoral scan
- Plaster cast scan and
additional 3D model
scans | Optical scan registration - Intraoral scan
- Plaster cast scan | Yes |
| | Panoramic curve | Panoramic curve | No |
| | Nerve | Nerve | No |
| | Improved Virtual teeth | Virtual teeth | Yes |
| | Grafts and volumes | Grafts and volumes | No |
| | Reorient axial images to
occlusal plane | Reorient axial images to
occlusal plane | No |
| | Planning tools | | |
| | Implant Library - Immediate smile
featuring Atlantis
abutment | Implant Library | Yes |
| | Place implant | Place implant | No |
| | Draw implant | Draw implant | No |
| | Edit implant - Multiple implant
Movement | Edit implant | Yes |
| | Collision detection | Collision detection | No |
| | Request SIMPLANT
guide wizard | Request SIMPLANT
guide wizard | Yes |
| Element | Proposed device
SIMPLANT 18 | Predicate device
SimPlant 2011
K110300 | Difference |
| | - with automatic
transfer to
mySIMPLANT.com | - with automatic
transfer to
Online Shop | |
| | - | Occlusion tool
Virtual occludator
Soft tissue simulation | Yes |
| Media for delivery | Software - file for download. | Software - magnetic media
(DVD). | Yes |
| Principles of
operation | Desktop application. | Desktop application. | No |
| Program language | C++ | C++ | No |
| Operating system | Windows | Windows | No |
Table 5-1 Substantial Equivalence Comparison Table
5
6
Analysis of differences:
The indications for use statement has been clarified to remove the example related to image import from a magnetic resonance scanner as it is not possible to import data from magnetic resonance scanning equipment into the subject SIMPLANT software.
Functionality changes are implemented to improve usability:
- Scan registration is expanded to allow for soft tissue creation and for import of 3D model scans to help the user when determining the ideal implant position. The improved Virtual teeth function offers more options and flexibility to shape and position the virtual teeth. The additional "multiple implant movement" function makes it easier for a user to simultaneously alter the positions of more than one implant relative to the bone, thereby maintaining their initial positions relative to one another.
- । In the predicate device, the complete Implant library had to be downloaded for each library update. In the proposed device, a partial upload is possible, and as such, reduces the download time for the user.
- । The new feature "Immediate Smile featuring Atlantis abutments" makes it easier for the user to see which implants are compatible with customized ATLANTIS Abutments. Also, the design of this abutment can be imported and made visible in the planning file of the proposed SIMPLANT 18.
The "Occlusion tool", "Virtual occludator" and "Soft tissue simulation" functions have been removed from the software's functionality.
7
The website for ordering patient specific surgical guides has changed. Consequently, the proposed SIMPLANT 18 directs the user automatically to the new mySIMPLANT web page instead of to the former Online Shop for ordering the guide.
The media for delivery of the proposed device has been changed. The original software was delivered on DVD, whereas the proposed device is delivered via file download for installation.
Summary of Software testing:
Software verification and validation was conducted to ensure the functionality and have been included to support the substantial equivalence of the subject SIMPLANT 18 software.
In principle, the software testing has consisted of testing of the software functionality containing the changes introduced since the approved predicate device SimPlant 2011 (K110300). . Software testing has been conducted in accordance with the software life cycle processes, as defined in IEC 62304.
The verification and validation testing has consisted of the following activities:
- Peer Code Review .
- Integration test .
- Internal release test .
- Smoke test •
- Formal system test ●
- Acceptance test .
- Beta test .
The results of verification and validation confirm that all user needs and performance requirements according to the design inputs are fulfilled.
7. Conclusion Regarding Substantial Equivalence:
The proposed SIMPLANT 18 is software 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. It is also intended as pre-planning software for dental implant placement and surgical treatment.
The proposed SIMPLANT 18 software, which is the subject of this premarket notification, has the same intended use and similar indications for use, incorporates the same technological characteristics and principles of operation as the predicate SimPlant 2011 (K110300) device. SIMPLANT 18 is tested and validated in the same way as the predicate SimPlant 2011 (K110300) device. Test data to verify the performance of the proposed SIMPLANT 18 have been included and the results of this testing confirmed the functionality and support the substantial equivalence of the proposed device SIMPLANT 18.