(308 days)
No reference devices were used in this submission.
No
The document describes standard image visualization, alignment, and planning tools without mentioning AI or ML algorithms. The "Mentions AI, DNN, or ML" field explicitly states "Not Found".
No
The device is a pre-operative planning and guide creation tool for dental implants, and does not directly provide therapy.
No
The device is a pre-operative planning and surgical guide creation tool, not a diagnostic device. It visualizes existing medical image data and assists in planning an intervention (implant placement), but it does not diagnose a disease or condition.
Yes
The device is explicitly described as "stand-alone software" and its function is limited to processing and visualizing medical image data and creating planning files for external manufacturing systems. It does not include or control any hardware components used in the manufacturing or surgical process.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- ImplaStation's Function: ImplaStation is software that processes medical images (CT/CBCT and optical scans) to plan dental implant placement and design surgical guides. It does not analyze biological specimens from the patient's body.
- Intended Use: The intended use clearly states it's a pre-operative tool for dental implant positioning and surgical guide planning based on imaging data.
Therefore, ImplaStation falls under the category of medical imaging software and surgical planning tools, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
ImplaStation is stand-alone software designed for trained qualified dental practitioners, including dental technicians. The software can be used to visualize a patient's medical image dataset output in DICOM format from third-party CT/CBCT scanners. ImplaStation is intended for use as a pre-operative tool for the dental implant(s) positioning based on the CT/CBCT image dataset aligned to optical 3D surface scan(s) and for the surgical guide planning result file creation. The surgical guide can be manufactured using a planning result file when used as input to 3D manufacturing systems.
3D manufacturing is out of ImplaStation software control, depends on many external factors and lie within the sole responsibility of the user.
Product codes
LLZ
Device Description
ImplaStation is stand-alone software designed for trained qualified dental practitioners. The key scientific concept (807.92(a)(4)) of the ImplaStation software is the visualization of a patient's medical image data (DICOM file from third-party CT/CBCT scanners) to pre-operative digital implant planning, surgical guide (drill guide) file (output of the pre-operative implant planning) creation. The data acquired by the optical scanner (scanned surface of the maxilla or mandible) can be aligned to the CT/CBCT reconstruction through a point-based registration technique. Virtual crown(s) design and nerve tracing can be used as additional tools to assist the specialist during an implant planning process. The ImplaStation library contains implant, abutment, drill, and sleeve files, which are encrypted files and approved by the corresponding implant manufactures. The software allows designing the surgical guide (drill guide) file and exporting the generated file to a 3th party external system for manufacturing. The device has no patient contact, nor does it control any life-sustaining devices.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT / CBCT scanner
Anatomical Site
maxilla or mandible, dental implant(s)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained qualified dental practitioners, including dental technicians.
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)
Nonclinical verification and validation testing were performed to ensure that the ImplaStation subject to this 510(k) Premarket Notification functions as intended. Testing has been carried out in accordance with the FDA guidance document: "General Principles of Software Validation: Final Guidance for Industry and FDA Staff", issued on January 11, 2002.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
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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December 3, 2021
Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Prodigident, Inc. % Andrii Gromov Chief Executive Officer 1350 Lake Street. Suite 1B ROSELLE IL 60172
Re: K210241
Trade/Device Name: ImplaStation Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: September 26, 2021 Received: November 1, 2021
Dear Andrii Gromov:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
. for
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210241
Device Name ImplaStation
Indications for Use (Describe)
ImplaStation is stand-alone software designed for trained qualified dental practitioners, including dental technicians.
The software can be used to visualize a patient's medical image dataset output in DICOM format from third-party CT/ CBCT scanners.
ImplaStation is intended for use as a pre-operative tool for the dental implant(s) positioning based on the CT/CBCT image dataset aligned to optical 3D surface scan(s) and for the surgical guide planning result file creation. The surgical guide can be manufactured using a planning result file when used as input to 3D manufacturing systems.
3D manufacturing is out of ImplaStation software control, depends on many external factors and lie within the sole responsibility of the user.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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I. SUBMITTER
PRODIGIDENT, Inc. 1350 Lake Street, Suite 1B Roselle, IL 60172, United States
Phone: 13 (0) 5290-7190 E-mail: andrey.gromov@prodigident.com
| Contact Person: | Andrii Gromov, CEO |
|---|---|
| Date Prepared: | December 30, 2020 |
II. DEVICE
| Name of Device: | ImplaStation |
|---|---|
| 510(k) number: | K210241 |
| Common or Usual Name: | Implant Planning and Surgical Guide Creation Software |
| Classification Name: | Medical image management and processing system |
| Regulation Number: | 21 CFR 892.2050 |
| Regulatory Class: | II |
| Product Code: | LLZ |
III. PREDICATE DEVICE
| Name of Device: | CoDiagnostiX Implant Planning Software |
|---|---|
| 510(k) number: | K130724 |
| Common or Usual Name: | Implant Planning and Surgical Guide Creation Software |
| Classification Name: | Medical image management and processing system |
| Regulation Number: | 21 CFR 892.2050 |
| Regulatory Class: | II |
| Product Code: | LLZ |
This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
ImplaStation is stand-alone software designed for trained qualified dental practitioners.
The key scientific concept (807.92(a)(4)) of the ImplaStation software is the visualization of a patient's medical image data (DICOM file from third-party CT/CBCT scanners) to pre-operative digital implant planning, surgical guide (drill guide) file (output of the pre-operative implant planning) creation.
The data acquired by the optical scanner (scanned surface of the maxilla or mandible) can be aligned to the CT/CBCT reconstruction through a point-based registration technique.
Virtual crown(s) design and nerve tracing can be used as additional tools to assist the specialist during an implant planning process.
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The ImplaStation library contains implant, abutment, drill, and sleeve files, which are encrypted files and approved by the corresponding implant manufactures. The software allows designing the surgical guide (drill guide) file and exporting the generated file to a 3th party external system for manufacturing. The device has no patient contact, nor does it control any life-sustaining devices.
Warning: Pathways of imaged nerves cannot be used as sole information for the clinician to make clinical decisions.
V. INDICATIONS FOR USE
ImplaStation is stand-alone software designed for trained qualified dental practitioners, including dentists and dental technicians.
The software can be used to visualize a patient's medical image dataset output in DICOM format from third-party CT/CBCT scanners.
ImplaStation is intended for use as a pre-operative tool for the dental implant(s) positioning based on the CT/CBCT image dataset aligned to optical 3D surface scan(s) and for the surgical guide planning result file creation. The surgical guide can be manufactured using a planning result file when used as input to 3D manufacturing systems.
3D manufacturing is out of ImplaStation software control, depends on many external factors and lie within the sole responsibility of the user.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The ImplaStation software covered in this submission is based on the same technological characteristics and has the same intended use as the legally cleared coDiagnostiX Implant Planning Software (predicate device).
Table 1. Identification of Similarities/Differences in Technological Characteristics between the ImplaStation software and coDiagnostiX Implant Planning Software (predicate device):
| No | Feature | Proposed Device
ImplaStation | Predicate Device coDiagnostiX Implant
Planning Software (K130724) |
|-----|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Indications for Use | ImplaStation is stand-alone software
designed for trained qualified dental
practitioners, including dentists and dental
technicians. The software can be used to
visualize a patient's medical image dataset
output in DICOM format from third-party
CT/CBCT scanners. The software aids the
user in the guided implant surgery
planning to provide a design of dental
restorative solutions.
ImplaStation is intended for use as a pre-
operative tool for the dental implant(s)
positioning based on the CT/CBCT image
dataset aligned to optical 3D surface
scan(s) and for the surgical guide file
creation, and export of the created file to
an external system for manufacturing. | CoDiagnostiX is an implant planning and
surgery planning software tool intended for
use by dental professionals who have
appropriate knowledge in dental
implantology and surgical dentistry. This
software reads imaging information output
from medical scanners such as CT or DVT
scanners. It allows pre-operative
simulation and evaluation of patient
anatomy and dental implant placement.
For automated manufacturing of drill
guides in the dental laboratory
environment, the coDiagnostiX can
provide printouts of template plans for the
creation of surgical templates using a
manually operated gonyX table. |
| 2. | Input Source | CT / CBCT scanner | CT / CBCT, DVT scanners |
| No | Feature | Proposed Device
ImplaStation | Predicate Device coDiagnostiX Implant
Planning Software (K130724) |
| 3. | Input Data | DICOM, .stl files | DICOM, .stl files |
| 4. | Output Data | .stl file | .stl file |
| 5. | Minimum system
hardware and software
requirements | macOS X 10.9 or newer; OS - Windows 7,
64-bit;
Central Processing Unit (CPU) - Intel Core
i3;
Memory (RAM) - 2GB;
Graphics Card - Intel HD Graphics 615;
Intel HD Graphics 620; NVIDIA GeForce
1GB,
HDD - 3GB of free space,
Monitor resolution - 1600 x 900 pixels | macOS X 10.9 or newer; OS - Windows 7,
64-bit
Central Processing Unit (CPU) - Intel®
Core™ 2 Duo processor P8600
Memory (RAM) - 8GB
Graphics Card - Not specified
HDD - 128 GB of free space
Monitor resolution - 1680 x 1050 pixels |
| 6. | Image registration
(alignment) | The scanned surface data acquired by the
optical/intraoral scanner can be aligned to
the CT/CBCT reconstruction through a
point-based registration technique | The scanned surface data acquired by the
optical/intraoral scanner can be aligned to
the CT/CBCT reconstruction through a
point-based registration technique |
| 7. | Projects management | Project exporting/importing | Project exporting/importing |
| 8. | Case visualization | 2D gray value images
3D model rendering
Panoramic mode
MPR mode
Individual editing of imaging artifacts | 2D gray value images
3D model rendering
Panoramic mode
MPR mode
Individual editing of imaging artifacts |
| 9. | DICOM data processing | DICOM segmentation, DICOM to STL
conversion | DICOM segmentation, DICOM to STL
conversion |
| 10. | STL data processing | System allows to process STL files, group
files, fix errors, edit and copy STL files | System allows to process STL files, group
files, fix errors, edit and copy STL files |
| 11. | Measurement tool | Distance/Angle | Distance/Angle:
Bone density measurement |
| 12. | Nerve tracing | Possible | Possible |
| 13. | Virtual Wax-up | Possible | Possible |
| 14. | Implant Planning tools | Implant, sleeve, drill, abutment, analog,
and pin positioning;
Custom Implant, Sleeve, Drill, Abutment,
and Pin creation;
Implant-to-implant, Implant-to-nerve
canal, Sleeve-to-Sleeve, and Sleeve-to-
STL surface distance/collision warning. | Implant, sleeve, drill, abutment, analog,
and pin positioning;
Custom Implant, Sleeve, Drill, Abutment,
and Pin creation;
Implant-to-implant, Implant-to-nerve
canal, and Sleeve-to-Sleeve surface
distance/collision warning. |
| No | Feature | Proposed Device
ImplaStation | Predicate Device coDiagnostiX Implant
Planning Software (K130724) |
| 15. | Surgical guide design | Tooth-supported surgical guide design
possible;
Gingiva-supported surgical guide design
possible;
Bone-supported surgical guide design
possible;
Export of surgical guide design data set
possible:
Offset, wall thickness and connector
thickness setting possible. | Tooth-supported surgical guide design
possible;
Gingiva-supported surgical guide design
possible;
Bone-supported surgical guide design
possible;
Export of surgical guide design data set
possible;
Offset, wall thickness and connector
thickness setting possible. |
| 16. | Surgical protocol design
and creation tool | Details protocol: available per implant
providing detailed implant, sleeve and
surgical protocol information together with
images of the planning views;
Surgical protocol: The sequence of
surgical instruments to be used as specified
by the selected guided surgery system
(selected manufacturers only) | Details protocol: available per implant
providing detailed implant, sleeve and
surgical protocol information together with
images of the planning views;
Surgical protocol: The sequence of
surgical instruments to be used as specified
by the selected guided surgery system
(selected manufacturers only) |
| 17. | Payment model | Pay per use
License Fee
Annual Fee | License Fee
Annual Fee |
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Guided oral surgery consists of the insertion of dental implants in the exact position, and depth, through the use of customized tooth-, bone-, or mucosa-supported surgical guides designed with dedicated software and physically realized by three-dimensional (3D) printing.
ImplaStation covered in this submission and the previously cleared coDiagnostiX Implant Planning Software (predicate devices) are meant for use with standard PC hardware and include similar intended use, technology, level of concern and major functionality related to visualization and processing medical image DICOM files, implant planning and surgical guide designing.
It should be noted that in addition to the Implant, Implant-to-nerve canal, and Sleeve-to-Sleeve collision warning system, ImplaStation has a Sleeve-to-STL surface distance/collision warning system. The ImplaStation software does not offer tools for bone density measurement. Studies regarding grev values in CBCT data showed that they cannot be standardized and allocated to specific anatomical structures as in CT. Therefore, Hounsfield units used for interpretation of CT data are not applicable for CBCT data and bone density measurements in CBCT are not reliable.
The difference between ImplaStation and coDiagnostiX Implant Planning Software does not raise additional concerns regarding its safety and effectiveness.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Nonclinical Testing:
Nonclinical verification and validation testing were performed to ensure that the ImplaStation subject to this 510(k) Premarket Notification functions as intended. Testing has been carried out in accordance with the FDA guidance document: "General Principles of Software Validation: Final Guidance for Industry and FDA Staff", issued on January 11, 2002.
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The Prodigident ImplaStation complies with the following standards:
- · IEC 62304
- ISO 13485
- ISO 14971
- · IEC 80001-2-2
- NEMA PS 3.1 3.20
Clinical Testing:
Clinical testing was not needed to support a claim of Substantial Equivalence to the predicate device.
Based on the performance as documented in the non-clinical study, the ImplaStation software was found to have a safety and effectiveness profile that is similar to the predicate device.
VII. CONCLUSIONS
Based on a comparison of intended use, technical characteristics, principle of operations, features and tools, and the test results, the subject device ImplaStation is found to be substantially equivalent in safety and effectiveness to the predicate device. Intended use and performance is found to be substantially equivalent to the predicate device.