(30 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard image processing and 3D modeling for planning and guide design.
No
The device is a planning and design software tool that does not directly treat or diagnose a medical condition.
No
Explanation: The device is described as a "planning and surgery planning software tool" that allows "pre-operative simulation of patient anatomy and dental implant placement." While it uses imaging information, its primary function is planning, not the diagnosis of a disease or condition.
Yes
The device description explicitly states "The device has no patient contact being a software only device." and the performance studies mention "Software, hardware, and integration verification and validation testing was performed," which is standard for software that interacts with hardware (like scanners and 3D printers) but is itself software-only. The device's function is entirely within the software environment for planning and exporting data.
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.
- Device Function: 3Shape Implant Studio is a software tool used for planning dental implant placement based on medical imaging data (CT and optical scans). It helps visualize anatomy and design surgical guides.
- No Sample Testing: The software does not perform any tests on biological samples from the patient. It processes existing imaging data.
- Intended Use: The intended use is for pre-operative planning and designing surgical guides, not for diagnosing a condition or providing information about a patient's health based on laboratory analysis of samples.
Therefore, while it is a medical device used in the dental field, it falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
3Shape Implant Studio 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 and optical scanners. It allows pre-operative simulation of patient anatomy and dental implant placement.
Surgical guides and the planned implant position can be exported as 3D models and the guides can be manufactured using said 3D models when used as input to 3D manufacturing systems.
Product codes
LLZ
Device Description
3Shape Implant Studio® is a stand-alone software device used to pre-operatively plan the placement of a dental implant based on the visualization of a patient's CT image, optionally aligned to an optical 3D surface scan. A virtual surgical quide can be designed and then exported to an external system for manufacturing.
The device has no patient contact being a software only device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT and optical scanners
Anatomical Site
maxilla and/or mandible region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals who have appropriate knowledge in dental implantology and surgical dentistry.
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, hardware, and integration verification and validation testing was performed in accordance with the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Issued on May 11, 2005).
The development of the subject software also utilized the following FDA guidances:
- Technical Considerations for Additive Manufactured Medical Devices; .
- · Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
Prior to release, verification and validation testing of the 3Shape Implant Studio® has been completed using approved acceptance criteria: Each user need has its own validation acceptance criteria; each specification has its own verification acceptance criteria; bug verification consists in ensuring issue is not reproducible; issues encountered by users during the summative evaluation have been reviewed and handled appropriately.
The validation suite includes validation of implemented mitigations related to device hazards identified in the risk management procedures.
All test results have been reviewed and approved, showing 3Shape Implant Studio® to be substantially equivalent in safety and effectiveness to the primary predicate device.
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.
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
September 9, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
3Shape Medical A/S % Mr. Rafael Aguila Official Correspondent Accelerated Device Approval Services, LLC 6800 S.W. 40th Street. Ste. 403 LUDLUM FL 33155
Re: K202256
Trade/Device Name: 3Shape Implant Studio Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: August 7, 2020 Received: August 10, 2020
Dear Mr. Aguila:
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 mediation-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
2
Indications for Use
510(k) Number (if known) K202256
Device Name
3Shape Implant Studio
Indications for Use (Describe)
3Shape Implant Studio 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 and optical scanners. It allows pre-operative simulation of patient anatomy and dental implant placement.
Surgical guides and the planned implant position can be exported as 3D models and the guides can be manufactured using said 3D models when used as input to 3D manufacturing systems.
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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3
510(K) SUMMARY K202256
Submitter Information
| Company Name: | 3Shape Medical A/S |
|---|---|
| Company Address: | Holmens Kanal 7 |
| DK-1060 Copenhagen K | |
| Company Phone: | |
| Company Fax: | +45 7027 2620 |
| +45 7027 2621 | |
| Contact Person: | Jenny Axel |
| Regulatory Affairs Specialist | |
| Date Summary Prepared: | September 4, 2020 |
Device Identification
| 510(k) number: | K202256 |
|---|---|
| Trade/proprietary Name: | 3Shape Implant Studio |
| Regulation Number: | 892.2050 |
| Classification: | Class 2 |
| Product Code: | LLZ |
Primary Predicate Device
The 3Shape Implant Studio® for implant planning and surgical guides (K202256), based on the information and supporting documentation provided, has the same indications for use, scientific concept and technical characteristics as the predicate device Straumann AG coDiagnostix
(K130724) and the reference device 3Shape Implant Studio™ 2015-1 (K152078) also manufactured by 3Shape Medical A/S.
Both, subject and predicate devices, are computer aided design software used by dental professionals trained in implantology for implant planning and the design of surqical quides after import of scan imaging data. The designed 3D models and surqical reports are exported from both devices. Therefore, the 3Shape Implant Studio® software (K202256) and the predicate device (K130724) are found to be similar in their indications for use, supported anatomic areas and the available relevant features and functionalities.
Indications for Use
3Shape Implant Studio® 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 and optical scanners. It allows pre-operative simulation and evaluation of patient anatomy and dental implant placement.
4
Image /page/4/Picture/1 description: The image contains the logo for 3Shape. The logo consists of the word "3shape" in a dark blue sans-serif font, followed by a red triangular symbol. The triangular symbol is composed of three smaller triangles arranged to form a larger triangle.
Surqical quides and the planned implant position can be exported as 3D models and the quides can be manufactured using said 3D models when used as input to 3D manufacturing systems.
Device Description
3Shape Implant Studio® is a stand-alone software device used to pre-operatively plan the placement of a dental implant based on the visualization of a patient's CT image, optionally aligned to an optical 3D surface scan. A virtual surgical quide can be designed and then exported to an external system for manufacturing.
The device has no patient contact being a software only device.
Scientific Concept
The underlying scientific concept is the visualization of an imported CT image from DICOM data to pre-operatively analyze and plan the placement of dental implant(s) in the maxilla and/or mandible region by taking the prosthetic and clinical requirements into consideration. Optionally, the CT image scan data can be aligned to optical 3D surface scan data or to a segmented CT scan of a denture. The implant and sleeve library files are available to the practitioner via encrypted library files, which are reviewed and approved by the original manufactures of the components. Moreover, the use of CAD design technology allows the design of a surgical quide, which can be exported to a 3rd party manufacturing device. The quide can be used for aiding the placement of the implant(s) to the intended position(s). PDF reports are generated to document the planning information and to provide an overview of the required surgical steps and components.
Summary of the technological characteristics
3Shape Implant Studio® is a software only device programmed in C# and has the following PC/laptop hardware requirements equivalent to the reference device:
| Item | Minimum
Requirements
3Shape Implant
Studio®
(K202256) | Minimum
Requirements
Straumann AG
coDiagnostix
(K130724) | Minimum
Requirements
Implant Studio™
2015-1
(K152078) |
|------------------------|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------|
| OS: | Windows 7, 8 or 10 64-
bit | Windows 7, Sp or Vista | Windows 7 or 8 64-bit |
| RAM: | 16 GB | 2 GB | 16 GB or better |
| Monitor
Resolution: | 1920x1080 | 1024x768 pixels | 1920x1200 pixels or higher |
| Video Card
Memory: | 2GB NVIDIA (GeForce
or Quadro), DirectX
10/11. Maxwell or
newer architecture
recommended | - | 2GB GeForce or better |
5
| Available
HDD
Space: | 500 GB | 1 GB free, plus 50 MB
per plan | 500 GB |
|----------------------------|--------------------------------|-----------------------------------|------------------------------------|
| CPU: | Intel Core i7 or
equivalent | Intel Core or AMD Athlon
64 X2 | Intel Core i7 or higher |
| Network: | Network Internet
connection | - | Network Internet
connection |
| Mouse: | With the wheel button | - | Mouse with wheel button
support |
35
3Shape Implant Studio® has the same indications for use and technical characteristics as the predicate device, Straumann AG coDiagnostix (K130724).
The following table compares all newly added features and functionalities between the subject, predicate and reference devices:
| Feature name | 3Shape
Implant
Studio® | Straumann
AG
coDiagnostix | Implant
Studio™
2015-1 |
|-----------------------------------------------------|------------------------------|---------------------------------|------------------------------|
| 510(k) Number | K202256 | K130724 | K152078 |
| Segmentation of Denture
CT scan | Yes | Yes | Yes |
| Alignment of CT scan data
via radiopaque markers | Yes | Yes | Yes |
| Option to manually align
two scan data set | Yes | Yes | Yes |
| Support for anchor pins | Yes | Yes | Yes |
| Gingiva supported surgical
guide design possible | Yes | Yes | Yes |
| Bone supported surgical
guide design possible | Yes | Yes | No |
- Picture archiving and communications system, 21 CFR 892.2050
The added feature for design of bone supported surgical guides with identified and implemented risk mitigations in 3Shape Implant Studio® (K202256) is identical in indications for use and the available features and functionalities compared to the predicate device.
6
sshar
Nonclinical Testing
Software, hardware, and integration verification and validation testing was performed in accordance with the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Issued on May 11, 2005).
The development of the subject software also utilized the following FDA guidances:
- Technical Considerations for Additive Manufactured Medical Devices; .
- · Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
Prior to release, verification and validation testing of the 3Shape Implant Studio® has been completed using approved acceptance criteria: Each user need has its own validation acceptance criteria; each specification has its own verification acceptance criteria; bug verification consists in ensuring issue is not reproducible; issues encountered by users during the summative evaluation have been reviewed and handled appropriately.
The validation suite includes validation of implemented mitigations related to device hazards identified in the risk management procedures.
All test results have been reviewed and approved, showing 3Shape Implant Studio® to be substantially equivalent in safety and effectiveness to the primary predicate device.
The 3Shape Implant Studio® complies with the following standards:
- · IEC 62304
- ISO 13485
- · ISO 14971
- · IEC 62366
- · IEC 80001-2-2
- · NEMA PS 3.1 3.20
Clinical Testing
Clinical testing is not a requirement and has not been performed.
Conclusion
Based on a comparison of intended use, indications for use, scientific concept, features, technical data, and test results, the 3Shape Implant Studio® is found to be as safe and effective as the primary predicate device. Therefore, 3Shape Implant Studio® is found to be substantially equivalent with the primary predicate device.