ImplantMax Software

K151152 · Saturn Imaging, Inc. · LLZ · Jan 12, 2016 · Radiology

Device Facts

• Record ID: K151152
• Device Name: ImplantMax Software
• Applicant: Saturn Imaging, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jan 12, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

ImplantMax Software is a stand-alone Windows-based software application to support the diagnosis and treatment planning for dental implantation. It is designed for qualified dental practitioners, including dentists and lab technicians. The software imports the medical image dataset of the patient in DICOM format from medical CT or dental CBCT scanners and transfers the dataset into 3D dataset for pre-operative planning and simulation of dental placement. The planned implant position can be exported and displayed as the position data of each joint of the articulated arm of ImplantMax Workstation. The user can manually set the position of ImplantMax Workstation arm to match the setting values displayed by ImplantMax Software. ImplantMax Workstation is set to the position to fabricate the surgical template. Please note that ImplantMax Workstation is not part of this 510(k) premarket notification.

Device Story

ImplantMax Software is a stand-alone Windows application for dental implant planning. It imports patient DICOM data from CT or CBCT scanners to generate 3D visualizations. Practitioners use the software to perform multiplanar reconstruction (MPR), panoramic views, and 3D image reconstruction. Key features include nerve canal identification, implant size simulation, implant positioning/alignment, abutment/crown simulation, and bone quality assessment via CT numbers. The software outputs planned implant coordinates, which are manually transferred to an external, non-patient-contacting articulated arm (ImplantMax Workstation) to fabricate surgical templates. Used in dental clinics or labs by dentists and technicians to improve surgical accuracy and treatment planning. The software does not contact the patient or control life-sustaining equipment.

Clinical Evidence

Bench testing only. Verification included functional testing against design inputs and image reconstruction accuracy using an acrylic phantom with markers. Stability testing confirmed long-time operation. Validation included pre-clinical testing with patient data (partially and fully edentulous) and a usability study with ten experienced dentists per IEC 62366:2007.

Technological Characteristics

Stand-alone Windows-based software. Inputs: DICOM data from CT/CBCT. Outputs: 3D visualization, implant position coordinates. Features: MPR, panoramic, 3D reconstruction, nerve module, bone density analysis. Connectivity: Standalone. Hardware requirements: Windows XP/7, Intel Pentium M-715 1.5GHz+, 2GB RAM, independent graphics card (ATI/nVidia) with 512MB+ memory.

Indications for Use

Indicated for the general public requiring dental implantation diagnosis and treatment planning. Used by qualified dental practitioners, including dentists and lab technicians, for pre-operative planning and simulation of dental implant placement.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• coDiagnostiX Implant Planning Software (K130724)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 12, 2016

Saturn Imaging, Inc. % Mr. Beender Yang President 79. Sec. 1. Xintai 5th Road, 14F-11 New Taipei City 22101 TAIWAN

Re: K151152

Trade/Device Name: ImplantMax Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 22, 2015 Received: January 7, 2016

Dear Mr. Yang:

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 [phone] or [phone] 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 [phone] or [phone] 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) K151152

Device Name ImplantMax Software

#### Indications for Use (Describe)

ImplantMax Software is a stand-alone Windows-based software application to support the diagnosis and treatment planning for dental implantation. It is designed for qualified dental practitioners, including dentists and lab technicians. The software imports the medical image dataset of the patient in DICOM format from medical CT or dental CBCT scanners and transfers the dataset into 3D dataset for pre-operative planning and simulation of dental placement.

The planned implant position can be exported and displayed as the position data of each joint of the articulated arm of ImplantMax Workstation. The user can manually set the position of ImplantMax Workstation arm to match the setting values displayed by ImplantMax Software. ImplantMax Workstation is set to the position to fabricate the surgical template. Please note that ImplantMax Workstation is not part of this 510(k) premarket notification.

The patient population is the general public.

| 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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# Appendix A - 510(k) Summary

### 5.1 Applicant's Name and Address

Saturn Imaging Inc. 79, Sec.1, Xintai 5th Rd., 14F-11 New Taipei City 221, Taiwan Telephone number: [phone] Fax Number: [phone] Contact Person: Beender Yang, President

- 5.2 Data of Submission: 04 / 16 / 2015
### 5.3 Device Information

| Trade Name: | ImplantMax Software |
|----------------------|---------------------------------------------------|
| Common Name: | Dental 3D diagnosis and implant planning software |
| Classification Name: | Image Processing System |
| 510(k) Number: | K151152 |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | LLZ |

### 5.4 Predicate Device

| Manufacturer: | Straumann US |
|--------------------|----------------------------------------|
| Trade Name: | coDiagnostiX Implant Planning Software |
| 510(k) Number: | K130724 |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | LLZ |

## 5.5 Device Description

ImplantMax is a software interface for the transfer and visualization of 3D medical imaging information from medical CT (computed tomography) or dental CBCT (cone-beam computed tomography) scanner. It is designed to support the diagnosis and treatment planning for dental implantation with the 3D graphic representation. To facilitate the planning, the major software functions are provided as follows.

MPR (multiplanar reconstruction), panoramic, and, 3D image reconstruction (1)

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for analyzing anatomical condition,

- (2) Graphic visualization interface for placing the implant in mandible or maxilla images,
- Nerve module for assisting users in distinguishing inferior alveolar nerve (3) (passing through mandibular canal),
- Simulation of different sized implants, (4)
- (2) Adjustment of implant location, including position and direction,
- Alignment function for multiple implants, (6)
- Simulation of abutment and crown, (7)
- Measurement tools for measuring length and angle, (8)
- (ਰ) Bone quality (indicated by CT number) displayed in the area around the implant.

The implant position can be exported and displayed as the joint position of the articulated arm of ImplantMax Workstation that is a separated manually-operated device for fabricating the surgical template.

## 5.6 Intended Use

ImplantMax Software is a stand-alone Windows-based software application to support the diagnosis and treatment planning for dental implantation. It is designed for qualified dental practitioners, including dentists and lab technicians. The software imports the medical image dataset of the patient in DICOM format from medical CT or dental CBCT scanners and transfers the dataset into 3D dataset for pre-operative planning and simulation of dental placement.

The planned implant position can be exported and displayed as the position data of each joint of the articulated arm of ImplantMax Workstation. The user can manually set the position of ImplantMax Workstation arm to match the setting values displayed by ImplantMax Software. ImplantMax Workstation is set to the position to fabricate the surgical template. Please note that ImplantMax Workstation is not part of this 510(k) premarket notification.

The patient population is the general public.

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# 5.7 Substantial Equivalence to Predicate Device

The comparison of intended use and technological characteristics of subject and predicate devices is as follows.

| Characteristic | Subject Device | Predicate Device | Difference Interpretation |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | K151152 | K130724 | - |
| Trade Name | ImplantMax Software | coDiagnostiX | - |
| Common Name | Dental 3D diagnosis and implant planning<br>software | Dental 3D diagnosis and implant planning software | - |
| Classification | Regulation number: 21 CFR 892.2050<br>Product code: LLZ | Regulation number: 21 CFR 892.2050<br>Product code: LLZ | - |
| Intended Use | ImplantMax Software is a stand-alone<br>Windows-based software application to support<br>the diagnosis and treatment planning for dental<br>implantation. It is designed for qualified dental<br>practitioners, including dentists and lab<br>technicians.<br><br>The software imports the medical image dataset<br>of the patient in DICOM format from medical CT<br>or dental CBCT scanners and transfers the<br>dataset into 3D dataset for pre-operative<br>planning and simulation of dental placement. | Straumann coDiagnostiX is an implant planning and<br>surgery planning software tool intended for use by<br>dental practitioners with appropriate training in<br>dental implantology.<br><br>This software reads imaging information output<br>from medical scanners such as CT or DVT scanners.<br>It allows pre-operative simulation and evaluation of<br>patient anatomy, dental implant placement and<br>surgical treatment options. | - |
| Characteristic | Subject Device | Predicate Device | Difference Interpretation |
| | The planned implant position can be exported<br>and displayed as the position data of each joint<br>of the articulated arm of ImplantMax<br>Workstation. The user can manually set the<br>position of ImplantMax Workstation arm to<br>match the setting values displayed by<br>ImplantMax Software. ImplantMax Workstation<br>is set to the position to fabricate the surgical<br>template. Please note that ImplantMax<br>Workstation is not part of this 510(k) premarket<br>notification. | For automated manufacturing of drill guides in the<br>dental laboratory environment, the coDiagnostiX<br>software allows for export of data to 3D<br>manufacturing systems, or coDiagnostiX can<br>provide printouts of template plans for the creation<br>of surgical templates using a manually operation<br>gonyX table. | ImplantMax Software does not<br>provide automated<br>manufacturing of surgical<br>templates.<br>ImplantMax Software is<br>intended to export the planned<br>implant position for the<br>creation of surgical templates<br>using a manually operated<br>ImplantMax Workstation. The<br>intended use is substantially<br>equivalent to coDiagnostiX<br>provides printouts of template<br>plans for the creation of<br>surgical templates using a<br>manually operation gonyX<br>table.<br>The difference does not raise<br>new issue of safety and<br>effectiveness. |

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### Appendix A Page 4 of 10

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| Characteristic | Subject Device | Predicate Device | Difference Interpretation |
|----------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------|
| Target Population | General public | General public | - |
| Software<br>Function | MPR (multiplanar reconstruction), panoramic, and, 3D image reconstruction for analyzing anatomical condition | Axial, cross-sectional, tangential, panoramic, 3D views for displaying the 3D volumetric data for diagnosis purpose | - |
| | Graphic visualization interface for placing the implant in mandible or maxilla images, | Various image views, such as axial, cross-sectional, tangential, and panoramic , provided for placing the implant | - |
| | Nerve module for assisting users in distinguishing inferior alveolar nerve (passing through mandibular canal) | Nerve module to assist in distinguishing the nerve mandibular channel | - |
| | Simulation of different sized implants | Different implants selected from implant database. Change the diameter and length of the implant selected. | - |
| | Adjustment of implant location, including position and direction | Aligning implant by moving and rotating the implant with the mouse | - |
| | Alignment function for multiple implants, | Parallelizing function for adjustment for adjacent images. | - |
| | Simulation of abutment and crown, | Abutment and virtual teeth tools provided | - |
| | Measurement tools for measuring length and | Active measurement tools, length and angle, for | - |

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| Characteristic | Subject Device | Predicate Device | Difference Interpretation |
|----------------|---------------------------------------------------|------------------------------------------------------|-------------------------------|
| | angle | individual measuring of implant position | |
| | | | |
| | Bone quality (indicated by CT number) | Bone densitometry with a density statistic for | |
| | displayed in the area around the implant | density measuring in the area around the | |
| | | positioned implant; a density allocation along and | |
| | | transverse to, the implant cover area is displayed | |
| | The treatment plan of the patient can be saved | All working steps are saved automatically to the | |
| | in the computer storage media. The plan can be | patient file, called the plan. | |
| | retrieved later on for revision. | | |
| | The implant position recorded in the plan can | The template plan can be printed for the manual | |
| | be exported from ImplantMax Software and | gonyX rotary table for surgical template fabrication | |
| | used as input data for the positioning device to | in the lab environment. The printout contains 4 | |
| | fabricate surgical templates in the laboratory | vernier scales (angulation) for each implant that | |
| | environment. The positioning device is a | guide the user to set the table to that implant | |
| | manual serial-linked articulated arm with four | direction. | |
| | rotary joints. For each target implant direction, | | |
| | four angulation counts of the joints are | | |
| | displayed on the screen to guide the user to set | | |
| | the arm to the target position. | | |
| Computer | OS: Windows XP/Win7 | OS: Microsoft Windows 7, XP, Vista. | The predicate device can be |
| System | CPU: Intel Pentium M-715, 1.5GHz or higher | CPU: Intel Core or AMD Athlon 64 X2 | run on Apple operating system |

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| Characteristic | Subject Device | Predicate Device | Difference Interpretation |
|-----------------------|--------------------------------------------------|---------------------------------------------------|-------------------------------|
| Requirement | Memory: 2G or higher | Main memory: 2GB | but ImplantMax Software |
| | Video Card: Independent graphics card (from | Hard disk: 1GB free, plus 50 MB per plan | cannot. The difference does |
| | ATI or nVidia) with 512M memory or higher | Screen resolution: 1024 x 768 pixels | not raise new issue of safety |
| | | The software can also be run on the Apple | and effectiveness. |
| | | operating system with minimum system | |
| | | requirements of: | |
| | | Macintosh computer with Intel process | |
| | | Mac OSX 10.6 or newer | |
| | | "Parallels Desktop" for Macintosh including valid | |
| | | Windows license | |
| Image Import | DICOM data format from CT/DVT scanner saved | DICOM data from CT/DVT scanner saved on | |
| | on CDROM, PC or network. | CDROM, PC or network. | |
| Anatomic Area | Maxilla, Mandible | Maxilla, Mandible | |
| Safety<br>Information | The device does not contact patient, nor does it | coDiagnostiX is not intended to be used in direct | |
| | control any life sustaining devices. | contact with the patient nor is it intended to be | |
| | | used with life sustaining devices. | |

# Conclusion

Based on the side- by- side comparison, the differences between the subject and predicate devices do not raise of safety and effectiveness. We conclude that ImplantMax Software is substantially equivalent to the predicate in technological characteristics of intended use, software function, material, computer system requirement, image data format,

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Appendix A Page 8 of 10

anatomic area, and safety information. The comparison demonstrates that ImplantMax Software is as effective, and performs as well as the predicate device.

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## 5.8 Performance Testing

Software verification and validation testings were performed to ensure that the device subject to this 510(k) Premarket Notification functions as intended and that design input matches design output. In particular, the following verification and validation activities were performed:

## Verification:

The functional testing was performed to verify the complete integrated system against the design inputs listed in the SDS document. The testing was performed under the engineering (development) environment by qualified personnel of Saturn. The testing results confirmed that the software is performed as designed. Performance test of image reconstruction verification was executed using an acrylic phantom with markers of known position. The testing results confirmed that the correction of the image reconstruction algorithm is verified to the acceptable criterion. The stability test was performed to confirm that the software is stable under long-time operation.

# Validation:

The pre-clinical testing using partially edentulous and fully edentulous patient data was performed to verify safety and effectiveness as intended. The testing results confirmed that the software is performed to meet the user needs listed in SRS document. The usability test was also performed to validate user interface (UI) design. The test was conducted by an independent usability lab. Ten experienced dentists from the dentistry department of two university hospitals were participated in the test. The testing results confirmed that the Ul design is acceptable for safety and effectiveness per IEC62366::2007 "Medical devices – Application of usability engineering to medical devices"

# 5.9 Safety Information

ImplantMax Software is a stand-alone software device for visualization of digital medical images. The device does not contact the patient, nor does it control any life sustaining devices.

All potential hazards have been identified and analyzed. The result of the analysis indicates that the device is of moderate level of concern per "Guidance for

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the Content of Premarket Submission for Software Contained in Medical Devices".

# 5.10 Conclusion

The information provided in this submission demonstrates that ImplantMax Software is substantially equivalent to the predicate device. The results of software validation indicate that the software is safe and effective for its intended use.