Maven Pro is intended for use as a front-end software interface for the transfer of imaging information from a medical scanner such as a Dental CT scanner. It is also intended for use as a planning and simulation software in the placement of dental implants and surgical treatment.
Device Story
Maven Pro is a 3D medical imaging software application used by dental professionals. It accepts imaging data from medical scanners, such as Dental CT scanners. The software provides tools for volume and IsoSurface rendering, segmentation, masking, sculpting, multi-planar reconstruction (MPR), and 2D/3D measurement and analysis. Users operate the software in a clinical setting to visualize patient anatomy, plan dental implant procedures, and simulate surgical treatments. The output consists of rendered images and analysis reports, which assist clinicians in diagnostic and surgical decision-making. The system features an open, modular architecture allowing for customization.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Software-based 3D medical imaging application. Features include volume/IsoSurface rendering, segmentation, masking, sculpting, MPR, and measurement tools. Operates as a front-end interface for medical scanners. Risk analysis conducted per EN ISO 14971:2009.
Indications for Use
Indicated for use as a front-end software interface for dental CT imaging data transfer and as planning/simulation software for dental implant placement and surgical treatment.
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).
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K130242
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## 510(k) Summary
Date of Submission: October 9, 2012
Submitter: nSequence 5420 Kietzke Lane, Suite 205 Reno, NV 89511
| Contact Person: | Daniel Llop, President/CEO |
|-----------------|----------------------------|
| Phone : | 775-827-6645 |
| Fax : | 775-827-6650 |
#### Subject Device:
| Proprietary Name: | Maven Pro |
|----------------------|----------------------------------------|
| Classification Name: | System, Image Processing, Radiological |
| Regulation: | 892.2050 |
| Product Code: | LLZ |
#### Predicate Devices:
| Name of device | Invivodental |
|----------------|-----------------|
| Manufacturer: | Anatomage, Inc. |
| K number: | K070803 |
| Product Code: | LLZ |
AUG 2 9 2013
#### Device Description:
Maven Pro Graphic Station is a fully-featured 3D imaging application in medicine. Its unique open architecture and modular framework make customization and integration options trivial. On demand, nSequence will create a fully customized 3D medical imaging solution.
Maven Pro Graphic Station supports all the common 3D medical imaging functionalities used by professional doctors to support their diagnosis. It includes various Volume and IsoSurface rendering, segmentation tools, masking and sculpting, MPR, 2D and 3D measurement and analysis tools. Since 2D imaging is still an important feature, it is possible to switch with a single click to a 2D view, use an even more sophisticated MPR view or switch back to the 3D view.
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K130242
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Maven Pro software is characterized by its intuitive user interface, 2D, MPR and 3D imaging, prime image quality and extensive visualization options, fast image rendering, measurement and analysis tools, and easy integrated reporting.
#### Intended Uses:
Maven Pro is intended for use as a front-end software interface for the transfer of imaging information from a medical scanner such as a Dental CT scanner. It is also intended for use as a planning and simulation software in the placement of dental implants and surgical treatment.
#### Risk Analysis Method:
The risk analysis for the device was conducted according to EN ISO 14971:2009.
#### Summary of Technological Characteristics:
A comparison of the predicate device and Maven Pro shows that many of technological characteristics of the two devices are similar. The differences between the two devices do not raise new questions of safety and effectiveness.
#### Conclusion:
Maven Pro is substantially equivalent to a legally marketed device. Although it has some technological characteristics that differ from that of predicate, it has the same intended use as the predicate and raises no new questions of safety and effectiveness.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 29, 2013
nSequence % Rhonda Alexander, MS, MPA Senior Regulatory Specialist Registrar Corp 144 Research Drive HAMPTON VA 23666
Re: K130242
Trade/Device Name: Maven Pro Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: July 16, 2013 Received: July 17, 2013
Dear Ms. Alexander:
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 for use stated in the enactment date of 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 I va may, morelor, manel of the Act include requirements for annual registration, listing of general connels proficioning 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 or any I ouvar statution and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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### Page 2 - Rhonda Alexander, MS, MPA
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resources.forYou/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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Smhi
for
Janine M. Morris 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
K130242 510(k) Number (if known):
Maven Pro Device Name:
Indications For Use:
Maven Pro is intended for use as a front-end software interface for the transfer of imaging information from a medical scanner such as a Dental CT scanner. It is also intended for use as a planning and simulation software in the placement of dental implants and surgical treatment.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
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