(210 days)
Not Found
No
The summary describes standard 3D medical imaging functionalities and analysis tools, with no mention of AI, ML, or related concepts.
No
The device is described as a software interface for image transfer, planning, and simulation, and an imaging application supporting diagnosis. It does not perform treatment or therapy.
Yes
The device description states that the software "supports all the common 3D medical imaging functionalities used by professional doctors to support their diagnosis," indicating its role in the diagnostic process.
Yes
The device description explicitly states "Maven Pro software" and describes its functionalities as a "3D imaging application" and "planning and simulation software." There is no mention of accompanying hardware components being part of the device itself, only that it interfaces with a medical scanner.
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 Maven Pro is for transferring imaging information from a medical scanner and for planning and simulation in dental implant placement and surgical treatment. This involves processing and visualizing medical images, which is not the function of an IVD.
- Device Description: The description focuses on 3D imaging functionalities, rendering, segmentation, measurement, and analysis tools applied to medical images. These are typical features of medical image processing and planning software, not IVD devices.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with biological specimens or the analysis of biological markers.
The device described is a medical image processing and planning software, which falls under a different regulatory category than IVDs.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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.
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Dental CT scanner
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional doctors
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)
Not Found
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).
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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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three flowing lines representing the body and arms.
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
3
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
4
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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