(14 days)
Not Found
Not Found
No
The summary mentions image segmentation and simulation, which are common image processing tasks, but does not explicitly mention or imply the use of AI/ML techniques. The "Mentions AI, DNN, or ML" field is "Not Found".
No
The device is described as software for image transfer, segmentation, and pre-operative simulation/evaluation, which are diagnostic and planning tools, not therapeutic interventions.
Yes
Explanation: The device is described as a software interface to transfer DICOM images from CT scanners, an image segmentation system to create dental anatomies, and a preoperative software for simulating/evaluating dental implant placement and surgical treatment options. These functions directly contribute to the diagnosis, treatment planning, or monitoring of a disease or condition, specifically in dentistry.
Unknown
The provided summary lacks a "Device Description" section, which is crucial for determining if the device is software-only or includes hardware components. While it describes software functions (image transfer, segmentation, simulation), it doesn't explicitly state that it is only software.
Based on the provided information, the GuideMia system is not an IVD (In Vitro Diagnostic).
Here's why:
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Intended Use: The intended use clearly states that the system is for:
- Transferring DICOM images.
- Image segmentation to create dental anatomies.
- Preoperative simulation/evaluation of dental implant placement and surgical treatment options.
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IVD Definition: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
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GuideMia's Function: The GuideMia system operates on medical images (DICOM from CT scans) and is used for planning and simulation related to surgical procedures. It does not perform tests on biological samples.
Therefore, the GuideMia system falls under the category of medical imaging software and surgical planning software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GuideMia system is intended as software interface to transfer DICOM images generated by CT scanners, an image segmentation system to create dental anatomies from scan images, and a preoperative software for simulating/evaluating dental implant placement and surgical treatment options.
Product codes
LLZ
Device Description
Not Found
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanners
Anatomical Site
dental
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Reference Device(s)
Not Found
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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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
MAY 3 1 2012
GuideMia Technologies LLC % Mr. Mark Job. Responsible Third Part Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K121466
Trade/Device Name: GuideMia Software System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 16, 2012 Received: May 17, 2012
Dear Mr. Job:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 11 you doen opener the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/1 description: The image shows a logo with two overlapping shapes inside a rounded square. The shapes resemble the letters 'P' and 'G', with the 'P' positioned above the 'G'. The 'P' is partially filled in with black, while the 'G' is entirely filled in with black. A small dot is visible to the left of the 'P'.
Indications for Use
510(k) Number
Device Name
GuideMia Software System
Common Name
Image processing system and preoperative software for simulating /evaluating dental implant placement and surgical treatment options
Indications for Use
The GuideMia system is intended as software interface to transfer DICOM images generated by CT scanners, an image segmentation system to create dental anatomies from scan images, and a preoperative software for simulating/evaluating dental implant placement and surgical treatment options.
AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
Samme Thorns
રાભ
Office of ce Fraination and Salet