(152 days)
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Not Found
No
The document explicitly states "The software is not to be used for computer aided diagnostic purposes, including mammography CAD," and there are no mentions of AI, DNN, or ML in the provided text.
No.
The software is a tool for medical professionals to aid in evaluation and information management of medical images for diagnostic purposes; it does not directly treat or prevent a disease or condition.
No
The text explicitly states: "The software is not to be used for computer aided diagnostic purposes, including mammography CAD." Although it aids in evaluating and managing medical images, it specifically excludes itself from being a diagnostic device.
Yes
The description focuses entirely on the software's functions related to image processing, management, and analysis of medical images. There is no mention of any accompanying hardware components that are part of the device itself. While it interacts with imaging modalities (hardware), the device being described is the software platform.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- CereMetrix Silver's function: The description clearly states that CereMetrix Silver is a software used to process and manage digital medical images (SPECT, PET, MRI, CT) of the brain. It aids in the evaluation and information management of these images.
- No mention of biological samples: There is no indication that this software interacts with or analyzes any biological samples from a patient. Its input is image data.
Therefore, CereMetrix Silver falls under the category of medical image processing and management software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CereMetrix Silver software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical image modalities include SPECT, PET, MRI and CT as supported by ACR/NEMA DICOM 3.0. CereMetrix Silver assists in the following indications:
· Receive, transmit, store, retrieve, display, print, and process brain images and DICOM objects derived from radiological diagnostic systems, and processing workstations, among others.
· Create, display and print reports from medical images.
· Registration and review of brain images for diagnosis, treatment evaluation, and treatment planning.
· Localization and definition of objects and the differentiation between hyper or hypo perfused tissue, as compared to a composite average, in medical images.
· Creation of clusters for applications including quantitative analysis and archiving clusters for patient follow-up and management.
· CereMetrix Silver is capable of processing and displaying the brain image data in traditional formats, as well as pseudo three-dimensional renderings.
· CereMetrix Silver provides manual and automatic report creation plus the ability to view these reports remotely.
· CereMetrix Silver allows for quantitative and statistical analysis of SPECT brain scans by comparing to a composite average.
When used for diagnostic purposes, the mobile web client is not intended to replace a fill workstation and should only be used when there is no access to a workstation.
The software is not to be used for computer aided diagnostic purposes, including mammography CAD.
Product codes
LLZ
Device Description
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Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
SPECT, PET, MRI and CT
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professionals
Description of the training set, sample size, data source, and annotation protocol
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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).
0
Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
CereMetrix Corp John Kelley President 991 Southpark Drive . Suite 200 Littleton, Colorado 80120
February 28, 2018
Re: K173145
Trade/Device Name: CereMetrix Silver Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: February 26, 2018 Received: February 27, 2018
Dear John Kelley:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173145/S003
Device Name CereMetrix Silver
The CereMetrix Silver software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical image modalities include SPECT, PET, MRI and CT as supported by ACR/NEMA DICOM 3.0. CereMetrix Silver assists in the following indications:
· Receive, transmit, store, retrieve, display, print, and process brain images and DICOM objects derived from radiological diagnostic systems, and processing workstations, among others.
· Create, display and print reports from medical images.
· Registration and review of brain images for diagnosis, treatment evaluation, and treatment planning.
· Localization and definition of objects and the differentiation between hyper or hypo perfused tissue, as compared to a composite average, in medical images.
· Creation of clusters for applications including quantitative analysis and archiving clusters for patient follow-up and management.
· CereMetrix Silver is capable of processing and displaying the brain image data in traditional formats, as well as pseudo three-dimensional renderings.
· CereMetrix Silver provides manual and automatic report creation plus the ability to view these reports remotely.
· CereMetrix Silver allows for quantitative and statistical analysis of SPECT brain scans by comparing to a composite average.
When used for diagnostic purposes, the mobile web client is not intended to replace a fill workstation and should only be used when there is no access to a workstation.
The software is not to be used for computer aided diagnostic purposes, including mammography CAD.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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