(87 days)
Not Found
No
The description mentions "pixel-by-pixel analysis and algorithmic filters applications" for image processing, which are traditional image processing techniques and do not inherently indicate the use of AI or ML. There is no mention of AI, ML, deep learning, or related terms.
No.
The software processes and displays images for analysis but does not directly treat or diagnose a disease.
Yes
Explanation: The device is designed to acquire, process, analyze, and display nuclear medicine image data from breast tissue, which are all steps involved in aiding medical professionals in reaching a diagnosis.
No
The device is described as software, but its function is directly tied to acquiring and processing data from a specific hardware gamma camera system (Gamma Medica-Ideas LumaGEM™). While the 510(k) focuses on the software, the device's operation is dependent on and integrated with a hardware component, making it a system rather than a standalone software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the software as being designed to acquire, store, communicate, process, analyze, and display nuclear medicine image data from a gamma camera system for breast imaging. This is focused on processing and displaying medical images, not on analyzing biological samples (like blood, urine, tissue) to diagnose or monitor a disease or condition.
- Device Description: The description reinforces the focus on image display and processing (window/level, measuring, filtering, etc.) of breast images from a gamma camera.
- Input Imaging Modality: The input is nuclear medicine image data, which is generated by a medical imaging device, not from a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on the analysis of such samples.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This software's function is centered around the manipulation and display of medical images.
N/A
Intended Use / Indications for Use
The Molecular Breast Imaging Software is designed to acquire nuclear medicine image data from the Gamma Medica-Ideas LumaGEM™ gamma camera systems. The Molecular Breast Imaging Software allows images and data to be stored, communicated, processed, analyzed and displayed on a compatible workstation.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The Gamma Medica-Ideas Molecular Breast Imaging Software ("MBI Software") is a software tool intended to display and process breast images captured with the Gamma Medica-Ideas LumaGEM" gamma camera systems. The MBI Software contains functions of study display, Gray and Inverse Gray Images, Window/Level changes, Measuring Tool, image processing, and Save, Sum, and Reload (both raw and processed). Image processing is based on pixel-by-pixel analysis and algorithmic filters applications. The MBI Software application supports simultaneous display of multiple images, allowing the user to visualize several angles of the imaged breast tissue at once. The MBI Software is compatible with DICOM and other formats.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
nuclear medicine image data (from Gamma Medica-Ideas LumaGEM™ gamma camera systems)
Anatomical Site
breast tissue
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)
All necessary performance bench testing was conducted on the MBI Software to support a determination of substantial equivalence to the predicate devices. The MBI Software is based on a clinically validated software application, which was designed for breast tissue screening using gamma cameras. All necessary verification and validation testing was conducted to ensure that the MBI Software performs as intended. This testing included:
- Software verification and validation
- Direct comparison testing between the subject device and the original application.
The results of the software verification and validation testing and the direct comparison testing has demonstrated that the Molecular Breast Imaging Software performs as intended.
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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GAMMA MEDICA-IDEAS, INC.
SECTION 5 510(k) SUMMARY
| 510(k) Notification K | / / / 173 / |
|---|---|
| ----------------------- | ------------- |
GENERAL INFORMATION
Applicant:
Gamma Medica-Ideas, Inc. 19355 Business Center Drive, Suite #8 Northridge, CA, 91324 U.S.A. Phone: 818-709-2468 Fax: 818-709-2464
Contact Person:
Albert Boniske Regulatory Consultant for Gamma Medica-Ideas, Inc. 755 N. Mathilda Avenue, Suite 100 Sunnyvale, CA 94085 U.S.A. Phone: 408-400-0856 ext. 113 Fax: 408-400-0865
Date Prepared: June 17, 2011
DEVICE INFORMATION
Trade Name:
Molecular Breast Imaging Software
Generic/Common Name:
Picture Archiving and Communications System
Classification:
21 CFR8892.2050
Product Code:
LLZ
PREDICATE DEVICE(S)
- HERMES HDAQ Acquisition Station and HERMES Workstation (K002782) .
- Segami Mirage (Release 5.0) (K010726) .
- Philips Medical Systems (Cleveland) NM Application Suite (K080961) .
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GAMMA MEDICA-IDEAS, INC.
SECTION 5 510(k) SUMMARY (CONT.)
INTENDED USE
The Molecular Breast Imaging Software is designed to acquire nuclear medicine image data from the Gamma Medica-Ideas LumaGEM™ gamma camera systems. The Molecular Breast Imaging Software allows images and data to be stored, communicated, processed, analyzed, and displayed on a compatible workstation.
PRODUCT DESCRIPTION
The Gamma Medica-Ideas Molecular Breast Imaging Software ("MBI Software") is a software tool intended to display and process breast images captured with the Gamma Medica-Ideas LumaGEM" gamma camera systems. The MBI Software contains functions of study display, Gray and Inverse Gray Images, Window/Level changes, Measuring Tool, image processing, and Save, Sum, and Reload (both raw and processed). Image processing is based on pixel-by-pixel analysis and algorithmic filters applications. The MBI Software application supports simultaneous display of multiple images, allowing the user to visualize several angles of the imaged breast tissue at once. The MBI Software is compatible with DICOM and other formats.
SUBSTANTIAL EQUIVALENCE
The proposed indications for use for the Molecular Breast Imaging Software are substantially equivalent to the indications for use for the predicate devices. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the Molecular Breast Imaging Software is substantially equivalent to the predicate devices.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
All necessary performance bench testing was conducted on the MBI Software to support a determination of substantial equivalence to the predicate devices. The MBI Software is based on a clinically validated software application, which was designed for breast tissue screening using gamma cameras. All necessary verification and validation testing was conducted to ensure that the MBI Software performs as intended. This testing included:
- . Software verification and validation
- Direct comparison testing between the subject device and the original application .
SUMMARY
The results of the software verification and validation testing and the direct comparison testing has demonstrated that the Molecular Breast Imaging Software performs as intended. As such, the Molecular Breast Imaging Software is substantially equivalent to the predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
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
Gamma Medica-Ideas Incorporated % Mr. Albert Boniske Senior Manager of Regulatory Affairs Experien Group LLC 755 N. Mathilda Avenue, Suite 100 SUNNYVALE CA 94085
15 2011
Re: K111731
Trade/Device Name: Molecular Breast Imaging Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 17, 2011 Received: June 20, 2011
Dear Mr. Boniske:
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. Iisting 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
3
medical device-related adverse events) (21 CFR $03); 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 809), please contact the Office of In Viro 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/MedicallDevices/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,
Mary Patel
Mary S. Pastel, Sc.D. 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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Indications for Use
510(k) Number (if known): K111731
Device Name: Molecular Breast Imaging Software
Indications for Use:
The Molecular Breast Imaging Software is designed to acquire nuclear medicine image data from the Gamma Medica-Ideas LumaGEM™ gamma camera systems. The Molecular Breast Imaging Software allows images and data to be stored, communicated, processed, analyzed and displayed on a compatible workstation.
Prescription Use _ X (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Page 1 of 1
Mary Statt
(Division Sign Off)
(Dwision Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K111731