(87 days)
IBIS Explorer and Markup Software is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
Besides general image interpretation and processing tools, IBIS provides specific tool sets for several clinical applications, including:
- . Oncology, including lesion marking and analysis
- . Anatomic structure marking, volume measurement and analysis
Only DICOM for presentation images can be used on an FDA approved monitor for mammography for image diagnosis.
Only uncompressed or non-lossy compressed images must be used for image diagnosis in mammography.
The IBIS Explorer and Markup Software is a picture archival and communications system (PACS) providing researchers, radiologists or health care professionals with the tools to accept, display, store, archive and manipulate digital medical images. The IBIS Explorer stores, archives and displays digital medical images, while the Markup Software allows for measurements of specified regions and report generation. Digital images supported by the software include but are not limited to bone scans, chest radiograph (x-ray), ultrasound, computed tomography (CT), and magnetic resonance imaqing (MRI).
The System is to be used by trained professionals who are responsible for the correct and accurate use of medical images and the subsequent diagnosis. In a typical clinical environment, the system would be used by a trained technician and radiologist.
The software is installed on an off-the-shelf PC computer system. It is intended to be used with uncompressed digital images that are saved in DICOM format.
Here's an analysis of the provided text regarding the IBIS Explorer and Markup Software, focusing on acceptance criteria and the study that proves device performance:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria are not explicitly numerical thresholds but rather functional and validation requirements. The device performance is generally stated as meeting these requirements.
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional Verification | Device meets all software requirements. | "Comprehensive design verification and validation (V&V) was performed to ensure that the IBIS Explorer and Markup Software meets its intended use, customer requirements and software requirements." |
| User Requirements Validation | Device meets customer/user requirements. | "Testing also included verifying the accuracy of the measurements of the Markup Software against the Visage PACS/CS predicate device." |
| Measurement Accuracy | Markup Software measurements are accurate (relative to predicate). | "Testing also included verifying the accuracy of the measurements of the Markup Software against the Visage PACS/CS predicate device." |
| Image Modality Support | Supports various DICOM image modalities from different scanners. | "Testing was conducted using various DICOM image modalities from different scanners (GE, Toshiba, Philips and Siemens)." |
| Clinical Usability/Quality | No anomalies affecting quality or clinical usability. | "Testing confirmed that no anomalies affect the quality or clinical usability of the system." |
| Substantial Equivalence | Same intended use, similar technological characteristics, no new safety/effectiveness questions. | "The IBIS Explorer and Markup Software is substantially equivalent to the predicate devices. The software has the same intended use and similar technological characteristics, which do not raise any new questions of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state a sample size for the test set of images used for verification and validation. It mentions "various DICOM image modalities."
- Data Provenance: The document states that testing was "conducted using various DICOM image modalities from different scanners (GE, Toshiba, Philips and Siemens)." This suggests a diverse set of images, likely retrospective data collected from these different scanner types. The country of origin of this data is not specified, but the testing itself was "conducted at MedQIA."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. The testing primarily focuses on software functionality, compliance with requirements, and comparison of measurement accuracy against a predicate device.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the test set. Given the nature of the testing described (functional verification and comparison against a predicate device for measurement accuracy), it seems unlikely an adjudication method for case interpretation or diagnosis was employed in the usual sense.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document describes design verification and validation, including functional testing and measurement accuracy comparison to a predicate device. It does not mention any study involving human readers or comparing performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the testing described appears to be a form of standalone testing for the functionality and measurement accuracy of the software itself. The phrase "verifying the accuracy of the measurements of the Markup Software against the Visage PACS/CS predicate device" implies testing the algorithm's output directly. However, the device is intended for use by trained professionals, implying a human-in-the-loop for interpretation and diagnosis, not the algorithm making diagnoses independently. The clinical usability was also assessed, which would be in the context of human use. So, while foundational testing was standalone, the overall clinical use is human-interfaced.
7. The Type of Ground Truth Used
For the "accuracy of the measurements of the Markup Software," the ground truth was essentially the measurements provided by the predicate device (Visage PACS/CS). This means the predicate device served as the reference standard for measurement accuracy. For other functional aspects, the ground truth was the expected output based on software and user requirements. There is no mention of pathology, expert consensus, or outcomes data being used as ground truth for this particular submission.
8. The Sample Size for the Training Set
The document does not mention a training set or any machine learning components. The device is described as a PACS system with image manipulation and measurement tools, not an AI-driven diagnostic algorithm that would typically require a training set. The "Performance Data" section describes Verification & Validation activities, not algorithm training.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied for this device, this question is not applicable based on the provided text.
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Appendix A: 510(k) Summary
AUG - 5 2011
1. Date of Summary: 30 June 2011
2. 510(k) Applicant
MedQlA 924 Westwood Blvd, Suite 650 Los Angeles, CA 90024 1-888-963-3742
Contact Person: Matthew Brown, PhD Phone: 310-794-8969 Fax: 310-794-8657 e-mail: mbrown@medqia.com
3. Device Overview
| Trade Name: | IBIS Explorer and Markup Software |
|---|---|
| Common Name: | Picture Archiving and Communication Systems (PACS) |
| Classification Name: | System, Image Processing, Radiological21 CFR 892.2050Product Code LLZ |
4. Predicate Device
The predicate devices identified for the IBIS Explorer and Markup Software are as follows:
| Trade Name | 510(k) Submitter | 510(k) Number |
|---|---|---|
| syngo® Dynamics | Siemens AG Medical Solutions | K053133, cleared on December 5, 2005 |
| VISAGE® PACS/CS 6.0 | Mercury Computer System, Inc | K082269, cleared to market on December 12, 2008 |
5. Device Description
The IBIS Explorer and Markup Software is a picture archival and communications system (PACS) providing researchers, radiologists or health care professionals with the tools to accept, display, store, archive and manipulate digital medical images. The IBIS Explorer stores, archives and displays digital medical images, while the Markup Software allows for measurements of specified regions and report generation. Digital images supported by the software include but are not limited to bone scans, chest
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radiograph (x-ray), ultrasound, computed tomography (CT), and magnetic resonance imaqing (MRI).
The System is to be used by trained professionals who are responsible for the correct and accurate use of medical images and the subsequent diagnosis. In a typical clinical environment, the system would be used by a trained technician and radiologist.
The software is installed on an off-the-shelf PC computer system. It is intended to be used with uncompressed digital images that are saved in DICOM format.
6. Intended Use
IBIS Explorer and Markup Software is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
Besides general image interpretation and processing tools, IBIS provides specific tool sets for several clinical applications, including:
- . Oncology, including lesion marking and analysis
- Anatomic structure marking, volume measurement and analysis .
Only DICOM for presentation images can be used on an FDA approved monitor for mammography for image diagnosis.
Only uncompressed or non-lossy compressed images must be used for image diagnosis in mammography.
7. Comparison to Predicate Device
The IBIS Explorer and Markup Software is substantially equivalent to the predicate devices. The software has the same intended use and similar technological characteristics, which do not raise any new questions of safety or effectiveness.
8. Performance Data
Comprehensive design verification and validation (V&V) was performed to ensure that the IBIS Explorer and Markup Software meets its intended use, customer requirements and software requirements. The V&V testing included functional verification of all software requirements and comprehensive validation of user requirements. Testing also included verifying the accuracy of the measurements of the Markup Software aqainst the Visage PACS/CS predicate device. Testing was conducted using various DICOM image modalities from different scanners (GE, Toshiba, Philips and Siemens). All testing was conducted at MedQIA and, therefore, represents a typical user site. Traceability of the test cases to the requirements ensures that all requirements have been verified and validated. Testing confirmed that no anomalies affect the quality or clinical usability of the system.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or 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
MedQIA % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC l 394 25" Street NW BUFFALO MN 55313
AUG - 5 2011
Re: K111319
Trade/Device Name: IBIS Explorer and Markup System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 5, 2011 Received: July 6, 2011
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 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/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.
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): K
Device Name:
Indications for Use:
IBIS Explorer and Markup Software is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
Besides general image interpretation and processing tools, IBIS provides specific tool sets for several clinical applications, including:
- . Oncology, including lesion marking and analysis
- . Anatomic structure marking, volume measurement and analysis
Only DICOM for presentation images can be used on an FDA approved monitor for mammography for image diagnosis.
Only uncompressed or non-lossy compressed images must be used for image diagnosis in mammography.
Image /page/4/Picture/10 description: The image shows the text "Prescription Use (Part 21 CFR 801 Subpart D)". There is a line drawn through the text, indicating that it is not for prescription use. The text is in a simple, sans-serif font and is left-aligned. The image is a close-up of the text, with no other objects or elements present.
AND/OR
Over-The-CounterUse (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary Scott
e of In Vitro Diagnostic Device Evaluation and Safety
510(k) K111319
Page of
§ 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).