(29 days)
ImageQube is intended for use by a physician or other medical professionals in the display and interpretation of medical images and demographic detail from all institutional imaging modalities, including, but not limited to, CT, MRI, NM, DR, US, PET Fusion, Angio and MG (including display of DICOM overlays and 3D Mammography images), along with secondary capture devices, such as film digitizers or other imaging sources. The ImageQube is designed for display, interpretation, storage and distribution of all modalities.
Only pre-processed DICOM For Presentation images can be interpreted for primary diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be viewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor meeting all the technical specifications required by the FDA for the Performance of Screening and Diagnostic Mammography. Images that are printed to film must be done using an FDA-approved printer for the diagnosis of digital mammography images. Efficient mammography screening makes toolbars and thumbnails available on each monitor, while also handling DICOM overlay display.
Acquired medical images may be displayed and manipulated further utilizing Multi-Planar Reconstruction (MPR), Anatomic Triangulation (AT), Dynamic Cross-Referencing, Maximum Intensity Projection (MIP), Slab and 3-D display, sent to and retrieved by radiologists in-house at facilities or at remote sites, stored, archived or printed. The ImageQube can operate as an independent device, or can also be interfaced with Rational Imaging PACS systems. Annotated print pages, transcribed reports and Key Image Summaries can also be accessed.
ImageQube is designed for use by a physician or other medical professionals in the acquisition of medical images and demographic detail from all institutional imaging modalities, including, but not limited to CT, MRI, NM, DR, US, PET Fusion, Angio and MG (including display of DICOM overlay and 3D Mammography images), along with secondary capture devices, such as film digitizers or other imaging sources. The acquired medical images and demographic information may be displayed, processed, reviewed, sent to and retrieved by radiologists at remote sites, stored, archived or printed. Multiplanar Reconstruction (MPR), Anatomic Triangulation (AT), Dynamic Cross-Referencing, Maximum Intensity Projection (MIP), Slab and 3D display are also available for optional use.
The provided text describes a 510(k) summary for the ImageQube device, which is an imaging processing system. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets those criteria.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, study design, expert qualifications, ground truth, and sample sizes for effectiveness studies are not available in the provided text.
Based on the information provided, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results. Instead, it states:
"Support of the substantial equivalence of the ImageQube device was provided as a result of software validation, which confirms all features of the ImageQube device were compliant with the software requirements."
This suggests that the acceptance criteria were primarily related to software functionality and compliance with requirements, rather than clinical performance metrics like sensitivity or specificity.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided text. The document refers to "software validation" but does not detail the test set size, its nature (e.g., medical images, synthetic data), or its provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available in the provided text. Since the validation mentioned is "software validation," it's unlikely that medical experts were involved in establishing ground truth in the traditional sense of clinical studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done, or at least not described in this document. The focus is on the device's functionality as a standalone imaging processing system, not on its impact on human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation was implicitly done through "software validation," which "confirms all features of the ImageQube device were compliant with the software requirements." This suggests testing the algorithm/software functionality independently of human interaction. However, no specific performance metrics (e.g., accuracy, speed) are provided, only a statement of compliance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The type of ground truth used is not explicitly stated. Given the focus on "software validation" and "compliance with software requirements," the ground truth likely involved predefined software specifications, expected output, or correct functionality, rather than clinical ground truth like pathology reports or expert consensus on medical findings.
8. The sample size for the training set
This information is not available in the provided text. The document describes a "software validation" which implies testing of developed software, but it doesn't mention a training set, which is typically associated with machine learning or AI models. Since the device is an "imaging processing system" and not specifically described as an AI/ML diagnostic tool, a training set as understood in AI development might not be applicable or simply not disclosed.
9. How the ground truth for the training set was established
This information is not available in the provided text, as a training set is not mentioned.
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Section 6
510(k) Summary
6. 510(k) Summary
This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT: | Intuitive Imaging Informatics, LLC |
|---|---|
| DATE PREPARED: | 17 July 2012 |
| CONTACT PERSON: | Cindy SimoniIntuitive Imaging Informatics, LLC30 Hackamore Lane, STE 6Bell Canyon, CA 91307Phone: 818.347.8909, x110Fax: 888.908.6242 |
| TRADE NAME: | ImageQube |
| CLASSIFICATION NAME: | System, Imaging Processing |
| DEVICE CLASSIFICATION: | Class II |
| REGULATION NUMBER | 892.2050 |
| PRODUCT CODE | LLZ |
| PREDICATE DEVICES: | ImageQube (K051037)Amicas PACS 6.0 (K082144)Candelis ImageGrid (K080333)Synapse Obliquus MIP/MPR/Fusion (K100881) |
Substantially Equivalent To:
The ImageQube is substantially equivalent in intended use, principal of operation and technological characteristics to the current marketed ImageQube, Amicas PACS 6.0, Candelis ImageGrid and Synapse Obliquus MIP/MPR Fusion devices.
Description of the Device Subject to Premarket Notification:
ImageQube is designed for use by a physician or other medical professionals in the acquisition of medical images and demographic detail from all institutional imaging modalities, including, but not limited to CT, MRI, NM, DR, US, PET Fusion, Angio and MG (including display of DICOM overlay and 3D Mammography images), along with secondary capture devices, such as film digitizers or other imaging sources. The acquired medical images and demographic information may be displayed, processed, reviewed, sent to and retrieved by radiologists at remote sites, stored, archived or printed. Multiplanar Reconstruction (MPR), Anatomic Triangulation (AT), Dynamic Cross-
Intuitive Imaging Informatics, Inc. Modified ImageQube
Page 11 of 65 Premarket Notification
JAN 2 9 2013
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Referencing, Maximum Intensity Projection (MIP), Slab and 3D display are also available for optional use.
Indication for Use:
ImageQube is intended for use by a physician or other medical professionals in the display and interpretation of medical images and demographic detail from all institutional imaging modalities, including, but not limited to, CT, MRI, NM, DR, US, PET Fusion, Angio and MG (including display of DICOM overlay and 3D Mammography images), along with secondary capture devices, such as film digitizers or other imaging sources. The ImageQube is designed for display, interpretation, storage and distribution of all modalities.
Only pre-processed DICOM For Presentation images can be interpreted for primary diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be viewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor meeting all the technical specifications required by the FDA for the Performance of Screening and Diagnostic Mammography. Images that are printed to film must be done using an FDAapproved printer for the diagnosis of digital mammography images. Efficient mammography screening makes toolbars and thumbnails available on each monitor, while also handling DICOM overlay display.
Acquired medical images may be displayed and manipulated further utilizing Multi-Planar Reconstruction (MPR), Anatomic Triangulation (AT), Dynamic Cross-Referencing, Maximum Intensity Projection (MIP), Slab and 3-D display, sent to and retrieved by radiologists in-house at facilities or at remote sites, stored, archived or printed. The ImageQube can operate as an independent device, or can also be interfaced with Rational Imaging PACS systems. Annotated print pages, transcribed reports and Key Image Summaries can also be accessed.
Technological Characteristics:
The ImageQube has the same technological characteristics and is similar in overall. design, principal of operation and configuration compared to the predicates. The table below illustrates the similarities and differences in Technological Characteristics between the devices.
| Modified ImageQube | ImageQube(K051037) | Amicas PACS 6.0(K082144) | Candelis ImageGrid(K080333) | Synapse ObliquusMIP/MPR/Fusion(K100881) | |
|---|---|---|---|---|---|
| Use | |||||
| Storing,distributing,displaying, | Yes | Yes | Yes | Yes | Yes |
Intuitive Imaging Informatics, Inc. Modified ImageQube
Page 12 of 65 Premarket Notification
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Section 6
510(k) Summary
| ModifiedImageQube | ImageQube(K051037) | Amicas PACS6.0(K082144) | CandelisImageGrid(K080333) | SynapseObliquusMIP/MPR/Fusion(K100881) | |
|---|---|---|---|---|---|
| analyzing,manipulatingand enhancingof images | |||||
| Standards | |||||
| DICOM (dataexchange) | Yes | Yes | Yes | Yes | Yes |
| JPEG (imagecompression) | Yes | Yes | Yes | Yes | Yes |
| Features | |||||
| MaximumIntensityProjection(MIP) | Yes | No | Yes | Yes | Yes |
| MultiplanarResolution(MPR) | Yes | No | Yes | Yes | Yes |
| DICOMOverlay | Yes | No | Yes | Yes | No |
| PET/CT Fusion | Yes | No | No | Yes | Yes |
| Slab | Yes | No | Yes | Unknown | Unknown |
| Critical Results | Yes | No | Yes | Unknown | Yes |
| Mammography | Yes | No | Yes | Yes | No |
| Peer Review | Yes | No | Unknown | Unknown | Yes |
Performance
Support of the substantial equivalence of the ImageQube device was provided as a result of software validation, which confirms all features of the ImageQube device were compliant with the software requirements.
Basis for Determination of Substantial Equivalence:
Upon reviewing and comparing intended use, design, principle of operation and overall technological characteristics, the ImageQube is determined by Intuitive Imaging Informatics, LLC to be substantially equivalent to existing legally marketed devices.
Intuitive Imaging Informatics, Inc. Modified ImageQube
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services-USA. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and the USA. The department's name is written in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
January 29, 2013
Intuitive Imaging Informatics, LLC c/o Mr. Jeff D Rongero Senior Project Manager 12 Laboratory Drive RESEARCH TRIANGLE PARK NC 27709 .
Re: K124048
.
Trade/Device Name: ImageQube Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 21, 2012 Received: December 31, 2012
Dear Mr. Rongero:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2-Mr. Rongero
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sean M. Boyd -S for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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5. Indications for Use Statement
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ImageQube
Indications for Use:
ImageQube is intended for use by a physician or other medical professionals in the display and interpretation of medical images and demographic detail from all institutional imaging modalities, including, but not limited to, CT, MRI, NM, DR, US, PET Fusion, Angio and MG (including display of DICOM overlays and 3D Mammography images), along with secondary capture devices, such as film digitizers or other imaging sources. The ImageQube is designed for display, interpretation, storage and distribution of all modalities.
Only pre-processed DICOM For Presentation images can be interpreted for primary diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be viewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor meeting all the technical specifications required by the FDA for the Performance of Screening and Diagnostic Mammography. Images that are printed to film must be done using an FDA-approved printer for the diagnosis of digital mammography images. Efficient mammography screening makes toolbars and thumbnails available on each monitor, while also handling DICOM overlay display.
Acquired medical images may be displayed and manipulated further utilizing Multi-Planar Reconstruction (MPR), Anatomic Triangulation (AT), Dynamic Cross-Referencing, Maximum Intensity Projection (MIP), Slab and 3-D display, sent to and retrieved by radiologists in-house at facilities or at remote sites, stored, archived or printed. The ImageQube can operate as an independent device, or can also be interfaced with Rational Imaging PACS systems. Annotated print pages, transcribed reports and Key Image Summaries can also be accessed.
AND/OR
Prescription Use X_ (21 CFR 801 Subpart D) Over-The-Counter Use (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 and Radiological Health (OIR)
Division Sign-off
Office of In Vitro Diagnostic Device Evaluation and Safety 510k ¥124048
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).