Intuitive's IRIS 1.0 Medical Image Processing Software
Earlier this year, Intuitive Surgical submitted an FDA 510(k) application for its medical imaging software.
"Device Description: The IRIS 1.0 System is a software only device that processes medical images and delivers segmented image studies (3D anatomical models) to clinicians. Diagnosis is not performed by the software; the end user (physician) is ultimately responsible for reviewing and interpreting the 3D anatomical models and the original CT study it is based on. The IRIS 1.0 System will deliver 3D renderings of patient anatomy to the Physician’s iOS device (iPad or iPhone). The physician will be able to view and manipulate the labeled MPRs (multiplanar reconstructions) and the 3D model on their iOS device. The physician also has the option of using the da Vinci® Surgical System TilePro input to display the 3D models in the High Resolution Stereo Viewer (HRSV) via a hardwire connection from the iOS device.The physician can view and order patient CT studies using the IRIS website or the IRIS iOS interface. The original image study will be anonymized and routed to Intuitive Surgical where image segmentation and quality assurance steps will be performed, before releasing the model to the Physician for review. The Physician can access the 3D Model using the IRIS App on an iOS device, where they will review it, compare it with the original image study, and approve or reject the model.
Another component of the IRIS 1.0 System is the networking and software infrastructure to route the image studies in and out of the hospital, manage ordering information, and manage data in accordance with HIPAA and Cybersecurity requirements. This infrastructure is composed of “Gateway” hardware and software and the cloud storage system used for storage and access of original and segmented image studies.
Intended Use/Indications for Use:The IRIS 1.0 System is intended as a medical imaging system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from CT imaging devices. It is also intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned multidimensional digital images. The IRIS 1.0 System is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.
Technological Characteristics: The IRIS 1.0 System is equivalent to the predicate device in terms of its indications for use, design, technology, and performance specifications.Modifications from the predicate include the difference in medical image acceptance (IRIS 1.0 only accepts CT images whereas the predicate uses CT and MR images), difference in mobile device compatibility (IRIS 1.0 is only compatible with iOS devices whereas the predicate can be used with iOS and Android devices) and a difference in alternative viewing platforms (IRIS 1.0 can be connected to the da Vinci Si and Xi surgical systems whereas the predicate can be used with a Virtual Reality headset). The subject device is the same as the predicate for a subset of modalities (CT, iOS devices). These modifications do not affect the substantial equivalence of the subject device as verification and validation testing have established there are no new issues of safety or effectiveness.
Performance Data: The IRIS 1.0 System was verified and validated according to a Moderate Level of Concern software device. The subject device met all required specifications and functioned as intended. Safety and performance of the IRIS 1.0 System has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing. Additionally, the software validation activities were performed in accordance with IEC 62304:2006/AC: 2015- Medical device software – Software life cycle processes, in addition to the FDA Guidance documents,“Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”, “Content of Premarket Submission for Management of Cybersecurity in Medical Devices”, and “Display Devices for Diagnostic Radiology; Guidance for Industry and Food and Drug Administration Staff.” In addition, compatibility with the TilePro display was also evaluated and the subject device met all requirements.
Summary: The IRIS 1.0 System raises no new questions of safety or effectiveness. Based on the intended use, technical characteristics, and performance data, the IRIS 1.0 System is equivalent to the predicate device in terms of safety, effectiveness, and performance."
Another component of the IRIS 1.0 System is the networking and software infrastructure to route the image studies in and out of the hospital, manage ordering information, and manage data in accordance with HIPAA and Cybersecurity requirements. This infrastructure is composed of “Gateway” hardware and software and the cloud storage system used for storage and access of original and segmented image studies.
Intended Use/Indications for Use:The IRIS 1.0 System is intended as a medical imaging system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from CT imaging devices. It is also intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned multidimensional digital images. The IRIS 1.0 System is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.
Technological Characteristics: The IRIS 1.0 System is equivalent to the predicate device in terms of its indications for use, design, technology, and performance specifications.Modifications from the predicate include the difference in medical image acceptance (IRIS 1.0 only accepts CT images whereas the predicate uses CT and MR images), difference in mobile device compatibility (IRIS 1.0 is only compatible with iOS devices whereas the predicate can be used with iOS and Android devices) and a difference in alternative viewing platforms (IRIS 1.0 can be connected to the da Vinci Si and Xi surgical systems whereas the predicate can be used with a Virtual Reality headset). The subject device is the same as the predicate for a subset of modalities (CT, iOS devices). These modifications do not affect the substantial equivalence of the subject device as verification and validation testing have established there are no new issues of safety or effectiveness.
Performance Data: The IRIS 1.0 System was verified and validated according to a Moderate Level of Concern software device. The subject device met all required specifications and functioned as intended. Safety and performance of the IRIS 1.0 System has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing. Additionally, the software validation activities were performed in accordance with IEC 62304:2006/AC: 2015- Medical device software – Software life cycle processes, in addition to the FDA Guidance documents,“Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”, “Content of Premarket Submission for Management of Cybersecurity in Medical Devices”, and “Display Devices for Diagnostic Radiology; Guidance for Industry and Food and Drug Administration Staff.” In addition, compatibility with the TilePro display was also evaluated and the subject device met all requirements.
Summary: The IRIS 1.0 System raises no new questions of safety or effectiveness. Based on the intended use, technical characteristics, and performance data, the IRIS 1.0 System is equivalent to the predicate device in terms of safety, effectiveness, and performance."
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