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.

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.

AI/ML Overview

This document (K182643) describes the FDA 510(k) clearance for the IRIS 1.0 System, a medical image processing software. No specific acceptance criteria or a detailed study proving the device meets those criteria are provided in the provided text, beyond general statements about "verification and validation."

The text states:

"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."

This indicates that internal testing was conducted to ensure the device met its specifications and functioned as intended, but the specific acceptance criteria (e.g., target accuracy, precision, recall for specific tasks) and the study results demonstrating meeting these criteria are not detailed.

Therefore, many of the requested details cannot be extracted directly from the provided text. However, based on the information provided, here's what can be inferred or explicitly stated:

Acceptance Criteria and Reported Device Performance

No explicit quantitative acceptance criteria or corresponding reported device performance metrics are provided in the document. The document generally states that the device "met all required specifications and functioned as intended." This implies that the internal acceptance criteria were met, but the specific metrics are not disclosed.

Acceptance Criteria (Example)	Reported Device Performance
Not specified in document	Not specified in document

Study Details

Given the statement "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," it can be inferred that some form of internal verification and validation study was conducted. However, granular details are largely absent.

1. Sample sized used for the test set and the data provenance:
* Test Set Sample Size: Not specified.
* Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text mentions "The original image study will be anonymized and routed to Intuitive Surgical where image segmentation and quality assurance steps will be performed," which implies a process where real-world data might be used, but the specifics of the test set are not provided.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Number of Experts: Not specified.
* Qualifications of Experts: Not specified. The document states a "physician... is ultimately responsible for reviewing and interpreting the 3D anatomical models and the original CT study it is based on," and that the physician "will review it, compare it with the original image study, and approve or reject the model." This suggests that physicians are involved in a quality assurance or review process, which might be related to ground truth establishment, but it's not explicitly confirmed for a formal test set ground truth.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Adjudication Method: Not specified.

4. 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:
* MRMC Study: Not mentioned in the provided text. The device is intended to "assist the clinician," but no study on the impact of this assistance on human reader performance (e.g., improved diagnostic accuracy, reduced reading time) is described.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Standalone Performance: The document states, "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." This strongly suggests the device is not intended for standalone diagnostic performance. While the software performs "segmentation and quality assurance steps," the specific standalone performance metrics for these functions are not provided, nor is a formal standalone study described.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Type of Ground Truth: Not explicitly stated. The process mentions that physicians "review it [the 3D model], compare it with the original image study, and approve or reject the model," implying that the original CT image and subsequent physician verification serve as a form of ground truth for the 3D anatomical models. However, the exact methodology for establishing ground truth for testing purposes is not detailed.

7. The sample size for the training set:
* Training Set Sample Size: Not specified. The document only mentions that "The original image study will be anonymized and routed to Intuitive Surgical where image segmentation and quality assurance steps will be performed," which describes the operational flow, not necessarily the training data for the AI.

8. How the ground truth for the training set was established:
* Training Set Ground Truth Establishment: Not specified.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is blue.

Intuitive Surgical, Inc. % Ms. Crystal Ong Sr. Regulatory Engineer 1266 Kifer Road SUNNYVALE CA 94086 February 22, 2019

Re: K182643

Trade/Device Name: IRIS 1.0 System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: January 18, 2019 Received: January 22, 2019

Dear Ms. Ong:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for

{1}------------------------------------------------

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below.
-------------------------------------------------------------------------	---------------------------------------------------------------------------------------------

Indications for Use

510(k) Number (if known)	K182643
Device Name	IRIS 1.0 System

Indications for Use (Describe)

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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDEDCONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

[As Required by 21 CFR 807.92(c)]

K182643

September 21, 2018

Submitter:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Official Contact:	Crystal OngSr. Regulatory EngineerPh: 408-523-8636Fax: 408-523-8907
Trade Name:	IRIS 1.0 System
Common Name:	Medical Image Processing Software
Classification:	Picture archiving and communications system (21 CFR 892.2050), LLZ
Predicate Device:	Ceevra Reveal 2.0 (K173274)

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.

{4}------------------------------------------------

Intended Use/Indications for Use:

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.

{5}------------------------------------------------

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.

Regulation Number and Section

§ 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).