The IntraSight System is used for the qualitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.

ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.

The pressure feature is intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.

Rotational 45MHz feature is intended for the qualitative evaluation of vascular morphology in the coronary arteries and vasculature. As an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. The pullback feature of the Spinvision (PIMr) withdraws the imaging core within the protective sheath for a maximum of 15 cm.

The FFR Modality is indicated in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.

The iFR Modality is intended to be used in conjunction with currently marketed Volcano pressure wires. In the coronary anatomy, the iFR modality has a diagnostic cut-point of 0.89 which represents an ischemic threshold and can reliably guide revascularization decisions during diagnostic catheterization procedure. When used as for a pullback assessment, the iFR modality is intended as a visual aid in decision making the relative location and severity of the stenoses such as, multiple lesions or diffuse disease.

Device Description

The IntraSight System provides qualitative and quantitative evaluation of vascular morphology in the coronary arteries and peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. The IntraSight System interfaces with Volcano Intravascular Ultrasound (IVUS) Imaging Catheters and pressure wires. When operating in the IVUS mode, the IVUS catheter uses a transducer near the distal tip to emit and receive high frequency sound waves. The system is then able to analyze the signal that is received by the transducer to differentiate between vessel structures and produce a 360° cross-sectional, tomographic image. When operating in the pressure mode, the system acquires intraluminal data from a pressure guide wire while simultaneously taking aortic pressure data from the established catheterization lab equipment. Catheters and guide wires are connected to the system via the Patient Interface Module (PIM).

AI/ML Overview

The provided text is a 510(k) summary for the Volcano IntraSight System, which is an imaging and pressure measurement system used in coronary and peripheral vasculature. The document clarifies that the IntraSight System is a modification of an already marketed device (Volcano s5i/CORE and CORE Mobile Precision Guided Therapy Systems, K173860). The focus of the 510(k) summary is to demonstrate substantial equivalence to the predicate device due to these modifications, not to establish the initial performance of a novel device.

Therefore, the summary primarily describes verification and validation activities conducted to ensure the modified device meets its specifications and remains substantially equivalent to the predicate, rather than presenting a standalone study with specific acceptance criteria and performance metrics for an AI/algorithm-driven device in the way a new diagnostic or prognostic AI algorithm would be evaluated.

Based on the provided information, I can answer some of your questions, but many cannot be answered because the document does not contain the details of a comparative effectiveness study or a standalone algorithm performance study with specific clinical acceptance criteria and results. It primarily mentions engineering and software verification activities.

Here's an attempt to answer based on the given text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria for clinical performance or reported device performance in the context of an AI/algorithm-driven diagnostic or prognostic task. The "Performance Data" section lists types of engineering and software verification tests performed (e.g., EMC, Electrical Safety, Environmental, Design Verification, Software Verification and Validation, Packaging Validation, Simulated Use/Usability Validation, Image Validation). These are not clinical acceptance criteria with specific performance metrics (like sensitivity, specificity, or AUC) as you would find for an AI study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document lists "Image Validation" as a type of performance data, but it does not specify the sample size, data provenance, or whether it was a test set for an algorithm. Given the nature of a 510(k) for modifications to an existing device, "Image Validation" likely refers to ensuring image quality equivalence or non-inferiority compared to the predicate, rather than a clinical study of an AI algorithm on a specific test set.

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 provided. There is no mention of a test set with ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

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 is not mentioned in the provided text. The document describes modifications to an existing imaging system (IntraSight System) and seeks substantial equivalence, not the clinical effect of an AI component on human performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone algorithm performance study is not mentioned. The IntraSight System itself is a device that includes hardware and software for imaging and pressure measurement, intended for use by clinicians, not a standalone AI algorithm being evaluated for accuracy independent of human interaction.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not provided. There is no mention of ground truth in the context of an AI algorithm evaluation.

8. The sample size for the training set

This information is not provided. The document does not describe the development or training of an AI algorithm in the context you are asking about. The "Software Verification and Validation" mentioned refers to the standard software development lifecycle for the device's operating system and features.

9. How the ground truth for the training set was established

This information is not provided.

In summary: The provided 510(k) summary is for a device system (IntraSight System) that underwent modifications, including updated hardware and software platforms. The "Performance Data" listed primarily pertains to engineering and software verification and validation activities to ensure the modified device remains substantially equivalent to its predicate. It does not present a clinical study evaluating the performance of an AI-driven diagnostic or prognostic algorithm with specific acceptance criteria, test sets, ground truth establishment, or human reader studies. Therefore, most of your questions, which are tailored to the evaluation of an AI algorithm's clinical performance, cannot be answered from this document.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 11, 2019

Volcano Corporation Kimberly Simon Regulatory Affairs Specialist 3721 Valley Centre Drive. Suite 500 San Diego, California 92130

Re: K190078

Trade/Device Name: IntraSight System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO, DSA, DSK Dated: January 15, 2019 Received: January 16, 2019

Dear Kimberly Simon:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 mediation-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).

Sincerelv.

Munk Jellman
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190078

Device Name

IntraSight System

Indications for Use (Describe)

The FFR Modality is indicated in all blood vessels, including coronary and peripheral arteries, to measure intravasular blood pressure during diagnostic angiography and/or interventional procedures.

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)

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510(k) SUMMARY

SPONSOR:	Volcano Corporation3721 Valley Centre Drive, Suite 500San Diego, CA 92130
CONTACT/SUBMITTER:	Kimberly SimonRegulatory Affairs SpecialistPhilips Volcano3721 Valley Centre Drive, Suite 500San Diego, CA 92130Tel: (858) 720-4113
DATE PREPARED:	January 15, 2019
DEVICE:	IntraSight
TRADE NAME:	IntraSight
COMMON NAME:	System, Imaging, Pulsed Echo, Ultrasonic
CLASSIFICATION:	21 CFR Part 892.1560IYO: Ultrasonic Pulsed Echo Imaging System21 CFR Part 870.2900DSA: Patient Transducer and Electrical Cable21 CFR Part 870.1110DSK: 870.1110 Blood Pressure Computer
PREDICATE DEVICE:	Volcano s5i/CORE and CORE Mobile Precision GuidedTherapy Systems (K173860)
DEVICE DESCRIPTION:	The IntraSight System provides qualitative and quantitativeevaluation of vascular morphology in the coronary arteriesand peripheral vasculature. It is also indicated as anadjunct to conventional angiographic procedures to providean image of vessel lumen and wall structures. TheIntraSight System interfaces with Volcano IntravascularUltrasound (IVUS) Imaging Catheters and pressure wires.When operating in the IVUS mode, the IVUS catheter usesa transducer near the distal tip to emit and receive highfrequency sound waves. The system is then able to analyzethe signal that is received by the transducer to differentiatebetween vessel structures and produce a 360° cross-sectional, tomographic image. When operating in thepressure mode, the system acquires intraluminal data from

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a pressure guide wire while simultaneously taking aortic pressure data from the established catheterization lab equipment. Catheters and guide wires are connected to the system via the Patient Interface Module (PIM).

INTENDED USE:

The IntraSight system is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.

The pressure feature is intended for use in all blood vessels. including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.

Rotational 45MHz feature is intended for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vasculature. As an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. The pullback feature of the Spinvision (PIMr) withdraws the imaging core within the protective sheath for a maximum of 15 cm.

The FFR Modality is indicated in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.

The iFR Modality is intended to be used in conjunction with currently marketed Volcano pressure wires. In the coronary anatomy, the iFR modality has a diagnostic cutpoint of 0.89 which represents an ischemic threshold and can reliably guide revascularization decisions during diagnostic catheterization procedure. When used as for a pullback assessment, the iFR modality is intended as a visual aid in decision making by indicating the relative location and severity of the stenoses such as, multiple lesions or diffuse disease.

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COMPARISON OF CHARACTERISTICS:

The IntraSight System is a modification to the currently marketed CORE Integrated System. The IntraSight System is a modification to the currently marketed CORE System cleared of K173860. The modifications to the CORE System include:

Reduced functional capability removal of the VH ● IVUS modality
New image signal processing hardware and . software, as the current image signal processing hardware is going end-of-life
Updated software platform (Endeavour App . Engine) to provide an improved User Interface
. Updated secondary user interface (bedside controller) to provide an improved ease of use
. Update to the FM-PIM in order to provide an adaptor for compatibility to the Verrata pressure wires, changes to PIM firmware, and fluid ingress protection

None of these modifications effect or alter the fundamental scientific technologies of the currently marketed device.

PERFORMANCE DATA:

Performance testing completed for a determination of substantial equivalence included the following:

Master Safety Testing (EMC and Electrical Safety) ●
Environmental Testing
Design Verification
Software Verification and Validation ●
Packaging Validation
Simulated Use / Usability Validation
Image Validation ●

Regulation Number and Section

§ 870.2900 Patient transducer and electrode cable (including connector).

(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).