IntraSight

K190078 · Volcano Corporation · DSA · Feb 11, 2019 · Cardiovascular

Device Facts

• Record ID: K190078
• Device Name: IntraSight
• Applicant: Volcano Corporation
• Product Code: DSA · Cardiovascular
• Decision Date: Feb 11, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2900
• Device Class: Class 2

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. 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 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.

Device Story

IntraSight System provides intravascular imaging and pressure measurement during catheterization. Inputs: high-frequency sound waves from IVUS catheters; intraluminal pressure data from pressure guide wires; aortic pressure data from lab equipment. Operation: system analyzes transducer signals to generate 360° cross-sectional tomographic images; calculates pressure ratios (FFR/iFR). Used in cath labs by physicians/technicians. Output: real-time images and pressure metrics displayed on system monitor. Clinical utility: aids visualization of vessel lumen/wall structures, assessment of stenosis severity, and revascularization decision-making. Benefits: improved diagnostic accuracy and procedural guidance for coronary/peripheral interventions.

Clinical Evidence

Bench testing only. Evidence includes master safety (EMC/electrical), environmental testing, design verification, software verification and validation, packaging validation, simulated use/usability validation, and image validation.

Technological Characteristics

Ultrasonic pulsed echo imaging system. Interfaces with IVUS catheters and pressure wires via Patient Interface Module (PIM). Features: 45MHz rotational imaging, ChromaFlo flow assessment, FFR/iFR pressure modalities. Software platform: Endeavour App Engine. Connectivity: interfaces with standard cath lab equipment. Hardware: updated image signal processing hardware, bedside controller, and FM-PIM with fluid ingress protection.

Indications for Use

Indicated for patients undergoing diagnostic angiography or interventional procedures in coronary and peripheral vasculature. Used for qualitative/quantitative evaluation of vascular morphology, blood flow/perfusion assessment, and intravascular blood pressure measurement. iFR modality indicated for coronary anatomy to guide revascularization decisions using a 0.89 ischemic threshold cut-point.

Regulatory Classification

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.

Predicate Devices

• Volcano s5i/CORE and CORE Mobile Precision Guided Therapy Systems (K173860)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 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 intravasular 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.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) SUMMARY

| SPONSOR: | Volcano Corporation<br>3721 Valley Centre Drive, Suite 500<br>San Diego, CA 92130 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Kimberly Simon<br>Regulatory Affairs Specialist<br>Philips Volcano<br>3721 Valley Centre Drive, Suite 500<br>San Diego, CA 92130<br>Tel: [phone] |
| DATE PREPARED: | January 15, 2019 |
| DEVICE: | IntraSight |
| TRADE NAME: | IntraSight |
| COMMON NAME: | System, Imaging, Pulsed Echo, Ultrasonic |
| CLASSIFICATION: | 21 CFR Part 892.1560<br>IYO: Ultrasonic Pulsed Echo Imaging System<br>21 CFR Part 870.2900<br>DSA: Patient Transducer and Electrical Cable<br>21 CFR Part 870.1110<br>DSK: 870.1110 Blood Pressure Computer |
| PREDICATE DEVICE: | Volcano s5i/CORE and CORE Mobile Precision Guided<br>Therapy Systems (K173860) |
| DEVICE DESCRIPTION: | The IntraSight System provides qualitative and quantitative<br>evaluation of vascular morphology in the coronary arteries<br>and peripheral vasculature. It is also indicated as an<br>adjunct to conventional angiographic procedures to provide<br>an image of vessel lumen and wall structures. The<br>IntraSight System interfaces with Volcano Intravascular<br>Ultrasound (IVUS) Imaging Catheters and pressure wires.<br>When operating in the IVUS mode, the IVUS catheter uses<br>a transducer near the distal tip to emit and receive high<br>frequency sound waves. The system is then able to analyze<br>the signal that is received by the transducer to differentiate<br>between vessel structures and produce a 360° cross-<br>sectional, tomographic image. When operating in the<br>pressure 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.

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 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 ●