FFR V2.5

K170133 · Philips Volcano · IYO · May 26, 2017 · Radiology

Device Facts

• Record ID: K170133
• Device Name: FFR V2.5
• Applicant: Philips Volcano
• Product Code: IYO · Radiology
• Decision Date: May 26, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

FFR v2.5 Modality of the s5/s5i/CORE and CORE Mobile Precision Guided Therapy System is indicated in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure angiography and/or interventional procedures. The iFR® Modality is intended to be used in conjunction with currently marketed Volcano pressure wires.

Device Story

FFR v2.5 software operates on Volcano s5/s5i/CORE and CORE Mobile systems; processes pressure signals from intravascular pressure guide wires. Measures Fractional Flow Reserve (FFR) during hyperemia (adenosine-induced) and Instant Wave-Free Ratio (iFR) during cardiac wave cycle periods of naturally minimized resistance. Provides real-time pressure data and visualization of patient anatomy. Used by clinicians in interventional suites; supports clinical decision-making regarding vessel stenosis significance. Modifications include ECG-less cardiac cycle detection and network broadcast of measurement data to third-party systems. Benefits include assessment of lesion severity without hyperemic agents (iFR) and improved workflow via ECG-independent processing.

Clinical Evidence

No clinical data provided. Substantial equivalence established via non-clinical performance testing, software verification, and validation against system-level requirements and risk controls.

Technological Characteristics

Software-based pressure measurement system; operates on Volcano s5/s5i/CORE platforms. Features ECG-less cardiac cycle detection algorithm and network data broadcast capability. Complies with IEC 62304 (Software life cycle processes).

Indications for Use

Indicated for patients undergoing diagnostic angiography or interventional procedures in coronary and peripheral arteries requiring intravascular blood pressure measurement.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• iFR Scout (FFR v2.4) (K150441)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 26, 2017

Philips Volcano Elaine Alan Regulatory Affairs Specialist 3721 Vallev Ctr. Dr. San Diego, California 92130

Re: K170133

Trade/Device Name: FFR v2.5 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO Dated: April 21, 2017 Received: April 24, 2017

Dear Elaine Alan:

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 of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

M.A. Hilleman

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) K170133

Device Name

FFR v2.5

Indications for Use (Describe)

FFR v2.5 Modality of the s5/s5i/CORE and CORE Mobile Precision Guided Therapy System is indicated in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure angiography and/or interventional procedures.

The iFR® Modality is intended to be used in conjunction with currently marketed Volcano pressure wires.

Type of Use (Select one or both, as applicable)

| <span style="font-size:12px">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|------------------------------------------------------------------------------------|
| <span style="font-size:12px">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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## 510(k) Summary

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.

| Date Prepared: | January 16, 2017 | |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Manufacturer: | Volcano Corporation<br>2870 Kilgore Road<br>Rancho Cordova, CA 95670<br>Establishment Registration Number: 2939520 | |
| Primary Contact<br>Person: | Elaine Alan<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>E-mail: [e-mail] | |
| Device: | Trade Name: | FFR v2.5 |
| | Classification Name: | Ultrasonic Pulsed Echo Imaging System |
| | Classification Regulation: | 21 CFR, Part 892.1560 |
| | Classification Panel: | Radiology |
| | Device Class: | Class II |
| | Product Code: | Product Code: IYO |
| Predicate Device: | Trade Name: | iFR Scout (FFR v2.4) |
| | Manufacturer: | Volcano Corporation |
| | 510(k) Clearance: | K150441 (March 20, 2015) |
| | Classification Name: | Ultrasonic Pulsed Echo Imaging System |
| | Classification Regulation: | 21 CFR, Part 892.1560 |
| | Classification Panel: | Radiology |
| | Device Class: | Class II |
| | Product Code: | Product Code: IYO |
| Device description: | The FFR v2.5 software is used to obtain pressure measurements and is installed<br>on the Volcano s5/CORE Systems. These systems are a multi-modality<br>platform that provides Intravascular Ultrasound (IVUS) Imaging, Fractional<br>Flow Reserve (FFR) pressure measurements, and Instant Wave-Free Ratio (iFR)<br>pressure measurements. Pressure measurements are obtained through the use of<br>pressure guide wires. Real-time image visualization of patient anatomy during<br>procedures. | |
| | FFR pressure measurements are obtained during fluoroscopic procedures after<br>the administration of a hyperemic agent such as adenosine. iFR pressure<br>measurements do not require the use of a hyperemic agent. The FFR Modality<br>is calculated based on the entire cardiac wave cycle, whereas the iFR® Modality<br>is calculated by isolation of the cardiac wave cycle where intracoronary<br>resistance is naturally constant and minimized and where intracoronary flow is<br>maximized. This results in the ability to measure pressure without<br>administration of a hyperemic agent with the iFR® Modality whereas the FFR<br>Modality pressure reading is calculated after administration of a hyperemic<br>agent. | |
| | Modifications to the software include the ability to take FFR and iFR<br>measurements without relying on ECG and allowing for broadcast FFR and iFR<br>measurement data to a third party system over a network. | |
| Indications for Use: | FFR v2.5 Modality of the s5/s5i/CORE and CORE Mobile Precision Guided<br>Therapy System is indicated in all blood vessels, including coronary and<br>peripheral arteries, to measure intravascular blood pressure during diagnostic<br>angiography and/or interventional procedures. | |
| | The iFR® Modality is intended to be used in conjunction with currently marketed<br>Volcano pressure wires | |
| | Based on the information provided above, the FFR v2.5 software is considered<br>substantially equivalent to the currently marketed and predicate device, the iFR<br>Scout (FFR v2.4 software) in terms of Indications for Use. | |
| Technological<br>characteristics: | The FFR v2.5 software has the same technological characteristics compared to<br>the predicate device. Modifications implemented in the FFR v2.5 software<br>include:<br>● ECG-less Cardiac Cycle Detection<br>● FM Broadcast | |
| | The differences between the FFR v2.5 software and the predicate device do not<br>raise any new questions regarding safety or effectiveness. Based on the<br>information provided in this 510(k) submission, the FFR 2.5 software is<br>considered substantially equivalent to the currently marketed predicate iFR<br>Scout (FFR v2.4) in terms of fundamental scientific technology. | |
| Summary of Non-Clinical Performance<br>Data: | Non-clinical performance testing has been performed on the FFR v2.5 software<br>and demonstrates compliance with the following International and FDA-<br>recognized consensus standards and FDA guidance documents: | |
| | ● IEC 62304 Medical device software – Software life cycle processes<br>(Edition 1.0, 2006). FDA/CDRH recognition number 13-32. | |
| | Software verification testing has been performed to cover system level<br>requirements as well as risk control measures. Results demonstrated that all<br>executed tests were passed. | |
| | Non-clinical validation testing has been performed to cover the intended use,<br>commercial claims, service, user needs, effectiveness of safety measures and<br>instructions for use. | |
| | Therefore, the FFR v2.5 software is substantially equivalent to the currently<br>marketed iFR Scout (FFR v2.4) in terms of safety and effectiveness. | |
| Summary of Clinical<br>Performance Data: | The FFR v2.5 software did not require clinical data since substantial<br>equivalence to the currently marketed predicate device was demonstrated with<br>the following attributes: | |
| | Indication for use; Technological characteristics; Non-clinical performance testing; and Safety and effectiveness. | |
| | These attributes demonstrated that the clinical performance of the modified<br>device is substantially equivalent to the predicate device. | |
| Substantial<br>Equivalence<br>Conclusion: | The FFR v2.5 software is substantially equivalent to the currently marketed<br>predicate device, the iFR Scout (FFR 2.4) in terms of indications for use,<br>technological characteristics and safety and effectiveness. | |
| | The modification to the FFR v2.5 software is within the controls and<br>predetermined specifications. Additionally, non-clinical performance tests<br>provided in this 510(k) premarket notification demonstrated substantial<br>equivalence to the predicate device and ensured that the modification is properly<br>introduced; verification and validation testing was conducted to ensure the<br>proper introduction of the modifications; conformance to IEC standards and<br>guidance documents were provided. The tests performed support substantial<br>equivalence of the modified device and demonstrate that the FFR v2.5 software<br>is as safe and effective as its predicate device without raising any new safety<br>and/or effectiveness concerns. | |

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