(129 days)
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No
The document describes software modifications for pressure measurements (FFR and iFR) and data broadcasting. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The focus is on calculation methods based on cardiac wave cycles and pressure measurements.
No.
The device is indicated to measure intravascular blood pressure and provides imaging, but it does not directly treat or cure a disease or condition. It is a diagnostic and measurement tool for "Precision Guided Therapy Systems."
Yes
The device is designed to measure intravascular blood pressure, specifically Fractional Flow Reserve (FFR) and Instant Wave-Free Ratio (iFR), which are parameters used by clinicians to assess and diagnose the severity of coronary and peripheral artery disease. The software obtains pressure measurements used for diagnostic purposes.
No
The device is described as software installed on a multi-modality platform (Volcano s5/CORE Systems) that includes hardware components for IVUS imaging and pressure measurements obtained through pressure guide wires. The software processes data from these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device, the FFR v2.5 Modality of the s5/s5i/CORE and CORE Mobile Precision Guided Therapy System, measures intravascular blood pressure directly within blood vessels during procedures. This is an in vivo measurement (within the living body), not an in vitro measurement (outside the living body).
- Intended Use: The intended use clearly states it's for measuring intravascular blood pressure during angiography and/or interventional procedures. This is a procedure performed directly on the patient.
- Device Description: The description details the use of pressure guide wires inserted into blood vessels to obtain measurements. This further confirms the in vivo nature of the device.
Therefore, while this device is a medical device used for diagnostic purposes (providing information about blood pressure within vessels), it does not meet the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
IYO
Device Description
The FFR v2.5 software is used to obtain pressure measurements and is installed on the Volcano s5/CORE Systems. These systems are a multi-modality platform that provides Intravascular Ultrasound (IVUS) Imaging, Fractional Flow Reserve (FFR) pressure measurements, and Instant Wave-Free Ratio (iFR) pressure measurements. Pressure measurements are obtained through the use of pressure guide wires. Real-time image visualization of patient anatomy during procedures.
FFR pressure measurements are obtained during fluoroscopic procedures after the administration of a hyperemic agent such as adenosine. iFR pressure measurements do not require the use of a hyperemic agent. The FFR Modality is calculated based on the entire cardiac wave cycle, whereas the iFR® Modality is calculated by isolation of the cardiac wave cycle where intracoronary resistance is naturally constant and minimized and where intracoronary flow is maximized. This results in the ability to measure pressure without administration of a hyperemic agent with the iFR® Modality whereas the FFR Modality pressure reading is calculated after administration of a hyperemic agent.
Modifications to the software include the ability to take FFR and iFR measurements without relying on ECG and allowing for broadcast FFR and iFR measurement data to a third party system over a network.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
all blood vessels, including coronary and peripheral arteries
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing has been performed on the FFR v2.5 software and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance documents:
● IEC 62304 Medical device software – Software life cycle processes (Edition 1.0, 2006). FDA/CDRH recognition number 13-32.
Software verification testing has been performed to cover system level requirements as well as risk control measures. Results demonstrated that all executed tests were passed.
Non-clinical validation testing has been performed to cover the intended use, commercial claims, service, user needs, effectiveness of safety measures and instructions for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
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.(b)
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.
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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 | |
| 2870 Kilgore Road | ||
| Rancho Cordova, CA 95670 | ||
| Establishment Registration Number: 2939520 | ||
| Primary Contact | ||
| Person: | Elaine Alan | |
| Regulatory Affairs Specialist | ||
| Phone: (858) 764-1281 | ||
| E-mail: elain.alan@philips.com | ||
| 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 | |
| on the Volcano s5/CORE Systems. These systems are a multi-modality | ||
| platform that provides Intravascular Ultrasound (IVUS) Imaging, Fractional | ||
| Flow Reserve (FFR) pressure measurements, and Instant Wave-Free Ratio (iFR) | ||
| pressure measurements. Pressure measurements are obtained through the use of | ||
| pressure guide wires. Real-time image visualization of patient anatomy during | ||
| procedures. | ||
| FFR pressure measurements are obtained during fluoroscopic procedures after | ||
| the administration of a hyperemic agent such as adenosine. iFR pressure | ||
| measurements do not require the use of a hyperemic agent. The FFR Modality | ||
| is calculated based on the entire cardiac wave cycle, whereas the iFR® Modality | ||
| is calculated by isolation of the cardiac wave cycle where intracoronary | ||
| resistance is naturally constant and minimized and where intracoronary flow is | ||
| maximized. This results in the ability to measure pressure without | ||
| administration of a hyperemic agent with the iFR® Modality whereas the FFR | ||
| Modality pressure reading is calculated after administration of a hyperemic | ||
| agent. | ||
| Modifications to the software include the ability to take FFR and iFR | ||
| measurements without relying on ECG and allowing for broadcast FFR and iFR | ||
| 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 | |
| Therapy System 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 | ||
| Based on the information provided above, the FFR v2.5 software is considered | ||
| substantially equivalent to the currently marketed and predicate device, the iFR | ||
| Scout (FFR v2.4 software) in terms of Indications for Use. | ||
| Technological | ||
| characteristics: | The FFR v2.5 software has the same technological characteristics compared to | |
| the predicate device. Modifications implemented in the FFR v2.5 software | ||
| include: | ||
| ● ECG-less Cardiac Cycle Detection | ||
| ● FM Broadcast | ||
| The differences between the FFR v2.5 software and the predicate device do not | ||
| raise any new questions regarding safety or effectiveness. Based on the | ||
| information provided in this 510(k) submission, the FFR 2.5 software is | ||
| considered substantially equivalent to the currently marketed predicate iFR | ||
| Scout (FFR v2.4) in terms of fundamental scientific technology. | ||
| Summary of Non-Clinical Performance | ||
| Data: | Non-clinical performance testing has been performed on the FFR v2.5 software | |
| and demonstrates compliance with the following International and FDA- | ||
| recognized consensus standards and FDA guidance documents: | ||
| ● IEC 62304 Medical device software – Software life cycle processes | ||
| (Edition 1.0, 2006). FDA/CDRH recognition number 13-32. | ||
| Software verification testing has been performed to cover system level | ||
| requirements as well as risk control measures. Results demonstrated that all | ||
| executed tests were passed. | ||
| Non-clinical validation testing has been performed to cover the intended use, | ||
| commercial claims, service, user needs, effectiveness of safety measures and | ||
| instructions for use. | ||
| Therefore, the FFR v2.5 software is substantially equivalent to the currently | ||
| marketed iFR Scout (FFR v2.4) in terms of safety and effectiveness. | ||
| Summary of Clinical | ||
| Performance Data: | The FFR v2.5 software did not require clinical data since substantial | |
| equivalence to the currently marketed predicate device was demonstrated with | ||
| 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 | ||
| device is substantially equivalent to the predicate device. | ||
| Substantial | ||
| Equivalence | ||
| Conclusion: | The FFR v2.5 software is substantially equivalent to the currently marketed | |
| predicate device, the iFR Scout (FFR 2.4) in terms of indications for use, | ||
| technological characteristics and safety and effectiveness. | ||
| The modification to the FFR v2.5 software is within the controls and | ||
| predetermined specifications. Additionally, non-clinical performance tests | ||
| provided in this 510(k) premarket notification demonstrated substantial | ||
| equivalence to the predicate device and ensured that the modification is properly | ||
| introduced; verification and validation testing was conducted to ensure the | ||
| proper introduction of the modifications; conformance to IEC standards and | ||
| guidance documents were provided. The tests performed support substantial | ||
| equivalence of the modified device and demonstrate that the FFR v2.5 software | ||
| is as safe and effective as its predicate device without raising any new safety | ||
| and/or effectiveness concerns. |
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