(129 days)
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.
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.
The provided text describes the 510(k) summary for the FFR v2.5 device, which is a software modification to an existing device (iFR Scout, FFR v2.4). The core claim is substantial equivalence to the predicate device, not necessarily meeting specific acceptance criteria through a clinical study.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
There are no specific quantitative acceptance criteria or reported device performance metrics in the provided document. The submission relies on demonstrating substantial equivalence to a predicate device. The performance is implied to be equivalent to the predicate (iFR Scout, FFR v2.4).
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative acceptance criteria. The document focuses on demonstrating substantial equivalence to the predicate device in terms of: | The FFR v2.5 software is considered substantially equivalent to the iFR Scout (FFR v2.4) based on: |
| - Indications for Use | - FFR v2.5 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 with currently marketed Volcano pressure wires. This is equivalent to the predicate. |
| - Technological characteristics | - Maintains the same fundamental scientific technology. Modifications (ECG-less Cardiac Cycle Detection, FM Broadcast) do not raise new safety or effectiveness questions. |
| - Non-clinical performance testing | - Demonstrated compliance with IEC 62304 and FDA guidance documents. Software verification testing covered system-level requirements and risk control measures, with all executed tests passed. Non-clinical validation testing covered intended use, commercial claims, service, user needs, effectiveness of safety measures, and instructions for use. |
| - Safety and effectiveness | - Considered equally safe and effective as the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "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."
Therefore, there was no test set of patient data used for a clinical study as part of this 510(k) submission. The non-clinical performance testing involved software verification and validation, but details on sample sizes for these tests (e.g., number of test cases, simulated scenarios) are not provided, nor is their provenance in terms of patient data.
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)
Since no clinical data or test set involving patient data was used, there were no experts involved in establishing ground truth for a clinical test set. The evaluation was primarily based on non-clinical software testing and comparison to the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
None, as no clinical test set was utilized.
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
No MRMC comparative effectiveness study was done. The submission did not involve clinical data or evaluation of human readers with/without AI assistance. The device is a software modification to a measurement system, not a diagnostic AI tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The document mentions "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." and "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."
While these describe standalone performance testing of the algorithm/software, specific details about the methodology, metrics, or if it constitutes a "standalone study" in the context of clinical performance are not provided. The objective was to ensure the modified software functions correctly according to specifications, not to establish clinical performance metrics in isolation.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the software verification and validation testing, the ground truth would have been pre-defined expected outputs and behaviors based on system requirements and predefined calculations/algorithms for FFR and iFR measurements. This is not equivalent to clinical ground truth established by medical experts or pathology.
8. The sample size for the training set
Not applicable. This submission is for a software modification (FFR v2.5) that is substantially equivalent to a predicate device (FFR v2.4). There is no indication that this particular submission involved a machine learning model requiring a training set. The descriptions point to traditional software development and testing rather than AI model development.
9. How the ground truth for the training set was established
Not applicable, as no training set (for a machine learning model) is mentioned in this submission.
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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 (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 Corporation2870 Kilgore RoadRancho Cordova, CA 95670Establishment Registration Number: 2939520 | |
| Primary ContactPerson: | Elaine AlanRegulatory Affairs SpecialistPhone: (858) 764-1281E-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 installedon the Volcano s5/CORE Systems. These systems are a multi-modalityplatform that provides Intravascular Ultrasound (IVUS) Imaging, FractionalFlow Reserve (FFR) pressure measurements, and Instant Wave-Free Ratio (iFR)pressure measurements. Pressure measurements are obtained through the use ofpressure guide wires. Real-time image visualization of patient anatomy duringprocedures. | |
| FFR pressure measurements are obtained during fluoroscopic procedures afterthe administration of a hyperemic agent such as adenosine. iFR pressuremeasurements do not require the use of a hyperemic agent. The FFR Modalityis calculated based on the entire cardiac wave cycle, whereas the iFR® Modalityis calculated by isolation of the cardiac wave cycle where intracoronaryresistance is naturally constant and minimized and where intracoronary flow ismaximized. This results in the ability to measure pressure withoutadministration of a hyperemic agent with the iFR® Modality whereas the FFRModality pressure reading is calculated after administration of a hyperemicagent. | ||
| Modifications to the software include the ability to take FFR and iFRmeasurements without relying on ECG and allowing for broadcast FFR and iFRmeasurement 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 GuidedTherapy System is indicated in all blood vessels, including coronary andperipheral arteries, to measure intravascular blood pressure during diagnosticangiography and/or interventional procedures. | |
| The iFR® Modality is intended to be used in conjunction with currently marketedVolcano pressure wires | ||
| Based on the information provided above, the FFR v2.5 software is consideredsubstantially equivalent to the currently marketed and predicate device, the iFRScout (FFR v2.4 software) in terms of Indications for Use. | ||
| Technologicalcharacteristics: | The FFR v2.5 software has the same technological characteristics compared tothe predicate device. Modifications implemented in the FFR v2.5 softwareinclude:● ECG-less Cardiac Cycle Detection● FM Broadcast | |
| The differences between the FFR v2.5 software and the predicate device do notraise any new questions regarding safety or effectiveness. Based on theinformation provided in this 510(k) submission, the FFR 2.5 software isconsidered substantially equivalent to the currently marketed predicate iFRScout (FFR v2.4) in terms of fundamental scientific technology. | ||
| Summary of Non-Clinical PerformanceData: | Non-clinical performance testing has been performed on the FFR v2.5 softwareand 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 levelrequirements as well as risk control measures. Results demonstrated that allexecuted tests were passed. | ||
| Non-clinical validation testing has been performed to cover the intended use,commercial claims, service, user needs, effectiveness of safety measures andinstructions for use. | ||
| Therefore, the FFR v2.5 software is substantially equivalent to the currentlymarketed iFR Scout (FFR v2.4) in terms of safety and effectiveness. | ||
| Summary of ClinicalPerformance Data: | The FFR v2.5 software did not require clinical data since substantialequivalence to the currently marketed predicate device was demonstrated withthe following attributes: | |
| Indication for use; Technological characteristics; Non-clinical performance testing; and Safety and effectiveness. | ||
| These attributes demonstrated that the clinical performance of the modifieddevice is substantially equivalent to the predicate device. | ||
| SubstantialEquivalenceConclusion: | The FFR v2.5 software is substantially equivalent to the currently marketedpredicate 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 andpredetermined specifications. Additionally, non-clinical performance testsprovided in this 510(k) premarket notification demonstrated substantialequivalence to the predicate device and ensured that the modification is properlyintroduced; verification and validation testing was conducted to ensure theproper introduction of the modifications; conformance to IEC standards andguidance documents were provided. The tests performed support substantialequivalence of the modified device and demonstrate that the FFR v2.5 softwareis as safe and effective as its predicate device without raising any new safetyand/or effectiveness concerns. |
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§ 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.