(112 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found". The description focuses on traditional imaging and pressure measurement techniques, and the performance studies analyze clinical outcomes based on established physiological parameters (iFR, FFR) and their cut-points, not on AI/ML model performance metrics.
No.
The device is used for diagnostic purposes like imaging, qualitative and quantitative evaluation of vascular morphology, blood flow information, and measuring intravascular blood pressure. It aids in guiding revascularization decisions but does not directly provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "VH IVUS is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature" and "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." Furthermore, 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." These statements directly indicate the device's role in diagnosis.
No
The device description explicitly states it is a "mobile imaging and pressure management system" and incorporates hardware components like pressure wires and imaging catheters, which are not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the qualitative and quantitative evaluation of vascular morphology, providing images of vessel lumen and wall structures, measuring intravascular blood pressure, and assessing blood flow information within the body (in vivo).
- Device Description: The description refers to a mobile imaging and pressure management system that uses pressure wires within blood vessels.
- Input Imaging Modality: The input is Ultrasonic Pulsed Echo Imaging, which is an in vivo imaging technique.
- Anatomical Site: The device is used in coronary arteries and peripheral vasculature, which are within the body.
IVDs, by definition, are used to examine specimens derived from the human body (such as blood, urine, or tissue) outside of the body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device operates directly within the patient's body.
N/A
Intended Use / Indications for Use
The Volcano 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.
VH IVUS is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations.
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 the wall structures. The Pullback feature of the imaging core within the protective sheath for a maximum of 15 cm.
The 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. 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.
Product codes (comma separated list FDA assigned to the subject device)
IYO
Device Description
The Volcano s5 ™/s5i/CORE™ Mobile Precision Guided Therapy System is a mobile imaging and pressure management system as previously described in K133323. The subject device incorporates the Volcano iFR® Modality cleared in K133323.
Pressure measurement is captured through the use of currently marketed pressure wires compatible with the currently marketed s5/s5i/CORE/CORE Mobile imaging and pressure measurement system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
coronary arteries, vessels of the peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject device is the same as the currently marketed predicate device. There are no changes to the pressure measurement wires for collection of data using the iFR" Modality.
Clinical data submitted to support the proposed modifications is documented in the ADVISE II, DEFINE-FLAIR and iFR SWEDEHEART studies.
The ADVISE II study demonstrated that an iFR cut-point of 0.89 matches best with an FFR ischemic cut-point of 0.80 with a specificity of 87.8% and sensitivity of 73.0% (C statistic: 0.90 (95% confidence interval (CI): 0.88 to 0.92, p
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 11, 2018
Volcano Corporation Christopher McLellan Manager. Regulatory Affairs 9965 Federal Drive Colorado Springs, Colorado 80921
Re: K173860
Trade/Device Name: s5/s5i/CORE/CORE Mobile Precision Guided Therapy System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO Dated: March 9, 2018 Received: March 12, 2018
Dear Christopher McLellan:
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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).
Sincerely, M & Thillel for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173860
Device Name
Volcano s5/s5i/CORE/CORE Mobile Precision Guided Therapy System
Indications for Use (Describe)
The Volcano 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.
VH IVUS is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations.
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 the wall structures. The Pullback feature of the imaging core within the protective sheath for a maximum of 15 cm.
The 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. 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Submitter l.
Volcano Corporation
3721 Valley Center Drive San Diego, CA 92130
Contact Person: Kimberly Simon
Telephone: (858) 720-4113 E-mail: kimberly.simon@philips.com
Date Prepared: December 19, 2017
II. Device
| Name of Device: | Volcano s5 ™ /s5i/CORE/CORE™ Mobile Precision Guided
Therapy System |
|-----------------------|------------------------------------------------------------------------|
| Common or Usual Name: | Ultrasonic pulsed echo imaging system. |
| Classification Name: | System, Imaging, Pulsed Echo, Ultrasonic (21 CFR 892.1560) |
| Regulatory Class: | II |
| Product Code: | IYO |
III. Predicate Device
Volcano s5 ™/s5i/CORE/CORE™ Mobile Precision Guided Therapy System (K133323).
Secondary Predicate Device
FFR v2.5 (K170133)
Reference Submissions for the Volcano s5 ™/s5i/CORE/CORE™ Mobile Precision Guided Therapy System:
5
IV. Device Description
The Volcano s5 TM/s5i/CORETM Mobile Precision Guided Therapy System is a mobile imaging and pressure management system as previously described in K133323. The subject device incorporates the Volcano iFR® Modality cleared in K133323.
Pressure measurement is captured through the use of currently marketed pressure wires compatible with the currently marketed s5/s5i/CORE/CORE Mobile imaging and pressure measurement system.
V. Indications for Use
The Volcano s5™/s5i/CORE™ Mobile Precision Guided Therapy 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.
VH IVUS is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations.
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 the wall structures. The Pullback feature of the PIMr withdraws the imaging core within the protective sheath for a maximum of 15 cm.
The 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. 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
6
catheterization procedure. When used 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.
VI. Comparison with the Predicate Device
The predicate device is the currently marketed Volcano s5/s5i/CORE/CORE Mobile Precision Guided Therapy System iFR Modality (cleared under K133323 with the same trade name). This submission is for a change in the indications for use of the currently marketed device. The indications for use for the iFR Modality of the subject device has been revised to reflect the currently recognized, and clinically supported physiological, dichotomous 0.89 intravascular pressure index from a hybrid approach of 0.75 – 0.80 to provide information to help inform decisions on whether to perform or defer percutaneous coronary intervention (PCl). 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 during diagnostic catheterization procedure. When used 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.
The Volcano FFR and iFR Modality Operator's Manual is being revised to include a dichotomous cutpoint for Instantaneous Wave-free Ratio (iFR) guidance in coronary revascularization decision-making to replace the hybrid approach described in the Volcano FFR and iFR Modality Operator's Manual of the currently marketed device. There are no changes to the device materials or intended use.
The Volcano s5/s5i/CORE Mobile Intravascular Imaging and Pressure System and the predicate device share the same intended use. These devices are software measure blood pressure in the coronary and peripheral vasculature.
The Volcano s5™/s5i/CORE™ Mobile Precision Guided Therapy System and the predicate device share the same general operating principal. Both devices use the same pressure wires and are both compatible with only the Volcano imaging and pressure systems.
Volcano s5™/s5i/CORE/CORE™ Mobile Precision Guided Therapy System and the predicate device share the same technological features.
The only difference between the Volcano s5/s5i/CORE/CORE Mobile Intravascular Imaging and Pressure System with iFR "Modality and the predicate device is the indications for use. The indications for use for the iFR Modality of the subject device has been changed to measure intravascular blood pressure using the iFR Modality diagnostic cut-point of 0.89 which represents an ischemic threshold and can reliably guide revascularization decisions during diagnostic catheterization procedure. When used 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.
The similarities between the subject Volcano s5/s5i/CORE/CORE Mobile Intravascular Imaging and Pressure System and the predicate device are illustrated in the table below.
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| Attribute/Feature | Volcano s5/s5i/CORE/CORE Mobile Precision
Guided Therapy System iFR Modality – K133323
(Predicate Device) | Volcano s5/s5i/CORE/CORE
Mobile Precision Guided
Therapy System
(Subject Device) |
|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The iFR Modality of the s5™/s5i/CORE/CORE™
Mobile Series 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. | The Volcano
s5™/s5i/CORE/CORE™ Mobile
Precision Guided Therapy
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.
VH IVUS is intended to be used
in conjunction with imaging
catheters during diagnostic
ultrasound imaging of the
peripheral and coronary
vasculature. The Volcano VH
IVUS System is intended to
semi-automatically visualize
boundary features and perform
spectral analysis of RF
ultrasound signals of vascular
features that the user may wish |
| Attribute/Feature | Volcano s5/s5i/CORE/CORE Mobile Precision
Guided Therapy System iFR Modality – K133323
(Predicate Device) | Volcano s5/s5i/CORE/CORE
Mobile Precision Guided
Therapy System
(Subject Device) |
| | | routine diagnostic ultrasound
imaging examinations.
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
the wall structures. The
Pullback feature of the PIMr
withdraws the imaging core
within the protective sheath for
a maximum of 15 cm.
The 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. |
| Attribute/Feature | Volcano s5/s5i/CORE/CORE Mobile Precision
Guided Therapy System iFR Modality – K133323
(Predicate Device) | Volcano s5/s5i/CORE/CORE
Mobile Precision Guided
Therapy System
(Subject Device) |
| | | 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 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. |
| Pressure Wires | SmartWire II, PrimeWire, PrimeWire Prestige,
PrimeWire Prestige Plus, Verrata, Verrata PLUS | SAME |
| Patient Isolation | Contained in the Patient Interface Module (PIM):
Electronic and Electrical Defibrillation proof
Isolation through 8mm bare fiberglass PCA
creepage with optical isolators and specially
wound transformers with 5KV insulation. | SAME |
| Environmental
Operating
Temperature,
Humidity and
Pressure Range | Operating Temperature: +10°C to +35°C Operating / Storage Humidity: 10% ≤ RH ≤ 95% Non-condensing Operating Pressure Range: 70-106kPa (526.3 – 797 mmHG) Storage Pressure Range: 50-106kPa (376 – 797 mmHg) | SAME |
| Display | Control room | SAME |
| Attribute/Feature | Volcano s5/s5i/CORE/CORE Mobile Precision
Guided Therapy System iFR Modality – K133323
(Predicate Device) | Volcano s5/s5i/CORE/CORE
Mobile Precision Guided
Therapy System
(Subject Device) |
| | 19" Non-medical grade powered through an
isolation transformer
Exam room | |
| | Use an existing Monitor in "Monitor Bank" Add a 19: non-medical grade to the x-ray boom (requires isolated power) 15" or 17" DC Powered Medical Grade Monitor mounted on the patient exam table 19" Monitor mounted on an additional boom (requires isolated power) | |
| User Controls | Control Console
Custom control panel that can be placed in control room or mounted bedside Touch Pad Custom touch pad that is mounted bedside Joy Stick Custom joystick that can be mounted bedside | SAME |
| Signal Processing | Base Band (identical custom PCI boards used) | SAME |
| FFR | Through identical custom PCI board | SAME |
| iFR® | Through identical custom PCI board (same custom PCI board as used for FFR) | SAME |
| Inputs | 100-240 VAC 50/60Hz Power Catheter/PIM connection ECG. Aortic high-level (from hemodynamic system) Ethernet (for DICOM Worklist) USB (for control devices) PS2 (for control devices) Touchpad | SAME |
| Attribute/Feature | Volcano s5/s5i/CORE/CORE Mobile Precision
Guided Therapy System iFR Modality – K133323
(Predicate Device) | Volcano s5/s5i/CORE/CORE
Mobile Precision Guided
Therapy System
(Subject Device) |
| | - Joystick | |
| Outputs | - Monitor display: 1280 x 1024 resolution
- 19" Monitor
- 19" Boom Monitor
- 17" Bedside Monitor
- Printer | SAME |
| Patient Interface
Module (PIM) | Compatible with Digital IVUS, Rotational IVUS, FFR
Pimmette | SAME |
| Connection to PIMs | Via direct connection to CPU or Connection Box | SAME |
| Accessories and
Peripherals | Bedside Touchpad Controller, Joystick Controller,
Connection Box, Control Console | SAME |
| Imaging
Specifications | Imaging boards and software | SAME |
| FFR Software
(includes iFR
Modality) | FFR Software Version v2.3 | FFR Software Version v2.5
(cleared in K170133) |
8
9
10
11
VII. Performance Data
The subject device is the same as the currently marketed predicate device. There are no changes to the pressure measurement wires for collection of data using the iFR" Modality. Performance data establishing the electrical safety and electromagnetic compatibility (EMC) of the device was previously reviewed in K133641 and K140291.
VIII. Clinical Data
Clinical evidence suggests the adoption of a dichotomous cut-point for Instantaneous Wave-free Ratio (iFR) guidance in coronary revascularization decision-making rather than the use of a hybrid approach as was previously documented in the Volcano FFR and iFR Modality Operator's Manual.
The clinical data submitted to support the proposed modifications is documented in the ADVISE II, DEFINE-FLAIR and iFR SWEDEHEART studies. The ADVISE II study demonstrated that Traditional 510(k) for Volcano s5/s5i/CORE/CORE Mobile Precision Guided Therapy System
12
an iFR cut-point of 0.89 matches best with an FFR ischemic cut-point of 0.80 with a specificity of 87.8% and sensitivity of 73.0% (C statistic: 0.90 (95% confidence interval (CI): 0.88 to 0.92, p 4 Escaned J, Echavarria-Pinto M, Garcia HM, et. al. Prospective Assessment of the Diagnostic Accuracy of Instantaneous Wave-Free Ratio to Assess Coronary Stenosis Results of ADVISE II International, Multicenter Study (ADenosine Vasodilator Independent Stenosis Evaluation II). JACC Cardiovasc Interv. 2015 May;8(6):824-33.
2 Davies JE, Sen S, Dehbi H-M, et. al. Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI. N Engl J Med. 2017 May 11;376(19):1824-1834.
3 Götberg M, Christiansen EH, Gudmundsdottir IJ, et al. Instantaneous Wave-free Ratio versus Fractional Flow Reserve to Guide PCI. N Engl J Med. 2017 May 11;376(19):1813-1823.
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IX. Conclusions
Based upon the information submitted in this premarket notification 510(k), the Volcano s5™/s5i/CORE/CORE™ Mobile Precision Guided Therapy System is substantially equivalent to the currently marketed predicate devices.