(62 days)
The Volcano s5/s5i Series Intravascular Imaging and Pressure 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 wall structures. The pullback feature of the PIMr withdraws the imaging core within the protective sheath for a maximum of 15 cm.
ComboMap™ Pressure and Flow System is a multi-mode system intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure and/or blood flow velocities during diagnostic angiography and/or interventional procedures.
Volcano s5/s5i Series Intravascular Imaging and Pressure System: This system is available in 3 configurations; 1) a tower or portable model, 2) an integrated model, and 3) an integrated model with communication capabilities with 3rd party angiography equipment. When operating in IVUS mode, the system console gathers and displays high-resolution intraluminal images that can be analyzed both qualitatively and quantitatively. In addition to supplying diagnostic information, the Volcano s5/s5i system is an adjunct to interventional therapies, such as balloon angioplasty. With ChromoFlo® (not available with Revolution catheter), a two-dimensional color map of relative blood velocities is overlaid on the grayscale image, providing additional information for vessel analysis. The In-Line Digital feature displays a two-dimensional, longitudinal view of the vessel. The angle of the longitudinal cut can be varied around the full 360 degrees. When operating in pressure mode, the system acquires intraluminal data from the pressure guidewire (SmartWire II and ComboWire II) while simultaneously taking aortic pressure data from the established ECG/EKG catheterization lab equipment.
ComboMap Pressure and Flow System: The ComboMap™ Pressure and Flow System is a computer-controlled (PC-based) instrument, which processes the information it receives from the transducer mounted in a Volcano Corporation SmartWireR Pressure Guide Wire (K021219), Volcano Corporation FloWireR Doppler Guide Wire (K905411, K912776, K921563, K972762), and/or external inputs, to produce real-time blood pressure and/or blood flow velocity. There are 4 modes available to operate from and switch between on the ComboMap™; System, Pressure, Flow, and Combo. Depending on the mode and setup selections made, the computer screen displays a combination of waveforms, measured values, and calculated parameters on the display screen. Additional controls also appear on the display screens. In the Pressure Mode, the ComboMap™ provides digital and graphical readout of mean aortic pressure from a guide catheter, mean SmartWireR pressure, and a calculated parameter, such as gradient or fractional flow reserve (FFR), and one of six (6) selected waveforms. The ComboMap™ also supplies an analog output of the SmartWireR pressure for display on a conventional physiologic monitoring system. In the Flow Mode, there are two (2) operating modes to measure blood flow velocity in either coronary or peripheral vessels. This is because in coronary arteries, maximum blood flow velocity occurs predominantly during diastole and in peripheral arteries, maximum flow occurs during systole. The ComboMap™ displays the waveforms selected and provides digital readout of calculated parameters such as average peak velocity (APV) and flow reserve. The ComboMap™ System offers the unique ability to simultaneously display pressure and velocity waveforms using the Combo Mode. Layout of the Pressure and Doppler display as well as selected waveforms is customized by the user allowing a combination of any of those described above in Pressure Mode and Flow Mode.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Volcano s5/s5i Series Intravascular Imaging and Pressure Systems and ComboMap Pressure and Flow System:
Acceptance Criteria and Device Performance
The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed device performance metrics. Instead, it relies on a general statement about compliance with internal procedures and a conclusion of substantial equivalence to predicate devices.
Table of Acceptance Criteria and Reported Device Performance:
| Feature/Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| General Device Functionality | Device performs as intended for intravascular imaging and pressure/flow measurements. | "The test results were found to be acceptable as required by the respective test plans and protocols." |
| Risk Management | Compliance with ISO 14971, IEC 60601-1-4, 21 CFR 820.30, and Medical Device Directive of the European Union (93/46/EEC). | "A risk analysis was conducted according to 803475-001 Risk Management... Applicable testing was performed... The test results were found to be acceptable..." |
| Substantial Equivalence | Device is substantially equivalent to predicate devices for its intended use. | "The discussion and data presented in this 510(k) and conformance with Design Controls and the Quality System Regulations establishes the Volcano s5/s5i Series Intravascular Imaging and Pressure System and ComboMap Pressure and Flow System to be substantially equivalent for its intended use to the predicate devices listed in this submission." |
Study Details
The provided 510(k) summary is a premarket notification for substantial equivalence, which primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device. It does not contain details of a clinical study or a performance study with specific quantitative results as would be typically found for novel devices or those requiring a PMA.
Here's what can be inferred or explicitly stated based on the text provided:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified. The document refers to "applicable testing" and "test plans and protocols" but does not provide details on the sample size of any test sets (e.g., patient data, phantom studies, etc.) or the provenance of any data used for performance validation.
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)
- Not specified. Given the nature of a 510(k) summary for substantial equivalence, it's unlikely that external experts were used to establish ground truth in the way one might for a novel diagnostic algorithm. The "ground truth" for showing substantial equivalence likely refers to the established performance of the predicate devices and internal validation processes against engineering specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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 evidence of an MRMC study. This submission predates the widespread regulatory focus on AI-driven clinical decision support and MRMC studies for such tools. The devices are described as imaging and pressure/flow systems, not AI-assisted diagnostic tools in the modern sense. The "VH IVUS" feature includes semi-automatic visualization and spectral analysis, which hints at some automated processing, but an MRMC study exploring human improvement with this feature is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Implied for some components, but not explicitly detailed. The devices are systems that acquire and display data (IVUS images, pressure/flow readings). The "semi-automatic visualization" and "spectral analysis" features of VH IVUS likely involve algorithms operating in a standalone capacity within the system to process data before presentation to the user. However, no specific standalone performance metrics for these algorithmic components are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified directly. For an imaging system, ground truth would typically come from a combination of:
- Predicate device comparison: The performance is benchmarked against the cleared predicate devices.
- Physical phantoms/simulators: For sensor accuracy (pressure, flow) and imaging resolution.
- Clinical observation: The ability to visualize structures and measure physiological parameters in patients, likely compared with established clinical methods.
The document only broadly states "applicable testing was performed as required by the Quality System to evaluate the modifications... The test results were found to be acceptable as required by the respective test plans and protocols."
8. The sample size for the training set
- Not applicable / Not specified. This submission is for hardware systems and their associated software for data acquisition and display. It does not describe a machine learning model that would require a "training set" in the modern AI sense. While some algorithms (like those for semi-automatic visualization or spectral analysis) might have been developed using data, the concept of a "training set" for regulatory submission in this context is not explicitly mentioned.
9. How the ground truth for the training set was established
- Not applicable / Not specified. See point 8.
§ 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.