(30 days)
The Volcano S5™ sories Intravascular Ultrasound Imaging and Pressure Systems 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 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 semiautomatically 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 PMr withdraws the imaging core within the protective sheath for a maximum of 15 cm.
The Volcano s5 Series Intravascular Ultrasound Imaging and Pressure Systems are currently available in 2 configurations: (1) a tower or a portable model, (2) an integrated model.
The Volcano S5 Intravascular Ultrasound Imaging and Pressure Systems are the integrated configurations that are integrated in the catheterization (cath) laboratory, meaning that the CPU is located outside the cath lab and the controls and accessories are cabled in a trench under the floor into the cath lab for use on the patient. Cables from the CPU enter the cath lab through trench and are consolidated through the Connection Box located in the cath lab which then distributes connections to all the S5 accessories and bedside peripherals.
The S5 tower systems are the tower/portable (roll-around or mobile) versions of the integrated system. These systems can be rolled into the cath lab itself and the accessories and bedside peripherals directly connect to the system.
There are two (2) operating modes available on both the integrated as well as the tower models of the Volcano Intravascular Ultrasound Imaging and Pressure Systems, namely: (1) the Intravascular Ultrasound (IVUS) imaging mode and (2) the Fractional Flow Reserve (FFR) pressure mode.
When operating the IVUS mode, the system console gathers and displays high-resolution intraluminal images that can be analyzed both quantitatively. When operating in pressure mode, the system acquires intraluminal data from a pressure guidewire while simultaneously taking aortic pressure data from the established ECG/EKG catheterization lab equipment. Catheters and guidewires are connected to the system via the Patient Interface Modules (PIMs).
As an accessorv to the S5 Systems, the Volcano CORE™ Control Pad is intended to be a secondary controller in the Volcano S5 Intravascular Ultrasound Imaging and Pressure Systems (integrated and mobile systems). It is intended to be used in the exam room, in the sterile field at the bedside in the exam room, in the control room, or on the mobile cart. Images, data, and case navigation controls are relayed to and from the CORE™ Control Pad display via the system central processing unit (CPU). These images, data and controls are presented in a graphical user interface (GUI) displayed on the touch screen of the CORE™ Control Pad. The GUI displayed on the screen of the CORE™ Control Pad will represent, but may not duplicate exactly, the intravascular ultrasound images displayed on the main system monitor. The relayed case navigation controls are intended to allow the user to navigate IVUS and FFR cases and to make measurements on intravascular ultrasound images that are presented on the primary system display. The CORE™ Control Pad touch screen display is an adjunct to the main display on the Volcano CORE™ Series Intra-vascular Imaging and Pressure System. The CORE™ Control Pad is not intended as a standalone diagnostic tool.
The provided text describes the Volcano CORE™ Control Pad, an accessory to the Volcano S5™/s5i® Intravascular Ultrasound Imaging and Pressure Systems. It is important to note that this document primarily focuses on the regulatory submission for an accessory device and not a new diagnostic algorithm or standalone AI device. As such, the typical "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of diagnostic performance (e.g., sensitivity, specificity) for an AI or medical imaging algorithm are not present here.
Instead, the "acceptance criteria" and "study" described relate to the safety and functionality of the accessory device and its substantial equivalence to the predicate.
Here's the information parsed based on your request, with the caveat that many typical AI-related study questions are not applicable to this submission:
Acceptance Criteria and Device Performance for the Volcano CORE™ Control Pad
The Volcano CORE™ Control Pad is an accessory, and its acceptance criteria are focused on ensuring it functions safely and effectively as a secondary controller for the existing Volcano S5 systems, without altering their fundamental technological characteristics or indications for use.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Software Functionality | Software Verification and Validation | Test results found acceptable by respective test plans and protocols. |
| Simulated Use | Simulated Use Validation | Test results found acceptable by respective test plans and protocols. |
| Electrical Safety | Electrical Safety | Test results found acceptable by respective test plans and protocols. |
| Electromagnetic Compatibility | Electromagnetic Compatibility | Test results found acceptable by respective test plans and protocols. |
| Packaging Integrity | Packaging Validation | Test results found acceptable by respective test plans and protocols. |
| Environmental Resilience | Extreme Temperature and Humidity | Test results found acceptable by respective test plans and protocols. |
| Physical Durability | Drop Test | Test results found acceptable by respective test plans and protocols. |
| Mounting Load | Test results found acceptable by respective test plans and protocols. | |
| Tensile Load CCP Pig Tail Cable | Test results found acceptable by respective test plans and protocols. | |
| Noise | Acoustic Noise Level Test CCP | Test results found acceptable by respective test plans and protocols. |
| Reliability | Reliability HALT (Highly Accelerated Life Testing) | Test results found acceptable by respective test plans and protocols. |
| Mean Time Between Failure (MTBF) | Test results found acceptable by respective test plans and protocols. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of clinical or algorithmic performance data (e.g., a set of patient images for diagnostic evaluation). The "tests" mentioned are engineering and product safety tests. Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable or provided in this submission summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable. The device is an accessory (control pad), not a diagnostic algorithm that requires expert-established ground truth for performance evaluation in a clinical context.
4. Adjudication Method for the Test Set
This is not applicable as there is no diagnostic "test set" requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done, as this document pertains to an accessory device and not primarily to the diagnostic performance of an AI algorithm or imaging interpretation. The submission states that the proposed device does not alter the technological characteristics or indications for use of the original S5 systems.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable. The Volcano CORE™ Control Pad is explicitly stated as "not intended as a standalone diagnostic tool." Its purpose is to provide a secondary interface for controlling the existing S5 systems.
7. Type of Ground Truth Used
This is not applicable. The tests performed are engineering and safety tests, not evaluations against a clinical ground truth like pathology, expert consensus, or outcomes data.
8. Sample Size for the Training Set
This is not applicable. There is no mention of a "training set" as this is not an AI or machine learning algorithm being developed or validated.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set mentioned.
§ 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.