(23 days)
The Volcano CORE™ Mobile 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 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.
The Volcano CORE™ Series Precision Guided Therapy Systems are currently available in 2 configurations: (1) a tower or a portable model, (2) an integrated model.
The Volcano CORE™ Precision Guided Therapy 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 CORETM accessories and bedside peripherals.
The CORE™ Mobile 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 Precision Guided Therapy Systems, namely: (1) the Intravascular Ultrasound (1VUS) 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 and qualitatively. 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 accessory to the CORE™ Systems, the Volcano CORE™ Control Pad is intended to be a secondary controller in the Volcano CORE™ Precision Guided Therapy 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 document (K133641) describes a 510(k) premarket notification for the Volcano CORE™ Control Pad, an accessory to the Volcano CORE™/CORE™ Mobile Precision Guided Therapy Systems. The submission focuses on demonstrating substantial equivalence to a predicate device and does not contain information about a study proving the device meets specific performance acceptance criteria in the way a new diagnostic algorithm might.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of performance acceptance criteria for the CORE™ Control Pad, nor does it report specific performance metrics like sensitivity, specificity, accuracy, or similar diagnostic measures. This is because the device is an accessory to an existing system, and its approval is based on demonstrating that it does not alter the fundamental technological characteristics, scientific technology, or indications for use of the predicate device. The performance data presented are primarily engineering and safety tests.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated for the accessory's 'performance' as a diagnostic tool) | Reported Device Performance (Summary of Test Results) |
|---|---|---|
| Software Verification & Validation | (Implied: Software functions as intended, no new critical errors) | "The test results were found to be acceptable by the respective test plans and protocols." |
| Simulated Use Validation | (Implied: Device functions correctly in simulated clinical scenarios) | "The test results were found to be acceptable by the respective test plans and protocols." |
| Electrical Safety | (Compliance with relevant electrical safety standards) | "The test results were found to be acceptable by the respective test plans and protocols." |
| Electromagnetic Compatibility | (Compliance with relevant EMC standards) | "The test results were found to be acceptable by the respective test plans and protocols." |
| Packaging Validation | (Packaging protects device during shipping/handling) | "The test results were found to be acceptable by the respective test plans and protocols." |
| Extreme Temperature & Humidity | (Device operates within specified environmental limits) | "The test results were found to be acceptable by the respective test plans and protocols." |
| Drop Test | (Device withstands specified drops without critical damage) | "The test results were found to be acceptable by the respective test plans and protocols." |
| Mounting Load | (Mounting mechanisms are robust) | "The test results were found to be acceptable by the respective test plans and protocols." |
| Tensile Load CCP Pig Tail Cable | (Cable connection withstands specified tensile forces) | "The test results were found to be acceptable by the respective test plans and protocols." |
| Acoustic Noise Level Test CCP | (Noise levels are within acceptable limits) | "The test results were found to be acceptable by the respective test plans and protocols." |
| Reliability HALT (Highly Accelerated Life Testing) | (Device demonstrates expected lifetime/durability) | "The test results were found to be acceptable by the respective test plans and protocols." |
| Mean Time Between Failure (MTBF) | (Device meets MTBF targets) | "The test results were found to be acceptable by the respective test plans and protocols." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of clinical data for diagnostic performance evaluation, as the device is an accessory. The tests conducted (e.g., software, electrical safety, environmental) involved the device itself rather than patient data. Therefore, details like data provenance (country of origin, retrospective/prospective) are not applicable or provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to the type of device and study described. No "ground truth" was established by experts for diagnostic performance, as the submission focuses on the safety and functional equivalence of an accessory.
4. Adjudication Method for the Test Set
Not applicable. There was no "test set" of clinical cases requiring expert adjudication for diagnostic performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed or described. The submission is not for a diagnostic algorithm that would typically require such a study to evaluate human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The CORE™ Control Pad is an accessory with a user interface; it is not a standalone diagnostic algorithm or AI. The document explicitly states: "The CORE™ Control Pad is not intended as a standalone diagnostic tool."
7. Type of Ground Truth Used
Not applicable. There was no ground truth used in the context of diagnostic accuracy, as the device is an accessory, not a diagnostic algorithm. The "ground truth" for the engineering and safety tests would be the established engineering specifications and safety standards.
8. Sample Size for the Training Set
Not applicable. The device is not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.