(65 days)
The Volcano 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 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 PIMr withdraws the imaging core within the protective sheath for a maximum of 15 cm.
The modified Volcano s5i™ Intravascular Ultrasound Imaging and Pressure System is an integrated model, with two (2) operating modes available. The Volcano s5i Imaging and Pressure system, is available in: (1) the Intravascular Ultrasound (IVUS) imaging mode and (2) the 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).
The provided text describes a 510(k) submission for a modification to the Volcano s5i™ Intravascular Ultrasound Imaging System. The modification involves a change to a new CPU motherboard.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Equivalence | The new CPU motherboard is designed to maintain current functionality and enhance user efficiency. The device shares intended use, same design characteristics, and the same fundamental scientific technology with the predicate device. |
| Signal Processing | Test results were found to be acceptable by the respective test plans and protocols. |
| Reliability (HALT) | Test results were found to be acceptable by the respective test plans and protocols. |
| Electrical Safety | Test results were found to be acceptable by the respective test plans and protocols. |
| Electromagnetic Compatibility | Test results were found to be acceptable by the respective test plans and protocols. |
| Software Performance | Test results were found to be acceptable by the respective test plans and protocols. |
Explanation: The key acceptance criteria for this submission are that the modified device (with the new CPU motherboard) performs equivalently to the previous version and continues to meet relevant safety and performance standards. The "Performance Data" section explicitly states that "Applicable testing was performed as required by the Quality System to evaluate the modifications" and that "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 specify a sample size for a test set (e.g., number of patients, images, or measurements). The testing described is primarily engineering and software verification/validation, not clinical performance testing with human data. The data provenance is not applicable as the testing is on the device's functional and technical aspects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. Given that the testing focuses on the functional and technical performance of a hardware component (CPU motherboard), it's unlikely that 'experts' in the clinical sense were used to establish ground truth in a clinical test set. The 'ground truth' would be defined by the technical specifications and expected behavior of the system, verified by engineers and quality assurance professionals.
4. Adjudication Method for the Test Set
This information is not provided in the document. Adjudication methods are typically relevant for human-in-the-loop studies or clinical performance evaluations involving multiple readers, which are not described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done for this submission. The submission is for a modification to an existing device (CPU motherboard change), and the focus is on demonstrating that the new component does not negatively impact the device's established performance or safety.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is an "Intravascular Ultrasound Imaging System," implying it's an imaging device that provides data to a human user. While the underlying functionalities (signal processing, software) were tested in a standalone manner (without a human interpreting clinical images from a patient in real-time as part of the test), the document does not describe "algorithm only" performance in the sense of an AI algorithm operating independently of human interaction for diagnosis or interpretation. The tests were on the device's technical aspects.
7. The Type of Ground Truth Used
The ground truth used for these tests would be the technical specifications and expected functional behavior of the device and its components (e.g., CPU, software, electrical components). For example, a signal processing test would compare the output against a known, correct signal. A software test would verify outputs against expected results for specific inputs. This is not clinical ground truth (like pathology or expert consensus on patient images) but rather engineering/technical ground truth.
8. The Sample Size for the Training Set
The document does not mention or imply a training set. This submission is for a hardware modification to an existing medical device, not for the development or validation of a new algorithm that would typically require a training set.
9. How the Ground Truth for the Training Set Was Established
As there is no training set mentioned in the document, this question is not applicable.
§ 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.