(28 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 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 Volcano s5™/s5i™ Intravascular Ultrasound Imaging and Pressure System is available in 3 configurations: (1) a tower or a portable model, (2) an integrated model, (3) an integrated model with communication capabilities with 3d party angiography equipment. There are two (2) operating modes available for all three models of the Volcano s5/s5i Imaging and Pressure system, namely: (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 Volcano s5™/s5i™ Intravascular Ultrasound Imaging System submission (K11706) describes performance data related to modifications made to the existing device, specifically the addition of a "Connection Box."
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists several tests performed for the new Connection Box. The acceptance criteria are not explicitly detailed with specific numerical thresholds but are generally stated as "acceptable by the respective test plans and protocols."
| Test Performed | Reported Device Performance | Acceptance Criteria (Implicit) |
|---|---|---|
| Connection Box PCA (Printed Circuit Assembly) design verification test | Test results found acceptable | Met design specifications and functional requirements |
| Connection Box drop test | Test results found acceptable | Withstood specified drop conditions without damage/malfunction |
| Connection Box IPX4 fluid ingress test | Test results found acceptable | Maintained protection against fluid ingress as per IPX4 rating |
| Reliability HALT test | Test results found acceptable | Demonstrated robustness and reliability under stress |
| Connection Box Power Distribution PCA MTBF test | Test results found acceptable | Met Mean Time Between Failures requirements |
| Electrical safety test | Test results found acceptable | Complied with electrical safety standards |
| Electromagnetic Compatibility test | Test results found acceptable | Complied with EMC standards for emissions and immunity |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a sample size for the test set used for the Connection Box performance data. It generally states that "Applicable testing was performed as required by the Quality System."
The data provenance is not specified (e.g., country of origin, retrospective or prospective). Given the nature of the tests (design verification, drop, fluid ingress, reliability, electrical, EMC), these would typically be internal, prospective engineering tests conducted on sample units of the Connection Box.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable to this submission. The tests conducted are engineering verification and validation tests for a new accessory (Connection Box), not clinical studies requiring expert ground truth for interpretation of medical images or data.
4. Adjudication Method:
This information is not applicable as there were no clinical studies or evaluations requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned. The submission focuses on the safety and effectiveness of a new accessory, the Connection Box, which is described as identical to the predicate device for its primary imaging and pressure functions, with the Connection Box only offering "ease of use by consolidating all the cables."
6. Standalone Performance:
The document describes the performance of the Connection Box itself through various engineering tests. These tests can be considered a form of standalone performance evaluation for the accessory. However, it's not "standalone algorithm performance" in the context of an AI/ML device.
7. Type of Ground Truth Used:
The ground truth for the Connection Box performance tests would be based on engineering specifications, industry standards, and regulatory requirements. For example:
- Design verification: Comparison against design blueprints and functional requirements.
- Drop test: Survival without damage or malfunction, usually against a specified drop height/surface.
- IPX4 fluid ingress: Successful prevention of fluid penetration, verified by established test procedures.
- Electrical safety/EMC: Conformance to specific regulatory standards (e.g., IEC standards).
8. Sample Size for the Training Set:
This information is not applicable. This submission concerns a hardware accessory for an existing medical device, not a new algorithm or AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there was no training set mentioned in the submission.
§ 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.