(29 days)
The Volcano s5™ 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 sem-iautomatically 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 perioheral 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 orovide 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 and 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 s5i® and 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. Some models of this configuration have the cables from the trench consolidated through the Connection Box located in the cath lab which then distributes connections to all the s5i/CORE accessories and bedside peripherals.
The Volcano s5™ and CORE™ Mobile tower systems are the tower/portable (rollaround or mobile) versions of the integrated 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 (IVUS) imaging mode and (2) the Fractional Flow Reserve (FFR) pressure mode.
As an accessory to the currently cleared s5 Series/CORE Systems , the Volcano LoMap is intended to allow the systems to interface with physiology monitors/hemodynamic monitoring equipment and aortic transducers for pressure level amplification.
The provided text is related to a 510(k) submission for the "Volcano LoMap" accessory for the Volcano s5™/s5i® CORE and CORE Mobile Series Precision Guided Therapy Systems.
Based on the document, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Reliability HALT | Acceptable |
| Electrical Safety | Acceptable |
| Electromagnetic Compatibility | Acceptable |
| Software Tests | Acceptable |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Applicable testing was performed as required by the Quality System to evaluate the modification." This implies internal testing, but specific sample sizes for these non-clinical tests (e.g., number of units tested for HALT) are not provided.
- Data Provenance: Not explicitly stated, but the tests are non-clinical, conducted internally by Volcano Corporation. It is implied to be retrospective in the sense that the device modification was already present and then tested.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This submission is for a device accessory (Volcano LoMap) that acts as an interface. The performance data presented is based on non-clinical engineering and software testing, not on clinical imaging or diagnostic accuracy where expert ground truth would be required.
4. Adjudication Method for the Test Set
- Not Applicable. As per point 3, this is non-clinical engineering and software testing, not clinical evaluation requiring adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No. The document explicitly states: "No human or animal clinical testing was performed for this premarket notification." Therefore, no MRMC study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No. The device in question (Volcano LoMap) is an interface accessory, not a standalone diagnostic algorithm. No standalone performance study in the context of an algorithm's diagnostic accuracy was conducted or is relevant here. The "software tests" refer to testing of the software's functionality and safety, not its diagnostic performance as a standalone algorithm.
7. Type of Ground Truth Used
- For the non-clinical tests (Reliability HALT, Electrical Safety, EMC, Software Tests), the ground truth would be established by engineering specifications, industry standards, and internal test protocols. For example, for Electrical Safety, the "ground truth" is compliance with specific electrical safety standards. For software, it would be successful execution according to design specifications.
8. Sample Size for the Training Set
- Not Applicable. This submission is for a device accessory. The "software tests" mentioned are likely for verification and validation of the device's software, not for training a machine learning algorithm. There is no indication of a training set for an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As per point 8, there is no mention of a training set or an AI/ML algorithm requiring a training set in this 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.