(90 days)
The Volcano Therapeutics, Inc. Volcano IVUS System is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano 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 Volcano Therapeutics. Inc. Volcano IVUS System is a combination of proprietary hardware and software and a phantom normalization device. The hardware portion consists of a high-speed computer, with monitor, specifically built for use in medical institutions; high-speed analog-to-digital conversion circuitry and proprietary gating circuitry. The system is connected to the output connectors of conventional IVUS systems and the ECG system using typical cabling. The IVUS radiofrequency output is used directly by the Volcano IVUS System and the ECG output is used to gate or time the collection / recording of the IVUS signal. The software that provides the user interface is Windows 2000 Professional. The Volcano IVUS System applications presently exist in two pieces. The first is the data acquisition package, IVUSLabRF. This application contains the drivers that control the Gage A/D converter card which digitizes the RF data from the IVUS console. It also manages the joining of the data from individual scans that constitute a "slice". The second software program is called IVUSLabVH. This program analyzes each of the slices. These images are visually reviewed and the control points are manually adjusted until they appear in the proper location on the vessel inner and outer borders. Once all the control points have been properly located the software produces a set of data files called "snaxel" files which define the coordinates of the control points. The black and white IVUS files and the snaxel files are loaded into the IVUSLabVH software which processes the data to produce the five color bit mapped Volcano IVUS image files. The system requires the use of a "phantom" to "normalize" the conventional IVUS output. The phantom is a small piece of acrylic material machined to allow placement over the IVUS catheter distal tip.
The provided 510(k) summary for the Volcano IVUS System (K042188) does not contain specific acceptance criteria, detailed study designs, or reported device performance metrics in the way typically expected for an AI/ML device.
Instead, this submission primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and compliance with general quality and safety standards.
Therefore, many of the requested fields cannot be directly extracted from the provided text. I will explain why each section cannot be populated directly and provide what information is available.
1. Table of Acceptance Criteria and Reported Device Performance
Information within the document: The document states, "Additionally, testing and validation exercises have produced results consistent with design input requirements." However, the design input requirements themselves, which would define the acceptance criteria and specific performance metrics, are not disclosed in this summary. No quantitative performance metrics (e.g., sensitivity, specificity, accuracy, dice coefficient, etc.) are reported for features like semi-automatic boundary visualization or spectral analysis.
| Acceptance Criteria (e.g., minimum sensitivity, detection rate, image quality metrics) | Reported Device Performance (with specific numerical values) |
|---|---|
| Not specified in the document. | Not specified in the document. |
2. Sample Size Used for the Test Set and Data Provenance
Information within the document: The document mentions "testing and validation exercises," but it does not specify any sample size for a test set, nor does it provide details on the data provenance (e.g., country of origin, retrospective/prospective nature).
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Information within the document: The summary does not mention any expert-led ground truth establishment process for the performance testing. The "semi-automatic border detection" description implies user interaction ("control points are manually adjusted"), but this is part of the device's operational workflow, not necessarily a ground truth adjudication process for performance evaluation.
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
Information within the document: As no specific test set and ground truth establishment is described, an adjudication method is also not mentioned.
- Adjudication Method: Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
Information within the document: There is no indication that an MRMC comparative effectiveness study was conducted or reported in this 510(k) summary. The focus is on demonstrating substantial equivalence to predicate devices, not on quantifying human performance improvement with or without AI assistance.
- MRMC Study Conducted: No.
- Effect Size (human readers with/without AI): Not applicable, as no such study was reported.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Information within the document: The device description clearly states, "These images are visually reviewed and the control points are manually adjusted until they appear in the proper location on the vessel inner and outer borders." This indicates it is a "semi-automatic" system, meaning it requires human-in-the-loop interaction for its primary function of boundary detection. Therefore, a standalone (algorithm only) performance would not be representative of its intended use and is not reported.
- Standalone Performance Study: Not reported, and the device's nature suggests it's designed for human-in-the-loop operation.
7. The Type of Ground Truth Used
Information within the document: The summary does not specify the type of ground truth used for performance evaluation. Given the context of IVUS imaging, potential ground truth types could include expert consensus on images, comparison to other imaging modalities or histology (though less common for real-time IVUS validation in this context). However, none are explicitly stated. The "manual adjustment of control points" refers to the user interaction with the device, not the ground truth for an independent test.
- Type of Ground Truth: Not specified.
8. The Sample Size for the Training Set
Information within the document: The document does not mention any training set or its sample size. This 510(k) submission predates the common requirements for detailed AI/ML model training data specifics.
- Sample Size for Training Set: Not specified.
9. How the Ground Truth for the Training Set Was Established
Information within the document: As no training set is mentioned (see point 8), the method for establishing its ground truth is also not described.
- How Ground Truth for Training Set Was Established: Not specified.
§ 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.