(71 days)
The HD-IVUS Ultrasound Imaging System (Console) is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
The HD-IVUS Ultrasound Imaging System is a minimally invasive intravascular ultrasound diagnostic imaging tool when used in conjunction with an intravascular ultrasound catheter. The System is a medical device for use by or on the order of a physician. The HD-IVUS Ultrasound Imaging System is comprised of a System Console with a touch screen monitor, a Roll Stand, a Patient Interface Module (PIM), a Power Supply, and an Intravascular Ultrasound Catheter (510(k) cleared and sold separately). The Catheter emits sound energy from a transducer at the distal tip of the catheter, which is guided into the coronary arteries of the heart. Sound waves that reflect from the inner vascular tissues are received bv the transducer and sent to the System Console where a high resolution, cross-sectional image is displayed in real time. The technique provides for in-vivo visualization of the coronary artery lumen, coronary artery wall morphology, and devices (such as stents) at or near the surface of the coronary artery wall.
The provided text describes the 510(k) Summary for the Silicon Valley Medical Instruments (SVMI) HD-IVUS Ultrasound Imaging System. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving device performance against those criteria as would be expected for an AI/CADe device.
Specifically, this document is a 510(k) summary for an imaging system, not an AI or CADe device. Therefore, it does not include acceptance criteria in terms of clinical performance metrics (like sensitivity, specificity, AUC) or a dedicated clinical study to prove the device meets such criteria. Instead, the "performance criteria" are focused on regulatory compliance and technical equivalence to a predicate device.
However, I can extract the information that is present and indicate where information is not available due to the nature of the submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance (Results Summary) |
|---|---|---|
| Electromagnetic Compatibility | IEC 60601-1-2 | Compliant with IEC 60601-1-2 |
| Electrical Safety and Acoustic Safety | IEC 60601-1, IEC 60601-1-4, and IEC 60601-2-37 | Compliant with IEC 60601-1, IEC 60601-1-4, and IEC 60601-2-37 |
| Acoustic Output | Does not exceed Track 3 limits (Predicate device specified) | Does not exceed Track 3 limits |
| Intended Use | Equivalent to predicate device (Boston Scientific iLab System) | Intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. (Identical to predicate's intended use description, though phrasing differs slightly) |
| Signal Type | Doppler, Echo (Predicate) | Doppler, Echo |
| Catheter Mechanical Drive | Patient Interface Module (PIM) (cleared with ultrasound system) | Motor Drive Unit (MDU) (cleared with ultrasound system) - Note: This is a design difference, not a performance criterion per se, but part of the equivalence claim. |
| Signal Conductor | Coaxial wire traveling down catheter (Predicate) | Coaxial wire traveling down catheter |
| Signal Generator/ Receiver Materials | PZT crystal transducer (Predicate) | PZT crystal transducer |
| Ultrasound Frequency | 40 MHz, 60 MHz ± 10% (Predicate) | 10 - 40 MHz ± 10% (Predicate specified 40 MHz, 60 MHz ± 10%; New device states 10-40MHz ± 10%. This is a significant difference in range, but the summary does not explain why it's considered equivalent.) |
| Method of Use | Intravascular (Predicate) | Intravascular |
| User Interface | PC-based system with keyboard and touch screen and mouse (Predicate) | PC-based system with keyboard and touch screen and mouse |
| Software Interface | Custom GUI (Predicate) | Custom GUI |
2. Sample size used for the test set and the data provenance
- Not Applicable. This document describes a 510(k) submission for an imaging device (ultrasound system), not an AI/CADe device that would typically involve a "test set" of patient data for performance evaluation. The "studies" mentioned refer to technical tests for regulatory compliance (EMC, electrical/acoustic safety) and comparison with a predicate device's technical specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See point 2. No clinical "ground truth" establishment by experts for a test set is described.
4. Adjudication method for the test set
- Not Applicable. See point 2.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI/CADe device and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is an ultrasound imaging system, not an algorithm, and is intended for use by a physician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. The "ground truth" in this context is the compliance with established electrical, acoustic, and electromagnetic standards, and the technical specifications of the legally marketed predicate device used for substantial equivalence comparison.
8. The sample size for the training set
- Not Applicable. This is an imaging device, not an AI/machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.