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510(k) Data Aggregation
(165 days)
CARDIOVASCULAR IMAGING SYSTEMS, INC.
The Sonicath Ultra Imaging Catheter is intended for the ultrasound examination of peripheral and coronary intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
The BSC Sonicath Ultra Imaging Catheter is a sterile, single-use disposable device used for the ultrasound examination of intravascular pathology in both the coronary and peripheral vasculatures. The Sonicath Ultra 2.9 F and 3.2 F Imaging Catheters and predicate devices consist of two main components: (1) the catheter body and (2) the imaging core. The imaging core of both the Sonicath Ultra and the predicate device imaging catheters is comprised of a hitorque, flexible, rotating drive cable with an outward looking ultrasonic transducer at the distal tip.
The Boston Scientific Corporation's Sonicath Ultra™ Imaging Catheter (K970049) was subjected to various non-clinical tests to demonstrate its safety and effectiveness. The device's acceptance criteria and performance are detailed below based on the provided 510(k) summary.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Bench Testing | |
| Catheter Shaft Tensile Strength | Determined to be acceptable and consistent with intended use. |
| Catheter Joint Tensile Strength | Determined to be acceptable and consistent with intended use. |
| Imaging Core Weld Joint Tensile Strength | Determined to be acceptable and consistent with intended use. |
| Acoustic Output Testing | |
| Acoustic Output Limits (FDA Track 1 limits) | Test results are below the FDA Track 1 limits. |
| Animal Testing | |
| In-vivo functional and imaging characteristics | Performance was consistent with the intended clinical use of the device. |
| Biocompatibility | |
| Compliance with ISO 10993-1 Part 1 | Meets the requirements for biocompatibility testing outlined in ISO 10993-1 Part 1. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the exact sample sizes for the test sets used in the bench, acoustic output, and animal testing.
- Bench Testing: The summary indicates "bench testing was included" without detailing the number of catheters or components tested.
- Acoustic Output Testing: "The Sonicath Ultra Imaging Catheter was tested for acoustic output" again without specific numbers.
- Animal Testing: "Animal testing was performed" without specifying the number of animals or the type of animal model.
The data provenance is from non-clinical studies (bench and animal testing) conducted by Boston Scientific Corporation, Sunnyvale. The report does not specify countries of origin for test data, but it is implied to be internal testing for regulatory submission in the U.S. It is prospective for the purposes of device evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The 510(k) summary focuses on non-clinical performance and substantial equivalence to predicate devices, not on diagnostic accuracy based on expert interpretation of images. Therefore, it does not mention a number of experts used to establish ground truth for a test set, nor their qualifications, as this type of study was not conducted or reported for this submission.
4. Adjudication Method for the Test Set
As there was no specific test set involving human interpretation requiring ground truth establishment or expert consensus on diagnostic findings, no adjudication method (like 2+1 or 3+1) was reported.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported in this 510(k) submission. Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance, as AI is not a component of, nor is it mentioned in relation to, this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study (algorithm only) was not done, as this device is an imaging catheter and not an AI or algorithm-based diagnostic tool. The performance evaluated was of the physical device itself.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the non-clinical tests was established as follows:
- Bench Testing: Engineering specifications and physical integrity standards (e.g., tensile strength values) for catheter components.
- Acoustic Output Testing: Governed by FDA Guidance (Revised 510(k) Diagnostic Ultrasound Guidance for 1993, and 510(k) Guide for Measuring and Reporting Acoustic Output of Diagnostic Ultrasound Medical Devices, December, 1985). The "ground truth" here is compliance with defined safety limits.
- Animal Testing: In-vivo functional and imaging characteristics were assessed against the "intended clinical use" of the device, likely by direct observation of imaging quality and catheter performance by the researchers conducting the animal studies.
8. The Sample Size for the Training Set
This submission is for a physical medical device (an imaging catheter), not a machine learning or AI algorithm. Therefore, the concept of a "training set" in the context of AI is not applicable here, and no training set sample size is provided.
9. How the Ground Truth for the Training Set Was Established
Since there was no "training set" in the context of an AI/ML algorithm, this question is not applicable. The device's design and manufacturing are based on established engineering principles and prior predicate device designs for which safety and effectiveness were already accepted.
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