(251 days)
Silicon Valley Medical Instrument's Kodama Intravascular Ultrasound Catheter 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 Kodama Intravascular Ultrasound Catheter is a minimally invasive intravascular ultrasound coronary imaging catheter. The Catheter is a medical device for use by or on the order of a physician. 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 by the transducer and sent to the Console (SVMI's HD-IVUS Ultrasound Imaging System) 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 document pertains to a 510(k) premarket notification for the Kodama Intravascular Ultrasound Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical study with strict acceptance criteria for diagnostic performance in the way AI/ML devices often do.
Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of diagnostic performance (e.g., sensitivity, specificity, reader studies, ground truth) is not applicable to this 510(k) submission.
This submission primarily relies on non-clinical performance testing to demonstrate that the new device meets established standards and performs comparably to its predicate device. The "acceptance criteria" here are compliance with these standards and comparable performance in specific engineering tests.
Here's a breakdown of the information available and what is not applicable:
- Table of acceptance criteria and the reported device performance:
| Characteristic | Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance |
|---|---|---|
| Performance Testing | Tensile Strength, torque strength, tip flexibility, crossability, pushability, traceability, etc. | Met all specifications. |
| Biocompatibility Testing | ISO 10993 inc. Cytotoxicity, Hemolysis, Pyrogenicity. | Compliant with ISO 10993-1. |
| Sterilization & Shelf Life | EtO Sterilization validation inc. EtO residuals. Shelf life validated to 6 months (for launch). | Compliant with ISO 11135-1. |
| Sterility | ISO 11135 (Sterile) | Compliant (Sterile) |
| Biocompatibility | ISO 10993 | Compliant |
| Ultrasound | ISO 60601-2-37 | Compliant |
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable: This was a non-clinical study involving engineering and performance tests, not a clinical study with a patient test set. The document does not specify sample sizes for the engineering tests but states "Met all specifications."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable: There was no "ground truth" in the diagnostic sense for this type of submission. The "ground truth" here is the adherence to engineering specifications and international standards, which is assessed during laboratory testing and verification.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: No clinical test set requiring adjudication was used.
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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 device is an Intravascular Ultrasound Catheter, not an AI-based diagnostic tool. No MRMC study was performed, and human readers are not "improving with AI" in this context.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This is a physical medical device (catheter) for ultrasound imaging, not an algorithm. Standalone performance as an algorithm is not relevant.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable: The "ground truth" for this submission are the accepted engineering standards and specifications (e.g., ISO standards) against which the device's physical and functional performance was tested.
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The sample size for the training set:
- Not Applicable: This is not an AI/ML device; therefore, there is no "training set."
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How the ground truth for the training set was established:
- Not Applicable: As there is no training set, this question is not applicable.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).