(188 days)
- The LipiScan™ IVUS Imaging System is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography.
a. The System is intended for the detection of lipid-core-containing plaques of interest.
b. The System is intended for the assessment of coronary artery lipid core burden. - The System is intended for ultrasound examination of coronary intravascular pathology.
a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
The InfraReDx LipiScan™ IVUS Imaging System is comprised of the catheter, catheter accessories, pull-back and rotation device and laser console with accessories.
The InfraReDx LipiScan™ IVUS Imaging System is designed for near-infrared examination of coronary arteries to detect lipid-core containing plaques and assess lipid core burden, as well as for ultrasound examination of coronary intravascular pathology.
The provided document, K093993, does not contain specific acceptance criteria or an evaluation study with quantitative performance metrics for the InfraReDx LipiScan™ IVUS Imaging System. The information focuses on demonstrating substantial equivalence to predicate devices based on design, intended use, operating principle, and safety testing.
Here's a breakdown of the information available and the aspects that are not available in the provided text:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The submission details bench, electrical safety, and acoustic output testing, stating that the device "meet[s] or exceed[s] performance requirements" and that "the device satisfies all performance and functional requirements," but it does not specify what those quantitative requirements or acceptance criteria were, nor does it present specific performance values (e.g., sensitivity, specificity for lipid core detection, or quantitative accuracy metrics for IVUS measurements).
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document mentions "Ex vivo and in vivo data is presented to support expanded indications for use." However, it does not provide any details regarding the sample size, data provenance (country of origin), or whether the data was retrospective or prospective for these studies.
3. 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):
This information is not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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:
This type of study is not mentioned in the document. The device is described as an imaging system, not an AI-assisted diagnostic tool in the context of comparative effectiveness with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not explicitly provided in the document, as the submission does not detail specific algorithm performance studies. The focus is on the integrated system's safety and functionality rather than standalone algorithmic performance metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document states "Ex vivo and in vivo data is presented to support expanded indications for use." While it implies comparison to some form of ground truth, the specific type of ground truth (e.g., histological analysis for lipid cores, or a gold standard for IVUS measurements) is not detailed.
8. The sample size for the training set:
This information is not provided. The document describes software verification and validation, but not a "training set" in the context of machine learning or AI, which is a common use of the term.
9. How the ground truth for the training set was established:
This information is not provided as there is no mention of a training set or ground truth establishment for such a set.
Summary of available information related to performance and testing:
- Non-clinical Test Results: Bench, electrical safety, and acoustic output safety testing were performed.
- Bench Testing: Evaluated performance and functionality, including hardware and software unit-level tests and system-level tests. Results "demonstrate that the device satisfies all performance and functional requirements." (No specific criteria or performance values are given).
- Electrical Safety Testing: Complies with EN 60601-1 and EN 60601-1-2 standards, verified by independent test facilities.
- Software Verification and Validation: Performed in accordance with applicable FDA guidance documents.
- Acoustic Output Testing: Performed in accordance with FDA Guidance, "Information for Manufactures Seeking Market Clearance of Diagnostic Ultrasound Systems and Transducers", issued September 30, 1997.
- Ex vivo and in vivo data: Presented to support expanded indications for use. (No further details on these studies are provided).
In conclusion, while the document confirms various tests were conducted to ensure safety and functionality, it lacks the specific quantitative acceptance criteria, detailed study designs, sample sizes, and expert qualifications that would typically describe the device's performance against defined criteria. The submission focuses on substantial equivalence based on overall functionality and safety testing rather than a detailed performance study with quantifiable metrics against specific acceptance thresholds.
§ 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).