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The Aortic root cannulae are intended for use in adult and pediatric patients to cannulate the aortic root for cardioplegic solution delivery into the coronary arteries and for venting of the heart during cardiopulmonary bypass surgery for periods of up to six hours.

The R501-R502 Aortic Root Cannula (hereinafter referred to as R501-R502 cannulae) are aortic root cannulae intended to be used to cannulate the aortic root, to vent and to deliver cardioplegic solution during heat bypass operations.

The device is available in two styles: with a vent line (R502) and without a vent line (R501). Both models consist of a flexible Polyvinylchloride (PVC) tubing body, a PVC flanged tip and luer connector. The introducer is made of stainless steel with a PVC obturator. The vent line model have an additional feature constituted by a vent line provided as integral part of the device. This attribute makes it possible to vent and also introduce cardioplegic solutions using the same device. These cannulae are available in a range of sizes as per table below:

The R501-R502 cannulae are a modified version of the currently marketed R501-R502 Aortic Root cannulae (K200612).

The provided text is a 510(k) premarket notification summary for a medical device, the R501-R502 aortic root cannulae. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets a specific set of acceptance criteria through a clinical study or a multi-reader, multi-case (MRMC) study.

Therefore, many of the requested details, such as acceptance criteria, expert ground truth, adjudication methods, MRMC studies, and standalone performance, are not applicable to this type of regulatory submission. The primary method of demonstrating safety and effectiveness in this document is comparison to a predicate device via non-clinical performance data and a statement of substantial equivalence.

Here's an explanation based on the provided text:

1. A table of acceptance criteria and the reported device performance:

This document does not contain a table of explicit acceptance criteria with corresponding device performance results in the way one would expect from a clinical trial or a formal validation study for a novel device. Instead, the performance is demonstrated through a comparison to a predicate device and adherence to applicable voluntary standards.

The non-clinical performance data section states: "The device passed all the testing in accordance with national and international standards." This implies that the acceptance criteria for these tests were meeting the requirements of the standards, but the specific numerical criteria and results are not detailed.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not applicable. The submission relies on non-clinical performance data (testing) and a comparison to a predicate device. There is no "test set" in the context of clinical data or AI model evaluation.
• Data Provenance: Not applicable. As there are no clinical studies or AI evaluations described, there is no "data provenance" in terms of subject demographics or study design. The non-clinical testing was conducted by Sorin Group Italia s.r.l.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No ground truth was established by experts for a test set in the context of this submission, as it focuses on substantial equivalence through non-clinical testing and comparison to a predicate.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No test set requiring expert adjudication is described.

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:

No MRMC comparative effectiveness study was done. This is explicitly stated in the document under "Clinical Performance Data": "No clinical testing was conducted in support of the R501-R502 Cannulae, as the indications for use and technical characteristics are equivalent to those of the predicate device, which has been on the market for several years with proven safety and efficacy of use."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical medical device (cannula), not an AI algorithm. Therefore, no standalone algorithm performance was assessed.

7. The type of ground truth used:

Not applicable. As no clinical studies or AI performance evaluations are described, the concept of "ground truth" (e.g., expert consensus, pathology, outcomes data) does not apply here. The submission relies on the established safety and efficacy of the predicate device and the results of non-clinical engineering and materials testing.

8. The sample size for the training set:

Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning or AI models.

9. How the ground truth for the training set was established:

Not applicable. There is no training set for this device.

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