Search Results

The Impella CP Introducer is intended for introduction of pacing leads or catheters into the body.

The Impella CP Introducer is packaged as a sterile kit. which includes an introducer sheath (consisting of sheath with sideport tubing, stopcock and hemostasis valve assembly), and dilators, and a guidewire. It is identical to the commercially available predicate device, Oscor Introducer set, Model Adelante-S2 Introducer (cleared under K122084).

This document (K192769) outlines the 510(k) submission for the Impella CP Introducer. However, it explicitly states that no additional qualification testing was required for the substantial equivalence determination because the device is identical to its commercially available predicate device, the Oscor Introducer set, Model Adelante-S2 Introducer (cleared under K122084).

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria is not present in this document, as such a study was deemed unnecessary for this submission.

Here's a breakdown of why this information isn't available based on the provided text:

1. A table of acceptance criteria and the reported device performance: This is not available because no new performance testing was conducted. The device is considered to perform identically to its predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no new test set was used.

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): Not applicable, as no new test set was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no new test set was used.

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 device is an introducer, not an AI or imaging device, so MRMC studies are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as no new testing or ground truth establishment was required.

8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.

9. How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.

In summary, the K192769 submission for the Impella CP Introducer relies entirely on its substantial equivalence to a predicate device (Oscor Introducer set, Model Adelante-S2 Introducer, K122084) due to their identical design, manufacturing, and performance characteristics. Therefore, the document does not contain details about new acceptance criteria or a study to prove their fulfillment.

Ask a specific question about this device