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The intended use for the PeriVac Kit is as follows: The PeriVac Kit is intended for use in pericardial aspiration and drainage in the presence of pericardial effusion and tamponade.

The PeriVac Kit is designed to provide all of the necessary components for site preparation, local anesthesia, puncture, aspiration and/or drainage, collection, and dressing for the completion of pericardial fluid aspiration. The kit is comprised of finished components and packaged to provide convenience for the user. The PeriVac Kit is comprised of 21 components pre-assembled and packaged to eliminate delays when initiating emergency pericardial aspiration of fluid. For customer convenience, the PeriVac Kit will be made available in four packaging configurations with the only difference between the kits being the catheter types and the inclusion of Lidocaine and Providone-Iodine solution. This submission addresses two components of the PeriVac Kit.

The provided text describes a 510(k) submission for a medical device, the PeriVac Kit, and its comparison to a predicate device. However, it does not contain information regarding acceptance criteria, study design, or performance metrics that would typically be associated with AI/ML device studies. This document is a regulatory submission for a traditional medical device (pericardiocentesis kit), not an AI/ML powered device.

Therefore, I cannot extract the requested information as it is not present in the provided text. The submission focuses on demonstrating substantial equivalence to a predicate device based on device characteristics and intended use, rather than presenting performance data from a clinical or non-clinical study in the context of acceptance criteria.

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The PeriVac Kit is intended for use in pericardial aspiration and drainage in the presence of pericardial effusion or tamponade.

The PeriVac Kit is a complete procedure tray for the purpose or pericardial aspiration and/or drainage. It contains the necessary components for site preparation, anesthesia, puncture, drainage, collection, and dressing.

This 510(k) premarket notification for the PeriVac Kit does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The submission is a substantial equivalence determination, which means the manufacturer is asserting that their device is as safe and effective as a legally marketed predicate device. This type of submission relies on demonstrating similarity to an already approved device rather than presenting new clinical study data with specific acceptance criteria typically seen for novel devices or those with higher risk classifications.

Here's a breakdown of why the requested information isn't available in this document:

1. Acceptance Criteria and Reported Device Performance: Not present. The submission focuses on comparing the "Modified Device" (PeriVac Kit) to a "Predicate Device" (Mansfield PeriVac Kit) in terms of intended use, description, single-use nature, sterilization method, manufacturer, and device classification. It doesn't present technical performance metrics or targets.

2. Sample Size and Data Provenance for Test Set: Not applicable. No test set for performance evaluation is described.

3. Number and Qualifications of Experts for Ground Truth: Not applicable. No ground truth establishment discussed.

4. Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is not an AI or imaging device where MRMC studies are typically performed.

6. Standalone Performance Study: Not applicable. The device is a medical kit for a procedure, not a standalone algorithm or diagnostic tool.

7. Type of Ground Truth Used: Not applicable.

8. Sample Size for Training Set: Not applicable. This is not a machine learning device.

9. How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided document is a 510(k) summary for a medical device kit, not a study evaluating performance against specific acceptance criteria. The FDA's determination of substantial equivalence (as shown in the attached letters) is based on the comparison to a predicate device, not on new clinical performance data for the PeriVac Kit itself.

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