PERIVAC KIT

• K Number: K032050
• Device Name: PERIVAC KIT
• Manufacturer: BOSTON SCIENTIFIC CORP.
• Date Cleared: 2003-08-08 ( 37 days)
• Product Code: DQX
• Regulation Number: 870.1330
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

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

Device Description

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.

AI/ML Overview

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.

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.