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The Peripheral Retrograde Cardioplegia Cannula is indicated for use in the delivery of blood or cardioplegic solution. Placement of the cannula may be performed either through the jugular vein or intraoperatively.

The BRMI Peripheral Retrograde Cannula is a triple lumen radiopaque cannula. The distal tip contains multiple infusion holes and a separate pressure monitoring lumen that terminates at a 3-way stopcock. A soft, low-pressure, manually inflated and deflated silicone occlusion balloon surrounds the distal body (proximal to the flow holes). The cannula has approximately 50cm of usable lumen length. Each Peripheral Retrograde Cannula is individually packaged sterile and non-pyrogenic in a sealed, peel-type pouch.

This document is a 510(k) summary for a medical device (Peripheral Retrograde Cardioplegia Cannula). It does not contain information about studies to prove acceptance criteria, as this type of device (a cannula) is typically cleared based on substantial equivalence to predicate devices rather than clinical performance studies with acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on:

• Device Description: What the device is and its components.
• Intended Use: How the device is meant to be used.
• Predicate Devices: Comparison to similar devices already on the market to demonstrate substantial equivalence.
• Regulatory Classification: The FDA's classification of the device.

There is no mention of:

• Acceptance criteria for performance.
• Any studies (clinical or otherwise) with sample sizes, data provenance, ground truth establishment, expert adjudication, or MRMC/standalone performance.

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