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• The filter is intended for use only with non-cellular fluid in the extra-. corporeal circuit prior to the initiation of cardiopulmonary bypass.
• The DPB30 disposable pre-bypass filter has been designed for single . use and should be discarded once the circuit is primed
• The device is intended for adult population only. .

DPB30 Disposable Pre-bypass Filter

The provided text is a 510(k) clearance letter from the FDA for a medical device called "DPB30 Disposable Pre-bypass Filter." This document does not contain information about acceptance criteria, clinical study results, or detailed performance data.

The letter explicitly states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This means that for a 510(k) submission, the manufacturer focused on demonstrating that their device is as safe and effective as existing, legally marketed devices, rather than conducting new clinical trials to prove efficacy against specific acceptance criteria.

Therefore, I cannot provide the requested information based on the given document. The document only covers:

• Device Name: DPB30 Disposable Pre-bypass Filter
• Intended Use: For use only with non-cellular fluid in the extra-corporeal circuit prior to the initiation of cardiopulmonary bypass. Designed for single use and intended for the adult population only.
• Regulatory Class: II (Two)
• Product Code: 74 JOW

To answer your questions about acceptance criteria and a study proving the device meets them, I would need a different type of document, such as a clinical study report or a detailed summary of safety and effectiveness (SSE) for a PMA (Premarket Approval) device, or a more comprehensive 510(k) summary that includes performance data.

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• . THE FILTER IS INTENDED FOR USE ONLY WITH NON-CELLULAR FLUID IN THE EXTRACORPOREAL CIRCUIT PRIOR TO THE INITIATION OF CARDIOPULMONARY BYPASS.
• THE DPB20™ DISPOSABLE PRE-BYPASS FILTER HAS . BEEN DESIGNED FOR SINGLE USE AND SHOULD BE DISCARDED ONCE THE CIRCUIT IS PRIMED.

Not Found

This is a 510(k) premarket notification for a disposable cardiopulmonary pre-bypass filter, not an AI/ML device. Therefore, the requested information about acceptance criteria, study design, expert involvement, and ground truth for an AI/ML device is not applicable to this document.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the primary regulatory pathway for this type of medical device. There is no mention of an AI/ML component or study involving such.

Ask a specific question about this device