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The Medline Anti-Reflux Valve allows the vent lumen of the gastric sump tube to neutralize the vacuum pressure in the stomach when the contents are fully evacuated, but prevents stomach contents from exiting the vent lumen. This reduces the risk that healthcare workers will be exposed to potentially infectious gastric fluids and also prevents unnecessary patient bedding and gown changes.

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I am sorry, but the provided text is a 510(k) premarket notification of intent to market a medical device (Medline Anti-Reflux Valve) and does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on the FDA's "substantial equivalence" determination, indicating that the device is similar enough to previously marketed devices that it doesn't require a full Premarket Approval (PMA) application. It discusses:

• Device Name: Medline Anti-Reflux Valve
• Regulation Number and Name: 21 CFR § 876.5980, Gastrointestinal tube and accessories
• Regulatory Class: II
• Product Code: FEG
• Indications for Use: Allows the vent lumen of the gastric sump tube to neutralize vacuum pressure in the stomach while preventing stomach contents from exiting, reducing exposure to gastric fluids for healthcare workers and preventing bedding/gown changes.

To provide the information you requested (acceptance criteria, study details, sample sizes, ground truth, etc.), I would need a different type of document, such as a clinical study report, a validation report, or a summary of safety and effectiveness data, which are not present in this 510(k) letter.

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