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The Flexiflo Low-Profile Balloon Gastrostomy tube is indicated for use as a replacement tube in an established stoma tract for pediatric, adult and elderly patients who cannot consume an adequate diet orally. Gastrostomy feeding may be indicated for patients with a functioning gut who require long-term feeding support. This includes patients in whom malnutrition already exists, or may result, secondary to neurologic diseases resulting in an abnormality in swallowing; tumors of the head, neck or esophagus; or upper airway diseases or oropharyngeal trauma resulting in an abnormality in swallowing. Some patients requiring chronic use of supplemental fluids are candidates for gastrostomy.

Flexiflo® Low-Profile Balloon Gastrostomy Tube Kit and Accessories

I am sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for the Flexiflo® Low-Profile Balloon Gastrostomy Tube Kit and Accessories. It states that the device is "substantially equivalent" to previously marketed devices and outlines regulatory responsibilities.

However, the document does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies (MRMC or standalone). It is a regulatory approval letter, not a scientific study report.

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