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The BioDerm® EID® is an external male catheter intended for the management of urinary incontinence in males. It facilitates urine drainage into a urine collection bag.

BioDerm® EID® MALE EXTERNAL INCONTINENCE DEVICE

This document, K963950, is a 510(k) summary for the BioDerm® EID® Male External Incontinence Device. It primarily focuses on demonstrating substantial equivalence to a predicate device and biocompatibility.

It does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

The document states:

• Indications for Use: The BioDerm® EID® is an external male catheter intended for the management of urinary incontinence in males. It facilitates urine drainage into a urine collection bag.
• Biocompatibility: The results of the biocompatibility tests show the device to be safe for its intended purpose.
• Substantial Equivalence: The BioDerm® EID® male external catheter is substantially equivalent to the Hollister PolyTech™, non-latex, self-adhesive urinary external catheter predicate device.

Therefore, I cannot provide the requested information in the format of acceptance criteria and performance study details because this 510(k) summary does not contain that level of detail regarding performance criteria or studies beyond basic biocompatibility and general safety for its intended purpose through substantial equivalence.

The questions you've asked (about sample size, ground truth, expert qualifications, etc.) are typically associated with studies evaluating the diagnostic or predictive performance of a device (e.g., an AI-powered image analysis tool). This device, an external catheter, is a physical medical device, and its "performance" is assessed differently, primarily through its physical properties, biocompatibility, and functional outcome (facilitating urine drainage), often compared to existing devices.

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