(100 days)
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.
§ 876.5250 Urine collector and accessories.
(a)
Identification. A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:(1) A urine collector and accessories intended to be connected to an indwelling catheter, which includes the urinary drainage collection kit and the closed urine drainage system and drainage bag; and
(2) A urine collector and accessories not intended to be connected to an indwelling catheter, which includes the corrugated rubber sheath, pediatric urine collector, leg bag for external use, urosheath type incontinence device, and the paste-on device for incontinence.
(b)
Classification —(1)Class II (special controls) for a urine collector and accessories intended to be connected to an indwelling catheter. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2)
Class I (general controls). For a urine collector and accessories not intended to be connected to an indwelling catheter, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.