(20 days)
The Hollister Urine Collection Pouch is intended to collect urine from incontinent men by encompassing the penis
The Hollister Urine Collection Pouch is a one-piece disposable system which collects urine by encompassing the penis. The pouch is made from odor-barrier film and features a synthetic skin barrier adhesive which aids in the protection of the skin. If required the precut opening in the barrier may be enlarged to accommodate the anatomy of the user. Strips of adhesive microporous tape may be used for additional security.
The provided document is a 510(k) summary for the Hollister Urine Collection Pouch. It describes a medical device and compares it to a predicate device for regulatory approval. This document does not contain any information about a study with acceptance criteria, reported device performance, sample sizes, expert ground truth, or adjudication methods in the context of an AI/ML device.
The document discusses:
- Device Description: A one-piece disposable system to collect urine from incontinent men.
- Predicate Device: Hollister Female Urine Collection Pouch, K862934.
- Technological Characteristics Comparison: A table comparing characteristics like intended use, barrier adhesive, barrier backing, barrier thickness, pouch film, drain valve, and drain valve tubing between the proposed and predicate devices.
- Biocompatibility: Assessment based on ISO 10993, FDA guidelines (G95-1), and USP. Materials were found biocompatible.
- Conclusion: The device is safe, effective, and substantially equivalent to the predicate device.
Therefore, I cannot fulfill your request as the information you are asking for (acceptance criteria and study details for an AI/ML device) is not present in the provided text. This document is from 1997 and pertains to a physical medical device, not an AI/ML system.
§ 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.