(66 days)
The purpose of this 510(k) Premarket Notification is to request clearance to market ProSys™ SAMECTM LA under the ConvaTec ProSys™ product line of incontinence products.
ProSys™ SAMEC™ LA is intended for use in the management of male urinary incontinence.
ProSys™ SAMEC™ LA is a one-piece self-adhering male external catheter.
This document is a 510(k) Premarket Notification for the ProSys™ SAMEC™ LA, a male external catheter. The document asserts substantial equivalence to a predicate device, the Mentor Urology, Inc.'s Freedom Cath® Self-Adhering Male External Catheter, based on indications, contraindications, and biocompatibility testing.
However, the provided text does not contain any information about acceptance criteria for a device's performance that would typically be evaluated in a study with a test set, ground truth, experts, or sample sizes related to clinical efficacy or diagnostic accuracy.
The information present focuses solely on the biocompatibility of the adhesive material and the latex rubber. It states:
- Adhesive material: Non-toxic, non-sensitizing, Primary Irritation Index of 0.25 (acceptable range: 0-2 for mildly irritating).
- Latex rubber: Non-toxic, non-irritating, non-sensitizing. Initially failed Cytotoxicity testing, but passed after a 1:32 dilution in the MEM Elution test.
**Therefore, I cannot provide the requested table and study details because the provided text does not describe a study involving:
- Acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy).
- A test set of data (e.g., patient samples, images).
- Ground truth established by experts.
- Sample sizes for test or training sets for an AI/algorithm.
- MRMC studies for human reader improvement.**
The "study" referenced is exclusively about biocompatibility testing, which has different types of acceptance criteria (e.g., irritation indices, passage of cytotoxicity tests at certain dilutions) than those for clinical performance of a diagnostic or therapeutic device that would involve AI.
§ 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.