(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.
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Image /page/0/Picture/1 description: The image shows the text 'K963265' in a handwritten style. Below this, the text 'ProSys™ SAMEC™ LA 510(k) Premarket Notification' is printed in a smaller, more formal font. The text appears to be part of a document or label, possibly related to a product or regulatory submission.
ITEM 8: 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
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. This device is not significantly different from other one-piece self-adhering male external catheters used in the management of male urinary incontinence. ProSys™ SAMECTM LA is substantially equivalent to Mentor Urology, Inc.'s Freedom Cath® Self-Adhering Male External Catheter. The indications and contraindications for ProSys™ SAMECTM LA are substantially equivalent to Freedom Cath® and other latex self-adhering male external catheters.
Biocompatibility testing demonstrated that the adhesive material used in ProSys™ SAMECTM LA is safe for human use. The adhesive material is non-toxic, non-sensitizing and resulted in a Primary Irritation Index of 0.25, where an index between 0 and 2 is classified as mildly irritating. Typically, any material which results in a Primary Irritation Index of 2 or less can be considered to have passed the Skin Irritation Test. In this case, the Primary Irritation Index of 0.25 is well within the range of acceptable values.
Biocompatibility testing demonstrated that the latex rubber is non-toxic, non-irritating, and non-sensitizing. The latex rubber did not pass Cytotoxicity (Agar Overlay or MEM Elution) testing. These test results are expected due to the fact that latex rubber is the positive control for these tests. According to USP guidelines, dilutions may be performed to determine a material's endpoint if it fails the MEM Elution test initially. The MEM Elution was repeated with a dilution of 1:32 latex rubber and passed.
The results of all testing are provided in Item 5.
Based upon the above information, ProSys™ SAMEC™ LA is substantially equivalent to Freedom Cath®.
§ 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.