PROSYS SAMEC LA

K963265 · Convatec, A Division of E.R. Squibb & Sons · EXJ · Oct 25, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K963265
• Device Name: PROSYS SAMEC LA
• Applicant: Convatec, A Division of E.R. Squibb & Sons
• Product Code: EXJ · Gastroenterology, Urology
• Decision Date: Oct 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5250
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

ProSys™ SAMECTM LA is intended for use in the management of male urinary incontinence.

Device Story

One-piece self-adhering male external catheter; manages urinary incontinence; device applied externally to male anatomy; adhesive secures device to skin; collects urine for drainage; used in clinical or home settings; operated by patient or caregiver; provides non-invasive alternative to indwelling catheters; improves patient hygiene and comfort.

Clinical Evidence

Bench testing only. Biocompatibility testing performed: Primary Irritation Index of 0.25 (classified as mildly irritating, within acceptable range). Cytotoxicity testing (MEM Elution) passed at 1:32 dilution.

Technological Characteristics

Latex rubber construction; self-adhering design; one-piece form factor. Biocompatibility verified per USP guidelines.

Indications for Use

Indicated for male patients requiring management of urinary incontinence.

Regulatory Classification

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.

Special Controls

*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 management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

Predicate Devices

• Freedom Cath® Self-Adhering Male External Catheter (Mentor Urology, Inc.)

Submission Summary (Full Text)

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OCT 25 1996
K963265
ProSys™ SAMECTM LA
510(k) Premarket Notification

# 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™ SAMECTM 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™ SAMECTM LA is substantially equivalent to Freedom Cath®.

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