HOLLISTER RETRACTED PENIS POUCH

K970443 · Hollister, Inc. · EXI · Feb 25, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970443
• Device Name: HOLLISTER RETRACTED PENIS POUCH
• Applicant: Hollister, Inc.
• Product Code: EXI · Gastroenterology, Urology
• Decision Date: Feb 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5250
• Device Class: Class 1

Intended Use

The Hollister Urine Collection Pouch is intended to collect urine from incontinent men by encompassing the penis

Device Story

One-piece disposable urine collection system for incontinent men; encompasses penis. Constructed from odor-barrier film (polyethylene/vinylidene chloride/vinyl chloride copolymer laminate) with synthetic hydrocolloid skin barrier adhesive. Features molded polyethylene drain valve and polyvinylchloride tubing. User may enlarge pre-cut barrier opening to fit anatomy; adhesive microporous tape strips optional for security. Used in clinical or home settings; managed by patients or caregivers. Collects urine to manage incontinence; protects skin via adhesive barrier.

Clinical Evidence

Bench testing only. Biocompatibility assessed per ISO 10993, FDA G95-1, and USP standards using material history and laboratory evaluations.

Technological Characteristics

Materials: Hydrocolloid synthetic skin barrier, non-woven polyethylene fabric backing, polyethylene/vinylidene chloride/vinyl chloride copolymer/polyethylene laminate odor-barrier film, molded polyethylene resin drain valve, molded polyvinylchloride resin tubing. Barrier thickness: 0.045 inch nominal. Non-sterile configuration. Biocompatibility per ISO 10993 and USP.

Indications for Use

Indicated for incontinent men requiring urine collection via a pouch system encompassing the penis.

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

• Hollister Female Urine Collection Pouch (K862934)

Submission Summary (Full Text)

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Hollister

Hollister Incorporated
2000 Hollister Drive
Libertyville, Illinois 60048-3781
P192
K970443

Hollister Incorporated
Urine Collection Pouch

510(k) Summary
FEB 25 1997

1. Submitter's name, Address and Contact Person

| Submitter | Contact Person |
| --- | --- |
| Hollister Incorporated | Joseph S. Tokarz |
| 2000 Hollister Drive | Manager, Regulatory Affairs |
| Libertyville, IL 60048 | Ph [phone] |
| | Fax [phone] |

Date Summary Prepared - February 3, 1997

2. Name of Device:
Hollister Urine Collection Pouch

3. Name of Predicate Device(s)
Hollister Female Urine Collection Pouch, K862934

4. Description of Device
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 pre-cut 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.

5. Statement of Intended Use
The Hollister Urine Collection Pouch is intended to collect urine from incontinent men by encompassing the penis

6. Statement of Technological Characteristics of the Device
The proposed device is substantially equivalent to the predicate device. The following is a chart comparing the two devices.

TEL [phone] FAX [phone]

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K970443
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# Hollister

## Hollister Incorporated
## Urine Collection Pouch

### Comparison of the Proposed Urine Collection Pouch and the Predicate Device

| Characteristic | Hollister Urine Collection Pouch | Hollister Female Urinary Pouch |
| --- | --- | --- |
| Premarket Notification | Current Submission | K862934 |
| Intended Use | to collect urine from incontinent men | to collect urine from incontinent women |
| Barrier Adhesive | Hydrocolloid Synthetic Skin Barrier | Hydrocolloid Synthetic Skin Barrier |
| Barrier Backing | Non-woven Polyethylene Fabric | Closed-Cell Ethylene Copolymer Foam |
| Barrier Thickness | .045 inch nominal | .064 inch nominal |
| Pouch Film | Polyethylene/Vinylidene Chloride,Vinyl Chloride Copolymer/ Polyethylene Laminate Odor Barrier Film | Polyethylene/Vinylidene Chloride,Vinyl Chloride Copolymer/ Polyethylene Laminate Odor Barrier Film |
| Drain Valve | Molded Polyethylene Resin | Molded Polyethylene Resin |
| Drain Valve Tubing | Molded Polyvinylchloride Resin | Molded Polyvinylchloride Resin |

## 8. Biocompatibility

The biocompatibility of the Urine Collection Pouch as a nonsterilized configuration was assessed based on principles and guidelines established by various governmental and standard setting organizations, such as:

- ISO 10993, International Standards Organization (ISO) Standard
- General Program Memorandum #G95-1, United States FDA Office of Device Evaluation
- United Stated Pharmacopeia (USP)

Material biocompatibility issues have been addressed based upon biomaterial history or in separate *in vitro* or *in vivo* laboratory evaluations using licensed commercial reference laboratories. Specific test methodology has been chosen, where appropriate, from test protocols established or recommended by the aforementioned agencies or organizations. Product use conditions have been mimicked in testing procedures where possible. These evaluations have been contracted either by Hollister or the suppliers of the materials.

Based upon the results of this assessment, the materials used to fabricate the Urine Collection Pouch are considered biocompatible and appropriate for their intended use.

## 8. Conclusion

Based upon the information presented above it is concluded that the proposed Urine Collection Device is safe and effective for its intended use and is substantially equivalent to the predicate device.

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