SELF RETAINING MALE EXTERNAL URINARY CATHETER

K962900 · Hollister, Inc. · EXJ · Sep 16, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K962900
• Device Name: SELF RETAINING MALE EXTERNAL URINARY CATHETER
• Applicant: Hollister, Inc.
• Product Code: EXJ · Gastroenterology, Urology
• Decision Date: Sep 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5250
• Device Class: Class 1

Intended Use

The Hollister Self Retaining Male External Catheter is a urosheath type incontinence device intended to be used as an external catheter to collect urine from urinary incontinent males.

Device Story

Condom-like external urinary catheter; constructed from natural rubber latex; features internal flap to protect penile skin from urine backwash and extend wear time; presented on plastic collar for application and shape retention. Device retains position on penis via elastic sheath design matching penile diameter; relies on outward force of penis against sheath walls for securement; requires no adhesive or two-piece attachment system. Used by incontinent males to collect urine; facilitates management of incontinence.

Clinical Evidence

Bench testing only; biocompatibility assessed via in-vitro and in-vivo evaluations per EN 30993, FDA G95-1, and USP guidelines.

Technological Characteristics

Material: Natural rubber latex. Design: Elastic sheath with internal flap and plastic application collar. Retention: Shape-based mechanical fit (no adhesive). Biocompatibility: Tested per EN 30993, USP, and FDA G95-1.

Indications for Use

Indicated for urinary incontinent males requiring an external urine collection device.

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 Non-Rolled Male External Urinary Catheter (K940269)
• Mentor Active Cath Self Adhesive Male External Urinary Catheter

Submission Summary (Full Text)

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K962900
SEP 16 1996

# Hollister Incorporated
Hollister Self Retaining Male External Urinary Catheter

## 510(k) Summary

### 1. Submitter's Name, Address and Contact Person

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

Date Summary Prepared - September 13, 1996

### 2. Name of Device:

Hollister Self Retaining Male External Urinary Catheter

### 3. Name of Predicate Device(s)

Hollister Non-Rolled Male External Urinary Catheter K#940269<br/>
Mentor Active Cath Self Adhesive Male External Urinary Catheter

### 4. Description of Device

The Hollister Self Retaining Male External Urinary Catheter is a condom-like device made from Natural Rubber Latex. The device features a unique inner flap that aids in the protection of the penile skin from irritation due to backwash of urine and helps to maximize wear time. The external catheter is presented on a plastic collar to enable easy application and maintain the catheter shape integrity during shipping.

### 5. Statement of Intended Use

The Hollister Self Retaining Male External Catheter is a urosheath type incontinence device intended to be used as an external catheter to collect urine from urinary incontinent males.

### 6. Statement of Technological Characteristics of the Device

Currently, there are two basic types of male external catheters in commercial distribution:

1. A two-piece catheter that relies on a strip of adhesive to be placed on the penis and the urosheath adhered to the adhesive strip. There is also a two-piece catheter that relies on a velcro strip or other material to be wrapped around the urosheath after it has been placed on the penis, and
2. A self adhesive catheter that is designed with an adhesive that has been applied to the inside of the urosheath.

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# Hollister Incorporated
## Hollister Self Retaining Male External Urinary Catheter

The proposed device differs from these types of external catheters in that it is not a two-piece system nor does it rely on an adhesive for securement. Instead the proposed device is retained on the penis of the wearer solely by virtue of its designed shape. The proposed device is designed to contain the portion of the penis exclusive of the glans in an elastic sheath which substantially matches the diameter of the penis in its extended position so that the penis provides its own outward force against the walls of the elastic sheath which results in the retaining of the device upon the penis.

## 7. Biocompatibility Assessment

Material Biocompatibility: Issues of biomaterial safety or biocompatibility have been addressed based upon the biomaterial history or in separate *in-vitro* or *in-vivo* evaluations using licensed commercial reference laboratories. Each assessment was conducted based on principles and guidelines established by various governmental and standard setting organizations among these are the following:

- EN 30993, European Commission (EC) Standard
- General Program Memorandum #G95-1, United States FDA Office of Device Evaluation
- United Stated Pharmacopeia (USP)

The materials used to construct the Hollister Self Retaining Male External Urinary Catheter are considered biocompatible and suitable for their intended use.

## 8. Conclusion

Based on the information presented above and within the body of the 510(k) premarket notification, it is concluded that the Hollister Self Retaining Male External Urinary Catheter Device is safe and effective for its intended use. The Hollister Self Retaining Male External Urinary Catheter is substantially equivalent to the predicate device(s).