← Product Code [EXI](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXI) · K963950

# BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE (K963950)

_Bioderm, Inc. · EXI · Jan 10, 1997 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXI/K963950

## Device Facts

- **Applicant:** Bioderm, Inc.
- **Product Code:** [EXI](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXI.md)
- **Decision Date:** Jan 10, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.5250
- **Device Class:** Class 1
- **Review Panel:** Gastroenterology, Urology
- **Attributes:** Therapeutic

## Indications for Use

The BioDerm® EID® is an external male catheter intended for the management of urinary incontinence in males. It facilitates urine drainage into a urine collection bag.

## Device Story

External male catheter; manages urinary incontinence; facilitates urine drainage into collection bag. Device applied externally to male anatomy; non-latex, self-adhesive design. Used in clinical or home settings; operated by patient or caregiver. Provides passive drainage path for urine; improves patient hygiene and comfort by containing incontinence.

## Clinical Evidence

Bench testing only; biocompatibility testing performed to confirm safety for intended use.

## Technological Characteristics

Non-latex, self-adhesive external catheter. Form factor designed for male anatomy. Passive drainage mechanism.

## Regulatory 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 PolyTech™, non-latex, self-adhesive urinary external catheter

## Submission Summary (Full Text)

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K963950
BIODERM
JAN 10 1997

# EXHIBIT 10.1: BioDerm® EID® MALE EXTERNAL INCONTINENCE DEVICE

## 510(k) SUMMARY

Submitted by:
Eric Flam, Ph.D.
NTL Associates, Inc.
East Brunswick, NJ 08816
(908)390-5656
October 1, 1996

Device Name: BioDerm® EID® MALE EXTERNAL INCONTINENCE DEVICE

(a) **Indications for Use**
The BioDerm® EID® is an external male catheter intended for the management of urinary incontinence in males. It facilitates urine drainage into a urine collection bag.

(b) **Biocompatibility**
The results of the biocompatibility tests show the device to be safe for its intended purpose.

(c) **Substantial Equivalence**
The BioDerm® EID® male external catheter is substantially equivalent to the Hollister PolyTech™, non-latex, self-adhesive urinary external catheter predicate device.

BioDerm, Inc. • 11300 49th St. N., Suite B, Clearwater, FL 34622 • 813-573-2866 • Fax 813-573-3448

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXI/K963950](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXI/K963950)

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