INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL

K965040 · Johnson & Johnson Medical, Inc. · HHW · Mar 10, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K965040
• Device Name: INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL
• Applicant: Johnson & Johnson Medical, Inc.
• Product Code: HHW · Obstetrics/Gynecology
• Decision Date: Mar 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.3575
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The INTROL* Bladder Neck Support Prosthesis with Removal Tool is indicated for the temporary management of genuine stress urinary incontinence.

Device Story

Device consists of circular, silicone elastomer bladder neck support prosthesis and high-density polypropylene/titanium dioxide removal tool. Tool features 7-inch rod with hook end and grip-enhanced handle with depth-gauge rings. Used in clinical setting or by patient; tool facilitates removal of prosthesis from vagina. Prosthesis provides mechanical support to bladder neck to manage stress urinary incontinence. Benefit: temporary symptom relief for incontinence.

Clinical Evidence

Bench testing only; biocompatibility testing demonstrated device is non-sensitizing and non-irritating.

Technological Characteristics

Prosthesis: medical grade silicone elastomer, circular, central aperture, two ridges. Removal tool: high density polypropylene, titanium dioxide pigment, rod-shaped, 7 inches long, hook end, depth-gauge rings. Manual operation.

Indications for Use

Indicated for temporary management of genuine stress urinary incontinence in patients requiring bladder neck support.

Regulatory Classification

Identification

A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.

Predicate Devices

• INTROL Bladder Neck Support Prosthesis

Submission Summary (Full Text)

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MAR 10 1997
K965040
510(k) - INTROL* Bladder Neck Support Prosthesis with Removal Tool
510(k) SUMMARY
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INTROL* Bladder Neck Support Prosthesis with Removal Tool

1. DATE PREPARED
December 16, 1996

2. SUBMITTER
Johnson & Johnson Medical, Inc.
2500 Arbrook Boulevard, P.O. Box 90130
Arlington, Texas 76004-3130

3. CONTACT
Ralph H. Larsen., [phone]
Sr. Project Manager, Regulatory Affairs

4. NAME OF THE MEDICAL DEVICE
Classification name: Pessary, vaginal
Common/usual name: Vaginal Pessary
Proprietary name: INTROL* Bladder Neck Support Prosthesis with Removal Tool

5. DEVICE CLASSIFICATION
The INTROL* Bladder Neck Support Prosthesis with Removal Tool has been classified by the FDA under the heading of Vaginal Pessary 85HHW as a Class II device.

6. STATEMENT OF SUBSTANTIAL EQUIVALENCE
INTROL* Bladder Neck Support Prosthesis with Removal Tool is substantially equivalent and identical in function to INTROL Bladder Neck Support Prosthesis marketed by Johnson & Johnson Medical, Inc.

7. INDICATIONS FOR USE
The INTROL* Bladder Neck Support Prosthesis with Removal Tool is indicated for the temporary management of genuine stress urinary incontinence.

8. PHYSICAL DESCRIPTION
The INTROL* Bladder Neck Support Prosthesis with Removal Tool is identical in all aspects to INTROL* Bladder Neck Support Prosthesis except for the addition of the Removal Tool. The Removal Tool is a rod shaped device, about 7 inches in length with a hook at one end and a handle at the opposite end. The handle is marked with a flat surface about 0.25 inch in width and 4 slightly elevated rings, each about 1 inch apart. The flat handle surface is on the same side of the tool as the open portion of the hook. This configuration indicates the direction of the functioning portion of the hook. The rings are present to enhance the grip of the tool and to enable the user to gauge the depth of the tool once it enters the vagina. The hook is designed to easily engage the front portion of the INTROL* Prosthesis's ring. The Removal Tool surface is smooth. The Removal Tool is composed of high density polypropylene and titanium dioxide pigment.

*Trademark
000 00094

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page 2 of 2
510(k) - INTROL* Bladder Neck Support Prosthesis with Removal Tool

INTROL* Bladder Neck Support Prosthesis is made from a medical grade silicone elastomer. The prosthesis is circular and symmetrically shaped with a central aperture and two ridges.

7. BIOCOMPATIBILITY

Safety tests demonstrate that INTROL* Bladder Neck Support Prosthesis with Removal Tool is non-sensitizing, and non-irritating and suitable for its intended use.

*Trademark
000 00095