RUSCH SUPRAPUBIC TRAY

K970021 · Rusch, Inc. · KOB · Feb 7, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970021
• Device Name: RUSCH SUPRAPUBIC TRAY
• Applicant: Rusch, Inc.
• Product Code: KOB · Gastroenterology, Urology
• Decision Date: Feb 7, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5090
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The kit is used for percutaneous bladder drainage and to drain fluids to and from the urinary tract.

Device Story

Kit for percutaneous bladder drainage; includes silicone catheter, plastic introducer assembly, attachment tape, optional scalpel. Introducer creates pathway for percutaneous insertion; removed after placement; catheter remains as conduit for fluid passage. Catheter variants: one pair of drainage eyes or six drainage eyes in pigtail configuration. Used by clinicians in clinical settings for urinary tract drainage.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological characteristics identical to predicate devices.

Technological Characteristics

Kit components: silicone catheter, plastic introducer, attachment tape, optional scalpel. Catheter features: 1 or 6 drainage eyes (pigtail). Principle: percutaneous insertion via introducer system, followed by introducer removal leaving catheter in situ for fluid drainage.

Indications for Use

Indicated for patients requiring percutaneous bladder drainage and fluid drainage to/from the urinary tract.

Regulatory Classification

Identification

A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.

Predicate Devices

• Rüsch SupraFoley Suprapubic Introducer and Foley Catheter
• Rüsch Simplastic Suprapubic Catheter
• Microvasive Percutaneous Suprapubic Balloon Catheter Set
• Cook Stamey Percutaneous Catheter Set
• Rüsch Suprapubic Catheters

Submission Summary (Full Text)

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Risch INTERNATIONAL A Subsidiary of Telefax Incorporated (USA)

Tall Pines Park
Jaffrey, NH 03452
532-7706
[phone]

510(k) Summary

K970021

FEB - 7 1997

Pin²

1. Submitter Name, Address, and Date of Submission:

Miss Karenann J. Brozowski
Group Regulatory Affairs Director
Rüsch International
Tall Pines Park
Jaffrey, NH 03452

Telephone: [phone]

Contact: Same as above.

2. Names of the Device, Common, Proprietary (if Known), and Classification.

Classification Name: Suprapubic Catheter and Accessories
Common Name: Suprapubic Catheter Kit
Proprietary Name: Rüsch Suprapubic Tray

3. Identification of the legally marketed device to which the submitter claims equivalence.

The Rüsch Suprapubic Tray is substantially equivalent in design and function to the Rüsch SupraFoley Suprapubic Introducer and Foley Catheter, Rüsch Simplastic Suprapubic Catheter, Microvasive Percutaneous Suprapubic Balloon Catheter Set, and the Cook Stamey Percutaneous Catheter Set and the Rüsch Suprapubic Catheters.

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K970021
P2012

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## 4. Description of the Device:

The kit consists of two major components: silicone catheter and plastic introducer assembly, along with attachment tape to fix the catheter to the skin, if required, and an optional scalpel. The kit is used for percutaneous bladder drainage. There are two types of silicone catheters. The first comes equip with one pair of drainage eyes. The second type of silicone catheter comes with six drainage eyes arranged in a pigtail shape.

## 5. Intended Use of the Device:

The kit is used for percutaneous bladder drainage and to drain fluids to and from the urinary tract.

The usage of this product is identical to previous devices, which have the same technological characteristics.

## 6. Summary of Technological Characteristics:

The following technological characteristics are the same or equivalent as predicate devices:

The kit consists of introducer system for the catheter, which provides the pathway for percutaneous insertion. One introduced the introducer system is removed, the catheter remaining provides the conduit for fluid passage to and from the urinary tract.

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