KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET
Applicant
The Kendal Co.
Product Code
KOB · Gastroenterology, Urology
Decision Date
Apr 23, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.5090
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Kendall CURITY Suprapubic Catheter Trays and kits are intended to provide urinary bladder drainage or irrigation by percutaneous placement of a suprapubic catheter. This is a useful method of controlling urinary bladder drainage postoperatively.
Device Story
Sterile, single-use suprapubic catheter trays and kits; provide bladder access for irrigation and urine drainage. Device consists of 100% silicone two-way balloon catheters (10, 12, 14 French) with drainage and inflation lumens; packaged with various accessories. Used in clinical settings for postoperative bladder management. Healthcare providers perform percutaneous placement to facilitate drainage; output is effective bladder management. Benefits include controlled urinary drainage and irrigation access.
Clinical Evidence
No clinical data. Bench testing only: biocompatibility per ISO-10993; functional/mechanical testing including flow rates, balloon burst volume, valve retention, bond strength, and load testing.
Technological Characteristics
100% silicone two-way balloon catheters; 10, 12, 14 French sizes. Sterile, single-use. Biocompatibility per ISO-10993. Mechanical testing: flow rates, balloon burst volume, valve retention, funnel/shaft bond strength, static/dynamic load, water loss.
Indications for Use
Indicated for patients requiring urinary bladder drainage or irrigation via percutaneous suprapubic catheter placement, particularly for postoperative bladder drainage control.
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
Kendall CURITY Suprapubic Drainage System (K842899)
Submission Summary (Full Text)
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K970969
# APR 23 1997
## Exhibit 6
### 510(k) Summary
#### Kendall CURITY Suprapubic Catheter Trays and Kits
In accordance with section 513(l) of the SMDA and as described in 21 CFR Part 807.3 final rule dated December 14, 1994, this summary is submitted by:
Kendall Healthcare Products Company
15 Hampshire Street
Mansfield, MA 02048
Date: February 6, 1997
1. **Contact Person**
David A. Olson, Regulatory Affairs
Telephone: (508) 261-8530
2. **Name of the Device**
Classification Name: Suprapubic Urological Catheter and Accessories
Common or Usual Name: Suprapubic Catheter
Proprietary Name: Kendall CURITY Suprapubic Catheter Trays and Kits
3. **Statement of Substantial Equivalence**
The Kendall CURITY Suprapubic Catheter Trays and Kits are substantially equivalent in intended use, design and function to the Kendall CURITY Suprapubic Drainage System, 510(k) No. K842899.
4. **Description of Device**
The Kendall Suprapubic Catheter Trays and Kits are sterile, single use devices which are designed to provide suprapubic access to the bladder for bladder irrigation and urine drainage. The proposed device consists of 100% silicone suprapubic catheters in 10, 12 and 14 French sizes packaged with various accessories.
The catheters are two-way balloon catheters having a drainage and inflation lumen.
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K970969
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5. **Device Intended Use**
The Kendall CURITY Suprapubic Catheter Trays and kits are intended to provide urinary bladder drainage or irrigation by percutaneous placement of a suprapubic catheter. This is a useful method of controlling urinary bladder drainage postoperatively.
6. **Product Comparison**
The Kendall CURITY Suprapubic Catheter Trays and Kits is equivalent to the referenced predicate device in that they are fabricated from similar materials, have the same function, equivalent indications for use, and similar designs.
7. **Nonclinical Testing**
Biocompatibility testing was performed on the catheter following ISO-10993 Biological Evaluation of Medical Devices. This testing found the material contained no toxic diffusible substances.
Functional/Mechanical testing was performed to determine flow rates, balloon burst volume, valve retention, funnel/shaft bond strength, static load, dynamic load, water loss and non-deflator test. Testing showed equivalence between the proposed catheter and commercially available suprapubic catheters.
