RUSCH SILICONE FOLEY CATHETER

K980870 · Rusch, Inc. · EZL · Jun 9, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980870
• Device Name: RUSCH SILICONE FOLEY CATHETER
• Applicant: Rusch, Inc.
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Jun 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Rusch Silicone Foley Balloon Catheter is used to drain fluids to and from the urinary tract.

Device Story

Rüsch Silicone Foley is a single-use, sterile, retention-type urological catheter. Device consists of a silicone shaft with an integrated retention balloon, a connecting funnel, and a Luer-activated valve. Available in sizes 8 Fr to 26 Fr with cylindrical, Coude, or Tiemann tips; pediatric versions include a stylet for placement. One lumen facilitates fluid drainage; a second lumen manages balloon inflation/deflation with sterile water; three-lumen models allow for urinary tract flushing. Profile shafts with drainage channels and coated options are available. Device is used in clinical settings for urinary tract management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Silicone catheter with silicone retention balloon, ported distal tip, and silicone funnel. Available in sizes 8 Fr to 26 Fr. Configurations include cylindrical, Coude, and Tiemann tips. Features include Luer-activated valve, optional coating, and optional profile shafts with drainage channels. Pediatric models include a stylet. Sterilization method not specified.

Indications for Use

Indicated for drainage of fluids to and from the urinary tract in patients requiring catheterization.

Regulatory Classification

Identification

A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

Predicate Devices

• Bard, Bardex (not specified)
• Mentor, 4 Sure (not specified)

Submission Summary (Full Text)

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# JUN - 9 1998

## 510 (k) Summary

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

Mr. James R. Whitney Group Regulatory Affairs Associate Rüsch International Tall Pines Park Jaffrey, New Hampshire 03452

[phone] Telephone: [phone] Facsimile:

Same as above Contact:

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

Classification Name: Urological Catheter

Common Name: Foley Catheter

Proprietary Name: Rüsch Silicone Foley

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

The Rusch Silicone Foley is substantially equivalent to the Bard, Bardex® and Mentor, 4 Sure®,

#### 4 . Description of the Device.

The Rusch Silicone catheter is of the retention type, commonly called a Foley catheter. The device is a single use, disposable, sterile with retention balloon, which is attached to the silicone shaft. One lumen is for draining fluids to and from the urinary tract. The second lumen is to inflate and deflate the balloon with sterile water. On models with a third lumen, it is used in conjunction with the first lumen for flushing the urinary tract. Sterile water is used for inflation and deflation of the balloon. The distal end has two opposite eye holes, which are used On the Tiemann tip there is one hole. for drainage. Cylindrical, Coude and Tiemann tips are available versions of this product. On the opposing end of the shaft, are a connecting funnel and a Luer activated valve.

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Pediatric sizes are available with the same configurations as the adult with the additional feature of a stylet that is inserted prior to the catheter placement. This product is available in sizes 8 Fr to 26 Fr, smooth and profile shafts. Both shafts are available in coated form. Profile shafts provide drainage channels along the shaft length.

#### 5. Intended Use of the Device.

The Rusch Silicone Foley is used to drain fluids to and from the urinary tract.

### ର . Summary of Technological Characteristics.

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

The silicone catheter with silicone balloon, ported distal tip, and silicone funnel with and without coating, is equivalent to predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN = 9 199

Mr. James R. Whitney Group Regulatory Affairs Associate Rusch International Tall Pines Park Jaffrey, New Hampshire 03452

Re: K980870 Rusch Silicone Foley Catheters Dated: May 29, 1998 Received: June 1, 1998 Regulatory Class: II 21 CFR §876.5130/Product Code: 78 EZL

Dear Mr. Whitney:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in . accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and 1 that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

W. Liao Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________ Rüsch Silicone Foley Catheter

Indications for Use:

The Rusch Silicone Foley Balloon Catheter is used to drain fluids to and from the urinary tract.

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Stalling
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR Over-The-Counter Use_