ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER

K980919 · Fortune Medical Instrument Corp. · EZL · Mar 31, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980919
• Device Name: ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER
• Applicant: Fortune Medical Instrument Corp.
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Mar 31, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Silicone Foley Balloon Catheter and Nelation Catheter are intended for use as urinary catheters to pass fluids to and from the urinary bladder.

Device Story

The device consists of 100% silicone catheters, including 2-way and 3-way Foley balloon catheters and Nelaton catheters. These catheters are inserted into the urinary bladder to facilitate the passage of fluids to and from the bladder. Used in clinical settings by healthcare professionals, the device provides a pathway for drainage or irrigation. The silicone material is chosen for biocompatibility. The device functions as a passive conduit; it does not involve electronic processing, sensors, or automated decision-making. It is a mechanical device intended for prescription use.

Clinical Evidence

Bench testing only.

Technological Characteristics

Constructed of 100% silicone. Device types include 2-way Foley balloon, 3-way Foley balloon, and Nelaton catheters. Mechanical device; no energy source, software, or connectivity. Sterilization method not specified.

Indications for Use

Indicated for patients requiring urinary catheterization to facilitate fluid drainage or irrigation of the urinary bladder.

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).

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 1 1998

Re: K980919

Ms. Karen U. Salinas Regulatory Consultant FortuneMedical Instrument Corporation c/o Holland & Associates 3722 Ave. Sausalito Irvine, CA 92606

100% Silicone 2-way Foley Balloon Catheter Dated: March 10, 1998 Received: March 11, 1998 Regulatory Class: II 21 CFR 876.5130/Procode: 78 EZL and 78 GBM

Dear Ms. Salinas:

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, market the device, 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 II (Special Controls) or 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and 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 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 questions on the promotion 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/cdrb/dsmaldsmam.html".

Sincerely yours.

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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510(k) number (if known): ____________________________________________________________________________________________________________________________________________________

K980919

Device Name:

All Silicone 2-Way Foley Balloon Catheter All Silicone 3-Way Foley Balloon Catheter All Silicone Nelation Catheter

Indications for Use:

The Silicone Foley Balloon Catheter and Nelation Catheter are intended for use as urinary catheters to pass fluids to and from the urinary bladder.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109) ✓

OR

Over-The-Counter Use_

Rober R. Sattler/

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 4804 510(k) Number