MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER

K982970 · Mri Manufacturing and Research, Inc. · EZL · Oct 28, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K982970
• Device Name: MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER
• Applicant: Mri Manufacturing and Research, Inc.
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Oct 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

This urological catheter is intended for the infusion of sterile solution into the bladder to irrigate, cleanse, or drain the contents of the bladder during surgical procedures.

Device Story

3-way Foley catheter; utilizes inflation balloon for bladder retention; facilitates infusion of sterile solutions for irrigation/cleansing and drainage of bladder contents. Used during surgical procedures. Operated by clinical staff.

Technological Characteristics

All-silicone construction; 3-way configuration; inflation balloon mechanism for retention.

Indications for Use

Indicated for patients requiring bladder irrigation, cleansing, or drainage during surgical procedures.

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

• ABCO Foley Catheter (K800307)

Submission Summary (Full Text)

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| OCT 28 1998 | 510(K) SUMMARY<br>(as required by 807.92(c)) | |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Submitter of 510(k): | Regulatory & Marketing Services, Inc. (RMS)<br>3234 Ella Lane<br>New Port Richey, FL 34655 | |
| | Phone:<br>Fax: | 813-376-4154<br>813-376-7186 |
| Contact Person: | Ed Ransom or Pat Lamb | |
| Date of Summary: | August 28, 1998 | |
| Trade Name: | 3-Way Foley Catheter | |
| Classification Name: | Foley Catheter | |
| Predicate Device: | ABCO Foley Catheter, K800307 | |
| Device Description/<br>Comparison: | Both the device in this submission and the predicate<br>device are used to irrigate and drain the bladder.<br>Both devices use an inflation balloon to retain the<br>Catheter in the bladder. Both devices are 3-way foley<br>Catheters. | |
| Intended Use: | This urological catheter is intended for the infusion<br>of sterile solution into the bladder to irrigate, cleanse,<br>or drain the contents of the bladder during surgical<br>procedures. | |

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Image /page/1/Picture/2 description: The image shows a black and white seal of the U.S. Department of Health & Human Services. The seal features the department's stylized logo, which consists of a stylized caduceus symbol with three intertwined snakes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the logo.

OCT 28 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MRI Manufacturing and Research, Inc. c/o.Mr. Ed Ransom President Regulatory & Marketing Services, Inc. 3234 Ella Lane New Port Richey, Florida 34655

Re: K982970

MRI's All Silicone Irrigation 3-way Foley Catheter Dated: October 12, 1998 Received: October 20, 1998 Regulatory Class: II 21 CFR 876.5130/Procode: 78 EZL

Dear Mr. Ransom:

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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Fecteral 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 (OS) 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 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 vitto 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.ida.gov/cdrb/dsmaldsmamain.html".

Sincerely your

Lillian Yin, Ph.D.
Director, Division of Reproductive

Director, Division of Reproducti 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): None Assigned At This Time |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | MRI's All Silicone Irrigation 3-Way Foley Catheter |
| Indications For Use: | This urological catheter is intended for the infusion of<br>Sterile solution into the b ladder to irrigate, cleanse,<br>or drain thecontents of the bladder during surgical<br>procedures. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Segen

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

ુલા 510(k) Number _ K982970

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)