EUROMEDICAL HAEMATURIA FOLEY CATHETER

K973076 · Unomedical Sdn Bhd · EZL · Sep 16, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K973076
• Device Name: EUROMEDICAL HAEMATURIA FOLEY CATHETER
• Applicant: Unomedical Sdn Bhd
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Sep 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The urological catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract.

Device Story

The Haematuria Foley catheter is a flexible tubular device designed for insertion through the urethra to facilitate fluid passage to or from the urinary tract. It features a spiral-reinforced shaft to prevent collapse during bladder suctioning. The device is available in various tip configurations, including Standard, Dufour, and Couvelaire, and is offered in sizes 16, 18, 20, 22, and 24 French. It is intended for use by healthcare professionals in clinical settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Natural latex with silicone coating. Design: Spiral-reinforced shaft for suction collapse prevention. Tip configurations: Standard, Dufour, Couvelaire. Sizes: 16-24 Fr. Sterilization: ETO. Connectivity: None (mechanical device).

Indications for Use

Indicated for patients requiring urinary tract drainage or fluid passage via urethral 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

• Euromedical Foley Catheter (K973076)

Submission Summary (Full Text)

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K973076

SEP 1 6 1998

## 510(K) SUMMARY (as required by 807.92(c))

Submitter of 510(k): Requlatory & Marketing Services, Inc. (RMS) 3234 Ella Lane New Port Richey, FL 34655

| Phone: | 813-376-4154 |
|--------|--------------|
| Fax: | 813-376-7186 |

Euromedical Foley Catheter

Euromedical Haematuria Foley Catheter

Contact Person:

Ed Ransom or Pat Lamb

Date of Summary:

August 11,1998

Trade Name:

Classification Name: Haematuria Foley Catheter

Predicate Device:

Device Description/ Comparison:

The Haematuria Foley catheter has a spiral reinforced shaft and eliminates collapse during suctioning from the bladder. The material is exactly the same as the already approved marketed foley catheter. It is available with a variety of tips, Standard, Dufour and Couvelaire.

| Materials | Euromedical<br>Haematuria | Euromedical<br>Foley Catheter |
|-------------------|-----------------------------------------|-------------------------------|
| Sizes, fr | 16, 18, 20, 22, 24 | Same |
| coating | silicone | same |
| Catheter | natural latex | same |
| Tip Configuration | Couvelaire, Defour and<br>Standard Tips | Standard Tip |
| | Sterilization | ETO |

Intended Use:

The urological catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract.

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Image /page/1/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUM" are arranged in a circular fashion around the left side of the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP | 6 1998

Euromedical Industries SDN. BHD. c/o Mr. Ed Ransom RMS Regulatory & Marketing Services, Inc. P.O. Box 1108 Elfers, FL 34680

Re: K973076 Euromedical Haematuria Foley Catheter Dated: August 7, 1998 Received: August 10, 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 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 Ouality 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 i 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 retro 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/dsmaldsmamain.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): K973076

Haematuria Foley Catheter Device Device Name:

Indications For Use:

The urological catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-()if) Division of Rep. 8 1. Beach 19 Countal, ENT, and Radiologics

510(k) Number .... . . . . . .......

Prescription Use
(Per 21 CFR 801.109)

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Over-The-Counter Use_

William Uhr
(Optional Format 1-2-96)

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