AMSURE RED RUBBER URETHRAL CATHETER

K030293 · Amsino International, Inc. · EYB · Feb 4, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K030293
• Device Name: AMSURE RED RUBBER URETHRAL CATHETER
• Applicant: Amsino International, Inc.
• Product Code: EYB · Gastroenterology, Urology
• Decision Date: Feb 4, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AMSure Red Rubber Urethral Catheter is intended for use in the drainage of fluid from the urinary tract

Device Story

AMSure Red Rubber Urethral Catheter is a urological device used for urinary tract fluid drainage. It is a passive, mechanical device operated by healthcare professionals in clinical settings. The catheter is inserted into the urethra to facilitate the removal of urine from the bladder. It functions as a conduit for fluid flow. No electronic, software, or algorithmic components are involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Red rubber material; urological catheter form factor; passive mechanical drainage; non-electronic; non-software.

Indications for Use

Indicated for drainage of fluid 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).

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 4 2004

Ching Ching Seah, Ph.D. Director of Research, Development and Regulatory Affairs Amsino International, Inc. 4501 Brickell Privado ONTARIO CA 91761

Re: K030293

Trade/Device Name: AMSure™ Red Rubber Urethral Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 EYB Dated: October 6, 2003 Received: December 19, 2003

## Dear Dr. Seah:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed prodicate 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) that do not require approval of a premarket approval application (PMA). 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (sec above) into cither class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mcan that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. Ixxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brygdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number: (if known)

AMSINO

K030293

Device Name:

AMSure Red Rubber Urethral Catheter

Indications for Use:

The AMSure Red Rubber Urethral Catheter is intended for use in the drainage of fluid 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)

Prescription V Use (Per 21 CFR 801. 109) OR

Over-The-Counter Use

Nancy C. Brogdon
Division Sign-Off)
Division of Reproductive, Abdominal,

Division of Reproductive, Abdominal,
and Radiological Devices
§10(k) Number K030293