AMSURE 100% SILICONE FOLEY CATHETER

K051059 · Amsino International, Inc. · EZL · Jun 28, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K051059
• Device Name: AMSURE 100% SILICONE FOLEY CATHETER
• Applicant: Amsino International, Inc.
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Jun 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AMSure 100% Silicone Foley Catheter is intended for use in the drainage of fluids to, and from, the urinary tract

Device Story

The AMSure 100% Silicone Foley Catheter is a urological device designed for urinary tract fluid drainage. It is a passive, mechanical device inserted into the urinary tract to facilitate the flow of urine. It is intended for use by healthcare professionals in clinical settings. The device functions as a conduit for fluid management, aiding in patient bladder drainage and monitoring. It does not involve electronic components, software, or automated processing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

100% silicone construction; urological catheter form factor; passive mechanical drainage; non-electronic; non-software; sterile.

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).

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows a logo of the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF" is stacked vertically on the left side of the eagle, and "HEALTH & HUMAN SERVICES" is stacked vertically on the right side of the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville"MD 20850

JUN 2 8 2005

Ching Ching Seah, Ph.D. Director of Research and Development Amsino International, Inc. 855 Towne Center Drive POMONA CA 91767

RE: K051059

Trade/Device Name: AmSure 100% Silicone Foley Catheter Regulation Number: 21 CFR § 876.5130 Regulation Name: Urological catheter and accessories

Regulatory Class: II Product Code: 78 EZL Dated: June 14, 2005 Received: June 17, 2005

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 predicate devices marketed in interstate commerce prior to the choosed, to e enactment date of the Medical Device Amendments, or to devices that have been May 20, 1710, the sharantinent 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 do inot roquier appreval controls provisions of the Act. The general controls provisions of the Act action in the generate 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 It your de roo is excelled to such additional controls. Existing major regulations affecting your Apple rar, the 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 mean that I loase or advisod 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 r carreres and registrating, 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) (2) Crice Part 820); and if applicable, the electronic 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) I mis letter will anow you to ought tuding of substantial equivalence of your device to a legally prematice notification: "The PDF mailig sification 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 If you desire specific acrise to your an of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prodoc note the regulation on your responsibilities under the Act from the 607.97). " Ou may oount varers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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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Amsino International. Inc. 855 Fowne Center Driver ............ 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 2011 11

AMSINO

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K051059
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## Indications for Use Statement

510(k) Number: (if known)

K051059

AMSure 100% Silicone Foley Catheter Device Name:

Indications The AMSure 100% Silicone Foley Catheter is intended for use in the drainage of fluids to, and from, the urinary tract for Use:

## 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

Nancy C. Hogdon

(Divisiok Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K051059