AMSURE FOLEY INSERTION TRAY

K030664 · Amsino International, Inc. · FCM · May 23, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K030664
• Device Name: AMSURE FOLEY INSERTION TRAY
• Applicant: Amsino International, Inc.
• Product Code: FCM · Gastroenterology, Urology
• Decision Date: May 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AMSure Foley Insertion Tray is intended for use in the drainage of urine from the bladder

Device Story

AMSure Foley Insertion Tray is a procedural kit used for catheterization. It facilitates the drainage of urine from the bladder. The tray contains various components necessary for the insertion procedure, including a catheter and Povidone Iodine Swabsticks. It is intended for use by healthcare professionals in clinical settings. The device assists in managing urinary retention or monitoring output. The inclusion of drug components (Povidone Iodine) requires separate regulatory consideration by the Center for Drug Evaluation and Research.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Procedural kit containing a urological catheter and accessories. Includes Povidone Iodine Swabsticks (regulated as a drug). Components must comply with 21 CFR 820 (Quality Systems) and relevant device regulations.

Indications for Use

Indicated for patients requiring urinary bladder drainage.

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 U.S. Department of Health & Human Services. 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 a stylized eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K030664

Trade/Device Name: AMSure ™Foley Insertion Tray

Regulation Number: 21 CFR 8876.5130

Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 FCM Dated: February 27, 2003 Received: March 3, 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 predicate 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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the tray have either been determined as substantially equivalent under the premarket notification process (Section 510/k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your tray. 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.

MAY 2 3 2003

If your device is classified (see above) into either 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 mean 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

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systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

In addition, we have determined that your device kit contains Povidone Iodine Swabsticks, which are subject to regulation as a drug.

Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing vour device with the drug components. For information on applicable Agency requirements for marketing this drug, we suggest you contact:

, " Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 [phone]

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, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/dsma/dsmamain.html.

Sincerely yours,

David H. Leyson

Nancy C. Brogdor 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)

K030664

Device Name:

AMSure Foley Insertion Tray

Indications for Use:

The AMSure Foley Insertion Tray is intended for use in the drainage of urine from the bladder

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Over-The-Counter Use

David A. Eygner
(Division Sign Off)

Division of Regronictiv Abaominal, and Radbrogen Device 510(k) Number ________________________________________________________________________________________________________________________________________________________________