FOOTPRINT URINARY DRAINAGE CATHETER

K090576 · Footprint Medical · EZD · Aug 12, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K090576
• Device Name: FOOTPRINT URINARY DRAINAGE CATHETER
• Applicant: Footprint Medical
• Product Code: EZD · Gastroenterology, Urology
• Decision Date: Aug 12, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Footprint Urinary Drainage Catheter is a flexible tube intended for drainage of urine from small pediatric or Neonatal patients. This is a prescription device intended for use for less than 30 days. It is not implanted and is not a life supporting device.

Device Story

Footprint Urinary Drainage Catheter is a flexible tube designed for urine drainage in neonatal and small pediatric patients. Used in clinical settings by healthcare professionals. Device is non-implanted and intended for short-term use (less than 30 days). Functions as a passive drainage conduit to facilitate urine removal from the bladder. Benefits include management of urinary output in vulnerable patient populations. Device is not life-supporting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Flexible tube; non-implanted; intended for short-term use (<30 days).

Indications for Use

Indicated for urine drainage in small pediatric or neonatal patients. Prescription use only; duration of use less than 30 days. Not for implantation; not life-supporting.

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)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a stylized emblem or logo. It features a series of three parallel, curved lines that resemble the wings of a bird in flight. The lines are thick and bold, creating a sense of movement and dynamism. The emblem is positioned in the upper portion of the image, with a faint, partial word or phrase visible below it, oriented vertically.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

## AUG 1 2 2009

Mr. Clyde N. Baker Regulatory Manager Footprint Medical, Inc. 1203 Camden Street SAN ANTONIO TX 78215

Re: K090576

Trade/Device Name: Footprint Urinary Drainage Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: July 24, 2009 Received: July 29, 2009

Dear Mr. Baker:

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 (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, 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 (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); medical device reporting (reporting of medical

{1}------------------------------------------------

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/cdrh/industry/support/index.html.

Sincerely yours,

Jandra M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## INDICATIONS FOR USE STATEMENT

090576

510(K) NUMBER (if known):

FOOTPRINT URINARY DRAINAGE CATHETER DEVICE NAME:

## INDICATIONS FOR USE:

The Footprint Urinary Drainage Catheter is a flexible tube intended for drainage of urine from small pediatric or Neonatal patients. This is a prescription device intended for use for less than 30 days. It is not implanted and is not a life supporting device.

## CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION

| PRESCRIPTION USE<br>(per 21 CFR 801.109) | XX |
|------------------------------------------|----|
|------------------------------------------|----|

I A M In Norg (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number

OR

Over The Counter Use

PAGE 6