GUARDIANCATHETER-URINARY DRAINAGE CATHETER

K063795 · Marian Medical, Inc. · GBM · Mar 5, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K063795
• Device Name: GUARDIANCATHETER-URINARY DRAINAGE CATHETER
• Applicant: Marian Medical, Inc.
• Product Code: GBM · Gastroenterology, Urology
• Decision Date: Mar 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The GuardianCatheter-Infant Urinary Drainage Catheter is a single lumen silicone urinary catheter intended to drain urine in the neonatal patient population. This catheter is NOT a Foley (balloon) type catheter.

Device Story

GuardianCatheter is a single-lumen silicone urinary catheter designed for neonatal urine drainage. Device functions as a passive conduit for urine collection; it is not a balloon-type (Foley) catheter. Used in clinical settings by healthcare professionals to manage urinary output in neonates. Provides a non-invasive method for urine collection to assist in patient monitoring and fluid management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-lumen silicone urinary catheter. Non-balloon design. Class II device (21 CFR 876.5130).

Indications for Use

Indicated for urine drainage in neonatal patients. Not for use as a Foley (balloon) catheter.

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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Ms. Sandra L. Winkler President Marian Medical, Inc. 319 Westport Drive LOUISVILLE KY 40207

K063795 Re:

Trade/Device Name: GuardianCatheter" -Infant Urinary Drainage Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: GBM Dated: December 20, 2006 Received: December 22, 2006

MAR 0 5 2007

Dear Ms. Winkler:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 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.

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 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 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/cdrh/industry/support/index.html

Sincerely yours,

Nancy C. Brogdon

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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## Indication for Use

510(K) Number (if Known): K063795

Device Name: GuardianCatheter-Infant Urinary Drainage Catheter

Indications for Use:

The GuardianCatheter-Infant Urinary Drainage Catheter is a single lumen silicone urinary catheter intended to drain urine in the neonatal patient population. This catheter is NOT a Foley (balloon) type catheter.

Prescription Use: _ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use: (21CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Bergdon

(Division Sign-Off) Division of Reproductive, Abdom and Radiological Device 510(k) Number