GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT

K070048 · Marian Medical, Inc. · FCM · Mar 15, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K070048
• Device Name: GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT
• Applicant: Marian Medical, Inc.
• Product Code: FCM · Gastroenterology, Urology
• Decision Date: Mar 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The GuardianCatheter-Infant Urinary Collection Kit is for urinary drainage and collection for use in the neonatal/pediatric patient population.

Device Story

GuardianCatheter-Infant Urinary Collection Kit is a procedural kit designed for urinary drainage and collection in neonatal and pediatric patients. The kit includes a urinary catheter and associated accessories to facilitate the collection process. It is intended for use by healthcare professionals in clinical settings. The device functions as a standard urological catheter system. The kit also contains drug components (Povidone Iodine antiseptic swabs, Surgilube, and KY-Jelly) which are subject to separate drug regulation. The device aids in patient management by providing a sterile, organized collection system for urine samples or drainage.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Urological catheter and collection kit. Includes catheter, antiseptic swabs, and lubricants. Class II device (21 CFR 876.5130). Product code FCM. Non-active, mechanical device.

Indications for Use

Indicated for urinary drainage and collection in neonatal and pediatric patients.

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}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three bars representing the department's services. The words "SERVICES. USA" are at the top of the logo, and the word "DEPARTM" is at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

MAR 1 5 2007

Re: K070048

Trade/Device Name: GuardianCatheter™-Infant Urinary Collection Kit Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: FCM Dated: December 28, 2006 Received: January 3, 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 (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 kit 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 kit. 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); 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.

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

Page 2 - Ms. Sandra Winkler

In addition, we have determined that your device kit contains Povidone Iodine antiseptic swabs, Surgilube® and KY-Jelly®, which are subject to regulation as drugs.

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 your device with the drug components. For information on applicable Agency requirements for marketing these 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/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

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

K070048

## Indication for Use

510(K) Number (if Known): N/A

Device Name: GuardianCatheter-Infant Urinary Collection Kit

Indications for Use:

The GuardianCatheter-Infant Urinary Collection Kit is for urinary drainage and collection for use in the neonatal/pediatric patient population.

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)

Nancyc Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number