ADVANCED UROLOGICAL CATHETER

K053429 · Entracare, LLC · EZL · Feb 8, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K053429
• Device Name: ADVANCED UROLOGICAL CATHETER
• Applicant: Entracare, LLC
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Feb 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Advanced Urological Catheter is used to pass fluids to or from the urinary tract.

Device Story

The Advanced Urological Catheter is a medical device designed to facilitate the passage of fluids into or out of the urinary tract. It is intended for use by healthcare professionals in clinical settings. The device functions as a conduit for drainage or irrigation of the urinary system. It is provided as a kit containing components that must be legally marketed or pre-amendment devices. The device is used to manage urinary flow, aiding in patient care related to urological conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Urological catheter and urine collector kit. Classified as Class II. Components must comply with 21 CFR 820 (Quality Systems) and other general controls. No specific materials or software algorithms described.

Indications for Use

Indicated for patients requiring the passage of fluids to or from the urinary tract. Prescription use only.

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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 FEB 8

2006

W. Cary Dikeman President EntraCare LLC 11315 Strang Line Road LENEXA KS 66215

Re: K053429

Trade/Device Name: Advanced Urological Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Product Codes: EZL and FCM Regulation Number: 21 CFR §876.5250 Regulation Name: Urine collector and accessories Product Code: FCN Regulatory Class: II Dated: January 20, 2006 Received: January 23, 2006

Dear Mr. Dikeman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we no re roved your and have determined the device is substantially equivalent to legally marketed rererched wices 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 the Medical Don't he Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the 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), as buobally 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 and farmer piovour kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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.

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

## Page 2 - Mr. Cary Dikeman

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 the 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.dsma/dsmamain.html.

Sincerely yours,

Nancy brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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

K053429
Page 1 of 7

## Indications for Use

510(k) Number (if known): KOSSE29

Device Name: Advanced Urological Catheter

Indications for Use:

The Advanced Urological Catheter is used to pass fluids to or from the urinary tract.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon

November 2005 EntraCare LLC: AUC

(Division Sign-Off)/ Division of Reproductive, Abdo minal, and Radiological Devices

510(k) Number K053429

6-2