MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC.

K052168 · Medline Industries, Inc. · EZL · Feb 16, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K052168
• Device Name: MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC.
• Applicant: Medline Industries, Inc.
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Feb 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To be used as a urological catheter inserted through the urethra to pass urine from urinary tract.

Device Story

Medline Silver Touch Silicone Foley Catheter is a urological device designed for urethral insertion to facilitate urine drainage from the bladder. The device features a silicone construction with a silver-based coating intended to provide antimicrobial properties. It is used in clinical settings by healthcare professionals for patients requiring short-term or long-term urinary catheterization. The device functions as a passive conduit for urine flow. By providing a sterile pathway for drainage, it assists in managing urinary retention or monitoring output, potentially reducing the risk of catheter-associated urinary tract infections through the silver-based surface treatment.

Clinical Evidence

Bench testing only.

Technological Characteristics

Silicone Foley catheter with silver-based antimicrobial coating. Designed for urethral insertion. Class II device (21 CFR 876.5130).

Indications for Use

Indicated for patients requiring urinary catheterization via the urethra to facilitate urine drainage. Contraindicated in individuals with known sensitivity or allergy to metallic silver or silver-containing organic or inorganic compounds.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/0/Picture/3 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird with its wings spread. The bird is facing to the right and appears to be in flight.

FEB 1 6 2006

Mr. Joe Dunn Dynacor Division QA Director Medline Industries, Inc. One Medline Place MUNDELEIN IL 60060

Re: K052168

Trade/Device Name: Medline Silver Touch™ Silicone Foley Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: November 14, 2005 Received: January 10, 2006

Dear Mr. Dunn:

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.

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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FI)A 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 11 you attent 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-five 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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## of Pagc

## Device Name: Silver TouchTM Silicone Foley Catheter

Indications for Use:

To be used as a urological catheter inserted through the urethra to pass urine from urinary tract.

## CONTRADICTIONS FOR USE

Those individuals with a known sensitivity or allergy to metallic silver or silver containing organics or inorganics are excluded from the use of this device.

Prescription Use_ XX ___________________________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

OR

Over-the-Counter Use ---------------------------------------------------------------------------------------------------------------------------------------------------------

(PLEASE DO NOT WRITE BLOEW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Segerson

Division Sign-Off) ivision of Reproductive. Abdominal and Radiological Dev 510(k) Number