Medline Silicone Foley Catheter

K142635 · Medline Industries, Inc. · EZL · Jan 9, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K142635
• Device Name: Medline Silicone Foley Catheter
• Applicant: Medline Industries, Inc.
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Jan 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Medline silicone Foley catheters are intended to be placed in the bladder, through the urethra, to drain urine into a collection device. Two-way catheters are intended for urological bladder drainage only. Three-way catheters are intended for urological bladder drainage and bladder irrigation.

Device Story

Medline Silicone Foley Catheters are flexible tubes inserted through urethra into bladder; facilitate urine drainage into external collection device. Three-way variants include additional lumen for bladder irrigation. Used in clinical settings by healthcare professionals. Device provides continuous drainage; assists in managing urinary retention or post-operative bladder care. Benefits include effective urine evacuation and irrigation capability.

Clinical Evidence

No clinical data. Safety and effectiveness supported by bench testing and substantial equivalence analysis.

Technological Characteristics

Silicone construction; two-way or three-way lumen configurations; various shaft sizes and balloon volumes. Functional performance testing conducted in accordance with ASTM F623.

Indications for Use

Indicated for patients requiring urological bladder drainage (two-way) or bladder drainage and irrigation (three-way) via urethral catheterization.

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).

Predicate Devices

• Well Lead silicone and latex catheters (K082815)

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.

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

January 9, 2015

Medline Industries, Inc. Matt Clausen Sr. Regulatory Affairs Specialist One Medline Place Mundelein, IL 60060

Re: K142635

> Trade/Device Name: Medline Silicone Foley Catheters Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: December 10, 2014 Received: December 15, 2014

Dear Matt Clausen,

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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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 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -A

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K142635

Device Name Medline silicone Foley catheters

#### Indications for Use (Describe)

Medline silicone Foley catheters are intended to be placed in the bladder, through the urethra, to drain urine into a collection device. Two-way catheters are intended for urological bladder drainage only. Three-way catheters are intended for urological bladder drainage and bladder irrigation.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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Image /page/3/Picture/0 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in a bold, sans-serif font, with the letters slightly spaced apart. Below the text is a stylized blue star shape with a curved line extending downwards from the center. The star and the text are both in the same shade of blue.

Medline Industries, Inc. One Medline Place Mundelein, IL 60060-4486

# 510(k) Summary (as required per 21 CFR 807.92)

# Summary Preparation Date

September 10, 2014

## Submitter / 510(k) Sponsor

Medline Industries, Inc. 1 Medline Place Mundelein, IL 60060

## Contact Person

Matt Clausen Sr. Regulatory Affairs specialist Phone: [phone] Fax: [phone]

### Device Name / Classification

Device Name: Silicone Foley Catheter Proprietary Name: Medline Silicone Foley Catheter Common Name: Foley Catheter Classification Name: Urological catheter and accessories (21 CRF 876.5130, product code - EZL)

## Predicate Device

Well Lead silicone and latex catheters, K082815

#### Device Description

Medline silicone Foley catheters are two-way Foley catheters which are placed in the bladder through the urethra. The urine drains out through the catheter into a collection device attached to the catheter. Threeway Foley catheters offer the option of irrigating the bladder through a 3rd lumen. These catheters have various balloon volumes, shaft sizes and irrigation features.

#### Indications for Use

Medline silicone Foley catheters are intended to be placed in the bladder, through the urethra, to drain urine into a collection device. Two-way catheters are intended for urological bladder drainage only. Three-way catheters are intended for urological bladder drainage and bladder irrigation.

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Image /page/4/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a bold, sans-serif font, with the letters slightly slanted to the right. Below the text is a stylized blue symbol that resembles a compass or a stylized medical cross. The logo is simple and modern, and the blue color gives it a professional and trustworthy feel.

Medline Industries, Inc. One Medline Place Mundelein, IL 60060-4486

# Summary of Technological Characteristics

Information within this Premarket Notification demonstrates that there are no significant differences in technological characteristics between Medline's silicone Foley catheters and the cited predicate device.

## Summary of Non-Clinical Testing

The safety and effectiveness of Medline's silicone Foley catheters is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification. Functional performance testing of the Medline silicone Foley catheter demonstrated device effectiveness in accordance with relevant ASTM F623 test methods.

#### Summary of Clinical Testing

Not applicable.

#### Conclusion

In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Medline silicone Foley catheter is safe, effective and substantially equivalent as described herein.