MEDLINE LATEX FOLEY CATHETER

K071423 · Medline Industries, Inc. · EZL · Jul 18, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K071423
• Device Name: MEDLINE LATEX FOLEY CATHETER
• Applicant: Medline Industries, Inc.
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Jul 18, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Medline Latex Foley Catheter is intended to be used as a urological catheter inserted through the urethra for the purpose of draining urine and other fluids from the urinary tract.

Device Story

Flexible tubular device; natural high-grade latex; silicone elastomer coating. Inserted through urethra into bladder; secured via balloon inflated with sterile water. Available in 2-way (drainage) and 3-way (drainage plus irrigation) configurations; various sizes (6-30 Fr) and balloon capacities (3cc, 5cc, 30cc). Used in clinical settings by healthcare professionals for patients with disrupted urination or requiring urine output monitoring. Urine drains from proximal eyelets through shaft to external collection device. Benefits include effective bladder drainage and irrigation.

Clinical Evidence

No clinical data. Substantial equivalence is based on identical design, materials, and performance specifications to the predicate device. Performance testing was conducted in accordance with relevant standards for the predicate.

Technological Characteristics

Natural high-grade latex construction; silicone elastomer coating applied via dipping. 2-way and 3-way configurations; 6-30 Fr sizes; 3cc, 5cc, 30cc balloon capacities. Sterile, single-use. Gamma irradiation sterilization. No software or electronic components.

Indications for Use

Indicated for male, female, and pediatric patients requiring drainage of urine and other fluids from the urinary tract. Contraindicated in individuals with known sensitivity or allergy to latex.

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

• Foleycath NR Latex Balloon Catheter (K903777)

Submission Summary (Full Text)

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K071423

### EXECUTIVE SUMMARY - Medline Latex Foley Catheter

#### Device Description

JUL 1 8 2007

A Foley catheter is needed when normal urination is disrupted or it is necessary to keep track of urine production. The catheter is threaded through the urinary duct (urethra) and into the bladder. It is secured by means of a balloon at the tip which is inflated with sterile water after insertion. The Medline Latex Foley Catheter offers 3 different balloon sizes (3cc, 5cc, 30cc) and a wide range of catheter sizes to accommodate pediatric and adult applications (refer to table below). The relative size of the Foley catheter is described using French units (Fr). 1 Fr is equivalent to 0.33 mm or .013".

| Catheter type | Balloon capacity | Size (Fr) | Item Number |
|-----------------|------------------|-----------|-------------|
| 2-way standard | 3cc | 6 | DYND11706 |
| 2-way standard | 3cc | 8 | DYND11708 |
| 2-way standard | 3cc | 10 | DYND11710 |
| 2-way standard | 5cc | 12 | DYND11752 |
| 2-way standard | 5cc | 14 | DYND11754 |
| 2-way standard | 5cc | 16 | DYND11756 |
| 2-way standard | 5cc | 18 | DYND11758 |
| 2-way standard | 5cc | 20 | DYND11760 |
| 2-way standard | 5cc | 22 | DYND11762 |
| 2-way standard | 5cc | 24 | DYND11764 |
| 2-way standard | 5cc | 26 | DYND11766 |
| 2-way standard | 5cc | 28 | DYND11768 |
| 2-way standard | 5cc | 30 | DYND11770 |
| 2-way coude tip | 5cc | 14 | DYND11214 |
| 2-way coude tip | 5cc | 16 | DYND11216 |
| 2-way coude tip | 5cc | 18 | DYND11218 |
| 2-way coude tip | 5cc | 20 | DYND11220 |
| 2-way coude tip | 5cc | 22 | DYND11222 |
| 2-way coude tip | 5cc | 24 | DYND11224 |
| 2-way standard | 30cc | 12 | DYND11772 |
| 2-way standard | 30cc | 14 | DYND11774 |
| 2-way standard | 30cc | 16 | DYND11776 |
| 2-way standard | 30cc | 18 | DYND11778 |
| 2-way standard | 30cc | 20 | DYND11780 |
| 2-way standard | 30cc | 22 | DYND11782 |
| 2-way standard | 30cc | 24 | DYND11784 |
| 2-way standard | 30cc | 26 | DYND11786 |
| 2-way standard | 30cc | 28 | DYND11788 |
| 2-way standard | 30cc | 30 | DYND11790 |
| 3-way standard | 30cc | 16 | DYND11800 |
| 3-way standard | 30cc | 18 | DYND11801 |
| 3-way standard | 30cc | 20 | DYND11802 |
| 3-way standard | 30cc | 22 | DYND11803 |
| 3-way standard | 30cc | 24 | DYND11804 |
| 3-way standard | 30cc | 26 | DYND11805 |

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The Medline Latex Foley Catheter is a flexible tubular device manufactured from natural high grade latex. For a listing of all the raw materials used, refer to attachment 2. It is sterile as packaged and intended for single patient use. The Medline Latex Foley Catheter consists of two types (2-way & 3-way) of devices. These catheters constitute a double or triple lumen drainage tube with two opposing eyelets on the proximal tip. On the other end of the catheter shaft, the urine drains out into an appropriate collection device. The 3-way catheter has an additional set of eyelets for irrigation purposes.

A silicon elastomer coating is applied to the catheter through a dipping process.

The catheters are supplied in individually packaged, sealed single use poaches. Packaging Materials: Paper/Poly/Mylar film Sealing Method: Heat sealed

#### Substantial Equivalence

| Feature | Proposed Device | Predicate Device |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Name | Medline Latex Foley Catheter | Foleycath NR Latex Balloon<br>Catheter (K903777) |
| Intended Use | The Medline Latex Foley<br>Catheter is intended to be used as<br>a urological catheter inserted<br>through the urethra for the<br>purpose of draining urine and<br>other fluids from the urinary tract. | The Foleycath is intended to be<br>used for the drainage of urine and<br>other fluids from the urinary<br>bladder. |
| Patient Populations | Male, Female & Pediatric | Male, Female & Pediatric |
| Types | • 2-way<br>• 3-way | • 2-way<br>• 3-way |
| Size Range (Fr) | • Pediatric (6-10)<br>• Female / Male (12-30) | • Pediatric (6-10)<br>• Female / Male (12-30) |
| Balloon Capacity | 3cc, 5cc, 30cc | 3cc, 5cc, 30cc |
| Material | Natural rubber latex | Natural rubber latex |
| Coating | Silicone | Silicone |
| Labeling | See attachment I | See attachment I |

#### Discussion of similarities and differences:

The proposed Medline Latex Foley Catheter is identical in intended uses, function and mode of operation to the predicate device which received marketing approval under K903777.

There are no significant differences between the two products. As reflected in the table above, they include identical product lines which support the same patient populations. They are fabricated from the same materials and designed in a same fashion.

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## Biocompatibility / Sterilization

Per the Guidance for Industry and FDA Staff, Format for Traditional and Abbreviated 510(k)s, August 12,2005, section 15 – "If identical materials are used in a predicate with the same type and duration of patient contact, you may identify the predicate in lieu of performing biocompatibility testing and state that your device is comprised of identical materials and that are processed by identical manufacturing methods."

As noted, this device is identical to that of WRP Foleycath (K903777). The manufacturing and sterilization methods remain unchanged. The history of the biocompatibility of these products is therefore well established.

The product is sterilized by a Gamma Irradiation method. Refer to attachment 2 for details of this process.

## Summary of Performance Testing

The Medline Latex Foley Catheter referenced in this submission is held to the same design, manufacture, and performance specifications as the currently marketed predicate device (K903777). The predicate device was tested in accordance with relevant standards for performance and function.

## Product Labeling

The labeling, dimensional drawings & promotional materials for this device can be found in Attachment 1.

### Conclusions

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

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL 1 8 2007

Mr. Matt Clausen Regulatory Affairs Medline Industries. Inc. One Medline Place MUNDELEIN IL 60060-4486

Re: K071423

Trade/Device Name: Medline Latex Foley Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: May 18, 2007 Received: May 25, 2007

Dear Mr. 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.

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.

Image /page/3/Picture/10 description: The image shows a circular seal with the text "1906-2006" at the top. The letters "FDA" are prominently displayed in the center of the seal. Below the letters, the word "Centennial" is written in a curved font. Three stars are arranged below the word "Centennial", and the entire seal is surrounded by a ring of small stars.

Protecting and Promoting Public Health

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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 21 CFR 884.xxxx 21 CFR 892 xxxxx Other

(Gastroenterology/Renal/Urology) (Obstetrics/Gynecology) (Radiology);

240-276-0115 240-276-0115 240-276-0120 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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# Indications for Use

510(k) Number (if known): K07/422

Device Name: Medline Latex Foley Catheter

Indications for Use:

The Medline Latex Foley Catheter is intended to be used as a urological catheter inserted through the urethra for the purpose of draining urine and other fluids from the urinary tract.

Precautions:

Do not use petroleum based ointments or lubricants.

Contraindications:

Those individuals with a known sensitivity or allergy to latex are excluded from the use of this device. Product use should be discontinued should signs of sensitization occur.

Prescription Use XX (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 IF NEEDED)

currence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K071423

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