EXPRESSWAY INTERMITTENT CATHETER

K061766 · Percutaneous Systems, Incorporated · EZD · Mar 9, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K061766
• Device Name: EXPRESSWAY INTERMITTENT CATHETER
• Applicant: Percutaneous Systems, Incorporated
• Product Code: EZD · Gastroenterology, Urology
• Decision Date: Mar 9, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Expressway Intermittent Catheter is intended to provide an intermittent pathway for draining fluids from and instilling fluids into the bladder. The device is indicated for providing lubricity during the catheter's advancement.

Device Story

Expressway Intermittent Catheter; urology catheter for intermittent bladder drainage or fluid instillation. Device features film membrane preloaded within catheter lumen to provide lubricity during advancement. Used by clinicians or patients for bladder management. Output is physical pathway for fluid transfer; facilitates catheter insertion by reducing friction.

Clinical Evidence

No clinical data; performance data not required.

Technological Characteristics

Urological catheter; includes film membrane preloaded within lumen for lubrication. Class II device (21 CFR 876.5130).

Indications for Use

Indicated for patients requiring intermittent bladder drainage or fluid instillation. Provides lubricity during catheter advancement.

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

• SLIP Urology Catheter, Percutaneous Systems, Inc.

Submission Summary (Full Text)

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K061766

## 510(k) SUMMARY

### Percutaneous Systems, Inc.'s Expressway Intermittent Catheter

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Percutaneous Systems, Inc. 1300 Crittenden Lane, Suite 101 Mountain View, CA 94043-1359

| Phone: | [phone] |
|------------|----------------|
| Facsimile: | [phone] |

Contact Person: Thomas Lawson

Date Prepared: March 1, 2007

# Common or Usual Name

Urology catheter

#### Classification Name

G-U Devices

### Predicate Device

SLIP Urology Catheter, Percutaneous Systems, Inc.

### Intended Use

The Expressway Intermittent Catheter is intended to provide an intermittent pathway for draining fluids from and instilling fluids into the bladder. The device is indicated for providing lubricity during the catheter's advancement.

# Technological Characteristics

The Expressway intermittent catheter consists of a film membrane preloaded within the lumen of a catheter.

### Performance Data

Not required.

MAR 0 3 2007

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K061766

# Substantial Equivalence

The Expressway Intermittent Catheter has the same intended use, indications for use, principles of operation and technological characteristics as the predicate device. Thus, the Expressway Intermittent Catheter is substantially equivalent to the cleared predicate device.

:

11. 11.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Thomas Lawson, Ph.D. Vice President, Clinical & Regulatory Affairs Percutaneous Systems, Inc. 1300 Crittenden Lane, Suite 101 MOUNTAIN VIEW CA 94043

MAR 0 9 2007

Re: K061766

Trade/Device Name: Expressway Intermittent Catheter, Models IC 2410-06 through IC 2440-18 Regulation Number: 21 CFR §876.5130

Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: February 13, 2007 Received: February 15, 2007

Dear Dr. Lawson:

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/2/Picture/11 description: The image is a circular logo with the text "1906-2006" at the top and the letters "FDA" in large, bold font in the center. Below the letters "FDA" is the word "Centennial" in a cursive font, and below that are three stars. The text around the circle reads "Leading the advancement of consumer protection & public health". The logo appears to be a commemorative emblem for the 100th anniversary of the Food and Drug Administration.

*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 | (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-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely vours.

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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510(k) Number (if known): K061766

Device Name: Expressway Intermittent Catheter

Indications for Use:

The Expressway Intermittent Catheter is intended to provide an intermittent pathway for draining fluids from and instilling fluids into the bladder. The device is indicated for providing lubricity during the catheter's advancement

Prescription Use X (Per 21 C.F.R. 801.109) AND/OR Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of l

David R. Bergman

(Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K061142