APPLIED URETERAL CATHETER

K020577 · Applied Medical Resources Corp. · EYB · May 22, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K020577
• Device Name: APPLIED URETERAL CATHETER
• Applicant: Applied Medical Resources Corp.
• Product Code: EYB · Gastroenterology, Urology
• Decision Date: May 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Intended Use

The Applied Ureteral Catheter is indicated for use in the urinary tract where drainage or irrigation of the surgical site is desired. It may be used to introduce fluids such as radiopaque contrast media and saline solutions. The catheter is radiopaque and has a hydrophilic coating to facilitate insertion.

Device Story

Applied Ureteral Catheter; 5 Fr body, 70 cm length; incorporates retentive pigtail coil at distal end for renal pelvis placement; spiral drainage holes allow irrigation/aspiration; hydrophilic coating facilitates insertion; radiopaque material. Used in clinical settings by physicians; placed over pre-positioned guidewire (up to .038 inches); coil straightened during insertion; luer lock hub connects to external drainage/irrigation systems. Device aids in site management; benefits patient via atraumatic design and secure retention.

Clinical Evidence

Bench testing only. Testing included irrigation flow rate, drainage flow rate, and coil retention strength. Biocompatibility verified per ISO 10993-1.

Technological Characteristics

5 Fr, 70 cm ureteral catheter; radiopaque material; hydrophilic coating (SL-6); pigtail coil design; luer lock connector. Compatible with guidewires up to .038 inches. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for use in the urinary tract for drainage, irrigation, or introduction of fluids (e.g., contrast media, saline) in patients requiring urological procedures.

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

• Pigtail Ureteral Catheter (K923729)

Submission Summary (Full Text)

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MAY 2 2 2002

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## 510(k) SUMMARY

| 510(k) NUMBER: | K020577 |
|----------------------|----------------------------------------------------------------------------------------------------------------------|
| SUBMITTED BY: | Applied Medical Resources Corporation<br>22872 Avenida Empresa<br>Rancho Santa Margarita, CA-92688<br>[phone] |
| CONTACT PERSON: | Anil Bhalani<br>Vice President of Regulatory Affairs and Clinical Programs |
| DATE OF PREPARATION: | May 10, 2002 |
| NAME OF DEVICE: | Ureteral Catheter |
| CLASSIFICATION NAME: | Catheter, Ureteral, Gastro-Urology<br>(Regulation Number 21CFR 876.5130, Urological catheter<br>and accessories) |
| TRADE NAME: | Applied Ureteral Catheter |
| PREDICATE DEVICE: | Pigtail Ureteral Catheter (Ureteral Catheter, K923729),<br>Cook Urological Inc., Spencer, IN. |

INTENDED USE STATEMENT: The Applied Ureteral Catheter is indicated for use in the urinary tract where drainage or irrigation of the surgical site is desired. It may be used to introduce fluids such as radiopaque contrast media and saline solutions. The catheter is radiopaque and has a hydrophilic coating to facilitate insertion.

SUMMARY STATEMENT: The Applied Ureteral Catheter has a 5 Fr body, 70 cms long. It incorporates a retentive pigtail coil at one end. The coil aids in retention of the catheter in the renal pelvis during use. Drainage holes are arranged in a spiral pattern extending over the length of the coil to allow for fluid to be irrigated/aspirated through the catheter. The tip of coil has a smooth, atraumatic design for ease of passage through the urinary tract. A luer lock connector is attached at the other end, which may be connected to a drainage or irrigation system as desired. The catheter body is radiopaque and is coated with a hydrophilic coating, which is activated when wet.

The ureteral catheter is designed for placement over a guidewire of up to .038 inches in diameter that is pre-positioned through the urological tract. The catheter coil is temporarily straightened as it is slid over the guidewire. It is pushed up the urological tract until it is placed in a desired position. The luer lock hub is then connected to a source of irrigation or drainage fluid to attain the desired irrigation/aspiration of the urological site.

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K020577
PAGE 2 OF 2

Page 2 of 2 510(k) Summary Applied Ureteral Catheter

The ureteral catheter will be supplied in a tyvek/mylar peel pouch (one per pouch) and placed in an outer product carton (one to ten pouches per carton). The ureteral catheter may also be supplied along with a guidewire of up to .038 inches in diameter as a kit.

The Applied Ureteral Catheter is similar in function and performance to ureteral catheters currently marketed for the same application. The following tests were performed on the Applied Ureteral Catheter.

- a. Irrigation Flow Rate
- b. Drainage Flow Rate
- c. Coil Retention Strength

Materials used in the manufacture of the Applied Ureteral Catheter were successfully tested to verify biocompatibility of the materials per ISO 10993-1.

Based on the above testing it was concluded that the Applied Ureteral Catheter is substantially equivalent to predicate devices and introduces no new safety and effectiveness issues when used as instructed.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text is centered and the background is white.

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that appears to be an abstract representation of an eagle or other bird-like figure.

## MAY 2 2 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Anil Bhalani Vice President of Regulatory Affairs and Clinical Programs Applied Medical Resources Corp. 22872 Avenida Empresa RANCHO SANTA MARGARITA CA 92688

Re: K020577

Trade/Device Name: Applied Ureteral Catheter with SL-6 Hydrophilic Coating Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 EYB Dated: February 19, 2002 Received: February 21, 2002

Dear Mr. Bhalani: ·

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 for abo barrent 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 (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. 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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Page 2

This letter will allow you to begin marketing your device as described in your 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:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, 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). Other general information on your responsibilities under the Act may be obtained 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/dsmaldsmamain.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

Applied Medical Resources is providing this separate cover page for the Applied Ureteral Catheter "Indications for Use" as required.

Not assigned 510(k) Number:

Ureteral Stent Device Name:

Indications for Use: The Applied Ureteral Catheter is indicated for use in the urinary tract where drainage or irrigation of the surgical site is desired. It may be used to introduce fluids such as radiopaque contrast media and saline solutions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The -Counter Use OR

(Optional Format -2-96)

David C. Segerson

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