COOK URETERAL BALLOON DILATION CATHETER SET

K040127 · Cook Urological, Inc. · EZN · Apr 6, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K040127
• Device Name: COOK URETERAL BALLOON DILATION CATHETER SET
• Applicant: Cook Urological, Inc.
• Product Code: EZN · Gastroenterology, Urology
• Decision Date: Apr 6, 2004
• Decision: SESK
• Submission Type: Traditional
• Regulation: 21 CFR 876.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cook Ureteral Balloon Dilation Catheter Set is used for Dilation prior to stone manipulation or ureteroscopy, and Dilating the intramural ureter. This device is sterile And intended for one-timeuse.

Device Story

The Cook Ureteral Balloon Dilation Catheter Set is a sterile, single-use medical device used by clinicians to dilate the ureter. The set consists of a 7 French, 65 cm long nylon balloon catheter with a hydrophilic coating and an inflation device. The device is operated by a physician in a clinical setting to facilitate stone manipulation or ureteroscopy. By inflating the balloon to a rated burst pressure of 20 ATM, the device mechanically dilates the intramural ureter, providing the necessary access for subsequent urological procedures. This process assists the clinician in safely navigating the ureter, potentially reducing procedural complications and improving patient outcomes during stone removal or diagnostic ureteroscopy.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Nylon with hydrophilic coating. Dimensions: 7 French diameter, 65 cm length. Rated burst pressure: 20 ATM. Energy source: Manual inflation device. Sterilization: Sterile, single-use.

Indications for Use

Indicated for patients requiring ureteral dilation prior to stone manipulation, ureteroscopy, or dilation of the intramural ureter.

Regulatory Classification

Identification

A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.

Predicate Devices

• Balloon Ureteral Dilator Set (K813278)
• Accent DGTM Balloon Ureteral Dilator Set (K905375)
• Ascend™ Balloon Dilation Catheter (K970041)
• Balloon Dilation Catheters (Bard)
• High Pressure Ureteral Dilatation Balloon Catheter (Microvasive)

Submission Summary (Full Text)

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APR = 6 2004

K040127

9

## I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

### Submitted By:

Debbie Schmitt Cook Urological, Inc. 1100 West Morgan Street Spencer, Indiana 47460

Device:

Trade Name:

Cook Ureteral Balloon Dilation Catheter Set (Not vet determined) Dilator, Catheter, Ureteral

Proposed Classification Name:

#### Predicate Devices:

The Cook Ureteral Balloon Dilation Catheter Set is substantial equivalent to predicate devices in terms of indications for use and design. Predicate devices include the Balloon Ureteral Dilator Set, D.C. #K813278 manufactured by Cook Urological, Accent DGTM Balloon Ureteral Dilator Set. D.C. #K905375 manufactured by Cook Urololgical, Ascend™ Balloon Dilation Catheter, D.C. #K970041, the Balloon Dilation Catheters manufactured by Bard and the High Pressure Ureteral Dilatation Balloon Catheter manufactured by Microvasive.

### Device Description:

The Cook Ureteral Balloon Dilation Catheter Set is used for dilation prior to ureteral stone manipulation or ureteroscopy, and dilating the intramural ureter. The materials used to construct the balloon and catheter is nylon with a hydrophilic coating. The Catheter is 7 French in diameter and is 65 cm's in length. The Rated Burst is 20 ATM's. The Set will include the balloon catheter and an inflation device. The product will be sold as sterile and intended for one-time use.

#### Substantial Equivalence:

The device will be manufactured according to specified process controls and Quality Assurance Program. The device will undergo packaging and sterilization procedures to devices currently marketed and distributed by Cook Urological. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.

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Image /page/1/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 an abstract symbol that resembles an eagle or a stylized human figure, with three curved lines forming the body and head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 6 2004

Ms. Debbie Schmitt Regulatory Affairs Manager Cook Urological 1100 W. Morgan Street SPENCER IN 47460

Re: K040127

Trade/Device Name: Cook® Ureteral Dilation Catheter Set Regulation Number: 21 CFR §876.5470 Regulation Name: Ureteral dilator Regulatory Class: II Product Code: 78 EZN Dated: March 10, 2004 Received: March 12, 2004

Dear Ms. Schmitt:

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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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.

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#### Page 2 - Ms. Debbie Schmitt

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 (21 CFR Part 807); listing (21 CFR Part 807). labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 the labeling regulation, 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). 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/dsma/dsmamain.html.

Sincerely yours.

Daniel A. Lynn

for
N
I

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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# PREMARKET NOTIFICATION

## INDICATIONS FOR USE STATEMENT

| 510(k) Number (if known): | Not yet assigned <span style="text-decoration:underline;">K040127</span> |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Cook Ureteral Balloon Dilation Catheter |
| Indications for Use: | The Cook Ureteral Balloon Dilation Catheter Set is used for<br>Dilation prior to stone manipulation or ureteroscopy, and<br>Dilating the intramural ureter. This device is sterile<br>And intended for one-timeuse. |

Prescription Use (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Knadon

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