COOK NEPHROSTOMY DILATION BALLOON CATHETER SET

K024050 · Cook Urological, Inc. · LJE · Feb 27, 2003 · GU

Device Facts

• Record ID: K024050
• Device Name: COOK NEPHROSTOMY DILATION BALLOON CATHETER SET
• Applicant: Cook Urological, Inc.
• Product Code: LJE · GU
• Decision Date: Feb 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Cook Nephrostomy Tract Balloon Dilation Catheter Set is used for one step, dilation of the musculofascial nephrostomy tract and placement of the working sheath.

Device Story

The Cook Nephrostomy Balloon Dilation Catheter Set is a medical device used for the dilation of the nephrostomy tract and placement of a working sheath. The device consists of a balloon catheter, a sheath, and an inflation gauge. It is intended for use by clinicians in a clinical setting. The device functions by inflating the balloon to dilate the tract, allowing for the subsequent placement of the working sheath. This process facilitates access for further urological procedures. The device is designed to be used in a single-step procedure, which may simplify the clinical workflow and potentially reduce the time required for tract dilation.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Nylon and Polyethylene balloon; Vinyl or TFE sheath. Dimensions: 7.3 Fr. diameter, 55cm long catheter; 32 Fr. diameter, 16cm long sheath. Includes inflation gauge. Sterilization: Standard procedures consistent with currently marketed devices.

Indications for Use

Indicated for the dilation of the musculofascial nephrostomy tract and placement of a working sheath in patients requiring nephrostomy procedures.

Predicate Devices

• NephroMax Balloon Dilatation Catheter Sets (Boston Scientific/Microvasive)
• Nephrostomy Dilation Balloons (Cook Urological)

Submission Summary (Full Text)

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510(k) Premarket Notification Cook Nephrostomy Balloon Dilation Catheter Set Cook Urological, Inc.

Ko 2 4050

8

FEB 2 7 2003

#### 510(k) SUMMARY I.

Submitted By:

Debbie Schmitt Cook Urological 1100 West Morgan Street Spencer, Indiana 47460 [phone]

December 6, 2002

Device

Nephrostomy Tract Dilation Balloon

Cook Nephrostomy Balloon Dilation Catheter Set

Trade Name:

Proposed Classification Name:

Class II Catheter, Nephrostomy 78LJE

### Predicate Devices:

The Cook Nephrostomy Balloon Dilation Catheter Set is substantially equivalent to predicate devices in terms of indication for use and design. Predicate devices include other Nephrostomy Dilation Balloons manufactured and marketed by Cook Urological and The NephroMax Balloon Dilatation Catheter Sets marketed by Boston Scientific/Microvasive.

### Device Description:

The materials used to construct the balloon are Nylon and Polyethylene. The Nephrostomy Balloon Catheter Set will be offered with a 7.3 Fr. diameter, 55cm long catheter, a 32 Fr. diameter, 16cm long sheath Vinyl or TFE and an inflation gauge.

#### Substantial Equivalence:

The device will manufactured according to specified process controls and a Quality Assurance Program. The device will undergo packaging and sterilization procedures similar to devices currently marketed and distributed by Cook Urological, Inc. The materials used to produce the devices are currently marketed by Cook Urological, Inc. 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 2 7 2003

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

Re: K024050

Trade/Device Name: Cook® Nephrostomy Dilation Balloon Catheter Set Regulation Number: None Regulatory Class: Unclassified Product Code: 78 LJE Dated: December 6, 2002 Received: December 9, 2002

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) 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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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 the 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" (21CFR Part 807.97) you may obtain. 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/dsma/dsmamain.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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## PREMARKET NOTIFICATION

### INDICATIONS FOR USE STATEMENT

1024050 510(k) Number (if known): Not yet assigned

Device Name:

Cook Nephrostomy Balloon Dilation Catheter Set

The Cook Nephrostomy Tract Balloon Dilation Catheter Set is used for one step, dilation of the musculofascial nephrostomy tract and placement of the working sheath.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use J/ (Per 21 CFR 801.109) OR

Over-The-Counter Use

David A. Symm

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