PEDIATRIC URINARY CATHETER

K060268 · Clay Kennard · GBM · Feb 24, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K060268
• Device Name: PEDIATRIC URINARY CATHETER
• Applicant: Clay Kennard
• Product Code: GBM · Gastroenterology, Urology
• Decision Date: Feb 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The urinary catheter is for use with patients requiring urine drainage, with chronic urine retention and with post void residual (PVR). The catheter is inserted into the urethra to reach the bladder allowing urine to drain.

Device Story

Pediatric urinary catheter; silicone tube; 3.5, 5.0, 6.5, and 8.0 French diameters; 16" length. Features integral female luer fitting, two eyelets near tip, shaft markings, and radiopaque line. Used in hospital or sub-acute settings by clinicians for urine drainage. Inserted into urethra to reach bladder. Facilitates urine drainage for patients with retention or PVR. Provided sterile for single-patient use.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Silicone tubing; polypropylene (PP) connector. 3.5-8.0 French diameters; 16" length. Features: integral female luer, two tip eyelets, shaft markings, radiopaque line. Sterile. Standalone device.

Indications for Use

Indicated for pediatric patients requiring urine drainage due to chronic urine retention or post-void residual volume (PVR).

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

• ProMedic Urinary Catheter (K031409)

Submission Summary (Full Text)

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Image /page/0/Picture/3 description: The image shows a close-up of handwritten text, which appears to be a combination of letters and numbers. The most prominent text is "K060268", written in a bold, somewhat messy style. Below this, there are additional markings and characters that are less clear, possibly including the number "2". The overall impression is that of a quick, handwritten note or label.

## Non-Confidential Summary of Safety and Effectiveness

| | Page 1 of 2<br>30-Jan-06 |
|------------------------------------------------------------------|------------------------------------------|
| Clay Kennard<br>2909 Browne Stone Rd.<br>Oklahoma City, OK 73120 | Tel [phone]<br>Fax [phone] |
| Official Contact: | Clay Kennard |
| Proprietary or Trade Name: | Urinary catheter |
| Common/Usual Name: | Urinary catheter |
| Classification Name: | Catheter, urethral (and Accessories) |
| Predicate Devices: | ProMedic ... K031409 |

Device Description:

The silicone pediatric urinary catheter is a small diameter tube of various diameters, 3.5, 5.0, 6.5, and 8.0 French and a length of 16". It has an integral female luer fitting. There are 2 eyelets near the tip of the tube. It has marking along the shaft of the tubing and an integral radiopaque line. It is provided sterile.

| Intended Use: | |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indicated Use -- | The urinary catheter is for use with patients requiring urine<br>drainage, with chronic urine retention and with post void residual<br>volume (PVR). The catheter is inserted into the urethra to reach<br>the bladder allowing urine to drain. |
| Environment of Use -- | Hospital, sub-acute, and environments where placement of a<br>urinary catheter is required. |

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## Non-Confidential Summary of Safety and Effectiveness

Page 2 of 2 30-Jan-06

## Comparison to Predicate Devices:

| Attribute | Proposed device | Predicate ProMedic<br>K031409 |
|---------------------------------------------------------------------------------------------------------------------------|-------------------|-------------------------------|
| Intended use | | |
| To be placed into the urethra to permit urine<br>drainage. | Yes | Yes |
| Intended for single patient use < 30 days | Yes | Yes |
| Prescription | Yes | Yes |
| Intended population infants | Yes | Yes |
| Intended Environment of Use - Hospital, sub-acute<br>or environments where placement of urinary<br>catheters is required. | Yes | Yes |
| Design Features | | |
| Provided in various diameters from 3.5 to 8 Fr | 3.5, 5, 6.5, 8 Fr | 3.5, 5, 6.5, 8 Fr - Yes |
| Standard female luer connector | Yes | Yes |
| Two (2) eyelet holes near tip | Yes | Yes |
| Radiopaque line entire length of tubing | Yes | Yes |
| Markings along the length of the tubing | Yes | Yes |
| Materials | | |
| Tubing - Silicone<br>and Connector - PP | Yes | Yes |
| Packaging | | |
| Sterile | Yes | Yes |
| Performance | | |
| None under Section 514 | Yes | Yes |

## Differences between Other Legally Marketed Predicate Devices

There are no significant differences between the intended device and the predicate -- ProMedic, Inc. Urinary Catheter – K031409.

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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - PUBLIC HEALTH SERVICE - USA" written around the edge. In the center of the seal is an abstract image of an eagle with its wings spread, with three wavy lines extending from the eagle's body. The seal is black and white.

FEB 2 4 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Clay Kennard 2909 Browne Stone Road OKLAHOMA CITY OK 73120

Re: K060268

Trade/Device Name: Pediatric Urinary Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: GBM Dated: January 30, 2006 Received: February 1, 2006

Dear Mr. Kennard:

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.

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 onc 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.

Sincercly 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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Page 1 of 1

| 510(k) Number: | K060268 (To be assigned) |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Pediatric Urinary Catheter |
| Indications for Use: | The urinary catheter is for use with patients requiring urine drainage, with chronic urine retention and with post-void residual volume (PVR). The catheter is inserted into the urethra to reach the bladder allowing urine to drain. |

Prescription Use XX (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 Broadn

(Division Sign-Off) Division of Reproductive, Abdon and Radiological Devices " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "