VITALCARE URETHRAL CATHETER

K021938 · Vitalcare, Inc. · GBM · Apr 22, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K021938
• Device Name: VITALCARE URETHRAL CATHETER
• Applicant: Vitalcare, Inc.
• Product Code: GBM · Gastroenterology, Urology
• Decision Date: Apr 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

VitalCare's Urethral Catheter are intended to be inserted ithrough the urethra to the bladder and utilized for passage of fluid from/to the urinary tract.

Device Story

The VitalCare Urethral Catheter is a urological device designed for insertion through the urethra into the bladder. It facilitates the drainage or infusion of fluids to and from the urinary tract. The device is intended for use by healthcare professionals in clinical settings. It functions as a passive conduit for fluid management, aiding in patient care related to urinary tract maintenance or drainage.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Urological urethral catheter; design and materials are similar to the predicate device. No specific material standards or software components described.

Indications for Use

Indicated for patients requiring urethral catheterization for the passage of fluid to or from the urinary tract.

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

• Kendall Urethral Catheter

Submission Summary (Full Text)

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APR 2 2 2003

## K021938

| Submitter: | VitalCare<br>15800 NW 13th Avenue<br>Miami Fl. 33169 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Michael McAvenia<br>Director of Quality Assurance<br>[phone]<br>Fax: [phone]<br>Internet: [e-mail] |
| Name of Device: | VitalCare Urethral Catheter |
| Predicate Device: | Kendall Urethral Catheter |
| Description of the New Device: | Urological Urethral Catheter |

510(k) Summary

## Intended Use of the New Device:

VitalCare's Urethral Catheter are intended to be inserted ithrough the urethra to the bladder and utilized for passage of fluid from/to the urinary tract.

## Comparison of the Technological Features of the New Device and Predicate Device:

The new device features and predicate features are similar. The pouch and contents of the pouch are similar.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of an eagle.

APR 2 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael McAvenia Director of Quality Assurance Vital Care, Inc. 15800 NW 13th Avenue MIAMI FL 33169

Re: K021938

Trade/DeviceName: VitalCare Urethral Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories

Regulatory Class: II Product Code: 78 GBM Dated: February 25, 2003 Received: February 27, 2003

Dear Mr. McAvenia:

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 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Snogdon

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

510(k) Number:

Device Name:

Urethral Catheter

Indications for Use:

VitalCare's Urethral Catheters are intended to be inserted through the urethra to the bladder and utilized for passage of fluid from/to the urinary tract.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use > (per 21 CFR 801.109)

David R. Searson

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