CAREVENT

K062240 · Chief Medical, LLC · KNY · Oct 16, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K062240
• Device Name: CAREVENT
• Applicant: Chief Medical, LLC
• Product Code: KNY · Gastroenterology, Urology
• Decision Date: Oct 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Indications for Use

The CareVent is intended for use with a Foley Urinary Catheter for the management of urinary drainage.

Device Story

CareVent is a manual valve device designed for attachment to the distal end of a Foley urinary catheter. It allows physicians or users to temporarily control urine flow from the bladder. The device can be left open for continuous drainage or manually closed for intermittent drainage. It is intended for use in clinical settings or by patients for bladder conditioning, diagnostic procedures, or comfort management. The device is provided sterile for single-patient use.

Clinical Evidence

Bench testing only. Testing evaluated general operation, valve operation, and fluid leak performance. All testing was successful.

Technological Characteristics

Manual valve mechanism for Foley catheter flow control. Materials are biocompatible and consistent with previously cleared devices. Provided sterile for single-patient use.

Indications for Use

Indicated for use with a Foley Urinary Catheter for the management of urinary drainage in patients requiring bladder conditioning, diagnostic procedures, or temporary flow control for comfort.

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

• Option-vm Urinary Catheter (K041983)
• AMSURE 100% Silicone Foley Catheter (K051059)

Submission Summary (Full Text)

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K06 2240

OCT 16 2006

## 510(k) Summary

#### General Information

Classification

Class II

Trade Name

CareVent

Submitter

Chief Medical LLC P.O. Box 772 105 Pioneer Lane Teton Village, WY. 83025

Contact

Scott Horn President

#### Intended Use

The CareVent is intended for use with a Foley Urinary Catheter for the management of urinary drainage.

#### Predicate Devices

K041983 Option-vm Urinary Catheter Opticon Medical, Inc.

- AMSURE 100% Silicone Foley Catheter K051059 Amsino International, Inc.
### Device Description

The CareVent device is used with a Foley catheter for the management of urinary drainage. The CareVent offers the physician/user a means to temporarily control the flow of urine from the bladder. Temporary control of urine may be desired for bladder conditioning, diagnostic procedures or patient comfort. The CareVent valve is easily inserted into the distal end of a Foley catheter and may be left open for

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K062240

continuous drainage or manually operated for temporarily closure. The device is provided sterile and for single patient use.

### Materials

All materials used in the manufacture of the CareVent are suitable for this use and have been used in numerous previously cleared products.

## Testing

Product testing was conducted to evaluate conformance to product specification. Testing included general operation, valve operation, and fluid leak. All testing was successful.

# Summary of Substantial Equivalence

The CareVent is equivalent to the predicate products. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like extensions. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure. The logo is black and white.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

# OCT 1 & 2006

Chief Medical Devices, LLC c/o Mr. Scott D. Horn P.O. Box 772 105 Pioneer Lane TETON VILLAGE WY 83025

Re: K062240

Trade/Device Name: CareVent Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: KNY Dated: July 26, 2006 Received: August 2, 2006

Dear Mr. Horn:

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.

Image /page/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. In the center of the logo is the acronym "FDA" in a bold, stylized font. Below the acronym is the word "Centennial" in a cursive font. There are three stars below the word "Centennial". The text "A Century of Protecting Your Health" surrounds the central elements of the logo.

Promoting Public H

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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.

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 this letter:

| 21 CFR 876.xxx . | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|------------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 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.

Sincerely yours,

NancyCbrogdon

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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K062240

# Indications for Use

510(k) Number (if known):

This application K062240

Device Name:

CareVent

Indications for Use:

The CareVent is intended for use with a Foley Urinary Catheter for the management of urinary drainage.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

& that's a valid JSON.

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

510(k) Number _

Over-The-Counter Use (Optional Format 1-2-96)

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