CATHASSIST

K052952 · Physician Technologies, Inc. · KNY · May 14, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K052952
• Device Name: CATHASSIST
• Applicant: Physician Technologies, Inc.
• Product Code: KNY · Gastroenterology, Urology
• Decision Date: May 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Accessory is used to assist routine adult female urethral catheterization in both hospital and office settings. Some of the clinical situations in which female catheterization is indicated include: 1. Major surgery; 2. Urinary retention; 3. Collection of a sterile "cath" urine specimen; 4. Bladder irrigation; and 5. Labor and Delivery. The Accessory is intended for use by: 1. Nurses and caregivers in the rapid and easy insertion of a female urinary catheter; 2. By adult females who are required to perform intermittent self catheterization following surgery; and 3. By adult females required to self-catheterize and who have motor or visual disabilities.

Device Story

CathAssist is a mechanical accessory designed to facilitate routine adult female urethral catheterization. It assists nurses, caregivers, or patients in the insertion process. Used in hospital, office, or home settings. The device simplifies the catheterization procedure, particularly for patients with motor or visual impairments, potentially improving ease of use and success rates for intermittent self-catheterization.

Indications for Use

Indicated for adult females requiring urethral catheterization for major surgery, urinary retention, sterile specimen collection, bladder irrigation, or labor and delivery. Also indicated for use by nurses/caregivers for assistance, and by adult females performing intermittent self-catheterization, including those with motor or visual disabilities.

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).

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY 2 4 2006

Physician Technologies, Inc. % Mr. Randall May Principal Consultant Randall May Consulting 4932 East Holbrook Street ANAHEIM CA 92807

Re: K052952

Trade/Device Name: CathAssist Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: KNY Dated: April 26, 2006 Received: April 28, 2006

Dear Mr. May:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Docuren by of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the encready to region date of the Medical Device Amendments, or to devices that provision in way 26, 1970, and characters with the provisions of the Federal Food, Drug, and Cosmetic have been roomasinou in a premarket 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 controls provisions or allabeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is elassinod (500 as 11) atitional controls. Existing major regulations affecting your Applo rar, tt fits) '60 objector 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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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.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

Sincerely vours.

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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## Indications for Use

## K052952 510(k) Number:

CathAssist™ Female Urinary Catheter Insertion Accessory Device Name:

Insertion Catheter Urinary CathAssist™ Female Indications for Use: The Accessory is used to assist routine adult female urethral catheterization in both hospital and office settings. Some of the clinical situations in which female catheterization is indicated include:

- 1. Major surgery;
- 2. Urinary retention;
- 3. Collection of a sterile "cath" urine specimen;
- 4. Bladder irrigation; and
- 5. Labor and Delivery.

Insertion CathAssist™ Urinary Catheter Female The Accessory is intended for use by:

- 1. Nurses and caregivers in the rapid and easy insertion of a female urinary catheter;
- 2. By adult females who are required to perform intermittent self catheterization following surgery; and
- 3. By adult females required to self-catheterize and who have motor or visual disabilities.

Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Thompson
Division Sign-Off

and Radiological Dev 510(k) Number

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