MEMCATH UROLOGY CATHETER, MODEL 101 -000 - 006

K993226 · Memcath Technologies, LLC · EZD · Dec 10, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K993226
• Device Name: MEMCATH UROLOGY CATHETER, MODEL 101 -000 - 006
• Applicant: Memcath Technologies, LLC
• Product Code: EZD · Gastroenterology, Urology
• Decision Date: Dec 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Memcath Urology Catheter is intended to provide an intermittent pathway for draining fluids from the bladder.

Device Story

The Memcath Urology Catheter is an intermittent urinary catheter designed to facilitate bladder drainage. The device consists of a PVC catheter tube equipped with a pre-loaded, self-deploying PTFE sheath membrane, which serves to increase lubricity during insertion. The system also incorporates a polyurethane snap ring and a polycarbonate/acrylic guide ring to secure the sheath. The device is intended for use by healthcare providers or patients to provide a pathway for fluid drainage. By reducing friction during insertion, the PTFE sheath is intended to improve patient comfort and ease of use during the catheterization process.

Clinical Evidence

Bench testing only. Testing included flow rate, stiffness, kink resistance, insertion/withdrawal load, pull test, body tensile, tip flex, sterility assurance level (SAL), and ethylene oxide (EtO) residuals. All results met established specifications.

Technological Characteristics

Materials: PVC (catheter tube), PTFE (sheath membrane), polyurethane (snap ring), polycarbonate/acrylic (guide ring). Design: Intermittent catheter with self-deploying sheath. Sterilization: Ethylene oxide (EtO).

Indications for Use

Indicated for patients requiring intermittent bladder drainage.

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

• Sherwood- Davis & Geck Argyle Rob-Nel Urological Catheter (K810216)

Submission Summary (Full Text)

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DEC I 0 1999

## 510(k) Summary

General Information

| Classification | Class II |
|----------------|-------------------------------------------------------------------------------------------------|
| Trade Name | Memcath Urology Catheter |
| Submitter | Memcath Technologies LLC<br>1777 Oakdale Avenue<br>West St. Paul, MN 55118-4031<br>651-450-7400 |

Contact

Marc Jaker Vice President

# Intended Use

The Memcath Urology Catheter is intended to provide an intermittent pathway for draining fluids from the bladder.

### Predicate Devices

Sherwood- Davis & Geck Argyle Rob-Nel Urological Catheter, K810216

### Device Description

The Memcath Urology Catheter is designed as an intermittent pathway for drainage of the bladder. The device consists of a PVC catheter tube with pre-loaded, self-deploying PTFE sheath membrane to increase lubricity during insertion. This catheter system also includes a polyurethane snap ring and polycarbonate/acrylic guide ring to secure the sheath.

# Materials

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

# Testing

Products were tested for:

- Flow Rate
- Stiffness
- Kink Resistance
- Insertion/Withdrawal load ●
- Pull Test ●
- Body Tensile ●
- Tip Flex .
- SAL ●
- EtO Residuals ●

All product testing met specifications

### Summary of Substantial Equivalence

The Memcath is equivalent to the predicate products from Sherwood-Davis & Geck Argyle Rob-Nel Urology Catheter. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent. Memcath Technologies believes the Model 101 - 000 - 006 is substantially equivalent to existing legally marketed devices.

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and the commend of the comments of the country

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC I 0 1999

Mr. Marc Jaker Vice President Memcath™ Technologies LLC 1777 Oakdale Avenue West St. Paul, MN 55118-4031 Re: K993226 Memcath™ Urology Catheter Model 101 -000 - 006 Dated: September 24, 1999 Received: September 27, 1999 Regulatory Class: Il 21 CFR §876.5130/Procode: 78 EZD 21 CFR §876.5130/Procode: 78 KOD

Dear Mr. Jaker:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act indude 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compiance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

| 510(k) Number (if known): | This application |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | MemcathTM Urology Catheter<br>Model 101-000-006 |
| Indications for Use: | The MemcathTM Urology Catheter is<br>intended to provide an intermittent<br>pathway for draining fluids from the<br>bladder. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Prescription Use V (Per 21 CFR 801.109)

Ulind h. Sypm

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

510(k) Number K99226

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

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