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.

AI/ML Overview

The Memcath Urology Catheter is intended to provide an intermittent pathway for draining fluids from the bladder. The device was found substantially equivalent to the Sherwood-Davis & Geck Argyle Rob-Nel Urological Catheter (K810216).

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Test Name	Acceptance Criteria (Specification)	Reported Device Performance
Flow Rate	Met specification	Met specification
Stiffness	Met specification	Met specification
Kink Resistance	Met specification	Met specification
Insertion/Withdrawal load	Met specification	Met specification
Pull Test	Met specification	Met specification
Body Tensile	Met specification	Met specification
Tip Flex	Met specification	Met specification
SAL (Sterility Assurance Level)	Met specification	Met specification
EtO Residuals	Met specification	Met specification

2. Sample Size and Data Provenance for Test Set

The document does not specify the sample sizes used for each test. The studies were conducted by Memcath Technologies LLC and submitted to the FDA in the United States. They appear to be prospective tests performed on newly manufactured devices.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The ground truth for these tests is based on established engineering and materials performance standards for medical devices and their intended use, rather than expert clinical consensus in interpreting data.

4. Adjudication Method for Test Set

Not applicable. The tests are objective measurements against defined specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a physical medical catheter, not an AI/software-as-a-medical-device (SaMD) that typically undergoes MRMC studies.

6. Standalone Performance Study

Yes, standalone performance studies were conducted. The "Testing" section explicitly states that "Products were tested for" a list of attributes, and "All product testing met specifications." This indicates that the device's performance was evaluated independently against pre-defined criteria.

7. Type of Ground Truth Used

The ground truth used for these performance tests is based on engineering specifications and established regulatory standards for urological catheters, often with reference to predicate devices. For example, "Flow Rate," "Stiffness," and "Kink Resistance" have objective, measurable benchmarks that must be met. "SAL" pertains to sterility standards, and "EtO Residuals" to acceptable levels of ethylene oxide post-sterilization.

8. Sample Size for Training Set

Not applicable. This device is a physical medical device, not an AI/machine learning model, so there is no "training set."

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for a physical medical device.

Summary

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DEC I 0 1999

510(k) Summary

General Information

Classification	Class II
Trade Name	Memcath Urology Catheter
Submitter	Memcath Technologies LLC1777 Oakdale AvenueWest St. Paul, MN 55118-4031651-450-7400

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

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus symbol. The logo is presented in black and white.

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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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 CatheterModel 101-000-006
Indications for Use:	The MemcathTM Urology Catheter isintended to provide an intermittentpathway for draining fluids from thebladder.

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)

Regulation Number and Section

§ 876.5130 Urological catheter and accessories.

(a)
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).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.