The catherer consists of a double or triple lumen drainage eye on the proximal tip. The threeway cather has an additional eye for irrigation purposes. The two-way catheter is available with a radiopaque option. The catherer is available in a combination of French sizes, balloon capacties and lengths to accommodate pediative and adult male and female applications. Available catheter lengths range from 10.6 to 15.8, French sizes from 6 to 26 and balloon sizes 1.5cc to 30cc.

AI/ML Overview

This document describes the Rochester Medical Corporation All Silicone Foley Catheter. The submission is a 510(k) for substantial equivalence to previously marketed predicate devices.

Acceptance Criteria and Device Performance (Study Information)

The device, a urological catheter, needs to meet the requirements of ASTM F 623-89 Standard Specifications for Foley Catheters and demonstrate biocompatibility.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
ASTM F 623-89 Standard Specifications for Foley Catheters	Meets requirements with the exception of requirements 5.3 and 5.5 regarding catheter tip and shaft diameters. The document states: "These exceptions are due to the proprietary manufacturing process that allows Rochester Medical to manufacture catheters with balloons that are incorporated into the catheter than being applied during a secondary operation, the tip diameter is equivalent to the balloon diameter which complies with therefore is not considered clinically significant."
Biocompatibility	Biocompatibility testing was completed on catheter samples including tests for: Cytotoxicity, Systemic Toxicity, Intracutaneous Reactivity, Muscle Implantation with Histopathology, Sensitization and Irritation. Results were acceptable for all tests.

Acceptance Criteria

Reported Device Performance

ASTM F 623-89 Standard Specifications for Foley Catheters

Meets requirements with the exception of requirements 5.3 and 5.5 regarding catheter tip and shaft diameters. The document states: "These exceptions are due to the proprietary manufacturing process that allows Rochester Medical to manufacture catheters with balloons that are incorporated into the catheter than being applied during a secondary operation, the tip diameter is equivalent to the balloon diameter which complies with therefore is not considered clinically significant."

Biocompatibility

Biocompatibility testing was completed on catheter samples including tests for: Cytotoxicity, Systemic Toxicity, Intracutaneous Reactivity, Muscle Implantation with Histopathology, Sensitization and Irritation. Results were acceptable for all tests.

Sample size used for the test set and the data provenance:
The document does not specify the exact sample size for the test sets (ASTM F 623-89 testing and biocompatibility testing). It mentions "catheter samples" for biocompatibility. No information regarding country of origin or whether the data was retrospective or prospective is provided. These are laboratory/bench tests rather than clinical studies on human subjects.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable (N/A). These are objective bench-top and laboratory tests, not subjective evaluations requiring expert consensus for ground truth.
Adjudication method for the test set:
N/A. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes, not for standard device performance and biocompatibility testing.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No. This is a 510(k) submission for a physical medical device (Foley catheter) and describes bench and biocompatibility testing, not an AI-assisted diagnostic tool or a comparative effectiveness study involving human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
N/A. This is a physical medical device, not an algorithm.
The type of ground truth used:
For the ASTM F 623-89 Standard Specifications, the ground truth is defined by the objective, measurable requirements stipulated in the standard.
For Biocompatibility testing, the ground truth is established by the accepted scientific methodologies and criteria for evaluating biological responses to medical devices.
The sample size for the training set:
N/A. This information is typically for AI/Machine Learning models, not for traditional medical device testing. The testing described is verification and validation.
How the ground truth for the training set was established:
N/A. This information is typically for AI/Machine Learning models.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Rochester Medical. The logo includes a circle with a check mark through it, and the words "Rochester" and "MEDICAL" in bold letters. The image also includes the date "JUL - 8 1998" at the top. The logo is black and white.

K481612
P171

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION 14.0

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92,

Submitter and Contact Person:	Mary M. WilenRochester Medical Corporation
Name of the Device:	Classification Name: Urological Catheter
	Common/Usual Name: All Silicone Foley Catheter
	Proprietary Name: Rochester Medical Corporation All Silicone Foley Catheter
	➤ Two-Way Foley Catheter
	➤ Three-Way Foley Catheter
	➤ Two-Way Radiopaque Foley Catheter

Predicate Device

The predicate device for purposes of substantial equivalence is the Rochester Medical Corporation All Silicone Folcy Catheter which receive matketing approval under K896053, Rusch Foley Catheters, and Bard Urological Inc. Foley Catheters.

Intended Use of the Device

For urological use only.

Device Description

Technological Characteristics

The catheter described in the 510(k) has similar technological and performance characteristics to the predicate devices. The cather is manufactured entirely from silicone elassomer. The predicate devices are manufactured from silicone elastomer, latex, rubber and red rubber. The device is supplied in French sizes ranging from 6 to 26 and balloon capacities 1.5cc to 30cc. The predicate devices are available in French sizes from 6 to 26 and balloon capacities 1.5cc to 75cc. The device is supplied in pediatric, male and female lengths. The predicate devices are supplied in pediative, male and female lengths. All of the devices are supplied sterile for single use.

Testing and Results

Test results indicate that the Rochester Medical Corocration All Silicone Foley catherers meet the requirements of ASTM F 623-89 Standard Specifications for Foley Catheters with the exception of requirements 5.3 and 5.5 regarding catheter tip and shaft diameters. These exceptions are due to the proprietary manufacturing process that allows Rochester Medical to manufacture catheters with balloons that are incorporated into the cather than being applied during a secondary operation, the tip diameter is equivalent to the balloon diameter which complies with therefore is not considered clinically significant. Biocompatibility testing was completed on catherer samples including tests for: CCytotoxicity, Systemic Toxicity, Intractaneous Reactivity, Muscle Implantation with Histopathology, Sensitization and Irlritation. Results were acceptable for all tests.

Rochester Medical Corporation All Silicone Foley Catheter Section 510(k) Notification 07/07/98

One Rochester Medical Drive Stewartville, MN 55976

Image /page/0/Picture/17 description: The image shows a logo with the text "ISO 9001 CERTIFIED". The text "ISO 9001" is in bold and is placed in the center of the logo. The word "CERTIFIED" is placed below "ISO 9001". The logo is surrounded by a globe-like design.

Tel: (507) 533-9600

Fax: (507) 533-9726

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 8 1998

Ms. Mary M. Wilen Director of Clinical and Regulatory Affairs Rochester Medical One Rochester Medical Drive Stewartville, Minnesota 55976

Re: K981612

Rochester Medical Corporation All Silicone Foley Catheter Dated: May 1, 1998 Received: May 6, 1998 Regulatory Class: II 21 CFR 876.5130/Procode: 78 EZL

Dear Ms. Wilen:

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 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (2) 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 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance 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/dsmaldsmam.html".

Sincerely yours

Lillian Yin Ph.D.

Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if Known): ____________________________________________________________________________________________________________________________________________________

Device Name: __All Silicone Two-Way Catheter, All Silicone Three-Way Foley Catheter, & Radiopaque Silicone Foley Catheter Rochester Medical Corporation

Indications for Use:

Two-Way Catheter: Urethral catheterization for bladder drainage.

Three -Way Catheter: Urethral catheterization for bladder drainage and bladder irrigation.

Radiopaque Catheter:

Urethral catheterization for bladder drainage with radiopaque substance for radiographic visualization.

INTENDED USE For urological use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Doler R Sathing/
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 98 16 510(k) Number _

Prescription Use_ (Per 21 CFR 801.109)

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.