The Kendall Coude Foley Catheter is a urological catheter designed with a bent tip to provide transurethral access to the obstructed bladder in the male patient for irrigation and urine drainage.

Device Description

The Kendall Ultraner Coude Foley Catheter is a sterile, single use unological catheter composed of natural rubber latex with a 5 cc or 30cc balloon and designed with a beat tip to provide transurethral access to an obstructed bladder, for purposes of irrigation and urine drainage. The Coude catheter is exclusively used in the male patient, typically in a hospital secting. The Kendall Ultramer Coude Foley Catheters will be marketed in 12-24 French sizes.

AI/ML Overview

The provided text describes a medical device, the Kendall Ultramer Coude Foley Catheter, and its 510(k) submission to the FDA. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against defined acceptance criteria in the manner requested for AI/software devices.

As such, many of the requested categories are not applicable to this type of traditional medical device submission. The primary "study" conducted here is nonclinical testing to ensure fundamental safety and equivalence.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What the device must achieve)	Reported Device Performance (What was found)
Biocompatibility: Meet ISO-10993 Biological Evaluation of Medical Devices standards.	Materials used in the Kendall Coude Foley Catheter are biocompatible.
Functional/Mechanical Performance: Meet ASTM F623-89 Standard Performance Specifications for Foley Catheters for: - Flow rates - Balloon integrity - Inflated balloon response to traction - Balloon volume maintenance - Balloon size - Shaft size - Deflation reliability	The Kendall Coude catheter was found to meet ASTM F623-89 Standard Performance Specifications for Foley Catheters for the listed parameters. Testing also verified equivalence to the predicate device.
Substantial Equivalence: Fabricated from similar materials, same function, equivalent indications for use, and similar overall design as the predicate device (Bardex Lubricath Coude Foley Catheter, 510(k) #K910195).	The Kendall Ultramer Coude Foley Catheter is equivalent to the referenced predicate device in materials, function, indications for use, and overall design.

2. Sample size used for the test set and the data provenance

Sample Size (Test Set): Not explicitly stated in terms of a "test set" for a diagnostic product. The nonclinical testing involves physical samples of the catheter, but the number of units tested for each functional/mechanical test is not provided.
Data Provenance: The testing was conducted internally by The Kendall Company ("Nonclinical testing was performed on the Kendall cather..."). The country of origin for the data is implicitly the USA (Mansfield, MA). It is a prospective evaluation of newly manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This device is a physical medical catheter, not an AI/diagnostic software. Ground truth for its performance is established through standardized engineering and biocompatibility testing, not expert interpretation of diagnostic data.

4. Adjudication method for the test set

Not Applicable. See point 3. Testing involves objective measurements against predefined standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is a physical device, not an AI or diagnostic software. Therefore, no MRMC study or AI assistance evaluation was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical device, not an algorithm or software. Its performance is inherent in its design and materials, and demonstrated through physical testing.

7. The type of ground truth used

Engineering Standards and Biocompatibility Standards:
- ASTM F623-89 Standard Performance Specifications for Foley Catheters: Provides quantifiable benchmarks for functional and mechanical aspects (e.g., flow rates, balloon integrity).
- ISO-10993 Biological Evaluation of Medical Devices: Provides standardized methods and criteria for evaluating the biocompatibility of medical devices.
- Predicate Device Equivalence: The ultimate "ground truth" for regulatory approval in this context is demonstrating substantial equivalence to a legally marketed predicate device, as required for a 510(k) submission.

8. The sample size for the training set

Not Applicable. This is a physical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

Not Applicable. See point 8.

Summary

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K990500

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II. 510(k) SUMMARY

Submitted by:	The Kendall Company15 Hampshire StreetMansfield, MA 02048
Contact Person:	Paul W. Evans(508) 261-8203
Date Prepared:	January 31, 1999
Proprietary Name:	Kendall Ultramer Coude Foley Catheter
Common Name:	Coude Foley Catheter
Classification Name:	Urological Catheter and accessories (21 CFR §876.5130(h))
Predicate Device:	Bardex Lubricath Coude Foley Catheter510(k) #K910195

Description of the Device:

Intended Use of the Device:

The Kendall Coude Foley catherer is a urological catherer designed with a bent tip to provide transurethral access to the obstructed bladder in the male patient for irrigation and uring drainage.

Technological Characteristics:

The Kendall Ultramer Coude Foley Catherer is equivalent to the referenced predicate device in that they are fabricated from similar materials, have the same function, equivalent indications for use, and similar overall design.

Nonclinical resting:

Biocompatibility resting was performed on the Kendall cather, following ISO-10993 Biological Evaluation of Medical Devices. The testing found that the Materials used in the Kendall Coude Foley Catheter are biocompatible.

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Fur. tional/mechanical testing was performed to determine flow rates, balloon integrity, inflated balloon response to traction, balloon volume maintenance, balloon size and shaft size, and deflation reliability. The testing found the Kendall Coude catheter to meet ASTM F623-89 Standard Performance Specifications for Foley Catheters. The testing also verified equivalence to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 8 1999

Mr. Paul W. Evans Director, Regulatory Affairs The Kendall Company 15 Hampshire Street Mansfield, MA 02048

Re: K990500 Kendall Ultramer Coude Foley Catheter Dated: September 9, 1999 Received: September 10, 1999 Regulatory Class: II 21 CFR §876.5130/Procode: 78 EZL

Dear Mr. Evans:

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 include requirements for annual registration, isting 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 regult 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 regulation (21 CFR Part 801 and additionally 809,10 for in vitto diagnosic devices), piease 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/dsma/dsmamain.html".

Sincerely yours,

CART Daniel J. Scheidt, M.D.

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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VII. INDICATIONS FOR USE STATEMENT

K 990500 510(k) Number: Kendall Coude Foley Catheter Device Name: _

Indications for Use: The Kendall Coude Foley Catheter is a urological catheter designed with a bent tip to provide transurethral access to the obstructed bladder in the male patient for irrigation and urine drainage.

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Concurrence of CDRD, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR §801.109)	✓
OR Over-The Counter Use

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

510(k) Number	K990500
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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.