The Bard® Dual Lumen Ureteral Catheter is intended to facilitate drainage and retrograde pyelogram of the upper urinary tract. This catheter will allow access to and navigation of a torturous ureter using standard endoscopic techniques.

Device Description

The Dual Lumen Ureteral Catheter is a bifurcated catheter with one lumen used for the passage of a quidewire and the other lumen used to inject or drain fluids. Each "Y" extension employs a female luer lock fitting used for connection to a syringe. The Dual Lumen is available in 10 Fr. with the catheter tip tapered to approximately 6 Fr. The working length of the catheter is 50 cm.

AI/ML Overview

The provided text describes a 510(k) summary for the Bard® Dual Lumen Ureteral Catheter. It discusses the device's description, intended use, and technological characteristics compared to a predicate device. However, it does not contain specific information about acceptance criteria or a study that rigorously proves the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or other quantitative measures typically associated with AI/ML or diagnostic devices.

The document states:

"The Bard® Dual Lumen Ureteral Catheter is constructed with biocompatible materials and has been tested for performance and found equivalent to the predicate device."

This statement implies that performance testing was conducted, and the device was found equivalent, but it does not specify what those performance tests entailed, what the acceptance criteria were, or the results of those tests. There is no table of acceptance criteria or reported device performance with numerical metrics.

Therefore, I cannot provide the requested information from the provided text as it does not contain the details of a study with acceptance criteria and reported device performance, sample sizes, ground truth establishment, or expert involvement as typically required for AI/ML device evaluations.

To reiterate, the document is a 510(k) summary for a medical device that appears to be a physical ureteral catheter, not an AI/ML or diagnostic software device. The questions you've asked are typical for evaluating AI/ML models or diagnostic tests, which rely on data and performance metrics. This document does not provide that kind of evaluation.

Summary

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows handwritten text that appears to be a combination of a code and a page number. The code reads 'K032521' and is positioned at the top of the image. Below the code, the text 'Page 1 of 2' is written in cursive, indicating that this is the first page of a two-page document. The handwriting is clear, although the style is informal.

Image /page/0/Picture/3 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are all capitalized and appear to be outlined in black. The font is simple and modern, and the word is easy to read.

510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

A. SUBMITTER INFORMATION:

C. R. Bard, Inc., Urological Division Submitter's Name: Address: 8195 Industrial Blvd. Covington, GA 30014

Contact Person: Contact Person's Telephone Number: Contact Person's Fax: Date of Preparation:

Frances E. Harrison, RAC 770-784-6257 770-784-6419 August 7. 2003

B. Device Name:

Trade Name:	Bard® Dual Lumen Ureteral Catheter
Common / Usual Name:	Ureteral Catheter
Classification Name:	Ureteral Catheter (21 CFR 876.5130)

C. PREDICATE DEVICE NAME:

Bard® Dual Lumen Ureteral Catheter Trade Name:

D. DEVICE DESCRIPTION:

{1}------------------------------------------------

K032521
Pu-ze zfz

Intended Use: ய்

F. TECHNOLOGICAL CHARACTERISTICS SUMMARY:

The Bard® Dual Lumen Ureteral Catheter is constructed of polyurethane. It has the same intended use, general design and is manufactured from the same biocompatible materials as the predicate devices.

Performance Data Summary: G.

The Bard® Dual Lumen Ureteral Catheter is constructed with biocompatible materials and has been tested for performance and found equivalent to the predicate device.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem that resembles a stylized caduceus, featuring a staff with a snake winding around it, though it is not a traditional caduceus. The emblem is rendered in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Frances E. Harrison, RAC Director, Regulatory Affairs C.R.Bard, Incorporated 8195 Industrial Boulevard COVINGTON GA 30014

NOV 1 4 2003

Re: K032521

Trade/Device Name: Bard® Dual Lumen Ureteral Catheter Regulation Number: 21 CFR& 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II

Product Code: 78 EYB Dated: August 7, 2003 Received: August 18, 2003

Dear Ms. Harrison

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require 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 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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.

{3}------------------------------------------------

Page 2

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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 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

{4}------------------------------------------------

K0.3 2521

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):	K032521
---------------------------	---------

Device Name:

Indications for Use:

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

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

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

(Division Sign-Off)		(Optional Format 1/2/96)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K032521

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.