The Bardex® Temperature-Sensing Foley Catheter, when connected to a Bard CritiCore® or Urotrack 224 monitor, or other 400-series Temperature Monitors, is intended for use in the drainage and/or collection and/or measurement of urine and in conjunction with an electronic urine monitor for the monitoring of core body temperature, in degrees Fahrenheit and degrees Celsius.

Device Description

The Bardex® Temperature-Sensing Foley Catheter is a two-way silicone Foley Catheter with a thermistor embedded in the third lumen. The catheters will be available uncoated, with a lubricious coating or with a silver and lubricious coating.

AI/ML Overview

The provided text is a 510(k) summary for the Bardex® Temperature-Sensing Foley Catheter. This type of submission is for medical devices, which typically do not involve the same kind of performance studies (e.g., studies with human readers, training and test sets, ground truth established by experts) as AI/ML software. Instead, the focus is on demonstrating substantial equivalence to a predicate device through engineering and functional testing.

Based on the provided text, here's a breakdown of the requested information, noting where it is not applicable or not provided for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Performance and functional testing standards are based on the FDA "Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters" dated September 12, 1994 and ASTM F623-99, "Standard Performance Specification for Foley Catheter.""

However, the specific acceptance criteria and detailed reported device performance (e.g., pass/fail for each standard) are not explicitly listed in the provided summary. The summary simply states that the new device "is held to the same design, manufacture, and performance specifications as the predicate (#K003289)."

Acceptance Criteria (Based on FDA Guidance / ASTM F623-99)	Reported Device Performance
Specific criteria not detailed in submission	Not explicitly reported in this summary
Adheres to design, manufacture, and performance specifications of predicate device	Device meets same specifications as predicate K003289

2. Sample Size Used for the Test Set and Data Provenance:

This information is not applicable in the context of an AI/ML device where "test sets" typically refer to data used to evaluate algorithm performance. For a physical medical device like a Foley catheter, testing involves engineering and functional tests on manufactured units. The sample size for these specific tests (e.g., how many catheters were tested for flow rate, balloon integrity, or temperature sensing accuracy) is not provided in this summary. Data provenance is also not relevant in this context.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This is not applicable. The "ground truth" concept, especially established by experts, is primarily relevant for AI/ML diagnostic or prognostic devices that interpret complex data (like medical images). For a temperature-sensing catheter, accuracy is typically verified against calibrated measurement standards, not expert consensus.

4. Adjudication Method for the Test Set:

This is not applicable for the same reasons as #3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

This is not applicable. MRMC studies are used to evaluate human reader performance with and without AI assistance, which is irrelevant for a physical medical device like a Foley catheter.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This is not applicable. There is no "algorithm" in the sense of AI/ML software for this device to be evaluated in a standalone manner. The device itself performs the temperature sensing and urine drainage.

7. The Type of Ground Truth Used:

For a temperature-sensing Foley catheter, the "ground truth" for its temperature sensing function would be established through calibration against recognized temperature standards using laboratory equipment, not expert consensus, pathology, or outcomes data. The summary does not detail the specific method for establishing the performance specifications, but it references ASTM F623-99, which would include such calibration and verification procedures.

8. The Sample Size for the Training Set:

This is not applicable. There is no "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable. There is no "training set" for this device.

Summary for the Bardex® Temperature-Sensing Foley Catheter:

The submission for the Bardex® Temperature-Sensing Foley Catheter is a 510(k) for a physical medical device, not an AI/ML software device. Therefore, many of the requested categories related to AI/ML software performance studies (e.g., test sets, training sets, expert ground truth, MRMC studies) are not applicable.

The core of the study described (implicitly) is demonstrating substantial equivalence to a predicate device (K003289). This is achieved by showing that the new device meets the same design, manufacturing, and performance specifications as the predicate. These specifications are, in turn, based on:

FDA "Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters" (September 12, 1994)
ASTM F623-99, "Standard Performance Specification for Foley Catheter"

While the specific acceptance criteria (e.g., exact temperature accuracy tolerance, flow rates, balloon inflation characteristics) and the detailed results of the functional and engineering tests are not provided in this summary, the FDA's clearance indicates that C.R. Bard, Inc. successfully demonstrated that the device met these established standards through their testing process. The "study" here refers to the engineering and functional verification processes conducted to ensure the device met the relevant industry standards and performed equivalently to the predicate.

Summary

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

K070582
DEC -

SECTION 5 BARDEX® TEMPERATURE-SENSING FOLEY CATHETER 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:

Submitter's Name	C.R. Bard, Inc.Bard Medical Division8195 Industrial Blvd.Covington, GA 30014
Contact Person:	Skip Rimer
Contact Person's Telephone Number:	770-784-6160
Contact Person's Fax:	770-784-6419
Date of Preparation:	January 10, 2007

B. DEVICE NAME:

Trade Name(s):	Bardex® Latex-Free Temperature-Sensing FoleyCatheter, Bardex® Lubri-Sil® Temperature-Sensing Foley Catheter, and Bardex® Lubri-Sil®I.C. Temperature-Sensing Foley Catheter
Common/Usual Name:	Temperature-sensing Foley catheter
Classification Product Code:	EZL – Catheter, Retention Type, Balloon21 CFR 876.5130
Subsequent Product Code:	MJC – Catheter, Urological (Antimicrobial) andAccessories21 CFR 876.5130

C. PREDICATE DEVICE NAME:

Trade Name(s): Bardex® Latex-Free Temperature-Sensing Foley Catheter, Bardex® Lubri-Sil® Temperature-Sensing Foley Catheter, and Bardex® Lubri-Sil® I.C. Temperature-Sensing Foley Catheter

D. DEVICE DESCRIPTION:

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

SECTION 5 BARDEX® TEMPERATURE-SENSING FOLEY CATHETER 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

E. INTENDED USE:

The Bardex® Temperature-Sensing Foley Catheter, when connected to a Bard CritiCore® or Urotrack 224 Monitor, or other 400-Series Temperature Monitors, is intended for use in the drainage and/or collection and/or measurement of urine and in conjunction with an electronic urine monitor for the monitoring of core body temperature, in degrees Fahrenheit and degrees Celsius.

F. TECHNOLOGICAL CHARACTERISTICS SUMMARY:

The subject device, Bardex® Temperature-Sensing Foley Catheter, has the same intended use, design and fundamental scientific technology as the predicate device.

G. PERFORMANCE DATA SUMMARY:

The Bardex® Temperature-Sensing Foley Catheter referenced in this submission is held to the same design, manufacture, and performance specifications as the predicate (#K003289). Performance and functional testing standards are based on the FDA "Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters" dated September 12, 1994 and ASTM F623-99, "Standard Performance Specification for Foley Catheter."

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized representation of an eagle with three wavy lines emanating from its head, symbolizing health, services, and human needs. The eagle is facing to the right.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

C.R. Bard, Inc. % Mr. Robert Mosenkis President Citech 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298

Re: K070582

Trade/Device Name: Bardex® All-Silicone Temperature-Sensing Foley Catheter

DEC 7 2007

Regulation Number: 21 CFR 876.5130

Regulation Name: Urological catheter and accessories

Regulatory Class: II

Product Code: EŽL

Dated: November 20, 2007

Received: November 21, 2007

Dear Mr. Mosenkis:

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 such 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.

the same of the same of the states of the states

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

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.

This letter will allow you to begin marketing your device as described in your Section 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

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}------------------------------------------------

SECTION 4 BARDEX® TEMPERATURE-SENSING FOLEY CATHETER INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Bardex® All-Silicone Temperature-Sensing Foley Catheter, Bardex® Lubri-Sil® Temperature-Sensing Foley Catheter, and the Bardex® Lubri-Si1® I.C. Temperature-Sensing Foley Catheter

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)

Nancy Brogdon

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1/2/96)

Page 4-1

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.