The Bardex® Lubri-Sil® All-Silicone Foley Catheter, and the Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter are indicated for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.

Some Foley catheters, especially those with larger (30cc) balloons are used to assist in hemostatis following surgery such as transurethral resection of the prostate.

Device Description

The subject device three-way Foley catheter is composed of a trifurcated silicone tube, a silicone balloon and a two-way valve (a valve that upon activation permits flow in either of two directions, i.e., for inflation of the balloon). The three-way designation of the catheter refers to the number of lumens in the catheter tubing. The tube has three lumens, one lumen for urinary drainage which is to be connected to a urine collection container (drainage bag or urine meter), one lumen with a two-way valve for inflation/deflation of the Foley balloon, and one lumen for irrigation of the bladder. Catheters with either a 5cc or 30cc balloon will be available with 16 through 24 Fr. shafts (i.e., 16, 18, 20, 22, and 24).

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, specifically the Bardex® Lubri-Sil® 3-Way Foley Catheter and Bardex® Lubri-Sil® I.C. 3-Way Foley Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the device performance information is presented differently than for a new, innovative AI device.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document does not explicitly present a discrete table of "acceptance criteria" for novel performance metrics with corresponding numerical "reported device performance" values in the way one might expect for a new AI diagnostic device. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device by meeting the same design, manufacturing, and performance specifications.

The relevant section states:

"The Bardex® Lubri-Sil® 3-Way Foley Catheter and Bardex® Lubri-Sil® I.C. 3-Way Foley Catheter referenced in this submission are held to the same design, manufacture, and performance specifications as the predicate (#K002868). 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. ISO 10993-1, "Biological Evaluation of Medical Devices," and ASTM F623-99, "Standard Performance Specification for Foley Catheter.""

Interpretation:
The "acceptance criteria" for this device are that it must comply with:

The same design, manufacture, and performance specifications as the predicate device (Bard® Lubri-Sil™ 3-Way Foley Catheter, Bard® Lubri-Sil™ I.C. 3-Way Foley Catheter).
FDA Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters (1994).
ISO 10993-1: Biological Evaluation of Medical Devices.
ASTM F623-99: Standard Performance Specification for Foley Catheter.

The "reported device performance" is essentially that the device met these specifications and standards, allowing the FDA to determine substantial equivalence. The document doesn't provide specific numerical results of these tests, but rather states that the device "is held to" these standards. The FDA's letter of clearance indicates that based on the submission, the device was found substantially equivalent, implying it met these underlying performance requirements.

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

Sample Size for Test Set: The document does not specify a sample size for a "test set" in the context of clinical performance data as we might see for an AI algorithm. The performance evaluation here refers to engineering and biocompatibility testing against established standards. These tests would involve a certain number of catheter units, but it's not a "test set" in the sense of patient data.
Data Provenance: The document does not provide information on data provenance (e.g., country of origin, retrospective/prospective) because it's not a study based on patient data analysis like an AI diagnostic algorithm would require. The "data" refers to the results of engineering and biocompatibility tests.

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

This information is not applicable to this 510(k) submission. The ground truth for a Foley catheter's performance is established by its adherence to physical design specifications, material properties, sterility, and functional tests (e.g., balloon inflation, flow rates, lack of leakage), and biocompatibility, as outlined in the referenced standards (FDA, ISO, ASTM). These are objective engineering and biological assessments, not subjective expert interpretations of images or clinical outcomes.

4. Adjudication method for the test set:

This is not applicable. There is no "adjudication method" in the context of expert consensus as there would be for subjective clinical assessments. The performance tests are objectively measured against defined criteria within the 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:

This is not applicable. This device is a physical medical device (Foley catheter), not an AI-powered diagnostic tool, and therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to its evaluation.

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

This is not applicable. This device is not an algorithm. It's a physical medical device.

7. The type of ground truth used:

The "ground truth" for this device, in the context of its safety and effectiveness, is established by:

Compliance with recognized standards: FDA guidance, ISO 10993-1 (biological evaluation), and ASTM F623-99 (physical performance standards).
Demonstration of substantial equivalence to a predicate device in terms of intended use, design, and fundamental scientific technology.
Objective engineering tests (e.g., burst strength, flow rates, sterility) and biocompatibility testing (e.g., cytotoxicity, sensitization) as required by the referenced standards.

8. The sample size for the training set:

This is not applicable. This device does not use a "training set" as it is not an AI algorithm.

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

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

In summary: The provided document is a 510(k) summary for a conventional medical device (Foley catheter). The "acceptance criteria" and "study" described are focused on demonstrating substantial equivalence to a predicate device and compliance with established engineering and biocompatibility standards, rather than evaluating the performance of an AI algorithm against a clinical ground truth. Many of the requested details (like sample sizes for test/training sets, expert qualifications, MRMC studies, and ground truth types) are specific to AI/diagnostic device evaluation and are not relevant to this type of medical device submission.

Summary

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K070558

SECTION 5 BARDEX® LUBRI-SIL® 3-WAY FOLEY CATHETER AND BARDEX® LUBRI-SIL® I.C. 3-WAY 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.

SUBMITTER INFORMATION: A.

JEC 77 2007

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

B. DEVICE NAME:

Contact Person's Fax: Date of Preparation:

Trade Name(s):	Bardex® Lubri-Sil® 3-Way Foley Catheter,Bardex® Lubri-Sil® I.C. Foley Catheter
Common/Usual Name:	Urological Foley catheter
Classification Product Code:	EZL - Catheter, Retention Type, Balloon21 CFR 876.5130
Subsequent Product Code:	MJC - Catheter, Urological (Antimicrobial) andAccessories21 CFR 876.5130

770-784-6419

August 16, 2007

C. PREDICATE DEVICE NAME:

Trade Name(s): Bard® Lubri-Sil™ 3-Way Foley Catheter, Bard® Lubri-Sil™ I.C. 3-Way Foley Catheter

D. DEVICE DESCRIPTION:

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SECTION 5 BARDEX® LUBRI-SIL® 3-WAY FOLEY CATHETER AND BARDEX® LUBRI-SIL® I.C. 3-WAY FOLEY CATHETER 510(K) SUMMARY OF SAFETY AND EFFECTIVENSS INFORMATION

E. INTENDED USE:

Bardex® Lubri-Sil® 3-Way Foley Catheter, and the Bardex® Lubri-Sil® I.C. 3-Way Foley Catheter are indicated for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.

Some Foley catheters, especially those with larger (30cc) balloons are used to assist in hemostatis following surgery such as transurethral resection of the prostate.

F. TECHNOLOGICAL CHARACTERISTICS SUMMARY:

The subject devices, Bardex® Lubri-Sil® 3-Way Foley Catheter and Bardex® Lubri-Sil® I.C. 3-Way Foley Catheter, have the same intended use, design and fundamental scientific technology as the predicate devices.

F. PERFORMANCE DATA SUMMARY:

The Bardex® Lubri-Sil® 3-Way Foley Catheter and Bardex® Lubri-Sil® I.C. 3-Way Foley Catheter referenced in this submission are held to the same design, manufacture, and performance specifications as the predicate (#K002868). 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. ISO 10993-1, "Biological Evaluation of Medical Devices," and ASTM F623-99, "Standard Performance Specification for Foley Catheter."

,上海

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a stylized graphic of three human figures in profile, with flowing lines representing movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC -7 2007

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

Re: K070558

Trade/Device Name: Bardex® Lubri-Sil® 3-wav Foley Catheter, Bardex® Lubri-Sil® I.C. Foley Catheter

Regulation Number: 21 CFR 876.5130

Regulation Name: Urological catheter and accessories

Regulatory Class: II

Product Code: EZL

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 (MA), 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 (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 Registed.

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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

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SECTION 4 BARDEX® ALL-SILICONE 3-WAY IRRIGATON FOLEY CATHETER INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K070558

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

Indications for Use:

Some Foley catheters, especially those with larger (30cc) balloons are used to assist in hemostatis following surgery such as transurethral resection of the prostate.

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

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Prescription Use ﮯ۔ (Per 21 CFR 801.109) Over-The-Counter Use __

Nancy C brogdon

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

(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.