The Bardex® Lubri-Sil® All-Silicone Lubricious Coated Foley Catheter 6 Fr is 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 nephrostomy tract.

Device Description

The Bardex® Lubri-Sil® All-Silicone Lubricious Coated Foley Catheter 6 Fr is a single use, sterile, 2-way, latex-free, hydrogel-coated Foley catheter and represents a product line extension to the current Bard Medical Division product line range of silicone Foley catheters found substantially equivalent in K984084 and K002868.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Bardex® Lubri-Sil® All-Silicone Lubricious Coated Foley Catheter 6 Fr, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Requirement	Reported Device Performance
Dimensional Requirements	Meet C.R. Bard Inc. dimensional requirements	Met C.R. Bard Inc. dimensional requirements
Friction	Coefficient of friction test	Passed coefficient of friction test
Flow Rate	ASTM F623-99 Standard Performance Specification for flow rate	Met ASTM F623-99 Standard Performance Specification for flow rate
Balloon Integrity	ASTM F623-99 Standard Performance Specification for balloon integrity	Met ASTM F623-99 Standard Performance Specification for balloon integrity
Balloon Pull-out Response	ASTM F623-99 Standard Performance Specification for inflated balloon response to pull out	Met ASTM F623-99 Standard Performance Specification for inflated balloon response to pull out
Balloon Volume Maintenance	ASTM F623-99 Standard Performance Specification for balloon volume maintenance	Met ASTM F623-99 Standard Performance Specification for balloon volume maintenance
Balloon/Shaft Size	ASTM F623-99 Standard Performance Specification for balloon and shaft size	Met ASTM F623-99 Standard Performance Specification for balloon and shaft size
Balloon Deflation	ASTM F623-99 Standard Performance Specification for balloon deflation reliability	Met ASTM F623-99 Standard Performance Specification for balloon deflation reliability
Biocompatibility	Biocompatibility testing	Performed successfully
Pediatric Catheter Specific	Additional testing established by C.R. Bard Inc. for a silicone-coated pediatric catheter	Additional testing for a silicone-coated pediatric catheter (details not specified in the provided text but stated as "provided within this 510(k)")

Study Details

The provided text describes a submission for a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than a de novo clinical study with a focus on comparative effectiveness against human readers or extensive ground truth establishment as might be seen with AI/ML devices.

Therefore, many of the requested points are not applicable or explicitly mentioned in the context of this type of submission.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify sample sizes for any "test set" in the context of clinical data. The testing mentioned (dimensional, friction, ASTM standards, biocompatibility) are laboratory/bench tests, not clinical evaluations with patient data.
- Data provenance is not applicable for the described bench testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. "Ground truth" in the clinical sense (e.g., for diagnostic accuracy) is not established or discussed for this device. The evaluations are against engineering specifications and industry standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This device's evaluation doesn't involve subjective interpretation that would require an adjudication method.
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:
- No. This is a medical device (Foley catheter), not an AI/ML diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant or performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the performance tests, the "ground truth" or reference is established by engineering specifications, C.R. Bard Inc. internal requirements, and recognized industry standards (ASTM F623-99). For biocompatibility, it would be established by relevant ISO standards or FDA guidance for biological evaluation of medical devices.
The sample size for the training set:
- Not applicable. This device's development does not involve a "training set" in the context of machine learning. Product design and testing are based on engineering principles and regulatory standards.
How the ground truth for the training set was established:
- Not applicable, as no "training set" is involved.

Summary

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K070508

5.0 510(k) Summary of Safety and Effectiveness

MAR 0 9 2007

Product :	Bardex® Lubri-Sil® All-Silicone LubriciousCoated Foley Catheter 6 Fr
Preparer/Contact	Michelle GudithSenior Regulatory Affairs ManagerBard Medical DivisionC.R. Bard Inc.8195 Industrial Blvd.Covington, Georgia 30014 USAPhone (770) 784-6722, Fax (770) 784-6722E-mail michelle.gudith(@crbard.com
Manufacturer	C.R. Bard Inc.
Date summary was prepared:	January 03, 2007
Name(s) of the device:	Bardex® Lubri-Sil® All-Silicone LubriciousCoated Foley Catheter 6 Fr
Identification of predicate device(s):	Rochester Medical Silicone Hydrophilic CoatedFoley CatheterBardex® All-Silicone Lubri-Sil® LubriciousCoated Foley Catheter, 2 and 3-way.Bardex® Lubri-Sil® I.C. All-Silicone LubriciousCoated Foley Catheter, 3-way.

5.1 ESTABLISHMENT REGISTRATION NUMBER

Owner/Operator: C.R. Bard Inc.

C.R. Bard Manufacturing Locations:

The device will be lubricious-coated at Moncks Corner, South Carolina, USA, Establishment Registration Number, 1030583.

Device packaging will occur at the Nogales, Sonora, Mexico, Establishment Registration Number, 9611950.

The device will be sterilized/distributed Covington, Georgia, USA, Establishment Registration Number, 1018223.

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Qualified Suppliers/Contract Manufacturers:

Uncoated catheters will be extruded and assembled at Degania Silicone, Ltd. in Tel Aviv, Israel. Registration Number, 8030107.

5.2 OFFICIAL CORRESPONDENT

Michelle Gudith Senior Manager, Regulatory Affairs Bard Medical Division C.R. Bard Inc. 8195 Industrial Blvd. Covington, Georgia 30014 USA Phone (770) 784-6722, E-mail michelle.gudith(@crbard.com

5.3 CLASSIFICATION

21 CFR 876.5130 Regulation Name: Urological Catheter Regulatory Class: Class II Product Code: EZL

5.4 CLASSIFICATION NAME

Urological Catheter/Catheter, Retention Type, Balloon

5.5 COMMON OR USUAL NAMES

Urological Foley Catheter

5.6 PROPRIETARY NAME

Bardex® Lubri-Sil® All-Silicone Lubricious Coated Foley Catheter 6 Fr

5.7 INTENDED USE

Confidential

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NOLLOHS

BOTCHIS

BOTON

ECTON

5.8 PREDICATE DEVICES

K000723 -	Rochester Medical Silicone Hydrophilic coated Foley catheters
K984084 -	Bardex® All-Silicone Lubri-Sil® Lubricious coated Foley catheter, 2-way.
K002868 -	Bardex® Lubri-Sil® All-Silicone Lubricious Coated Foley catheter, 3-way.Bardex® Lubri-Sil® I.C. All-Silicone Lubricious Coated Foley cathete3-way.

5.9 DESCRIPTION OF THE DEVICE:

Intended Use:

Device Description

Technological Characteristics

The catheters described in this 510(k) have similar technological and performance characteristics to the predicate devices. The catheters are manufactured from silicone and have a lubricious/hydrophilic coating, just as the predicate devices from C.R. Bard Inc. and Rochester Medical.

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Evaluation of Substantial Equivalence:

The device is a line extension of the C.R. Bard Foley Catheter product line of lubricious-coated silicone catheters. The 6 Fr size adds another pediatric size in addition to the 8 and 10 Fr sizes currently commercially available. In addition, Rochester Medical's 510(k) includes a 6 Fr size made of silicone with a hydrophilic coating.

The new device was tested to meet C.R. Bard Inc. dimensional requirements, coefficient of friction test and ASTM F623-99 Standard Performance Specification for Foley Catheter for flow rate, balloon integrity, inflated balloon response to pull out, balloon volume maintenance, balloon and shaft size, and balloon deflation reliability. Biocompatibility testing has also been performed successfully. Additional testing established by C.R. Bard Inc. for a silicone-coated pediatric catheter are also provided within this 510(k).

Conclusion

The proposed Barde - Lubri-Sil® All-Silicone Lubricious coated Foley Catheter 6 Fr is substantially equivalent to commercially available devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its head, body, and feet. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAR 0 9 2007

C. R. Bard, Inc. c/o Mr. Robert Mosenkis President CITECH 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298

Re: K070508

Trade/Device Name: Bardex® Lubri-Sile All-Silicone Lubricious Coated Foley Catherer 6 Fr Regulation Number: 21 CFRT §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: February 21, 2007 Received: February 22, 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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/4/Picture/10 description: The image shows a logo with the text "1906-2006 FDA Centennial" in a circular design. There are three stars below the word Centennial. The text "Protecting and Promoting Public Health" is written in a decorative font below the logo.

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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 (OS) 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 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)	240-276-011
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-011
21 CFR 892.xxxx	(Radiology)	240-276-012
Other		240-276-010

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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

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Indications for Use Statement

510(k) Number (if known): Unknown K070508

Device Name: Bardex® Lubri-Sil® All-Silicone Lubricious Coated Foley Catheter 6 Fr

Indications for Use: The Bardex® Lubri-Sil® All-Silicone Lubricious Coated Foley Catheter 6 Fr is 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 nephrostomy tract.

AND/OR Prescription Use: (21 CFR 801 Subpart D)

Over-the-Counter Use: (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Segarra

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070508

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C.R. Bard, Inc.

Confidential

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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.