The Bardex I. C. 4-Way Foley Catheter is indicated for use in bladder/urinary tract drainage/irrigation and to assist in hemostasis and surgical site drainage following procedures such as transurethral resection of the prostate.

Device Description

The Bardex I. C. 4-Way Foley Catheter is a new catheter design incorporating the addition of a fourth lumen for prostatic drainage and the addition of several prostatic drainage eyes proximal to the balloon.

AI/ML Overview

The provided text is a 510(k) summary for the Bardex I. C. 4-Way Foley Catheter, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study involving experts, AI, or controlled ground truth assessment.

Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria cannot be extracted from this specific document. The document highlights the technological characteristics and intended use of the device and compares them to existing predicate devices. It states that performance and functional testing standards are based on a "Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters."

Here's an attempt to answer the questions based on the available information, noting where information is not present:

Acceptance Criteria and Device Performance Study Information

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria with corresponding performance metrics in the format of a clinical or performance study. Instead, it focuses on qualitative and structural characteristics compared to predicate devices for substantial equivalence.

Acceptance Criteria Category (Derived from predicate comparison)	Reported Device Performance (Bardex I.C. 4-Way Foley Catheter)
Indications or Intended Use	Bladder/urinary tract drainage/irrigation, assist in hemostasis and surgical site drainage following procedures such as transurethral resection of the prostate. (Equivalent to predicates, with the added prostatic drainage feature).
Disposable	Yes
Sterile	Yes
Catheter Base Material	Red Latex
X-Ray Opaque	Yes
Coating	Silver/Hydrogel
Drainage Eyes Proximal to Balloon	5 Drainage Eyes (New feature)
Tip Type – Drainage Eyes Distal to Balloon	Open Concave Tip (Couvelaire) and 3 additional eyes
Fr. Sizes Available	18-24 Fr.
Foley Balloon Size	30cc
Available Packaged Singly	Yes
Tip Shape	Coude
Number of Lumens	4 lumens (New feature)

Note: The document states "Performance and functional testing standards are based on the 'Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters' dated September 12, 1994." However, the results of these tests, specific acceptance criteria, or a detailed study report are not included in this summary.

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

This document does not describe a clinical or performance test set for evaluating the device against acceptance criteria in the manner typically associated with AI/software device evaluation. It focuses on device characteristics for regulatory submission.

Sample Size: Not applicable/Not provided in this summary.
Data Provenance: Not applicable/Not provided in this summary.

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

This document does not describe a process for establishing ground truth using experts, as it's not a study evaluating diagnostic or prognostic performance requiring expert interpretation.

Number of Experts: Not applicable/Not provided.
Qualifications of Experts: Not applicable/Not provided.

4. Adjudication Method for the Test Set

Not applicable, as no expert-adjudicated test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned as this is not an AI/diagnostic imaging device.

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

Not applicable, as this is a physical medical device (catheter), not an algorithm or software.

7. The Type of Ground Truth Used

Not applicable in the context of device performance claims based on this 510(k) summary. The "ground truth" here is the physical and functional specifications of the device itself and its comparison to legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable, as this is a physical medical device and not an AI or machine learning algorithm.

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

Not applicable.

Summary

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

K9831.01

NOV C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30209

SECTION VI

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's Information:
Submitter's Name: Address:

Contact Person: Contact Person's Phone: Contact Person's Fax: Date of Preparation:

C. R. Bard, Inc., Urological Division 8195 Industrial Blvd. Covington, Georgia 30014 Georgia C. Abernathy (770) 784-6454 રન્ડ જુ (770) 784-6419 8-31-98

B. Device Name:
Bardex I. C. 4-Way Foley Catheter Trade Name: Common / Usual Name: Antimicrobial Catheter Catheter, Urological (Antimicrobial) and Accessories Classification Name:
C. Predicate Device Names:

Trade Name:	Bard Latex Urinary Catheters
Trade Name:	Bard Hydrogel/Silver-Coated Foley Catheter

D. Device Description:

E. Intended Use:

F. Technological Characteristics Summary:

Table VI-1 provides a tabulated comparison summary of the technological characteristics of the Bardex I. C. 4-Way Foley Catheter versus the predicate device.

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

Table VI-1
Comparison Summary of Technological Characteristics

ProductCharacteristic	Bard 4-Way Catheter(this 510(k))	Bard Latex UrinaryCatheters(Predicate device)(#K922431)	Bard Hydrogel/Silver-Coated Foley Catheter(Predicate device)(#K910318)
Indications orIntended Use	The Bardex I.C. 4-Way FoleyCatheter is indicated for usein bladder/urinary tractdrainage/irrigation and toassist in hemostasis andsurgical site drainagefollowing procedures such astransurethral resection of theprostate.*	Bard Catheters are intendedfor use in the drainage and/orcollection and/ormeasurement of urine and inbladder/urinary tract irrigationand to assist in hemostasisfollowing surgery such astransurethral resection of theprostate.	The Bard Hydrogel/Silver-Coated Foley Catheter isintended for use in thedrainage and/or collectionand/or measurement of urineand in bladder/urinary tractirrigation and to assist inhemostasis following surgerysuch as transurethral resectionof the prostate.
Disposable	Yes	Yes	Yes
Sterile	Yes	Yes	Yes
Catheter BaseMaterial	Red Latex	Red Latex	Red Latex
X-Ray Opaque	Yes	Yes	Yes
Coating	Silver/Hydrogel	Hydrogel	Silver/Hydrogel
Drainage EyesProximal toBalloon	5 Drainage Eyes *	None	None
Tip Type –Drainage EyesDistal toBalloon	Open Concave Tip(Couvelaire) and 3 additionaleyes	Single Eye	Open Concave Tip(Couvelaire) and 2 opposedeyes
Fr. SizesAvailable	18-24 Fr.	22-24 Fr.	18-24 Fr.
Foley BalloonSize	30cc	30cc	30cc
AvailablePackagedSingly	Yes	Yes	Yes
Tip Shape	Coude	Coude	Coude
Number ofLumens	4 lumens*	3 lumens	3 lumens
Catalog # ofexample	1865SIXX**	6003LXX**	1859SIXX**

New feature(s) this 510(k)

** XX = French size (e.g., 1865SIXX = 1865SI18, 1865SI20, 1865SI22, 1865SI24)

Performance Data Summary: G.

The Bardex I. C. 4-Way Foley Catheter referenced in this submission is held to the same design, manufacture, and performance specifications as those catheters currently manufactured. Performance and functional testing standards are based on the "Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters" dated September 12, 1994.

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/2/Picture/3 description: The image shows the date November 3, 1998. The month is abbreviated as NOV. The number 3 is written in a simple, sans-serif font. The year 1998 is also written in a similar font.

Ms. Georgia Abernathy Regulatory Affairs Associate C.R. Bard, Incorporated Medical Division 8195 Industrial Blvd. Covington, Georgia 30209

Re: K983101 Bardex I.C. 4-Way Foley Catheter Dated: October 22, 1998 Received: October 26, 1998 Regulatory Class: II 21 CFR §876.5130/Product Codes: 78 MJC

Dear Ms. Abernathy:

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 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, 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 (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 requirement, 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 regulation may result 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 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 vitro diagnostic devices), please 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/dsmamain.html".

Sincerely yours

William Yin

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

SECTION 1 - D

INDICATIONS FOR USE STATEMENT

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

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

(Optional Format 1/2/96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
K983101

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.