The Bard UroForce Balloon Dilation Catheter is a dual-lumen catheter with a Nydex® two-layer nylon balloon mounted on its distal tip and with two radiopaque markers beneath the balloon that define the working length. The lumen labeled "balloon" is for balloon inflation. The additional lumen allows the catheter to track over a 0.038"(.97mm) guidewire and can be used for monitoring of pressure or infusion of medication and/or contrast medium.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Bard® UroForce™ Balloon Dilation Catheter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to "Performance and functional testing standards" based on the FDA's "Draft Guidance for the Content of Premarket Notifications for Urological Balloon Dilatation Catheters," dated January 24, 1992. While specific quantitative acceptance criteria are not explicitly listed in numerical form, the document implies that the device met these standards. The "Reported Device Performance" below is derived from the "Technological Characteristics Summary" which compares the device to its predicates. The "Performance Data" section then states that the device's test results indicate substantial equivalence to the predicate device, implying it met the unstated acceptance criteria.

Characteristic	Acceptance Criteria (Implied by FDA Guidance)	Reported Device Performance (Bard® UroForce™ Balloon Dilation Catheter)
Balloon Burst Strength	Adequate to intended use (not quantified)	25 atm (max.)
Balloon Distensibility	Conforms to functional requirements	(Characteristic not separately quantified, but passed bench testing)
Balloon Inflation Time	Within acceptable duration	(Characteristic not separately quantified, but passed bench testing)
Balloon Diameter & Profile	Within specified tolerances	Diameters: 4, 5, 6, 7, 8 mm; Lengths: 4, 6, 10 cm
Operating Pressure	Meets functional requirement	10 atm
Guidewire Compatibility	Compatible with standard guidewires	0.038"
Other characteristics	Substantially equivalent to predicate	(As detailed in Table VI-1: Nylon, 2 layers; X-Ray Opaque; 6 Fr. Size; etc.)

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

Sample Size: The document does not specify the sample size for the test set. It mentions "Bench testing was conducted" but doesn't provide the number of units tested.
Data Provenance: The data is from bench testing, which implies it was conducted in a laboratory setting. There is no information in the provided text regarding the country of origin of the data, nor whether it was retrospective or prospective, as these terms are typically associated with human clinical studies.

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

This information is not provided in the given text. The "Performance Data" section discusses "bench testing" against FDA guidance, which typically wouldn't involve human experts establishing ground truth in the same way a clinical study would for diagnostic accuracy.

4. Adjudication Method for the Test Set:

This information is not provided. As the testing was bench testing for performance and functional standards, an adjudication method in the context of expert review (e.g., 2+1) is not applicable or described.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. This type of study is typically used for diagnostic devices that involve human interpretation of images or other data, often with and without AI assistance, to measure the impact on human reader performance. The device described is a physical medical device (balloon dilation catheter), and its evaluation focuses on physical performance and functional characteristics.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The concept of "standalone" performance without human-in-the-loop is typically relevant for diagnostic algorithms or AI systems. This device is a physical medical instrument. The "Performance Data" section describes standalone bench testing of the device's physical and functional characteristics (e.g., burst strength, distensibility), which could be considered an analogous concept to "standalone" in this context, meaning the device's intrinsic properties were evaluated.

7. The Type of Ground Truth Used:

The ground truth for the bench testing was established by "Performance and functional testing standards" based on the FDA "Draft Guidance for the Content of Premarket Notifications for Urological Balloon Dilatation Catheters," dated January 24, 1992. This guidance effectively defines the expected performance parameters and the methods for measuring them.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. This device is a physical medical instrument, not an algorithm or AI system that requires a "training set" in the machine learning sense. The device itself is manufactured to specifications, and its performance is verified through testing, not "trained."

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

This information is not applicable as there is no training set for a physical medical device.

Summary

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Bard Medical Division C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014

K993840 0. 1083

BARD

SECTION VI

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

A. Submitter 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, GA 30014 Angela L. Bunn 770-784-6135 770-784-6419 November 10, 1999

B. Device Name:
Trade Name: Common/Usual Name: Classification Name:

Bard® UroForce™ Balloon Dilation Catheter Balloon Dilation Catheter Dilator, Catheter, Ureteral

C. Predicate Device Name(s):
Trade Name: Trade Name: Opti-Plast® Centurion™ 5.5F PTA Catheter Bard® A-Trac Urological Balloon Dilation Catheter
D. Device Description:
The Bard UroForce Balloon Dilation Catheter is a dual-lumen catheter with a Nydex® two-layer nylon balloon mounted on its distal tip and with two radiopaque markers beneath the balloon that define the working length. The lumen labeled "balloon" is for balloon inflation. The additional lumen allows the catheter to track over a 0.038"(.97mm) guidewire and can be used for monitoring of pressure or infusion of medication and/or contrast medium.
E. Intended Use:
180-06

The Bard UroForce Balloon Dilation Catheter is indicated for dilation of the urinary tract.

F. Technological Characteristics Summary:
Table VI-1 provides a comparison summary of the technological characteristics of the Bard UroForce Balloon Dilation Catheter versus the predicate devices.

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Table VI-1 Bard® UroForce™ Balloon Dilation Catheter of the
Bard® UroForce™ Balloon Dilation Catheter to Predicate Devices

Characteristics	UroForce BalloonDilation Catheter	Opti-Plast CenturionPTA Catheter	A-Trac UrologicalCatheter
Indications For Use	The Bard UroForceBalloon Dilation Catheteris indicated for dilation ofthe urinary tract.	The Opti-Plast Centurion5.5F PTA Catheter isrecommended for use in thePercutaneous TransluminalAngioplasty (PTA) of theIliac, Femoral and Renalarteries and for thetreatment of obstructivelesions of native orsynthetic arteriovenousdialysis fistulae. Thecatheter is not for use in theCoronary arteries.	The Bard A-TracUrological BalloonDilation Catheter isindicated for use in thedilation of the ureter orurethra through theworking channel of anendoscope.
Reuse Status	Disposable. For singlepatient use only.	Disposable. For singlepatient use only.	Disposable. For singlepatient use only.
Sterile	Yes	Yes	Yes
Catheter Balloon Material	Nylon, 2 layers	Nylon, 2 layers	PET, Single layer
X-Ray Opaque	yes	yes	yes
Fr. Size	6	5.5	5
Balloon Lengths	4, 6, 10 cm	2, 4 cm	4, 8, 10 cm
Balloon Diameters	4, 5, 6, 7, 8 mm	4, 5, 6, 7, 8, 9, 10 mm	4, 5, 6, 7, 8 mm
Operating Pressure	10 atm	10 atm	10 atm
Rated Burst Pressures	25 atm (max.)	17-20 atm	12-15 atm
Overall Catheter Length	89.5 cm	86 cm**	96 cm
Guidewire Lumen Length	85.5 cm	84.5 cm**	95.5 cm
Active Shaft Length	75 cm*	75 cm**	75 cm*
Guidewire Compatibility	0.038"	0.035"	0.035"
Shaft/Tip Design(under balloon)	one piece with drawndown tip	two piece with bonded tip	two piece with bondedtip
Stopcock Attached	Yes	No	No
Stylet	Yes	Yes	Yes
Balloon Sheath	Yes	Yes	Yes

Excludes strain relief

** Shorter and longer shaft lengths are available

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K993840

p. 3 of 3

G. Performance Data:

Performance and functional testing standards are based on the FDA "Draft Guidance for the Content of Premarket Notifications for Urological Balloon Dilatation Catheters," dated January 24, 1992. Bench testing was conducted for the following characteristics: balloon burst strength, balloon distensibility, balloon inflation time and balloon diameter and profile. The test results indicate that the Bard UroForce Balloon Dilation Catheter is substantially equivalent to the stated predicate device, that there are no new safety or effectiveness issues, and that the device can be utilized for its stated indication.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 31 2000

Ms. Angela L. Bunn Regulatory Affairs Associate C. R. Bard, Inc. 8195 Industrial Boulevard Covington, GA 30014

Re: K993840 Bard® UroForce™ Balloon Dilation Catheter Dated: November 10, 1999 Received: November 12, 1999 Regulatory Class: II 21 CFR §876.5470/Procode: 78 EZN

Dear Ms. Bunn:

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 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 the Electronic Product 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 Compilance 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION I - D

INDICATIONS FOR USE STATEMENT

x993840 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ___ Bard® UroForce™ Balloon Dilation Catheter

Indications for Use:

The Bard® UroForce™ Balloon Dilation Catheter is indicated for dilation of the urinary tract.

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

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR

(Optional Format 1/2/96)

Stat

(Division Sign-Off) (Division of Reproductive, Abdominal, EN and Radiological Devi 510(k) Number

Regulation Number and Section

§ 876.5470 Ureteral dilator.

(a)
Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.(b)
Classification. Class II (performance standards).