The Bard® X-Force™ Nephrostomy Balloon Dilation Catheter is recommended for use in the dilation of the nephrostomy tract and for placement of the working sheath.

Device Description

The Bard® X-Force™ Nephrostomy Balloon Dilation Catheter is composed of a dual lumen shaft with inflation and guidewire lumens and a dilation balloon on the distal end. The catheter has a radiopaque band which corresponds with the distal end of the balloon's working length to facilitate radiographic visualization and placement. A high pressure stopcock is used on the inflation lumen to maintain pressure after removal of the pressurization apparatus.

AI/ML Overview

The provided document K051316 is a 510(k) Pre-Market Notification for the Bard® X-Force™ Nephrostomy Balloon Dilation Catheter. This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device. As such, the document focuses on demonstrating substantial equivalence rather than conducting a de novo study with acceptance criteria for a novel device.

Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth establishment are not applicable in the context of this 510(k) submission.

Here's an breakdown of what can be extracted based on the provided text:

1. A table of acceptance criteria and the reported device performance

Not Applicable: This 510(k) submission does not present specific acceptance criteria with quantifiable metrics that need to be met by the device. Instead, it relies on demonstrating substantial equivalence to a predicate device through performance testing. The "reported device performance" is summarized as having "the same scientific technology as the predicate device" and that "appropriate testing to determine substantial equivalence was completed."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not Applicable: The document describes "appropriate testing to determine substantial equivalence," which includes "testing to accompany Draft Guidance for the Content of Performance Data for Percutaneous Transluminal Balloon Dilation Catheters (January 24, 1992)." This implies physical and functional testing of the catheter itself (e.g., burst pressure, durability, etc.) rather than a clinical study involving patient data or a "test set" of cases. Therefore, concepts like sample size for a test set, country of origin, retrospective/prospective data provenance are not relevant for this type of submission.

3. 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: As there is no clinical "test set" in the sense of patient data requiring expert interpretation, the establishment of ground truth by clinical experts is not relevant to this submission. The "ground truth" for this device would be its physical and mechanical properties meeting engineering specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable: Given the absence of a clinical test set requiring human interpretation, adjudication methods are not relevant.

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

Not Applicable: This device is a physical medical instrument (a nephrostomy balloon dilation catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or evaluation of AI assistance is entirely irrelevant.

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

Not Applicable: As stated above, this is a physical medical device, not an algorithm. Standalone algorithm performance is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable for clinical ground truth: The "ground truth" for this device's performance would be engineering specifications and standards described in the referenced "Draft Guidance for the Content of Performance Data for Percutaneous Transluminal Balloon Dilation Catheters (January 24, 1992)". This would involve physical and mechanical testing to ensure the balloon inflates correctly, the catheter has appropriate strength and flexibility, and other functional parameters are met. Clinical outcomes data or pathology are not used to establish ground truth for this type of device in a 510(k) submission.

8. The sample size for the training set

Not Applicable: "Training set" is a concept related to machine learning and AI. This device is a physical catheter, so there is no training set.

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

Not Applicable: As there is no training set, this question is not relevant.

Summary based on the document:

The Bard® X-Force™ Nephrostomy Balloon Dilation Catheter received 510(k) clearance based on substantial equivalence to the Cook® Ultraxx™ Nephrostomy Balloon Catheter. The primary evidence presented involved "appropriate testing to determine substantial equivalence" in accordance with the "Draft Guidance for the Content of Performance Data for Percutaneous Transluminal Balloon Dilation Catheters (January 24, 1992)." This guidance would outline the specific physical and mechanical tests required to demonstrate that the device performs as intended and is as safe and effective as the predicate device. However, the document does not contain the detailed results of these tests or specific acceptance criteria, as is typical for the publicly available 510(k) summary.

Summary

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

K051316
Page 1 of 2

Image /page/0/Picture/2 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are all capitalized and appear to be filled with black. The font is simple and geometric, with a consistent stroke width throughout each letter. The overall impression is clean and modern.

JUL 1 8 2005

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATIC

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

SUBMITTER INFORMATION: A.

C. R. Bard. Inc. Submitter's Name: Bard Urological Division 8195 Industrial Blvd. Address: Covington, GA 30014

John C. Knorpp Contact Person: 770-784-6451 Contact Person's Telephone Number: 770-784-6419 Contact Person's Fax: May 19, 2005 Date of Preparation:

B. DEVICE NAME:

Trade Name(s):	Bard® X-Force™ Nephrostomy Balloon DilationCatheter
Common/Usual Name:	Nephrostomy Balloon Dilation Catheter
Classification Names:	78 LJE - Catheter, Nephrostomy
CFR Reference:	N/A - Unclassified

C. PREDICATE DEVICE NAME:

Cook® Ultraxx™ Nephrostomy Balloon Catheter Trade Names:

Device Description: D.

E. Intended Use:

The Bard® X-Force™ Nephrostomy Balloon Dilation Catheter is recommended for use in the dilation of the nephrostomy tract and for placement of the working sheath.

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Ko 51316
Page 2 of 2

Technological Characteristics Summary: F.

The subject Bard® X-Force™ Nephrostomy Balloon Dilation Catheter has the The subject Dard® X-F orce - Nophrootemy Balloon in the scientific technology as the predicate device.

Performance Data Summary: G.

The appropriate testing to determine substantial equivalence was completed. This includes testing to accoming with Draft Guidance for the Content of This InCludes testing in deserations inal Balloon Dilation Catheters (January 24, 1992).

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Image /page/2/Picture/2 description: The image shows a black and white emblem or logo. The emblem features a stylized bird with three distinct lines forming its body and wings, giving it a sense of movement. The bird is positioned in the center of a circular border, with text partially visible along the border, suggesting it is part of the emblem's design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2005

Mr. John C. Knorpp Manager, Regulatory Projects Bard Urological Division C.R. Bard, Inc. 8195 Industrial Blvd. COVINGTON GA 30014-2655

Re: K051316

Trade/Device Name: Bard® X-Force™ Nephrostomy Balloon Dilation Catheter Regulation Number: None Regulatory Class: Unclassified Product Code: LJE Dated: May 19, 2005 Received: May 20, 2005

Dear Mr. Knorpp:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced in We have reviewed your Section 110(x) prematically equivalent (for the indications for use stated in
above and have determined the device is substantially equivales commerc above and have delemined the devices is substant in interstate commerce prior to a the enclosure) to legally marketco prodical Device Amendments, or to devices that have been May 28, 1976, the enactified in the Freded For the Federal Food, Drug, and Cosmetic Act (Act) that reclassitied in accordance with the provisions of and issues of the may, therefore, market the A do not require approval of a prematics approvide approvisions of the Act. The Actualisms provisions of the Act device, subject to the general controls of the real good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Ontrols) or class III (Prematket If your device is classified (see above) mio cideols. Existing major regulations affecting your Approval), it may be subject to such additions, Title 21, Pars 800 to 898. In addition, FDA
device can be found in the Code of Federal Regulations, Title 21, Paris 800 to 89 device can be Tound in the Code of Federal Register in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that FDA s issualice of a substance requirements of the Act or any
FDA has made a determination that your device complex with other comply with all FDA has made a determination that your devices frail agencies. You must comply with all the Federal statutes and regulations administered of other in the first (2 CFR Part 807), labeling Act's requirements, including, but not mined to reguirements as set for in the quality systems (QS)
(21 CFR Part 801); good manufacturing practice requirements as set to prov (21 CFR Part 801); good manufacturing practice the electronic product radiation control provisions
regulation (21 CFR Part 820); and if applica 1950 (Sections 531-542 of the Act): 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manseting your antial equivalence of your device to a legally premarket notification. The PDA Inding of sacsantial of the report 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 If you desire spective advice for your dovies on our 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 " (21 CFR Also, please note the regulation entitled, "Thiseration on your responsibilities under the Act from the 807.97). You may outlin other general micronal 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 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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C.R. Bard, Inc., Bard Urological Division Bard® X-Force™ Off It Burd, The Particle Callation Catheter
Bard® X-Force™ Nephrostomy Balloon Dilation Catheter
Premarket Notification Premarket Notification [510(k)]

K051316

1.3 Indications for Use Statement
510(k) Number (if known):	K051316
Device Name:	Bard® X-Force™ Nephrostomy Balloon Dilation Catheter
Indications for Use:

The Bard® X-Force™ Nephrostomy Balloon Dilation Catheter is recommended for use in the dilation of the nephrostomy tract and for placement of the working sheath.

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

Over-The-Counter Use (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

(Division Sign-Off)	Nancy C Brogdon
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K051316

(Recommended Format 11/13/2003)

Regulation Number and Section

N/A