The NephroMax Balloon Catheter, styled after the Gruntzig technique, is a multiple lumen catheter with a dilatation balloon mounted at the distal tip. Provided with the balloon catheter is a 24F (8 mm) or 30F (10 mm) renal sheath. Dilatation balloon catheters are used to exert radial force to dilate nephrostomy tracts. The balloon features a silicone coating to reduce friction between the balloon surface and renal sheath.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the NephroMax Balloon Dilatation Catheter:

Acceptance Criteria and Study Details for NephroMax Balloon Dilatation Catheter

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria for each test. Instead, it describes "performance testing" conducted to "demonstrate equivalence" to the predicate device. The reported "performance" is that the results "demonstrate equivalence of the NephroMax Balloon Catheter to the predicate balloon dilatation catheter."

Test Parameter	Acceptance Criteria (Explicitly Stated)	Reported Device Performance (as stated)
Effective Working Length	Not explicitly stated	Demonstrates equivalence
Catheter Tip Length/RO Marker Location	Not explicitly stated	Demonstrates equivalence
Deflation Time	Not explicitly stated	Demonstrates equivalence
Balloon Diameter/Length at Rated Burst Pressure	Not explicitly stated	Demonstrates equivalence
Balloon Compliance	Not explicitly stated	Demonstrates equivalence
Multiple Inflation	Not explicitly stated	Demonstrates equivalence
Balloon Burst	Not explicitly stated	Demonstrates equivalence
Proximal Balloon Bond Tensile	Not explicitly stated	Demonstrates equivalence
Balloon Protector Removal Force	Not explicitly stated	Demonstrates equivalence
Guidewire Passability	Not explicitly stated	Demonstrates equivalence

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

Sample Size: The text states "samples aged at T=0 and T=7 months accelerated aging" were used. However, it does not specify the number of samples per test or per aging condition.
Data Provenance: The study was a bench evaluation conducted by Boston Scientific Corporation. The data is thus prospective in the sense that it was generated specifically for this submission, and its origin is internal to the manufacturer. No country of origin for external data is mentioned, as it is a bench test.

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

This information is not applicable to the type of study performed. The testing described is a bench evaluation (mechanical and physical performance tests) and does not involve human expert assessment for "ground truth" in the way clinical studies or visual diagnostic AI systems would. The "ground truth" is based on objective measurements against engineering specifications and comparison to the predicate device.

4. Adjudication Method for the Test Set

This information is not applicable as it was a bench evaluation, not a study requiring adjudication of expert opinions or clinical outcomes.

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

No, an MRMC comparative effectiveness study was not performed, nor is it relevant to this device. This device is a medical instrument (balloon catheter), not an AI diagnostic or assistance tool. The submission is a traditional 510(k) for a medical device redesign/update, focusing on physical and mechanical performance.

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

No, a standalone algorithm performance study was not done because this is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing implicitly refers to engineering specifications, design requirements, and the established performance characteristics of the predicate device. The tests aim to demonstrate that the new device meets these specifications and performs equivalently to the predicate.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is a physical device being evaluated through bench testing, not a machine learning model.

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

This information is not applicable for the reasons stated above (no training set for a physical device).

Summary

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Nephromax Balloon Dilatation Catheter Traditional 510(k)

SECTION 5

:510(k) Summary for NephroMax™ High Pressure Balloon Dilatation Catheter

A. Sponsor

Boston Scientific Corporation Urology and Women's Health Division 100 Boston Scientific Way Marlborough, MA 01756

B. Contact

Lauren Anderson Senior Specialist, Regulatory Affairs 508-683-4707 lauren.anderson@bsci.com

Donna Gardner Director, Regulatory Affairs 508-683-4398 gardnerd@bsci.com

C. Device Name

NephroMax 116 High Pressure Balloon Dilatation Catheter Trade name: Common/usual name: Catheter, Nephrostomy Classification Name: LJE - Catheter, Nephrostomy Pre-Amendment

D. Predicate Device

Trade name: Nephrostomy Balloon Dilatation Catheter Common/usual name: Catheter, Nephrostomy Classification Name: LJE - Catheter, Nephrostomy Pre-Amendment

Premarket Notification: Boston Scientific, K952968

E. Device Description

F. Intended Use

The NephroMax Balloon Catheters are recommended for dilatation of the nephrostomy tract.

Proprietary and Confidential Information of Boston Scientific Corporation

SEP 18 2012

510K SUMMARY

Boston Scientific

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K121614 page 2 of 2

Nephromax Balloon Dilatation Catheter Traditional 510(k)

Boston Scientific

SECTION 5		510K SUMMARY
-----------	--	--------------

G. Technological Characteristics

The NephroMax Balloon Catheter has the same technological characteristics and fundamental multi-lumen balloon dilatation catheter design as the predicate device. The proposed NephroMax Balloon Catheter is available in four configurations with three balloon sizes.

H. Substantial Equivalence

A direct comparison of key characteristics demonstrates that the proposed balloon dilatation catheter is substantially equivalent to the predicate device in terms of intended use, technological characteristics, and performance characteristics. The NephroMax Balloon Catheter is as safe, as effective, and performs as well as the predicate device.

I. Performance Testing (Bench Evaluation)

Boston Scientific has conducted performance testing with samples aged at T=0 and T=7 months accelerated aging in support of the balloon design change and additional size configurations. The following testing was completed to evaluate the effects of the design change and sizes:

Effective Working Length .
0 Catheter Tip Length/ RO Marker Location
Deflation Time .
Balloon Diameter/Length at Rated Burst Pressure .
Balloon Compliance .
Multiple Inflation .
Balloon Burst .
Proximal Balloon Bond Tensile .
Balloon Protector Removal Force .
. Guidewire Passability

The results of the performance testing demonstrate equivalence of the NephroMax Balloon Catheter to the predicate balloon dilatation catheter. The NephroMax Balloon Catheters are considered safe and effective for their intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle, with its wings spread and its head turned to the left.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP

2012

Ms. Lauren Anderson Senior Regulatory Affairs Specialist. Boston Scientific Corporation 100 Boston Scientific Way MARLBOROUGH MA 01752

Re: K121614

Trade/Device Name: Nephromax™ High Pressure Balloon Dilatation Catheter Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LJE Dated: July 30, 2012 Received: August 22, 2012

Dear Ms. Anderson :

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(x) premation is ubstantially equivalent (for the indications referenced above and nave determined the act roo sevedicate devices marketed in interstate for use stated in the enclosure) to regarly manotes province Amendments, or to commerce prior to May 20, 1970, the chaofficial with the provisions of the Federal Food, Drug, devices that have been reciassified in accordance with are preval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act. The and Cosment Act (Act) that do not require approval controls provisions of the Act. The Y ou may, therefore, market the device, basics to the gentration, listing of
general controls provisions of the Act include requirements for annual registration, includers an general controls of the fict increase a and prohibitions against misteraling and adulteration. Please note: CDRH does not evaluate in trutting related to contract liability.
adulteration. Please note: CDRH does not evaluate in truturely and not mislea adulteration. Please note: CDNT does not Cranado miconnation in and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) mo cation major regulations affecting your device can be
it may be subject to additional controls. it may be subject to additional controls. LAIsung mayors 800 to 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Paris 800 to 898. In additio found in the Code of I edelar Rogations) concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a succession other requirements of the Act
that FDA has made a determination that your device complies with of the Act that FDA has made a decemmation that your are research agencies. You must or any Federal statules and regulations administed to: registration and listing and listing of medi comply with all the Act s requirements, incruding, occhior manufactures
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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

Page 2 -

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set device-related adverse events) (21 OFF 009), good in applicable, the electronic a forum in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please II you desire specific advice tor your control so more offices/CDRH/CDRHOffices/ucm115809.htm for go to http://www.ida.gov.it.badiological Health's (CDRH's) Office of Compliance. Also, please the Center for Devilocs and Radiotegrounding by reference to premarket notification" (21CFR Patt note the regulation emilion, "informating of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the I ou may obtain other general mormanional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Benjamin R. Civiletti

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Nephromax Balloon Dilatation Catheter Traditional 510(k)

INDICATIONS FOR USE SECTION 4 2 3 1 1 1 1 1 1 1

Indications for Use Statement

510(k) Number	To be determined. K121614
Device Name	Nephromax™ High Pressure Balloon Dilatation Catheter
Indications For Use	The Nephromax™ High Pressure Balloon Dilatation Catheters are recommended for dilatation of the nephrostomy tract.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

loymmhm

Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K121614

Proprietary and Confidential Information of Boston Scientific Corporation

Regulation Number and Section

N/A