The Sterling Monorail PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, renal, and carotid arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

Device Description

The Sterling Monorail Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter is a high performance balloon catheter for peripheral indications. The device features an ultra low profile, semi-compliant balloon combined with a low profile tip. The catheter is compatible with either 0.014 in (0.36 mm) or 0.018 in (0.46 mm) guidewires.

The Sterling Monorail PTA Balloon Dilatation Catheter is a Monorail brand rapid exchange catheter with a semi-compliant balloon fixed at the distal tip. The balloon catheter has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of guidewires 0.014 in / 0.018 in (.36 mm / .46 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures.

The catheter includes a tapered tip to facilitate advancement of the catheter to and through the stenosis. Two radiopaque marker bands (one proximal and one distal), in conjunction with fluoroscopy, enable accurate positioning of the balloon. Markers on the 80 cm and 90 cm effective length catheters indicate the exit of the dilatation catheter tip out of the guiding catheter (one at 50 cm and two at 60 cm). Markers on the 135 cm and 150 cm effective length catheters indicate the exit of the dilatation catheter tip out of the guiding catheter (one at 90 cm and two at 100 cm). The effective lengths of the balloon catheter are 80 cm, 90 cm, 135 cm, and 150 cm. A needle with a luer port is included for flushing the distal inner lumen prior to the insertion of appropriate guidewires.

AI/ML Overview

The provided text is a Food and Drug Administration (FDA) 510(k) premarket notification for a medical device called the Sterling™ Monorail™ PTA Balloon Dilatation Catheter. This document primarily focuses on establishing "substantial equivalence" to predicate devices, rather than presenting a detailed clinical study for novel device performance claims. Therefore, much of the requested information regarding acceptance criteria and performance studies for a new AI/software-based device will not be found in this type of submission.

However, I can extract the information available and explain why some of the requested points are not applicable to this document.

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

The document states that the "Sterling Monorail PTA Balloon Dilatation Catheter met all acceptance criteria for the bench and biocompatibility testing with results similar to the predicate." However, the specific quantitative acceptance criteria for each test and the corresponding reported performance values are not explicitly listed in a table format in this document. Instead, it provides a general statement of compliance.

It lists the types of tests performed:

Test Type	Specific Tests Mentioned
Biocompatibility	- MEM Elution Cytotoxicity
	- Hemocompatibility (Direct Contact)
	- Chemical Characterization-USP Physicochemical
	- Natural Rubber Latex
Bench Testing (in-vitro performance)	- Bond Integrity
	- Working Length
	- Deflation Time
	- Balloon Rated Burst Pressure (RBP)
	- Balloon Multiple Inflation
	- Crossing Profile
	- Full Catheter Tensile Extension and Deflation
	- Balloon Burst Mode
	- Balloon Compliance
	- Balloon Nominal Diameter
	- Burst in a Stent
	- Balloon Body Length
	- Guidewire Movement
	- Sheath Withdrawal
	- Balloon Multiple Inflation in a Stent
	- Particulate Evaluation
	- Proximal Balloon Bond and Shaft Tensile Strength
	- Marker Band to Balloon Alignment
	- Torque After Conditioning

2. Sample sizes used for the test set and the data provenance

The document does not specify sample sizes for each of the listed tests. The provenance of the data is generally in-vitro bench testing and biocompatibility testing, likely conducted by the manufacturer (Boston Scientific) in controlled laboratory environments. This is typical for a 510(k) submission and not considered "country of origin" in the sense of clinical data. It is neither retrospective nor prospective clinical data; it is in-vitro (laboratory) data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to a 510(k) submission for a mechanical medical device like a balloon catheter. "Ground truth" established by human experts is typically relevant for AI/software devices where human interpretation is involved. For this device, the "truth" is determined by physical measurements and chemical analyses against established engineering and biological standards.

4. Adjudication method for the test set

This question is also not applicable. Adjudication methods are used in studies where there is subjective interpretation of data, often by multiple human readers, to establish a consensus or "ground truth." For the bench and biocompatibility tests of this device, the results are typically objective measurements against predefined specifications.

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

This question is not applicable. The device described is a physical medical instrument (a balloon catheter), not an AI/software device. Therefore, no MRMC study involving human readers and AI assistance would be performed for this device.

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

This question is not applicable. The device is a physical balloon catheter, not an algorithm or software. It does not perform any standalone algorithmic analysis.

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

For the bench testing, the "ground truth" is defined by established engineering specifications and medical device standards (e.g., ISO, ASTM, internal company specifications for performance characteristics like burst pressure, deflation time, etc.). For biocompatibility, the ground truth is against established biological safety standards (e.g., ISO 10993-1). This is not expert consensus, pathology, or outcomes data in the clinical sense, but rather compliance with scientific and engineering benchmarks.

8. The sample size for the training set

This question is not applicable. This device is not an AI/software device that would use a "training set."

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

This question is not applicable, as there is no training set for this type of medical device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure, with three faces merging into one another. The symbol is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.

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

September 25, 2014

Boston Scientific Corp. Ms. Diane Nelson Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311-1566

Re: K141150

Trade/Device Name: Sterling MR PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: August 21, 2014 Received: August 25, 2014

Dear Ms. Nelson.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting 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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K141150 510(k) Number (if known):

Device Name: Sterling™ Monorail™ Balloon Dilatation Catheter

Indications for Use:

Sterling™ Monorail™ Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infrapopliteal, renal, and carotid arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

Prescription Use × (Part 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Summary

per 21 CFR §807.92

Submitter'sName andAddress	Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311
Contact NameandInformation	Diane NelsonRegulatory Affairs SpecialistPhone: 763-255-0813Fax: 763-494-2222e-mail: diane.nelson@bsci.com
Date Prepared	02 May 2014
ProprietaryName	Sterling™ Monorail™ PTA Balloon Dilatation Catheter
Common Name	PTA Balloon Dilatation Catheter
Product Code	LIT - Catheter, Angioplasty, Peripheral, Transluminal
Classification	Class II, 21 CFR Part 870.1250 - Percutaneous Catheter
PredicateDevice(s)	Sterling™ Monorail™ PTA Balloon Dilatation Catheter, K053118, cleared16 December 2005
	Sterling™ OTW PTA Balloon Dilatation Catheter, K132430, cleared 17October 2013
	Sterling™ SL Monorail™ and OTW PTA Balloon Dilatation Catheters,K093720, cleared 23 December 2009
DeviceDescription	The Sterling Monorail Percutaneous Transluminal Angioplasty (PTA)Balloon Dilatation Catheter is a high performance balloon catheter forperipheral indications. The device features an ultra low profile, semi-compliant balloon combined with a low profile tip. The catheter iscompatible with either 0.014 in (0.36 mm) or 0.018 in (0.46 mm) guidewires.
	The Sterling Monorail PTA Balloon Dilatation Catheter is a Monorail brandrapid exchange catheter with a semi-compliant balloon fixed at the distal tip.The balloon catheter has a coaxial shaft design. The outer lumen is usedfor inflation of the balloon, and the wire lumen permits the use of guidewires0.014 in / 0.018 in (.36 mm / .46 mm) to facilitate advancement of thecatheter to and through the stenosis to be dilated. The balloon is designedto provide an inflatable segment of known diameter and length atrecommended pressures.
	The catheter includes a tapered tip to facilitate advancement of the catheterto and through the stenosis. Two radiopaque marker bands (one proximaland one distal), in conjunction with fluoroscopy, enable accurate positioningof the balloon. Markers on the 80 cm and 90 cm effective length cathetersindicate the exit of the dilatation catheter tip out of the guiding catheter (oneat 50 cm and two at 60 cm). Markers on the 135 cm and 150 cm effectivelength catheters indicate the exit of the dilatation catheter tip out of theguiding catheter (one at 90 cm and two at 100 cm). The effective lengths ofthe balloon catheter are 80 cm, 90 cm, 135 cm, and 150 cm. A needle witha luer port is included for flushing the distal inner lumen prior to the
Intended Use/Indications forUse of Device	The Sterling Monorail PTA Balloon Dilatation Catheter is indicated forPercutaneous Transluminal Angioplasty in the peripheral vasculature,including iliac, femoral, popliteal, infra-popliteal, renal, and carotid arteries,and for the treatment of obstructive lesions of native or syntheticarteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheralvasculature.

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insertion of appropriate guidewires.

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Comparison of Technological Characteristics

The Sterling Monorail PTA Balloon Dilatation Catheter will incorporate a substantially equivalent design, packaging, fundamental technology, materials, manufacturing, sterilization and intended use as those featured in the predicate BSC Sterling Monorail and OTW Balloon Dilatation Catheters.

Comparison to Predicate Device in Materials and Manufacturing

Characteristic	Comparison to Predicates
Manifold	Same material and design serving the same function.
Manifold BondAdhesive	Same material and design serving the same function.
Corewire	Same material and design serving the same function.
Outer Shaft	Same material and design serving the same function.
Inner Shaft	Same material, colorant and design serving the samefunction.
Balloon	Same material and design serving the same functionand fundamental technology.
Markerbands	Same component serving the same function.
Proximal Marks	Same material and design serving the same function.
Coating	Same coating serving the same function.
Bumper Tip	Same material, colorant and design serving the samefunction.
SterilizationMethod	Same method.
SAL	Same level of assurance.
BalloonDiameters	Additional balloon diameters: 1.5, 2.0, and 2.5mm.
BalloonLengths	Additional balloon lengths: 100, 150, 200, and220mm.
UsableCatheterLengths	Additional catheter lengths: 90 and 150cm.
Rated BurstPressure(RBP)	Same Rated Burst Pressure.
RecommendedIntroducerSheathCompatibility	Sheath compatibility within the predicate compatibilityrange, same function.
RecommendedGuidewire	Same compatibility.
Packaging	Same function and design.

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PerformanceData	Bench testing and biocompatibility testing were performed to support adetermination of substantial equivalence. The results of these tests providereasonable assurance that the proposed device has been designed andtested to assure conformance to the requirements for its intended use. TheSterling Monorail PTA Balloon Dilatation Catheter met all acceptancecriteria for the bench and biocompatibility testing with results similar to thepredicate. No new safety or performance issues were raised during thetesting and, therefore, these devices may be considered substantiallyequivalent to the predicate devices.
	The following biocompatibility and bench testing were completed on theSterling Monorail PTA Balloon Dilatation Catheter:
	BiocompatibilityThe device was tested for biocompatibility per ISO 10993-1 for shortduration contact with blood (<24 hours). The testing included MEM ElutionCytotoxicity, Hemocompatibility (Direct Contact), ChemicalCharacterization-USP Physicochemical, and Natural Rubber Latex.The following leveraged in-vitro performance tests were completed on theSterling Monorail PTA Balloon Dilatation Catheter:
	BenchBond IntegrityWorking LengthDeflation TimeBalloon Rated Burst Pressure (RBP)Balloon Multiple InflationCrossing ProfileFull Catheter Tensile Extension andDeflation	Balloon Burst ModeBalloon ComplianceBalloon Nominal DiameterBurst in a StentBalloon Body LengthGuidewire MovementSheath Withdrawal
	Balloon Multiple Inflation in a StentParticulate EvaluationProximal Balloon Bond and ShaftTensile Strength	Marker Band to Balloon AlignmentTorque After Conditioning
Conclusion	Based on the Indications for Use, technological characteristics, safety andperformance testing, the Sterling™ Monorail™ PTA Balloon DilatationCatheter has been shown to be appropriate for its intended use and isconsidered to be substantially equivalent to the Sterling™ Monorail™ PTABalloon Dilatation Catheter (K021721 cleared 16 December 2005) and theSterling™ OTW Balloon Dilatation Catheter (K132430 cleared 17 October2013) and the Sterling™ SL Monorail™ and OTW PTA Balloon DilatationCatheters (K093720 cleared 23 December 2009).

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).