The Coyote MONORAIL PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

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.

The Sterling SL Monorail PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Ultra-soft SV Balloon Dilatation Catheter is recommended for the Percutaneous Transluminal Angioplasty of the iliac, femoral, ilio-femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Description

The Coyote™ Monorail™ Percutaneous Transluminal Angioplasty Balloon Dilatation Catheters (Coyote MR) are high performance balloon catheters for peripheral vascular indications. The devices feature an ultra low profile, semi-compliant balloon combined with a low profile tip. The catheter is compatible with 0.014 in (0.36 mm) guidewires.

The Sterling™ Monorail™ Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter (Sterling MR) 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 Sterling™ SL Monorail™ Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter (Sterling SL) is high performance balloon catheter for peripheral vascular indications featuring a low profile, semi-compliant balloon combined with a low profile tip. They are a line extension to the existing Sterling catheters and include smaller diameter and longer length balloons. The catheters have 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" (0.36 mm) or 0.018" (0.46 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated.

The Ultra-Soft SV™ Monorail™ Balloon Dilatation Catheter 0.018 is a sterile, single use, Monorail catheter with a semi-compliant balloon near the distal tip which inflates to a known diameter and length at a specific pressure. The catheter consists of a double lumen at the distal end and a single lumen catheter at the proximal end. The 0.018 in. guide wire compatible balloon catheter is available in diameters of 4.0 - 7.0 mm in 1.5 and 2.0 cm balloon lengths.

AI/ML Overview

The provided text describes several medical devices, all Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheters from Boston Scientific Corporation. The submission K162350 seeks to declare these devices substantially equivalent to already cleared predicate devices.

Acceptance Criteria and Device Performance (Summary for all listed devices):

The core of the acceptance criteria and device performance evaluation for all listed devices is based on demonstrating substantial equivalence to their respective predicate devices. This is achieved through non-clinical bench and first-article testing.

Acceptance Criteria Category	Description	Reported Device Performance (Summary)
Functional Equivalence	The device must function comparably to its predicate device for its intended use. This includes performance characteristics like burst pressure, inflation/deflation times, guidewire compatibility, tip entry profile, etc.	"Bench and first article testing were performed to support a determination of substantial equivalence." (Repeated for all devices). The testing assures conformance to requirements for intended use and did not raise new safety or performance issues.
Material Equivalence	The materials used in the device must be safe and perform comparably to the predicate device.	The devices have the "same [...] materials [...] as the applicable predicate device."
Design Equivalence	The design of the device, aside from specific modifications being justified, should be substantially similar to the predicate device.	The devices have the "same [...] design (with the exception of the corewire design) [...] as the applicable predicate device." The modified corewire was the specific change being evaluated.
Sterilization Equivalence	The sterilization method used for the device must be effective and comparable to the predicate device.	The devices have the "same [...] sterilization method [...] as the applicable predicate device."
Packaging Equivalence	The packaging must maintain sterility and protect the device adequately, comparable to the predicate device's packaging.	The devices have the "same [...] packaging materials as the applicable predicate device."
Biocompatibility	The materials must be biocompatible. (While not explicitly listed as a test, this is an inherent requirement for medical devices and would be covered under material safety and predicate device comparison). This is implied by the "no new safety or performance issues" statement.	"No new safety or performance issues were raised during the device testing." (Implies biocompatibility was considered and met).
Safety	No new safety concerns should be introduced by the device or its modifications.	"No new safety or performance issues were raised during the device testing."
Performance	The device's overall performance for its intended use should be equivalent to the predicate.	"The results of these tests provide reasonable assurance that the proposed device with the modified corewire has been designed and tested to assure conformance to the requirements for its intended use."

Study Details:

Sample sizes used for the test set and the data provenance:
The document explicitly states that "Bench and first article testing were performed". This indicates that physical samples of the devices were manufactured and subjected to various tests. However, the exact sample sizes (e.g., number of catheters tested for burst pressure, number of inflation/deflation cycles) are not provided in this summary. The data provenance is internal to Boston Scientific Corporation ("Made in USA" is implied by manufacturing and sterilization facilities in the US, but not explicitly stated for the testing data itself). The studies were retrospective in the sense that they were conducted on produced devices to demonstrate equivalence prior to broader market release with the modification.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This submission is for a medical device (catheter) and relies on non-clinical bench testing and first article testing. It is not a clinical study involving human patients or the interpretation of medical images. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense (e.g., radiologists interpreting images) is not applicable. The "ground truth" for these tests would be established by engineering specifications, regulatory standards, and performance characteristics of the predicate device. The experts involved would be engineers, QA/QC personnel, and regulatory affairs specialists who designed, executed, and reviewed these non-clinical tests. Their specific numbers and detailed qualifications are not provided in this summary.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
As this is non-clinical bench and first-article testing, the concept of an adjudication method used in clinical trials or diagnostic accuracy studies (e.g., for resolving discrepancies in expert interpretations) is not applicable. Test results are typically compared against pre-defined engineering specifications and performance data of the predicate device. Review and approval of the test results would involve internal quality and regulatory processes, but not "adjudication" in the clinical sense.
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 MRMC comparative effectiveness study was done. This submission is for a physical medical device (a catheter), not an AI-powered diagnostic tool, and therefore does not involve human readers interpreting cases or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No standalone algorithm performance study was done. This submission is for a physical medical device (a catheter), not an algorithm or software.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this submission is based on:
- Engineering specifications and design requirements for the device.
- Performance data and characteristics of the predicate devices, which have already demonstrated safety and effectiveness.
- Relevant industry standards and regulatory guidance for similar medical devices.
- The absence of new safety or performance issues during the "bench and first article testing."
The sample size for the training set:
Not applicable. This submission is for a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, which are not involved here.
How the ground truth for the training set was established:
Not applicable. As a "training set" is not relevant for this device, how its ground truth would be established is also not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection.

November 4. 2016

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

Boston Scientific Corporation Ka Xiong Regulatory Affairs Specialist One Scimed Place Maple Grove, Minnesota 55311-1566

Re: K162350

Trade/Device Name: Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter. Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter. Sterling SL Monorail Percutaneous Transluminal Angioplastv Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018" Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT, DOY Dated: October 6. 2016 Received: October 7, 2016

Dear Ka Xiong:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices 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 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 devices 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Mache Jackson

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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510(k) Number (if known)

K162350

Device Name

Coyote™ Monorail™ Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Number (if known) K162350

Device Name

Sterling™ Monorail™ Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

{4}------------------------------------------------

510(k) Number (if known)

K162350

Device Name

Sterling™ Monorail™ Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

{5}------------------------------------------------

510(k) Number (if known)

K162350

Device Name

Sterling™ SL Monorail™ Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Number (if known) K162350

Device Name Ultra-Soft SVTM Monorail™ Balloon Dilatation Catheter 0.018"

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	X
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Summary Per 21 CFR §807.92

Common orUsual Name	Percutaneous Transluminal Angioplasty Dilatation Catheter
Trade Name(s)	Coyote™ Monorail™ Percutaneous Transluminal AngioplastyBalloon Dilatation Catheter - formally known as .014Monorail PTA Dilatation Catheter
Product Code	LIT - Catheter, Angioplasty, Peripheral, Transluminal
Classification ofDevice	Class II - 21 CFR 870.1250
Submitter's Nameand Address	Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311-1566
Contact Nameand Information	Ka Zoua XiongRegulatory Affairs SpecialistPhone: 763-494-2970Fax: 763-494-2222Email: Kazoua.Xiong@bsci.com
Date Prepared	06 October 2016
Section 514 of theAct PerformanceStandards	Currently no FDA mandated or voluntary performancestandards exist for this device.
EstablishmentRegistrationNumbers	Owner /Operator:Boston ScientificCorporation300 Boston Scientific WayMarlborough, MA 01752ERN: 9912058Manufacturing Facility:Boston ScientificCorporationTwo Scimed PlaceMaple Grove, MN 55311ERN: 2134265Sterilization Facilities:BSC Coventry8 Industrial DriveCoventry, RI 02816USA
Predicate Devices	K111295 - Coyote™ Monorail™ Percutaneous TransluminalAngioplasty Balloon Dilatation Catheter, cleared 31 May2011

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DeviceDescription	The Coyote™ Monorail™ Percutaneous TransluminalAngioplasty Balloon Dilatation Catheters (Coyote MR) arehigh performance balloon catheters for peripheral vascularindications. The devices feature an ultra low profile, semi-compliant balloon combined with a low profile tip. Thecatheter is compatible with 0.014 in (0.36 mm) guidewires.
Intended Use/Indications forUse	The Coyote MONORAIL PTA Balloon Dilatation Catheter isindicated for Percutaneous Transluminal Angioplasty (PTA)in the peripheral vasculature, including iliac, femoral,popliteal, infra-popliteal and renal arteries, and for thetreatment of obstructive lesions of native or syntheticarteriovenous dialysis fistulae.
Comparison ofRequiredTechnologicalCharacteristics	The proposed Coyote MR is substantially equivalent to theexisting Coyote MR cleared by FDA under premarketnotification K111295 (31May2011). Coyote MR has the sameintended use, scientific technology, design (with theexception of the corewire design), materials, sterilizationmethod, and packaging materials as the applicable predicatedevice.
Summary of Non-Clinical TestSummary	Bench and first article testing were performed to support adetermination of substantial equivalence. The results of thesetests provide reasonable assurance that the proposed devicewith the modified corewire has been designed and tested toassure conformance to the requirements for its intended use.No new safety or performance issues were raised during thedevice testing.
Conclusion	Based on the indications for use, technologicalcharacteristics, and safety and performance testing, theproposed Coyote MR with the modified corewire has beenshown to be appropriate for its intended use and isconsidered to be substantially equivalent to its predicate(K111295).

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Common or UsualName	PTA Balloon Dilatation Catheter
Trade Name(s)	Sterling™ Monorail™ Percutaneous Transluminal AngioplastyBalloon Dilatation Catheter
Product Code	DQY - Catheter, Percutaneous
Classification ofDevice	Class II - 21 CFR 870.1250
Submitter's Nameand Address	Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311-1566
Contact Name andInformation	Ka Zoua XiongRegulatory Affairs SpecialistPhone: 763-494-2970Fax: 763-494-2222Email: Kazoua.Xiong@bsci.com
Date Prepared	06 October 2016
Section 514 of theAct PerformanceStandards	Currently no FDA mandated or voluntary performance standardsexist for this device.
EstablishmentRegistrationNumbers	Owner /Operator:	Boston Scientific Corporation300 Boston Scientific WayMarlborough, MA 01752ERN: 9912058
	ManufacturingFacility:	Boston Scientific CorporationTwo Scimed PlaceMaple Grove, MN 55311ERN: 2134265
	SterilizationFacilities:	BSC Coventry8 Industrial DriveCoventry, RI 02816USA
		Synergy Health (Tullamore)IDA Business & Technology ParkTullamoreCounty OffalyIreland

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Predicate Devices	K053118 - Sterling™ Monorail™ Percutaneous TransluminalAngioplasty Balloon Dilatation Catheter, cleared 16 December 2005K141150 - Sterling™ Monorail™ Percutaneous TransluminalAngioplasty Balloon Dilatation Catheter, cleared 25 September2014
Device Description	The Sterling™ Monorail™ Percutaneous Transluminal AngioplastyBalloon Dilatation Catheter (Sterling MR) is a Monorail brand rapidexchange catheter with a semi-compliant balloon fixed at the distaltip. The balloon catheter has a coaxial shaft design. The outerlumen is used for inflation of the balloon, and the wire lumenpermits the use of guidewires 0.014 in / 0.018 in (.36 mm / .46 mm)to facilitate advancement of the catheter to and through thestenosis to be dilated. The balloon is designed to provide aninflatable segment of known diameter and length at recommendedpressures
Intended Use/Indications for Use	The Sterling Monorail PTA Balloon Dilatation Catheter is indicatedfor Percutaneous Transluminal Angioplasty in the peripheralvasculature, including iliac, femoral, popliteal, infra-popliteal, renal,and carotid arteries, and for the treatment of obstructive lesions ofnative or synthetic arteriovenous dialysis fistulae. This device isalso indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
Comparison ofRequiredTechnologicalCharacteristics	The proposed Sterling MR is substantially equivalent to the existingSterling MR devices cleared by FDA under premarket notificationsK053118 (16Dec2005) and K141150 (25Sep2014). Sterling MR hasthe same intended use, scientific technology, design (with theexception of the corewire design), materials, sterilization method,and packaging materials as the applicable predicate device.
Summary of Non-Clinical TestSummary	Bench testing and first article testing were performed to support adetermination of substantial equivalence. The results of these testsprovide reasonable assurance that the proposed device with themodified corewire has been designed and tested to assureconformance to the requirements for its intended use. No newsafety or performance issues were raised during the device testing.
Conclusion	Based on the indications for use, technological characteristics, andsafety and performance testing, the proposed Sterling MR with themodified corewire has been shown to be appropriate for itsintended use and is considered to be substantially equivalent to itspredicate (K053118).

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Common or Usual Name	PTA Balloon Dilatation Catheter
Trade Name(s)	Sterling™ Monorail™ Percutaneous Transluminal AngioplastyBalloon Dilatation Catheter
Product Code	LIT - Catheter, Angioplasty, Peripheral, Transluminal
Classification of Device	Class II - 21 CFR 870.1250
Submitter's Name and Address	Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311-1566
Contact Name and Information	Ka Zoua XiongRegulatory Affairs SpecialistPhone: 763-494-2970Fax: 763-494-2222Email: Kazoua.Xiong@bsci.com
Date Prepared	06 October 2016
Section 514 of the Act Performance Standards	Currently no FDA mandated or voluntary performance standardsexist for this device.
Establishment Registration Numbers	Owner/Operator: Boston Scientific Corporation300 Boston Scientific WayMarlborough, MA 01752ERN: 9912058Manufacturing Facility: Boston Scientific CorporationTwo Scimed PlaceMaple Grove, MN 55311ERN: 2134265Sterilization Facilities: BSC Coventry8 Industrial DriveCoventry, RI 02816USASynergy Health (Tullamore)IDA Business & Technology ParkTullamoreCounty OffalyIreland
Predicate Devices	K141150 - Sterling™ Monorail™ Percutaneous TransluminalAngioplasty Balloon Dilatation Catheter, cleared 25 September2014
Device Description	The Sterling™ Monorail™ Percutaneous Transluminal AngioplastyBalloon Dilatation Catheter (Sterling MR) is a Monorail brand rapidexchange catheter with a semi-compliant balloon fixed at the distaltip. The balloon catheter has a coaxial shaft design. The outerlumen is used for inflation of the balloon, and the wire lumenpermits the use of guidewires 0.014 in / 0.018 in (.36 mm / .46 mm)to facilitate advancement of the catheter to and through thestenosis to be dilated. The balloon is designed to provide aninflatable segment of known diameter and length at recommendedpressures.
Intended Use/Indications for Use	The Sterling Monorail PTA Balloon Dilatation Catheter is indicatedfor Percutaneous Transluminal Angioplasty in the peripheralvasculature, including iliac, femoral, popliteal, infra-popliteal, renal,and carotid arteries, and for the treatment of obstructive lesions ofnative or synthetic arteriovenous dialysis fistulae. This device isalso indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
Comparison ofRequiredTechnologicalCharacteristics	The proposed Sterling ME is substantially equivalent to the existingSterling ME cleared by FDA under premarket notification K141150(25Sep2014). Sterling ME has the same intended use, scientifictechnology, design (with the exception of the corewire design),materials, sterilization method, and packaging materials as theapplicable predicate device.
Summary of Non-Clinical TestSummary	Bench testing and first article testing were performed to support adetermination of substantial equivalence. The results of these testsprovide reasonable assurance that the proposed device with themodified corewire has been designed and tested to assureconformance to the requirements for its intended use. No newsafety or performance issues were raised during the device testing.
Conclusion	Based on the indications for use, technological characteristics, andsafety and performance testing, the proposed Sterling ME with themodified corewire has been shown to be appropriate for itsintended use and is considered to be substantially equivalent to itspredicate (K141150).

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Common or UsualName	Percutaneous Transluminal Angioplasty Dilatation Catheter
Trade Name(s)	Sterling™ SL Monorail™ Percutaneous Transluminal AngioplastyBalloon Dilatation Catheter
Product Code	LIT - Catheter, Angioplasty, Peripheral, Transluminal
Classification ofDevice	Class II - 21 CFR 870.1250
Submitter's Nameand Address	Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311-1566
Contact Name andInformation	Ka Zoua XiongRegulatory Affairs SpecialistPhone: 763-494-2970Fax: 763-494-2222Email: Kazoua.Xiong@bsci.com
Date Prepared	06 October 2016
Section 514 of theAct PerformanceStandards	Currently no FDA mandated or voluntary performance standardsexist for this device.
EstablishmentRegistrationNumbers	Owner /Operator: Boston Scientific Corporation300 Boston Scientific WayMarlborough, MA 01752ERN: 9912058
	ManufacturingFacility: Boston Scientific CorporationTwo Scimed PlaceMaple Grove, MN 55311ERN: 2134265
	SterilizationFacilities: BSC Coventry8 Industrial DriveCoventry, RI 02816USASynergy Health (Tullamore)IDA Business & Technology ParkTullamoreCounty OffalyIreland
Predicate Devices	K093720- Sterling™ SL Monorail™ Percutaneous TransluminalAngioplasty Balloon Dilatation Catheter, cleared 23 December 2009

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Device Description	The Sterling™ SL Monorail™ Percutaneous TransluminalAngioplasty Balloon Dilatation Catheter (Sterling SL) is highperformance balloon catheter for peripheral vascular indicationsfeaturing a low profile, semi-compliant balloon combined with a lowprofile tip. They are a line extension to the existing Sterlingcatheters and include smaller diameter and longer length balloons.The catheters have a coaxial shaft design. The outer lumen is usedfor inflation of the balloon, and the wire lumen permits the use ofguidewires 0.014" (0.36 mm) or 0.018" (0.46 mm) to facilitateadvancement of the catheter to and through the stenosis to bedilated.
Intended Use/Indications for Use	The Sterling SL Monorail PTA Balloon Dilatation Catheter isindicated for Percutaneous Transluminal Angioplasty (PTA) in theperipheral vasculature, including iliac, femoral, ilio-femoral,popliteal, infra-popliteal and renal arteries, and for the treatment ofobstructive lesions of native or synthetic arteriovenous dialysisfistulae.
Comparison ofRequiredTechnologicalCharacteristics	The proposed Sterling SL is substantially equivalent to the existingSterling SL cleared by FDA under premarket notification K093720(23Dec2009). Sterling SL has the same intended use, scientifictechnology, design (with the exception of the corewire design),materials, sterilization method, and packaging materials as theapplicable predicate device.
Summary of Non-Clinical TestSummary	Bench testing and first article testing were performed to support adetermination of substantial equivalence. The results of these testsprovide reasonable assurance that the proposed device with themodified corewire has been designed and tested to assureconformance to the requirements for its intended use. No newsafety or performance issues were raised during the device testing.
Conclusion	Based on the indications for use, technological characteristics, andsafety and performance testing, the proposed Sterling SL with themodified corewire has been shown to be appropriate for itsintended use and is considered to be substantially equivalent to itspredicate (K093720).

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Common or Usual Name	Balloon Dilation Catheter
Trade Name(s)	Ultra-Soft SV™ Monorail™ Balloon Dilatation Catheter 0.018"
Product Code	DQY - Catheter, Percutaneous
Classification of Device	Class II - 21 CFR 870.1250
Submitter's Name and Address	Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311-1566
Contact Name and Information	Ka Zoua XiongRegulatory Affairs SpecialistPhone: 763-494-2970Fax: 763-494-2222Email: Kazoua.Xiong@bsci.com
Date Prepared	06 October 2016
Section 514 of the Act Performance Standards	Currently no FDA mandated or voluntary performancestandards exist for this device.
Establishment Registration Numbers	Owner /Operator:Boston Scientific Corporation300 Boston Scientific WayMarlborough, MA 01752ERN: 9912058Manufacturing Facility:Boston Scientific CorporationTwo Scimed PlaceMaple Grove, MN 55311ERN: 2134265Sterilization Facilities:BSC Coventry8 Industrial DriveCoventry, RI 02816USA	Owner /Operator:	Boston Scientific Corporation300 Boston Scientific WayMarlborough, MA 01752ERN: 9912058	Manufacturing Facility:	Boston Scientific CorporationTwo Scimed PlaceMaple Grove, MN 55311ERN: 2134265	Sterilization Facilities:	BSC Coventry8 Industrial DriveCoventry, RI 02816USA
Owner /Operator:	Boston Scientific Corporation300 Boston Scientific WayMarlborough, MA 01752ERN: 9912058
Manufacturing Facility:	Boston Scientific CorporationTwo Scimed PlaceMaple Grove, MN 55311ERN: 2134265
Sterilization Facilities:	BSC Coventry8 Industrial DriveCoventry, RI 02816USA
Predicate Devices	K021735- Ultra-Soft SV™ Monorail™ Balloon DilatationCatheter 0.018", cleared 08 August 2002

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DeviceDescription	The Ultra-Soft SV™ Monorail™ Balloon Dilatation Catheter0.018 is a sterile, single use, Monorail catheter with a semi-compliant balloon near the distal tip which inflates to a knowndiameter and length at a specific pressure. The catheterconsists of a double lumen at the distal end and a singlelumen catheter at the proximal end. The 0.018 in. guide wirecompatible balloon catheter is available in diameters of 4.0 -7.0 mm in 1.5 and 2.0 cm balloon lengths.
Intended Use/Indications forUse	The Ultra-soft SV Balloon Dilatation Catheter is recommendedfor the Percutaneous Transluminal Angioplasty of the iliac,femoral, ilio-femoral, popliteal, renal arteries and for thetreatment of obstructive lesions of native or syntheticarteriovenous dialysis fistulae.
Comparison ofRequiredTechnologicalCharacteristics	The proposed USSV MR is substantially equivalent to theexisting USSV MR cleared by FDA under premarketnotification K021735 (08Aug2002). USSV MR has the sameintended use, scientific technology, design (with the exceptionof the corewire design), materials, sterilization method, andpackaging materials as the applicable predicate device.
Summary ofNon-Clinical TestSummary	Bench testing and first article testing were performed tosupport a determination of substantial equivalence. Theresults of these tests provide reasonable assurance that theproposed device with the modified corewire has beendesigned and tested to assure conformance to therequirements for its intended use. No new safety orperformance issues were raised during the device testing.
Conclusion	Based on the indications for use, technological characteristics,and safety and performance testing, the proposed USSV MRwith the modified corewire has been shown to be appropriatefor its intended use and is considered to be substantiallyequivalent to its predicate (K021735).

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).