Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018

K162350 · Boston Scientific Corporation · LIT · Nov 4, 2016 · Cardiovascular

Device Facts

• Record ID: K162350
• Device Name: Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018
• Applicant: Boston Scientific Corporation
• Product Code: LIT · Cardiovascular
• Decision Date: Nov 4, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 Story

Monorail rapid exchange balloon dilatation catheters for peripheral vascular interventions; coaxial shaft design; semi-compliant balloon at distal tip; compatible with 0.014" or 0.018" guidewires. Used in clinical settings by physicians to dilate stenotic lesions or post-dilate stents. Device advanced over guidewire to target site; balloon inflated to specific pressure to restore vessel patency. Benefits include improved blood flow and treatment of dialysis access obstructions. Modified corewire design compared to predicates; otherwise identical in materials and operation.

Clinical Evidence

Bench testing and first article testing only. No clinical data provided.

Technological Characteristics

Monorail rapid exchange balloon dilatation catheters; coaxial shaft design; semi-compliant balloon; 0.014" or 0.018" guidewire compatibility. Materials and sterilization methods are identical to predicate devices. No software or electronic components.

Indications for Use

Indicated for patients requiring percutaneous transluminal angioplasty (PTA) in peripheral vasculature (iliac, femoral, popliteal, infra-popliteal, renal, and carotid arteries) and treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae. Sterling and Sterling SL models also indicated for post-dilatation of balloon-expandable and self-expanding stents.

Regulatory Classification

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.

Predicate Devices

• Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter (K111295)
• Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter (K053118)
• Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter (K141150)
• Sterling SL Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter (K093720)
• Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018" (K021735)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:100%;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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510(k) Number (if known) K162350

Device Name

Sterling™ Monorail™ Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter

Indications for Use (Describe)

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.

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

| <span style="font-size:10px;"> <svg height="15" width="15"> <rect fill="white" height="15" stroke="black" stroke-width="1" width="15" x="0" y="0"></rect> <path d="M2 2 L13 13 M2 13 L13 2" stroke="black" stroke-width="1"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size:10px;"> <svg height="15" width="15"> <rect fill="white" height="15" stroke="black" stroke-width="1" width="15" x="0" y="0"></rect> </svg> </span> 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 [e-mail]

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

510(k) Number (if known)

K162350

Device Name

Sterling™ Monorail™ Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter

Indications for Use (Describe)

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.

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

| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------|
| <span></span> 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 [e-mail]

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

510(k) Number (if known)

K162350

Device Name

Sterling™ SL Monorail™ Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter

#### Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"> <span style="margin-right:5px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span style="margin-right:5px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

### 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 [e-mail]

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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)

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.

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

| Prescription Use (Part 21 CFR 801 Subpart D) | <div>X</div> |
|----------------------------------------------|--------------|
| 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 [e-mail]

{7}------------------------------------------------

# 510(k) Summary Per 21 CFR §807.92

| Common or<br>Usual Name | Percutaneous Transluminal Angioplasty Dilatation Catheter |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name(s) | Coyote™ Monorail™ Percutaneous Transluminal Angioplasty<br>Balloon Dilatation Catheter - formally known as .014<br>Monorail PTA Dilatation Catheter |
| Product Code | LIT - Catheter, Angioplasty, Peripheral, Transluminal |
| Classification of<br>Device | Class II - 21 CFR 870.1250 |
| Submitter's Name<br>and Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311-1566 |
| Contact Name<br>and Information | Ka Zoua Xiong<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared | 06 October 2016 |
| Section 514 of the<br>Act Performance<br>Standards | Currently no FDA mandated or voluntary performance<br>standards exist for this device. |
| Establishment<br>Registration<br>Numbers | Owner /Operator:<br>Boston Scientific<br>Corporation<br>300 Boston Scientific Way<br>Marlborough, MA 01752<br>ERN: 9912058<br><br>Manufacturing Facility:<br>Boston Scientific<br>Corporation<br>Two Scimed Place<br>Maple Grove, MN 55311<br>ERN: 2134265<br><br>Sterilization Facilities:<br>BSC Coventry<br>8 Industrial Drive<br>Coventry, RI 02816<br>USA |
| Predicate Devices | K111295 - Coyote™ Monorail™ Percutaneous Transluminal<br>Angioplasty Balloon Dilatation Catheter, cleared 31 May<br>2011 |

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| Device<br>Description | The Coyote™ Monorail™ Percutaneous Transluminal<br>Angioplasty Balloon Dilatation Catheters (Coyote MR) are<br>high performance balloon catheters for peripheral vascular<br>indications. The devices feature an ultra low profile, semi-<br>compliant balloon combined with a low profile tip. The<br>catheter is compatible with 0.014 in (0.36 mm) guidewires. |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/<br>Indications for<br>Use | The Coyote MONORAIL PTA Balloon Dilatation Catheter is<br>indicated for Percutaneous Transluminal Angioplasty (PTA)<br>in the peripheral vasculature, including iliac, femoral,<br>popliteal, infra-popliteal and renal arteries, and for the<br>treatment of obstructive lesions of native or synthetic<br>arteriovenous dialysis fistulae. |
| Comparison of<br>Required<br>Technological<br>Characteristics | The proposed Coyote MR is substantially equivalent to the<br>existing Coyote MR cleared by FDA under premarket<br>notification K111295 (31May2011). Coyote MR has the same<br>intended use, scientific technology, design (with the<br>exception of the corewire design), materials, sterilization<br>method, and packaging materials as the applicable predicate<br>device. |
| Summary of Non-<br>Clinical Test<br>Summary | Bench and first article testing were performed to support a<br>determination of substantial equivalence. The results of these<br>tests provide reasonable assurance that the proposed device<br>with the modified corewire has been designed and tested to<br>assure conformance to the requirements for its intended use.<br>No new safety or performance issues were raised during the<br>device testing. |
| Conclusion | Based on the indications for use, technological<br>characteristics, and safety and performance testing, the<br>proposed Coyote MR with the modified corewire has been<br>shown to be appropriate for its intended use and is<br>considered to be substantially equivalent to its predicate<br>(K111295). |

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| Common or Usual<br>Name | PTA Balloon Dilatation Catheter | |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Trade Name(s) | Sterling™ Monorail™ Percutaneous Transluminal Angioplasty<br>Balloon Dilatation Catheter | |
| Product Code | DQY - Catheter, Percutaneous | |
| Classification of<br>Device | Class II - 21 CFR 870.1250 | |
| Submitter's Name<br>and Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311-1566 | |
| Contact Name and<br>Information | Ka Zoua Xiong<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | |
| Date Prepared | 06 October 2016 | |
| Section 514 of the<br>Act Performance<br>Standards | Currently no FDA mandated or voluntary performance standards<br>exist for this device. | |
| Establishment<br>Registration<br>Numbers | Owner /Operator: | Boston Scientific Corporation<br>300 Boston Scientific Way<br>Marlborough, MA 01752<br>ERN: 9912058 |
| | Manufacturing<br>Facility: | Boston Scientific Corporation<br>Two Scimed Place<br>Maple Grove, MN 55311<br>ERN: 2134265 |
| | Sterilization<br>Facilities: | BSC Coventry<br>8 Industrial Drive<br>Coventry, RI 02816<br>USA |
| | | Synergy Health (Tullamore)<br>IDA Business & Technology Park<br>Tullamore<br>County Offaly<br>Ireland |

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| Predicate Devices | K053118 - Sterling™ Monorail™ Percutaneous Transluminal<br>Angioplasty Balloon Dilatation Catheter, cleared 16 December 2005<br>K141150 - Sterling™ Monorail™ Percutaneous Transluminal<br>Angioplasty Balloon Dilatation Catheter, cleared 25 September<br>2014 |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | The Sterling™ Monorail™ Percutaneous Transluminal Angioplasty<br>Balloon Dilatation Catheter (Sterling MR) is a Monorail brand rapid<br>exchange catheter with a semi-compliant balloon fixed at the distal<br>tip. The balloon catheter has a coaxial shaft design. The outer<br>lumen is used for inflation of the balloon, and the wire lumen<br>permits the use of guidewires 0.014 in / 0.018 in (.36 mm / .46 mm)<br>to facilitate advancement of the catheter to and through the<br>stenosis to be dilated. The balloon is designed to provide an<br>inflatable segment of known diameter and length at recommended<br>pressures |
| Intended Use/<br>Indications for Use | The Sterling Monorail PTA Balloon Dilatation Catheter is indicated<br>for Percutaneous Transluminal Angioplasty in the peripheral<br>vasculature, including iliac, femoral, popliteal, infra-popliteal, renal,<br>and carotid arteries, and for the treatment of obstructive lesions of<br>native or synthetic arteriovenous dialysis fistulae. This device is<br>also indicated for post-dilatation of balloon expandable and self-<br>expanding stents in the peripheral vasculature. |
| Comparison of<br>Required<br>Technological<br>Characteristics | The proposed Sterling MR is substantially equivalent to the existing<br>Sterling MR devices cleared by FDA under premarket notifications<br>K053118 (16Dec2005) and K141150 (25Sep2014). Sterling MR has<br>the same intended use, scientific technology, design (with the<br>exception of the corewire design), materials, sterilization method,<br>and packaging materials as the applicable predicate device. |
| Summary of Non-<br>Clinical Test<br>Summary | Bench testing and first article testing were performed to support a<br>determination of substantial equivalence. The results of these tests<br>provide reasonable assurance that the proposed device with the<br>modified corewire has been designed and tested to assure<br>conformance to the requirements for its intended use. No new<br>safety or performance issues were raised during the device testing. |
| Conclusion | Based on the indications for use, technological characteristics, and<br>safety and performance testing, the proposed Sterling MR with the<br>modified corewire has been shown to be appropriate for its<br>intended use and is considered to be substantially equivalent to its<br>predicate (K053118). |

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| Common or Usual Name | PTA Balloon Dilatation Catheter |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name(s) | Sterling™ Monorail™ Percutaneous Transluminal Angioplasty<br>Balloon 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 Corporation<br>One Scimed Place<br>Maple Grove, MN 55311-1566 |
| Contact Name and Information | Ka Zoua Xiong<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared | 06 October 2016 |
| Section 514 of the Act Performance Standards | Currently no FDA mandated or voluntary performance standards<br>exist for this device. |
| Establishment Registration Numbers | Owner/Operator: Boston Scientific Corporation<br>300 Boston Scientific Way<br>Marlborough, MA 01752<br>ERN: 9912058<br><br>Manufacturing Facility: Boston Scientific Corporation<br>Two Scimed Place<br>Maple Grove, MN 55311<br>ERN: 2134265<br><br>Sterilization Facilities: BSC Coventry<br>8 Industrial Drive<br>Coventry, RI 02816<br>USA<br><br>Synergy Health (Tullamore)<br>IDA Business & Technology Park<br>Tullamore<br>County Offaly<br>Ireland |
| Predicate Devices | K141150 - Sterling™ Monorail™ Percutaneous Transluminal<br>Angioplasty Balloon Dilatation Catheter, cleared 25 September<br>2014 |
| Device Description | The Sterling™ Monorail™ Percutaneous Transluminal Angioplasty<br>Balloon Dilatation Catheter (Sterling MR) is a Monorail brand rapid<br>exchange catheter with a semi-compliant balloon fixed at the distal<br>tip. The balloon catheter has a coaxial shaft design. The outer<br>lumen is used for inflation of the balloon, and the wire lumen<br>permits the use of guidewires 0.014 in / 0.018 in (.36 mm / .46 mm)<br>to facilitate advancement of the catheter to and through the<br>stenosis to be dilated. The balloon is designed to provide an<br>inflatable segment of known diameter and length at recommended<br>pressures. |
| Intended Use/<br>Indications for Use | The Sterling Monorail PTA Balloon Dilatation Catheter is indicated<br>for Percutaneous Transluminal Angioplasty in the peripheral<br>vasculature, including iliac, femoral, popliteal, infra-popliteal, renal,<br>and carotid arteries, and for the treatment of obstructive lesions of<br>native or synthetic arteriovenous dialysis fistulae. This device is<br>also indicated for post-dilatation of balloon expandable and self-<br>expanding stents in the peripheral vasculature. |
| Comparison of<br>Required<br>Technological<br>Characteristics | The proposed Sterling ME is substantially equivalent to the existing<br>Sterling ME cleared by FDA under premarket notification K141150<br>(25Sep2014). Sterling ME has the same intended use, scientific<br>technology, design (with the exception of the corewire design),<br>materials, sterilization method, and packaging materials as the<br>applicable predicate device. |
| Summary of Non-<br>Clinical Test<br>Summary | Bench testing and first article testing were performed to support a<br>determination of substantial equivalence. The results of these tests<br>provide reasonable assurance that the proposed device with the<br>modified corewire has been designed and tested to assure<br>conformance to the requirements for its intended use. No new<br>safety or performance issues were raised during the device testing. |
| Conclusion | Based on the indications for use, technological characteristics, and<br>safety and performance testing, the proposed Sterling ME with the<br>modified corewire has been shown to be appropriate for its<br>intended use and is considered to be substantially equivalent to its<br>predicate (K141150). |

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| Common or Usual<br>Name | Percutaneous Transluminal Angioplasty Dilatation Catheter |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name(s) | Sterling™ SL Monorail™ Percutaneous Transluminal Angioplasty<br>Balloon Dilatation Catheter |
| Product Code | LIT - Catheter, Angioplasty, Peripheral, Transluminal |
| Classification of<br>Device | Class II - 21 CFR 870.1250 |
| Submitter's Name<br>and Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311-1566 |
| Contact Name and<br>Information | Ka Zoua Xiong<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared | 06 October 2016 |
| Section 514 of the<br>Act Performance<br>Standards | Currently no FDA mandated or voluntary performance standards<br>exist for this device. |
| Establishment<br>Registration<br>Numbers | <b>Owner /Operator:</b> Boston Scientific Corporation<br>300 Boston Scientific Way<br>Marlborough, MA 01752<br>ERN: 9912058 |
| | <b>Manufacturing<br/>Facility:</b> Boston Scientific Corporation<br>Two Scimed Place<br>Maple Grove, MN 55311<br>ERN: 2134265 |
| | <b>Sterilization<br/>Facilities:</b> BSC Coventry<br>8 Industrial Drive<br>Coventry, RI 02816<br>USA<br><br>Synergy Health (Tullamore)<br>IDA Business & Technology Park<br>Tullamore<br>County Offaly<br>Ireland |
| Predicate Devices | K093720- Sterling™ SL Monorail™ Percutaneous Transluminal<br>Angioplasty Balloon Dilatation Catheter, cleared 23 December 2009 |

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| Device Description | The Sterling™ SL Monorail™ Percutaneous Transluminal<br>Angioplasty Balloon Dilatation Catheter (Sterling SL) is high<br>performance balloon catheter for peripheral vascular indications<br>featuring a low profile, semi-compliant balloon combined with a low<br>profile tip. They are a line extension to the existing Sterling<br>catheters and include smaller diameter and longer length balloons.<br>The catheters have a coaxial shaft design. The outer lumen is used<br>for inflation of the balloon, and the wire lumen permits the use of<br>guidewires 0.014" (0.36 mm) or 0.018" (0.46 mm) to facilitate<br>advancement of the catheter to and through the stenosis to be<br>dilated. |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/<br>Indications for Use | The Sterling SL Monorail PTA Balloon Dilatation Catheter is<br>indicated for Percutaneous Transluminal Angioplasty (PTA) in the<br>peripheral vasculature, including iliac, femoral, ilio-femoral,<br>popliteal, infra-popliteal and renal arteries, and for the treatment of<br>obstructive lesions of native or synthetic arteriovenous dialysis<br>fistulae. |
| Comparison of<br>Required<br>Technological<br>Characteristics | The proposed Sterling SL is substantially equivalent to the existing<br>Sterling SL cleared by FDA under premarket notification K093720<br>(23Dec2009). Sterling SL has the same intended use, scientific<br>technology, design (with the exception of the corewire design),<br>materials, sterilization method, and packaging materials as the<br>applicable predicate device. |
| Summary of Non-<br>Clinical Test<br>Summary | Bench testing and first article testing were performed to support a<br>determination of substantial equivalence. The results of these tests<br>provide reasonable assurance that the proposed device with the<br>modified corewire has been designed and tested to assure<br>conformance to the requirements for its intended use. No new<br>safety or performance issues were raised during the device testing. |
| Conclusion | Based on the indications for use, technological characteristics, and<br>safety and performance testing, the proposed Sterling SL with the<br>modified corewire has been shown to be appropriate for its<br>intended use and is considered to be substantially equivalent to its<br>predicate (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 Corporation<br>One Scimed Place<br>Maple Grove, MN 55311-1566 | | | | | | |
| Contact Name and Information | Ka Zoua Xiong<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | | | | | | |
| Date Prepared | 06 October 2016 | | | | | | |
| Section 514 of the Act Performance Standards | Currently no FDA mandated or voluntary performance<br>standards exist for this device. | | | | | | |
| Establishment Registration Numbers | <table><tr><td>Owner /Operator:</td><td>Boston Scientific Corporation<br/>300 Boston Scientific Way<br/>Marlborough, MA 01752<br/>ERN: 9912058</td></tr><tr><td>Manufacturing Facility:</td><td>Boston Scientific Corporation<br/>Two Scimed Place<br/>Maple Grove, MN 55311<br/>ERN: 2134265</td></tr><tr><td>Sterilization Facilities:</td><td>BSC Coventry<br/>8 Industrial Drive<br/>Coventry, RI 02816<br/>USA</td></tr></table> | Owner /Operator: | Boston Scientific Corporation<br>300 Boston Scientific Way<br>Marlborough, MA 01752<br>ERN: 9912058 | Manufacturing Facility: | Boston Scientific Corporation<br>Two Scimed Place<br>Maple Grove, MN 55311<br>ERN: 2134265 | Sterilization Facilities: | BSC Coventry<br>8 Industrial Drive<br>Coventry, RI 02816<br>USA |
| Owner /Operator: | Boston Scientific Corporation<br>300 Boston Scientific Way<br>Marlborough, MA 01752<br>ERN: 9912058 | | | | | | |
| Manufacturing Facility: | Boston Scientific Corporation<br>Two Scimed Place<br>Maple Grove, MN 55311<br>ERN: 2134265 | | | | | | |
| Sterilization Facilities: | BSC Coventry<br>8 Industrial Drive<br>Coventry, RI 02816<br>USA | | | | | | |
| Predicate Devices | K021735- Ultra-Soft SV™ Monorail™ Balloon Dilatation<br>Catheter 0.018", cleared 08 August 2002 | | | | | | |

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| Device<br>Description | The Ultra-Soft SV™ Monorail™ Balloon Dilatation Catheter<br>0.018 is a sterile, single use, Monorail catheter with a semi-<br>compliant balloon near the distal tip which inflates to a known<br>diameter and length at a specific pressure. The catheter<br>consists of a double lumen at the distal end and a single<br>lumen catheter at the proximal end. The 0.018 in. guide wire<br>compatible balloon catheter is available in diameters of 4.0 -<br>7.0 mm in 1.5 and 2.0 cm balloon lengths. |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/<br>Indications for<br>Use | The Ultra-soft SV Balloon Dilatation Catheter is recommended<br>for the Percutaneous Transluminal Angioplasty of the iliac,<br>femoral, ilio-femoral, popliteal, renal arteries and for the<br>treatment of obstructive lesions of native or synthetic<br>arteriovenous dialysis fistulae. |
| Comparison of<br>Required<br>Technological<br>Characteristics | The proposed USSV MR is substantially equivalent to the<br>existing USSV MR cleared by FDA under premarket<br>notification K021735 (08Aug2002). USSV MR has the same<br>intended use, scientific technology, design (with the exception<br>of the corewire design), materials, sterilization method, and<br>packaging materials as the applicable predicate device. |
| Summary of<br>Non-Clinical Test<br>Summary | Bench testing and first article testing were performed to<br>support a determination of substantial equivalence. The<br>results of these tests provide reasonable assurance that the<br>proposed device with the modified corewire has been<br>designed and tested to assure conformance to the<br>requirements for its intended use. No new safety or<br>performance issues were raised during the device testing. |
| Conclusion | Based on the indications for use, technological characteristics,<br>and safety and performance testing, the proposed USSV MR<br>with the modified corewire has been shown to be appropriate<br>for its intended use and is considered to be substantially<br>equivalent to its predicate (K021735). |