Rubicon 14, 18 and 35 Support Catheters

K171913 · Boston Scientific Corporation · DQY · Jul 25, 2017 · Cardiovascular

Device Facts

• Record ID: K171913
• Device Name: Rubicon 14, 18 and 35 Support Catheters
• Applicant: Boston Scientific Corporation
• Product Code: DQY · Cardiovascular
• Decision Date: Jul 25, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Rubicon Support Catheter is intended to facilitate placement and support of guidewires and other interventional devices within the peripheral vasculature and to allow for exchange of guidewires, and provide a conduit for the delivery of saline or contrast solutions.

Device Story

Multipurpose intravascular support catheter; used in peripheral vasculature. Physician backloads catheter over pre-positioned guidewire; advances to target area via fluoroscopic imaging; may be introduced through existing introducer sheath or guide catheter. Functions as conduit for saline/contrast injection and support for guidewires/interventional devices. Facilitates lesion crossing and device exchange. Benefits patient by enabling precise navigation and delivery of interventional tools during peripheral procedures.

Clinical Evidence

No clinical data. Bench testing only, focusing on packaging integrity, pouch seal strength, and label adhesion.

Technological Characteristics

Intravascular support catheter; available in 65cm, 90cm, 135cm, and 150cm shaft lengths. Complies with ISO 10555-1 and ISO 10555-4. Sterile, single-use. No electronic components or software.

Indications for Use

Indicated for use in the peripheral vasculature to facilitate guidewire/interventional device placement and support, guidewire exchange, and delivery of saline or contrast solutions.

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

• Rubicon™ 14 Support Catheter (K112303)
• Rubicon™ 18 Support Catheter (K122394)
• Rubicon™ 35 Support Catheter

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

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

July 25, 2017

Boston Scientific Corporation Ms. Ka Zoua Xiong Regulatory Affairs Specialist Three Scimed Place Maple Grove, Minnesota 55311-1566

Re: K171913

Trade/Device Name: Rubicon 14, 18 and 35 Support Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: June 22, 2017 Received: June 26, 2017

Dear Ms. Xiong:

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

{1}------------------------------------------------

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 device 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,

# 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

{2}------------------------------------------------

### Indications for Use

510(k) Number (if known) K171913

Device Name Rubicon™ 14, 18 and 35 Support Catheters

Indications for Use (Describe)

The Rubicon Support Catheter is intended to facilitate placement and support of guidewires and other interventional devices within the peripheral vasculature and to allow for exchange of guide a conduit for the delivery of saline or contrast solutions.

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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

## 510(k) Summary

## Per 21 CFR §807.92

| Common or Usual<br>Name | Percutaneous Catheter |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name(s) | Rubicon™ 14, 18 and 35 Support Catheters |
| Product Code | DQY - Percutaneous Catheter |
| Classification of<br>Device | Class II - 21 CFR 870.1250 |
| Submitter's Name<br>and Address | Boston Scientific Corporation<br>Three Scimed Place, C275<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 | 22 June 2017 |
| Section 514 of the<br>Act Performance<br>Standards | 6-301: ISO 10555-1 Second edition 2013-06-15<br>Intravascular catheters -- Sterile and single-use intravascular<br>catheters -- Part 1: General requirements<br>6-322: ISO 10555-4 Second edition 2013-06-15<br>Intravascular catheters -- Sterile and single-use catheters -- Part 4:<br>Balloon dilatation catheters |
| Establishment<br>Registration<br>Numbers | Owner /Operator:<br>Boston Scientific Corporation<br>300 Boston Scientific Way<br>Marlborough, MA 01752<br>ERN: 9912058<br><br>Manufacturing Facility:<br>Boston Scientific 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 | K112303 - Rubicon™ 14 Support Catheter<br>K122394 - Rubicon™ 18 Support Catheter<br>Rubicon™ 35 Support Catheter |
| Device Description | The Rubicon™ 14, 18 and 35 Support Catheters (Rubicon) are<br>multipurpose intravascular device that can be used for wire<br>exchanges, saline or contrast injection and to support a guidewire<br>or other devices to cross peripheral lesions. They are available in<br>65cm, 90cm, 135cm, and 150cm shaft lengths.<br><br>To use the Rubicon Support Catheter, the physician backloads the<br>distal tip of the support catheter over a pre-positioned guidewire,<br>ensuring the guidewire exits the proximal hub/luer and advances<br>the support catheter to the target area.<br><br>The Rubicon Support Catheter may also be introduced through a<br>previously positioned, appropriately sized introducer sheath or<br>guide sheath/catheter, advancing the Rubicon Support Catheter to<br>its desired location while using fluoroscopic imaging. |
| Intended Use/<br>Indications for Use | The Rubicon Support Catheter is intended to facilitate placement<br>and support of guidewires and other interventional devices within<br>the peripheral vasculature and to allow for exchange of<br>guidewires, and provide a conduit for the delivery of saline or<br>contrast solutions. |
| Comparison of<br>Required<br>Technological<br>Characteristics | Rubicon is substantially equivalent to the existing Rubicon devices<br>cleared by FDA under Premarket Notifications K112303 and<br>K122394 (09 Nov 2011 and 30 Aug 2012, respectively). Rubicon<br>has the same intended use, scientific technology, design,<br>materials, and sterilization method. The packaging dimensions and<br>pouch materials were modified as compared to the applicable<br>predicate devices. |

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

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

| Non-Clinical Test<br>Summary | The following bench testing were performed to support a<br>determination of substantial equivalence:<br>Pouch Seal Strength Catheter Withdrawal from the Carrier Tube Angle Clip Retention Angled Clip Removal Pouch Sterile Barrier Integrity - Bubble Pouch Sterile Barrier Integrity – Visual Shelf Carton Condition Master Shipping Carton Condition Label Adhesion and Print Quality |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The results of these tests provide reasonable assurance that the<br>proposed packaging modifications have been designed and tested<br>to assure conformance to the requirements for its intended use. No<br>new safety or performance issues were raised during bench<br>testing. |
| | The proposed packaging changes did not require new<br>biocompatibility or device bench testing to support substantial<br>equivalence. Therefore, testing results from the predicate<br>devices still apply. |
| Clinical Testing | Clinical evaluation was not required to support a determination of<br>substantial equivalence. |
| Conclusion | Based on the indications for use, technological characteristics, and<br>safety and performance testing, the proposed Rubicon™ 14, 18<br>and 35 Support Catheters have been shown to be appropriate for<br>its intended use and are considered to be substantially equivalent<br>to their respective predicates (K112303 and K122394). |