RUBICON 18 SUPPORT CATHETER

K122394 · Boston Scientific Corp · DQY · Aug 30, 2012 · Cardiovascular

Device Facts

• Record ID: K122394
• Device Name: RUBICON 18 SUPPORT CATHETER
• Applicant: Boston Scientific Corp
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 30, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Rubicon Support Catheters are multipurpose intravascular devices that can be used for wire exchanges, saline, contrast injection and to support a guidewire or other CTO (Chronic Total Occlusion) devices. The Support Catheter can be back loaded over a pre-positioned guidewire or may be introduced through a previously positioned appropriately sized introducer sheath and advanced to the targeted area of the lesion. The guidewire is advanced through the lesion and the support catheter is advanced over the wire until the guidewire exits the lesion and the Support Catheter reaches the patent lumen of the vessel.

Device Story

Rubicon 18 and 35 Support Catheters are multipurpose intravascular devices used in peripheral vasculature. Features include ultra-low profile tip, lubricious hydrophilic coating on distal 40 cm, and 3 radiopaque markers for geometry estimation. Proximal end includes female luer-lock port for guidewire entry and fluid injection. Operated by physicians in clinical settings. Device is back-loaded over pre-positioned guidewire or introduced via introducer sheath. Advanced to lesion site to support guidewire/CTO devices or facilitate wire exchange. Provides conduit for saline/contrast delivery. Benefits include improved guidewire support and navigation through lesions to patent vessel lumen.

Clinical Evidence

No clinical data. Evidence consists of in-vitro performance bench testing and biocompatibility testing leveraged from the predicate device (K112303). Bench tests included effective length, inner/outer diameter, marker band spacing, contrast flow rate, sheath insertion/withdrawal force, burst pressure, tensile strength, kink resistance, torque strength, radiopacity, and coating integrity. All tests met established specifications.

Technological Characteristics

Percutaneous catheter; hydrophilic coating on distal 40 cm; 3 radiopaque markers; female luer-lock port. Materials, design, and manufacturing processes are equivalent to predicate K112303. Sterilization method not specified but consistent with predicate. No software or electronic components.

Indications for Use

Indicated for facilitating placement and support of guidewires and interventional devices within peripheral vasculature, exchanging guidewires, and delivering 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)

Submission Summary (Full Text)

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Special 510(k) Submission Rubicon™ 18 and 35 Support Catheter

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## 510(k) Summary per 21 CFR §807.92

AUG 30 2012

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| Submitter's<br>Name and<br>Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311 | |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Contact Name<br>and Information | Diane Nelson<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] | |
| Date Prepared | 06 August 2012 | |
| Proprietary<br>Name | Boston Scientific Rubicon™ 18 Support Catheter<br>Boston Scientific Rubicon™ 35 Support Catheter | |
| Common Name | Percutaneous Catheter | |
| Product Code | DQY | |
| Classification | Class II, 21 CFR Part 870.1250 | |
| Predicate<br>Device | Boston Scientific Corporation K112303 09 November 2011<br>Rubicon™ 14 Support Catheter | |
| Device<br>Description | The Boston Scientific Rubicon Support Catheters feature an ultra low profile<br>tip, a lubricious hydrophilic coating that is applied to the surface of the distal<br>40 cm of the catheter, and 3 radiopaque markers spaced equally along the<br>distal shaft which aid in estimating geometry within the vascular system. The<br>distal radiopaque marker is positioned approximately 2mm away from the<br>distal catheter tip. The proximal portion of the catheter includes one female<br>luer-lock port connected to the proximal end of the catheter for guidewire entry<br>and fluid injection. | |
| Intended Use of<br>Device | The Rubicon Support Catheters are multipurpose intravascular devices that<br>can be used for wire exchanges, saline, contrast injection and to support a<br>guidewire or other CTO (Chronic Total Occlusion) devices. The Support<br>Catheter can be back loaded over a pre-positioned guidewire or may be<br>introduced through a previously positioned appropriately sized introducer<br>sheath and advanced to the targeted area of the lesion. The guidewire is<br>advanced through the lesion and the support catheter is advanced over the<br>wire until the guidewire exits the lesion and the Support Catheter reaches the<br>patent lumen of the vessel. | |
| Indications for<br>Use | The Rubicon Support Catheter is intended to facilitate placement and support<br>of guidewires and other interventional devices within the peripheral<br>vasculature and to allow for exchange of guidewires, and provide a conduit for<br>the delivery of saline or contrast solutions. | |
| Comparison of<br>Technological<br>Characteristics | Rubicon 18 Support Catheter and Rubicon 35 Support Catheter incorporate<br>substantially equivalent device design and materials, packaging design and<br>materials, fundamental technology, manufacturing processes, sterilization<br>process, and intended use as those featured in the predicate device, Boston<br>Scientific Rubicon 14 Support Catheter (K112303). | |
| Performance<br>Data | Biocompatibility testing was completed and submitted as part of the Rubicon<br>14 Support Catheter (K112303). The Rubicon 18 and 35 Support Catheters<br>are equivalent in design, materials, and manufacturing to the Rubicon 14<br>Support Catheter, cleared by the FDA November 9, 2011. Since no changes<br>have been implemented that would affect the biocompatibility of the devices,<br>these results are applicable to the subject devices. | |
| | Biocompatibility tests were leveraged from predicate Rubicon 14: | |
| | MEM Elution Cytotoxicity | Hemolysis Assay Indirect Extraction |
| | Guinea Pig (Maximization)<br>Sensitization | Partial Thromboplastin Time |
| | Intracutaneous Reactivity | In Vitro Hemocompatibility Assay |
| | Systemic Toxicity (Acute) | Complement Activation |
| | Materials Mediated Rabbit<br>Pyrogen | USP Physicochemical |
| | Hemolysis Assay Direct Contact | Natural Rubber Latex |
| | The following in-vitro performance bench tests confirm the performance<br>characteristics: | |
| | Effective Length | Sheath Insertion and Withdrawal Force |
| | Inner Diameter - Distal Shaft | Catheter Shaft Burst Pressure |
| | Outer Diameter - Proximal Shaft | Catheter Tensile |
| | Outer Diameter - Distal Shaft | Shaft Kink Resistance |
| | Marker Band Spacing | Torque Strength |
| | Contrast Flow Rate | Radiopacity |
| | Flow rates for DFU labeling | Coating Integrity |
| | All test results demonstrate that the materials, manufacturing process, and<br>design of the Rubicon 18 and 35 Support Catheters meet the established<br>specifications necessary for consistent performance according to its intended<br>use. | |
| Conclusion | Based on the indications for use, technological characteristics, safety and<br>performance testing, the Rubicon 18 and 35 Support Catheters have been<br>shown to be appropriate for their intended use and are considered to be<br>substantially equivalent to the Rubicon 14 Support Catheter (K112303). | |

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## Special 510(k) Submission Rubicon™ 18 and 35 Support Catheter

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

. AUG 3 0 2012

Boston Scientific Corp. % Diane Nelson One Scimed Place Maple Grove, MN 55311-1566

Re: K122394

Trade/Device Name: Rubicon 18 and 35 Support Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 6, 2012 Received: August 7, 2012

Dear Ms. Nelson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Diane Nelson

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Cui A. Killeen

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

Enclosure

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## Indications for Use Statement

510(k) Number (if known)

K122394

Device Name:

Rubicon™ Support Catheters

The Rubicon Support Catheter is intended to facilitate placement and support of Indications for Use 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.A. Hillbern

ision Sian-C Division of Cardiovascular Devices

V 122394 510(k) Number

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