RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX

K100892 · Boston Scientific Corp · KRA · Apr 12, 2010 · Cardiovascular

Device Facts

• Record ID: K100892
• Device Name: RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX
• Applicant: Boston Scientific Corp
• Product Code: KRA · Cardiovascular
• Decision Date: Apr 12, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Renegade™ Hi-Flo™ Fathom™ Kit is intended for peripheral vascular use. The Fathom guidewire can be used to selectively introduce and position the Renegade Hi-Flo microcatheter in the peripheral vasculature. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels.

Device Story

The Renegade Hi-Flo Fathom Kit is a microcatheter kit used in peripheral vascular procedures. It includes a Renegade Hi-Flo microcatheter, Fathom-16 steerable guidewire, steam shaping mandrel, rotating hemostatic valve (RHV), torque device, and guidewire introducer. The microcatheter features a radiopaque distal tip for fluoroscopic visualization and a luer adapter for RHV attachment. The Fathom-16 guidewire, with a Nitinol distal tip, is inserted into the vasculature to guide the microcatheter to the target site. The physician uses the torque device to steer the guidewire. Once positioned, the microcatheter allows for controlled, selective infusion of diagnostic, embolic, or therapeutic agents. The device facilitates minimally invasive vascular access and targeted delivery of materials, potentially improving procedural outcomes in peripheral vasculature.

Clinical Evidence

No clinical data. Substantial equivalence is based on non-clinical performance data, including component compatibility, packaging/functional testing, and sterilization qualification.

Technological Characteristics

Kit includes microcatheter, Fathom-16 steerable guidewire (Nitinol distal tip), steam shaping mandrel, rotating hemostatic valve, torque device, and introducer. Microcatheter lumen accommodates guidewires ≤ 0.018 in; outer surface is coated with radiopaque distal marker. Guidewire max diameter 0.016 in. Sterilization via contract sterilization cycle.

Indications for Use

Indicated for peripheral vascular use in patients requiring selective introduction and positioning of a microcatheter for the infusion of diagnostic, embolic, or therapeutic materials.

Regulatory Classification

Identification

A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

Predicate Devices

• Boston Scientific Renegade Hi-Flo Microcatheter Kit (K000177)

Submission Summary (Full Text)

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K100892

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## Cardiovascular

One Scimed Place Maple Grove, MN 55311-1566 763.494.1700 Tel www.bostonscientific.com

## 510(k) Summary per 21 CFR §807.92 (c)

APR 1 2 2010

| Submitter's<br>Name and<br>Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311 | |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Name<br>and Information | Scott Sepple<br>Regulatory Affairs Specialist<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] | |
| Date Prepared | March 30, 2010 | |
| Trade Name | Renegade™ Hi-Flo™ Fathom™ Kit | |
| Common Name | Microcatheter kit | |
| Classification<br>Name | Catheter, continuous flush<br>(21 CFR Part 870.1210, Product Code KRA) | |
| Predicate Device | Boston Scientific<br>Renegade Hi-Flo<br>Microcatheter Kit<br>K000177 SE: 7 April 2000 | |
| Device<br>Description | The Renegade Hi-Flo Fathom Kit includes a Renegade<br>Hi-Flo Microcatheter, a Fathom-16 Steerable Guidewire, a<br>steam shaping mandrel, a rotating hemostatic valve (RHV),<br>a guide wire torque device, and a guide wire introducer.<br><br>The Renegade Hi-Flo Microcatheter lumen is able to<br>accommodate steerable guidewires that are ≤ 0.018 in (0.46<br>mm) in diameter. The outer surface of the microcatheter<br>distal segment is coated and has a radiopaque marker at<br>the distal tip to facilitate fluoroscopic visualization. The<br>distal tip of the microcatheter is steam shapeable using the | |
| Device<br>Description,<br>continued | included steam shaping mandrel and the proximal end of<br>the microcatheter incorporates a standard luer adapter to<br>facilitate the attachment of the rotating hemostatic valve<br>(RHV). | |
| | The Fathom-16 Steerable Guidewire has a maximum<br>diameter of 0.016 in (0.41 mm). The distal portion of the<br>device is coated for lubricity and is radiopaque to facilitate<br>fluoroscopic visualization. The torque device included with<br>the guidewire attaches to the proximal end of the guidewire<br>and functions as a steering mechanism. The guidewire<br>introducer facilitates insertion of the guide wire into the<br>microcatheter hub and/or hemostatic valve and may be<br>used to shape the guidewire distal tip. | |
| Indications for<br>Use | The Renegade Hi-Flo Fathom Kit is intended for peripheral<br>vascular use. The Fathom guidewire can be used to<br>selectively introduce and position the Renegade Hi-Flo<br>microcatheter in the peripheral vasculature. The<br>microcatheter can be used for controlled and selective<br>infusion of diagnostic, embolic, or therapeutic materials into<br>vessels. | |
| | Indications for use for the Renegade Hi-Flo Fathom Kit are<br>a combination of the indications for use of the Renegade<br>Hi-Flo Microcatheter and Fathom-16 Steerable Guidewire. | |
| Comparison of<br>Technological<br>Characteristics | The Renegade Hi-Flo Fathom Kit technological<br>characteristics are identical to the predicate Boston<br>Scientific Renegade Hi-Flo Microcatheter Kit. | |
| | The Renegade Hi-Flo Fathom Kit and predicate kit both<br>contain a microcatheter, a guidewire, a microcatheter steam<br>shaping mandrel, a rotating hemostatic valve (RHV), a<br>guidewire torque device, and a guidewire introducer. The<br>primary difference between the predicate and subject kit is<br>the guidewire. The predicate kit includes the BSC Transend<br>Guidewire and the Renegade Hi-Flo Fathom Kit includes<br>the Fathom-16 Steerable Guidewire. The Fathom-16<br>Steerable Guidewire features a smaller outer diameter, a<br>Nitinol distal tip, and longer lengths compared to the<br>Transend-18 Guidewire included in the predicate kit. | |

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| Non-Clinical<br>Performance<br>Data | Determination of substantial equivalence is based on an<br>assessment of non-clinical performance data. Non-clinical<br>performance data submitted in support of substantial<br>equivalence is based on the Failure Modes/Effects Analysis<br>(FMEA) risk analysis method completed for the Renegade<br>Hi-Flo Fathom Kit to assess the impact of the modifications<br>to the predicate device. | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Testing performed and summarized as a result of the<br>completed FMEA and how this testing supports substantial<br>equivalence is described below. | |
| | Test Data Submitted | How results support SE |
| | Subject kit components<br>compatibility | Results demonstrate<br>impact of modification to<br>replace Transend-18<br>Guidewire with Fathom-16<br>Steerable Guidewire |
| | Packaging performance/<br>functional testing | Results demonstrate<br>impact of modifications to<br>predicate kit packaging |
| | Performance testing of the<br>kit guidewire post-<br>sterilization | Results demonstrate<br>impact to Fathom-16<br>Steerable Guidewire as a<br>result of contract sterilizer<br>and sterilization cycle for<br>predicate kit |
| | Sterilization qualification<br>summary | Results demonstrate<br>impact to Fathom-16<br>Steerable Guidewire as a<br>result of contract sterilizer<br>and sterilization cycle for<br>predicate kit |

All testing performed and data included in submission demonstrate passing results according to executed verification protocols. Therefore, results of non-clinical performance data submitted supports substantial equivalence to predicate device.

## Clinical Performance Data

Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.

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| Conclusion | Modification does not affect the intended use or alter the<br>fundamental scientific technology of the predicate Boston<br>Scientific Renegade Hi-Flo Microcatheter Kit. |
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| Based on the Indications for Use, unaltered technological<br>characteristics, and submitted non-clinical performance data<br>supporting this modification, the Boston Scientific Renegade<br>Hi-Flo Fathom Kit is shown to be appropriate for its intended<br>use and demonstrates that the device is as safe, as<br>effective, and performs as well as the predicate device. | |

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

APR 1 2 2010

Boston Scientific Corporation c/o Mr. Scott Sepple Regulatory Affairs Specialist One Scimed Place Maple Grove, Minnesota 55311

Re: K100892

Trade/Device Name: Renegade Hi-Flo Fathom Kit Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: Class II (two) Product Code: KRA Dated: March 30, 2010 Received: March 31, 2010

Dear Mr. Sepple:

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. Iisting 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

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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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Dma R. V. Aumer

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

510(k) Number (if known):

510(k) Number (if known): K100892

Device Name: Renegade™ Hi-Flo™ Fathom™ Kit

Indications for Use:

The Renegade™ Hi-Flo™ Fathom™ Kit is intended for peripheral vascular use. The Fathom guidewire can be used to selectively introduce and position the Renegade Hi-Flo microcatheter in the peripheral vasculature. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Cardiovascular Devices

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510(k) Number KTOO892