RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT

K140329 · Boston Scientific · KRA · May 15, 2014 · Cardiovascular

Device Facts

• Record ID: K140329
• Device Name: RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT
• Applicant: Boston Scientific
• Product Code: KRA · Cardiovascular
• Decision Date: May 15, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Renegade HI-FLO FATHOM Kit / System: The Renegade HI-FLO FATHOM Kit / System 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. Renegade HI-FLO Microcatheter and Kit: The Renegade HI-FLO Microcatheter is intended for peripheral vascular use. The microcatheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. Diagnostic, embolic, or therapeutic agents to be used in accordance with specifications outlined by the manufacturer.

Device Story

Single-lumen, multipurpose microcatheter for peripheral vasculature; used to access distal, tortuous vessels by tracking coaxially over steerable guidewire. Once positioned, enables controlled, selective infusion of diagnostic, embolic, or therapeutic agents. Features tapered OD (3.0F proximal to 2.8F distal), Hydro Pass hydrophilic coating for lubricity, and radiopaque distal tip for fluoroscopic visualization. Distal tip is steam-shapeable using included mandrel. Operated by physicians in clinical settings. Benefits include improved access to difficult-to-reach peripheral sites for targeted therapy delivery.

Clinical Evidence

No clinical data; substantial equivalence determination based on bench testing only.

Technological Characteristics

Single-lumen catheter; braided shaft; Hydro Pass hydrophilic coating; radiopaque distal tip; steam-shapeable distal tip; 80-150 cm lengths; 0.69 mm ID; accommodates guidewires ≤ 0.47 mm (0.018 in).

Indications for Use

Indicated for patients requiring peripheral vascular access for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials. Used to access distal, tortuous vasculature via coaxial tracking over a steerable guidewire.

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

• Renegade™ HI-FLO™ FATHOM™ Kit (K100892)
• Renegade HI-FLO Microcatheter and Kit (K000177)

Submission Summary (Full Text)

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MAY 1 5 2014

K140329 Page 1 of 3

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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 | Mark Murphy<br>Senior Regulatory Affairs Specialist<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] | |
| Date Prepared | February 7, 2014 | |
| Trade Name | Renegade™ HI-FLO™ FATHOM™ Kit<br>Renegade™ HI-FLO™ FATHOM™ System<br>Renegade™ HI-FLO™ Microcatheter<br>Renegade™ HI-FLO™ Kit | |
| Common Name | Catheter, Continuous Flush | |
| Classification | Class II per 21 CFR Part 870.1210<br>Product Code: KRA<br>Classification Panel: Cardiovascular | |
| Predicate Device | Renegade™ HI-FLO™ FATHOM™ Kit<br>(K100892, 12 April 2010) | |
| | Renegade HI-FLO Microcatheter and Kit<br>(K000177, 07 April 2000) | |
| Device<br>Description | The Boston Scientific Renegade HI-FLO Microcatheter<br>devices are single lumen, multipurpose catheters intended<br>for use in the peripheral vasculature. The basic operating<br>principle is to advance the microcatheter through a guide<br>catheter and track coaxially over a steerable guidewire in<br>order to access the treatment site. Once the target region<br>has been accessed, the microcatheter can be used to<br>deliver diagnostic, embolic, or therapeutic materials into<br>vessels. | |
| Device<br>Description<br>(cont'd) | The Renegade Hi-Flo Microcatheter incorporates a taper in<br>its outside diameter along its length from the 3.0F (1.0 mm)<br>proximal outer diameter (OD) to the flexible 2.8F (0.93 mm)<br>distal OD. The inner diameter (ID) of the microcatheter is<br>0.69 mm (0.027 in) minimally in the proximal and distal<br>regions. The microcatheter lumen is able to accommodate<br>steerable guidewires that are ≤ 0.47 mm (0.018 in) in<br>diameter. The microcatheter is available in 80, 105, 115,<br>135, and 150 cm usable lengths. | |
| | The distal end of the microcatheter is coated with Hydro<br>Pass™ hydrophilic coating for lubricity. The Renegade Hi-<br>Flo Microcatheter has a radiopaque marker at the distal tip<br>to facilitate fluoroscopic visualization. The distal tip of the<br>microcatheter is steam shapeable and can be bent to the<br>desired geometry with a steam shaping mandrel accessory<br>packaged with the device. The proximal end of the<br>microcatheter incorporates a hub with a standard luer to<br>facilitate the attachment of accessories. | |
| Indication for<br>Use | Renegade HI-FLO FATHOM Kit / System:<br>The Renegade HI-FLO FATHOM Kit / System is intended<br>for peripheral vascular use. The FATHOM guidewire can be<br>used to selectively introduce and position the Renegade HI-<br>FLO 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. | |
| | Renegade HI-FLO Microcatheter and Kit: | |
| | The Renegade HI-FLO Microcatheter is intended for<br>peripheral vascular use. The microcatheter can be coaxially<br>tracked over a steerable guidewire in order to access distal,<br>tortuous vasculature. Once the subselective region has<br>been accessed, the microcatheter can be used for the<br>controlled and selective infusion of diagnostic, embolic, or<br>therapeutic materials into vessels. Diagnostic, embolic, or<br>therapeutic agents to be used in accordance with<br>specifications outlined by the manufacturer. | |
| Comparison of<br>Technological<br>Characteristics | The Renegade HI-FLO Microcatheters are similar in<br>fundamental design, function, device materials, packaging,<br>sterilization, operating principle, intended use / indication for<br>use and fundamental technology as the predicate devices.<br>The modification from the predicate device included a<br>change to the braided shaft material. | |

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## Non-Clinical Performance Data

The following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device. The Renegade HI-FLO Microcatheters met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing.

- Static Burst Pressure .
- Dynamic Burst Test (Infusion Pressure) .
- Catheter Distal Joint Tensile Strength .
- Hub to Shaft Tensile Strength .
- . Kink Radius of Curvature
- Distal OD Reduction .
- Distal Tip Flexibility .
- Proximal Shaft Stiffness .
- . Radiopacity

Clinical Performance Data

Conclusion

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

Boston Scientific has demonstrated that the modification made to the Renegade HI-FLO Microcatheters are substantially equivalent in fundamental design, technology, function, device materials, packaging, sterilization, operating principle, and intended use / indication for use as the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and is smaller than the eagle symbol.

Public Health Service

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

May 15, 2014

Boston Scientific Corporation Mr. Mark Murphy Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311

Re: K140329

> Trade/Device Name: Renegade HI-FLO Microcatheter, Renegade HI-FLO Microcatheter Kit, Renegade HI-FLO FATHOM System, Renegade HI-FLO FATHOM Kit

Regulation Number: 21 CFR 870.1210

Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: April 14, 2014 Received: April 15, 2014

Dear Mr. Murphy,

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 that + 27 theol 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

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Page 2 - Mr. Mark Murphy

Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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 yours

for 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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## K140329

Special 510(k) Premarket Notification Renegade HI-FLO Microcatheters

## Indications for Use

510(k) Number (if known): K140329

| Device Name | Indication For Use |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Renegade HI-FLO FATHOM Kit | The Renegade HI-FLO FATHOM Kit / System is intended for<br>peripheral 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 microcatheter can<br>be used for controlled and selective infusion of diagnostic, embolic,<br>or therapeutic materials into vessels. |
| Renegade HI-FLO FATHOM<br>System | be used for controlled and selective infusion of diagnostic, embolic,<br>or therapeutic materials into vessels. |
| Renegade HI-FLO Microcatheter | The Renegade HI-FLO Microcatheter is intended for peripheral<br>vascular use. The microcatheter can be coaxially tracked over a<br>steerable guidewire in order to access distal, tortuous vasculature.<br>Once the subselective region has been accessed, the microcatheter<br>can be used for the controlled and selective infusion of diagnostic,<br>embolic, or therapeutic materials into vessels. Diagnostic, embolic, or<br>therapeutic agents to be used in accordance with specifications<br>outlined by the manufacturer. |
| Renegade HI-FLO Kit | |

Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)

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

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

Concurrence of Center for Devices and Radiological Health (CDRH)

Ke

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