DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS

K132947 · Boston Scientific Corp · KRA · Oct 18, 2013 · Cardiovascular

Device Facts

• Record ID: K132947
• Device Name: DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS
• Applicant: Boston Scientific Corp
• Product Code: KRA · Cardiovascular
• Decision Date: Oct 18, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Direxion and Direxion HI-FLO Torqueable Microcatheters are intended for peripheral vascular use. The pre-loaded Fathom and Transend Guidewires can be used to selectively introduce and position the microcatheter in the peripheral vasculature. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.

Device Story

Direxion and Direxion HI-FLO Torqueable Microcatheters are peripheral vascular catheters designed for selective infusion of diagnostic, embolic, or therapeutic materials. Devices feature hydrophilic-coated distal shafts, radiopaque markers for fluoroscopic visualization, and steam-shapeable distal tips. Available in small (2.5F-2.7F) and large (2.9F-3F) lumen configurations to accommodate steerable guidewires (Fathom-16, Transend 14/18). Operated by physicians in clinical settings under fluoroscopic guidance. Pre-loaded guidewire configurations facilitate navigation through distal, tortuous vasculature. Output is the delivery of therapeutic or diagnostic agents to specific vessel sites. Benefits include improved pushability, steerability, and torqueability for accessing challenging anatomy.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included microcatheter luer compatibility, ID/OD verification, coating integrity, particulate evaluation, tensile strength, corrosion resistance, kink resistance, distal tip flexibility, proximal shaft pushability, torsional strength, maximum infusion pressure, leakage testing, embolic/PVA compatibility, chemical compatibility, guide catheter/guidewire/accessory compatibility, shelf life, packaging, sterilization, and biocompatibility.

Technological Characteristics

Peripheral vascular microcatheters with hydrophilic coating and radiopaque distal markers. Available in small (2.5F-2.7F) and large (2.9F-3F) lumen sizes. Steam-shapeable distal tips. Proximal end features standard luer with rotating hemostatic valve or Y-adapter. Materials and sterilization methods are consistent with predicate. No software or electronic components.

Indications for Use

Indicated for peripheral vascular use in patients requiring selective infusion of diagnostic, embolic, or therapeutic materials. Used for navigation and positioning within the peripheral vasculature.

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 Microcatheter (K100892)

Reference Devices

• Fathom-16 Steerable Guidewire (K111485)
• Transend 14 Steerable Guidewire (K971254)
• Transend 18 Steerable Guidewire (K964611)

Submission Summary (Full Text)

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## 510(k) Summary

Per 21 CFR §807.92

#### Submitter's Name and Address

Contact Name and Information

Boston Scientific Corporation One Scimed Place Maple Grove, MN 55311 USA

Maureen Sundeen Principal of Regulatory Affairs 763-494-2903 Phone: [phone] Fax: Email: [e-mail]

Date Prepared

Common Name

Classification

Predicate Device

Proprietary Name

September 18, 2013

Single Product Configurations Direxion™ Torqueable Microcatheter

Direxion™ HI-FLO™ Torqueable Microcatheter

Preloaded Guidewire System Configurations Direxion™ Fathom™-16 System Pre-Loaded Torqueable Microcatheter

Direxion™ Transend™-14 System Pre-Loaded Torqueable Microcatheter

Direxion™ HI-FLO™ Fathom™-16 System Pre-Loaded Torqueable Microcatheter

Direxion™ HI-FLO™ Transend™-18 System Pre-Loaded Torqueable Microcatheter

Continuous Flush Catheters

Class II per 21 CFR 870.1210 Product Code: KRA Classification Panel: Cardiovascular

Boston Scientific Renegade HI-FLO Microcatheter (K100892, KRA, April 12, 2010)

OCT 1 8 2013

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#### Intended Use / Indications for Use

The Direxion and Direxion HI-FLO Torqueable Microcatheters are intended for peripheral vascular use. The pre-loaded Fathom and Transend Guidewires can be used to selectively introduce and position the microcatheter in the peripheral vasculature. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.

#### Device Description

The Direxion Microcatheter is available in small and large lumens. The Direxion Torqueable Microcatheter (Direxion) is a small lumen microcatheter with a distal outside diameter of 2.5F (0.85 mm), and a maximum outside diameter of 2.7F (0.95 mm). It has an inside diameter of 0.021 in (0.5 mm) minimally in the proximal and distal regions. The microcatheter lumen is able to accommodate steerable guidewires with diameters ≤ 0.018 in (0.47 mm).

The Direxion HI-FLO Torqueable Microcatheter (Direxion HI-FLO) is a large lumen microcatheter with a distal outside diameter of 2.9F (1.00 mm), and a maximum outside diameter of 3F (1.05 mm). It has an inside diameter of 0.027 in (0.6 mm) minimally in the proximal and distal regions. The microcatheter lumen is able to accommodate steerable guidewires with diameters ≤ 0.021 in (0.53 mm).

The Direxion and Direxion HI-FLO Microcatheters are available in a variety of tip shapes (Straight, Bern, Swan Neck, and J Shape) to aid with accessing challenging anatomy. The distal outer surface of the microcatheter is coated with a hydrophilic coating. A radiopaque marker is located at the distal tip to facilitate fluoroscopic visualization. Some Direxion Microcatheters have a second marker 3 cm proximal to the first marker. The distal tip of the microcatheter is steam shapeable. The proximal end incorporates a standard luer with rotating hemostatic valve (RHV) or Y-adapter.

The Direxion and Direxion HI-FLO Microcatheters are available with the following preloaded guidewires:

#### Fathom-16 Steerable Guidewire (K111485)

- 0.016 in (0.41 mm) diameter; 140 or 180 cm lengths

#### Transend 14/18 Steerable Guidewires (K971254 / K964611)

- 0.014 in (0.37 mm) or 0.018 in (0.47 mm) diameters; 135, 165 or 190 cm lengths

The guidewires have a hydrophilic coating to provide lubricity, which aids in the navigation of distal, tortuous vasculature. The guidewires are radiopaque to allow for visualization under fluoroscopy and the tips are shapeable.

Accessories may include a RHV or Y-adapter, steam shaping mandrel, microcatheter introducer, quidewire introducer and torque device.

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#### Comparison of Technological Characteristics

The Direxion and Direxion HI-FLO Torqueable Microcatheters are similar in fundamental design, function, device materials, packaging, sterilization, operating principle, intended use / indication for use and fundamental technology as the predicate device, Renegade HI-FLO Microcatheter. The modifications from the predicate device include changes to catheter design and materials for added pushability, steerability, and torqueability in accessing the treatment site. In addition the microcatheters are provided with preloaded guidewires for physician convenience. A minor change was made to the packaging design to accommodate the preloaded guidewires.

#### Performance Data

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

- Microcatheter Luer Compatibility �
- Microcatheter ID / OD Verification .
- Catheter Usable Length .
- . Microcatheter Coating Integrity
- Particulate Evaluation ●
- Tensile Strength .
- Corrosion Resistance .
- Kink Resistance o
- Distal Tip Flexibility ●
- Proximal Shaft Pushability .
- Torsional Strength .
- Maximum Infusion Pressure o
- . Freedom from Liquid Leakage
- Embolic Coil Compatibility .
- PVA Particle and Embolic Sphere o Compatibility
- Chemical Compatibility .
- . Guide Catheter Compatibility
- Guidewire Compatibility .
- Torque Device Compatibility .
- Y-Adapter / RHV Compatibility .
- Shelf Life .
- Packaging Testing .
- Sterilization .
- Biocompatibility .

#### Conclusion

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

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

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

October 18, 2013

Boston Scientific Corporation Ms. Maureen Sundeen Principal of Regulatory Affairs One Scimed Place Maple Grove, MN 55311

Re: K132947

Trade/Device Name: Direxion™ Torqueable Microcatheter and Direxion™ HI-FLO™

Torqueable Microcatheter

Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheters Regulatory Class: II Product Code: KRA Dated: September 18, 2013 Received: September 19, 2013

Dear Ms. Sundeen:

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Maureen Sundeen

forth in the quality systems (OS) 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" (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.

ﮧ ، ، ،

Sincerely vours.

# Bram D. Zockerman -S

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

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Special 510(k) Premarket Notification Direxion Microcatheters

### Indications for Use

510(k) Number (if known):

#### Device Name:

Direxion™ Torqueable Microcatheter Direxion™ HI-FLO™ Torqueable Microcatheter Direxion ™ Fathom ™ - 16 System Pre-Loaded Torqueable Microcatheter Direxion™ Transend™-14 System Pre-Loaded Torqueable Microcatheter Direxion™ HI-FLO™ Fathom™-16 System Pre-Loaded Torqueable Microcatheter Direxion™ HI-FLO™ Transend™-18 System Pre-Loaded Torqueable Microcatheter

#### Indications for Use:

The Direxion and Direxion HI-FLO Torqueable Microcatheters are intended for peripheral vascular use. The pre-loaded Fathom and Transend Guidewires can be used to selectively introduce and position the microcatheter in the peripheral vasculature. The microcatheter can be used for controlled and selective infusion of diagnostic, or therapeutic materials into the vessel.

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 Center for Devices and Radiological Health (CDRH)

Bram D. Zucker 2013.10.18 14

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