TRUEPATH CTO DEVICE

K140288 · Boston Scientific Corp · PDU · Apr 16, 2014 · Cardiovascular

Device Facts

• Record ID: K140288
• Device Name: TRUEPATH CTO DEVICE
• Applicant: Boston Scientific Corp
• Product Code: PDU · Cardiovascular
• Decision Date: Apr 16, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. The device is contraindicated for use in carotid arteries. The TruePath Extension Wire is designed to extend the TruePath CTO Device so that a catheter can be exchanged for another catheter.

Device Story

TruePath CTO Device is a sterile, disposable, steerable 0.018" OD guidewire with an active diamond-coated tip; used with a battery-operated Control Unit. System includes guidewire, Control Unit, shaping tool, and extension wire. During peripheral artery procedures, the Control Unit powers a motor to rotate the guidewire tip at ~13,000 RPMs; mechanical rotation creates a pathway through chronic total occlusions. In passive mode, it functions as a standard guidewire. The device features a 165 cm working length with a hydrophilic coating and radiopaque distal tip. Used by physicians in clinical settings to facilitate guidewire placement, allowing subsequent catheter exchange via the extension wire. Benefits include improved ability to cross challenging arterial occlusions.

Clinical Evidence

Bench testing only. In-vitro performance testing included effective length, distal shroud detachment, motor housing detachment, and run life testing under normal and increased resistance conditions. No clinical data was required or provided.

Technological Characteristics

0.018" OD steerable guidewire; diamond-coated active tip; hydrophilic coating; 165 cm working length; radiopaque distal 3 cm. Battery-operated motor unit provides mechanical rotation (~13,000 RPM). System includes shaping tool and extension wire. Sterilized device; disposable components.

Indications for Use

Indicated for facilitating intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. Contraindicated for use in carotid arteries.

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

• ReVascular Therapies Chronic Total Occlusion (RVT CTO) Device (K101599)

Submission Summary (Full Text)

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APR 1 6 2014

# 510(k) Summary

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## per 21 CFR §807.92

| Submitter's<br>Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311 | | | |
|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------|--|
| Contact Name<br>and<br>Information | Carol Tiffany<br>Senior Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] | | | |
| Date Prepared | 04 February 2014 | | | |
| Proprietary<br>Name | TruePath™ CTO Device | | | |
| Common Name | CTO Device | | | |
| Product Code | PDU - Catheter for Crossing Total Occlusions | | | |
| Classification | Class II, 21 CFR Part 870.1250 - Percutaneous Catheter | | | |
| Predicate<br>Device(s) | ReVascular Therapies Chronic K101599 18 January 2011<br>Total Occlusion (RVT CTO) Device<br>(marketed as TruePath CTO Device) | | | |
| Device<br>Description | The TruePath CTO Device is a sterile, disposable, steerable, 0.018" OD<br>Guidewire with an Active Tip for penetrating chronic total occlusions and is<br>used with a sterile, disposable battery-operated Control Unit during a single<br>patient procedure. The TruePath CTO system consists of the TruePath<br>CTO Device, Control Unit, Shaping Tool, and the TruePath Extension<br>Wire. | | | |
| | The TruePath CTO Device consists of a distal 0.018"guidewire assembly<br>and a Motor Housing with a Connector Cable to the Control Unit. The<br>TruePath CTO Device has a 165 cm working length with a hydrophilic<br>coating. The distal tip is shapeable and the cone shaped portion is<br>diamond coated. The distal 3 cm of the guidewire is radiopaque. | | | |
| | The Control Unit, when activated, allows current to flow to the motor to turn<br>the driveshaft, located within the stationary hollow outer shaft. The active<br>tip at the most distal end of the guidewire assembly rotates at<br>approximately 13,000 RPMs under no load conditions. In active mode the<br>TruePath guidewire assembly creates a pathway through the lesion via<br>mechanical rotation. In the passive mode the guidewire assembly<br>functions as guidewire. | | | |
| | The shaping tool is an accessory provided with the TruePath CTO Device<br>to shape the tip if desired. The TruePath Extension Wire can be attached<br>to the TruePath guidewire assembly to create an extended guidewire that<br>can be used to exchange a catheter without moving the TruePath CTO<br>Device from the artery. | | | |
| Intended<br>Use/Indications<br>for Use | The TruePath CTO Device is indicated to facilitate the intra-luminal<br>placement of conventional guidewires beyond peripheral artery chronic<br>total occlusions.<br>The device is contraindicated for use in carotid arteries. | | | |
| The TruePath Extension Wire is designed to extend the TruePath CTO<br>Device so that a catheter can be exchanged for another catheter. | | | | |
| Comparison of<br>Technological<br>Characteristics | The TruePath CTO Device incorporates substantially equivalent device<br>materials, device configuration, packaging, fundamental technology,<br>manufacturing processes, sterilization process and intended use as those<br>featured in the Boston Scientific predicate device. | | | |
| Comparison to Predicate Device: | | | | |
| | Characteristic | Proposed compared to Predicate | | |
| | Mechanism of Action | Same Mechanism of Action | | |
| | Components | Same components, configuration, design and function.<br>Two additional components to the motor housing. | | |
| | Materials | Same with exception of the motor housing components. | | |
| | Packaging | Same packaging materials and configuration. | | |
| | Sterilization<br>Method/SAL | Same method and level of assurance. | | |
| | Device Compatibility | Same compatibility. | | |
| | Device Dimensions | Same dimensions. | | |
| | Effective Length | Same length device. | | |
| | Radiopacity | Same radiopacity. | | |
| | Biocompatibility | Same biocompatibility. | | |
| Performance<br>Data | Bench testing was performed to support a determination of substantial<br>equivalence. The results of these tests provide reasonable assurance that<br>the proposed device has been designed and tested to assure conformance<br>to the requirements for its intended use. No new safety or performance<br>issues were raised during the testing and, therefore, these devices may be<br>considered substantially equivalent to the predicate devices. | | | |
| | The following in-vitro performance tests were completed: | | | |
| | Effective Length | | Baseline Motor Current | |
| | Distal Shroud Detachment | | Motor Housing Detachment | |
| | Run Life II (operating at normal<br>resistance) | | Run Life III (operating at<br>increased resistance) | |
| Conclusion | Based on the indications for use, technological characteristics, safety and | | | |

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Based on the indications for use, technological characteristics, safety and performance testing, the TruePath CTO Device has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the RVT (TruePath) CTO Device as submitted in K101599.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

April 16, 2014

Boston Scientific, Inc. c/o Ms. Carol Tiffany Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311

Re: K140288

Trade/Device Name: TruePath™ CTO Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU · Dated: March 18, 2014 Received: March 19, 2014

Dear Ms. Tiffany:

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 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.

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### Page 2 - Ms. Carol Tiffany

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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

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

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# Indications for Use

510(k) Number (if known): _

TruePath™ CTO Device Device Name:

Indications for Use:

The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. Contraindications: The device is contraindicated for use in carotid arteries.

The TruePath Extension Wire is designed to extend the TruePath CTO Device so that a catheter can be exchanged for another catheter.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

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### Concurrence of CDRH, Office of Device Evaluation (ODE)

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Boston Scientific Corporation