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 Description

The TruePath CTO Device is a sterile, disposable, steerable, 0.018" OD Guidewire with an Active Tip for penetrating chronic total occlusions and is used with a sterile, disposable battery-operated Control Unit during a single patient procedure. The TruePath CTO system consists of the TruePath CTO Device, Control Unit, Shaping Tool, and the TruePath Extension Wire.
The TruePath CTO Device consists of a distal 0.018"guidewire assembly and a Motor Housing with a Connector Cable to the Control Unit. The TruePath CTO Device has a 165 cm working length with a hydrophilic coating. The distal tip is shapeable and the cone shaped portion is 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 the driveshaft, located within the stationary hollow outer shaft. The active tip at the most distal end of the guidewire assembly rotates at approximately 13,000 RPMs under no load conditions. In active mode the TruePath guidewire assembly creates a pathway through the lesion via mechanical rotation. In the passive mode the guidewire assembly functions as guidewire.
The shaping tool is an accessory provided with the TruePath CTO Device to shape the tip if desired. The TruePath Extension Wire can be attached to the TruePath guidewire assembly to create an extended guidewire that can be used to exchange a catheter without moving the TruePath CTO Device from the artery.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the TruePath™ CTO Device. The submission focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and performance data from bench testing.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in quantitative terms (e.g., minimum pass rates, specific thresholds). Instead, it lists the types of performance tests conducted and generally states that the "results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." It concludes that "No new safety or performance issues were raised during the testing."

Therefore, the table will reflect the types of tests performed and the qualitative outcome reported.

Acceptance Criteria (Implied)	Reported Device Performance
Bench Testing:	Satisfactory:
Effective Length	Conformance to requirements
Distal Shroud Detachment	No new safety or performance issues raised
Motor Housing Detachment
Run Life II (normal resistance)
Run Life III (increased resistance)
Baseline Motor Current

2. Sample size used for the test set and the data provenance

The document states that "Bench testing was performed" and lists several in-vitro performance tests. It does not specify the sample size for these tests. The data provenance is in-vitro (bench testing), meaning it was conducted in a lab setting, not on human subjects. There is no information regarding the country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The study described is bench testing, not a clinical study involving human assessment or ground truth established by experts in a diagnostic context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided. The study described is bench testing, which does not involve adjudication by experts in the way clinical studies often do for establishing ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There was no MRMC comparative effectiveness study done. This device is a mechanical medical device (a guidewire for CTOs), not an AI-powered diagnostic tool. Therefore, the concept of "human readers improving with AI assistance" is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a physical guidewire; there is no "algorithm" or standalone performance in the sense of an AI or software device. The bench testing evaluated the physical performance of the device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as it applies to diagnostic accuracy from expert consensus, pathology, or outcomes data is not applicable to this submission. The "ground truth" in this context refers to the defined specifications and performance requirements for the mechanical characteristics of the device, against which the bench test results were evaluated.

8. The sample size for the training set

There is no training set mentioned in the document. This device is a mechanical guidewire and its performance was evaluated through bench testing against established engineering parameters, not through a machine learning approach requiring a training set.

9. How the ground truth for the training set was established

Since there is no training set for this type of device submission, this question is not applicable.

Summary

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APR 1 6 2014

510(k) Summary

per 21 CFR §807.92

Submitter'sAddress	Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311
Contact NameandInformation	Carol TiffanySenior Regulatory Affairs SpecialistPhone: 763-494-1106Fax: 763-494-2222e-mail: carol.tiffany@bsci.com
Date Prepared	04 February 2014
ProprietaryName	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
PredicateDevice(s)	ReVascular Therapies Chronic K101599 18 January 2011Total Occlusion (RVT CTO) Device(marketed as TruePath CTO Device)
DeviceDescription	The TruePath CTO Device is a sterile, disposable, steerable, 0.018" ODGuidewire with an Active Tip for penetrating chronic total occlusions and isused with a sterile, disposable battery-operated Control Unit during a singlepatient procedure. The TruePath CTO system consists of the TruePathCTO Device, Control Unit, Shaping Tool, and the TruePath ExtensionWire.
	The TruePath CTO Device consists of a distal 0.018"guidewire assemblyand a Motor Housing with a Connector Cable to the Control Unit. TheTruePath CTO Device has a 165 cm working length with a hydrophiliccoating. The distal tip is shapeable and the cone shaped portion isdiamond coated. The distal 3 cm of the guidewire is radiopaque.
	The Control Unit, when activated, allows current to flow to the motor to turnthe driveshaft, located within the stationary hollow outer shaft. The activetip at the most distal end of the guidewire assembly rotates atapproximately 13,000 RPMs under no load conditions. In active mode theTruePath guidewire assembly creates a pathway through the lesion viamechanical rotation. In the passive mode the guidewire assemblyfunctions as guidewire.
	The shaping tool is an accessory provided with the TruePath CTO Deviceto shape the tip if desired. The TruePath Extension Wire can be attachedto the TruePath guidewire assembly to create an extended guidewire thatcan be used to exchange a catheter without moving the TruePath CTODevice from the artery.
IntendedUse/Indicationsfor Use	The TruePath CTO Device is indicated to facilitate the intra-luminalplacement of conventional guidewires beyond peripheral artery chronictotal occlusions.The device is contraindicated for use in carotid arteries.
The TruePath Extension Wire is designed to extend the TruePath CTODevice so that a catheter can be exchanged for another catheter.
Comparison ofTechnologicalCharacteristics	The TruePath CTO Device incorporates substantially equivalent devicematerials, device configuration, packaging, fundamental technology,manufacturing processes, sterilization process and intended use as thosefeatured 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.Two additional components to the motor housing.
	Materials	Same with exception of the motor housing components.
	Packaging	Same packaging materials and configuration.
	SterilizationMethod/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.
PerformanceData	Bench testing was performed to support a determination of substantialequivalence. The results of these tests provide reasonable assurance thatthe proposed device has been designed and tested to assure conformanceto the requirements for its intended use. No new safety or performanceissues were raised during the testing and, therefore, these devices may beconsidered 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 normalresistance)		Run Life III (operating atincreased 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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird-like figure, 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

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/4/Picture/12 description: The image shows the name "Kenneth J. Cavanaugh -S" in a bold, sans-serif font. The name is written in black ink on a white background. The letters are evenly spaced and the name is easy to read. There is a logo in the middle of the name.

Boston Scientific Corporation

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).