(70 days)
No
The description focuses on mechanical rotation and a battery-operated control unit, with no mention of AI or ML capabilities.
No
The device is designed to facilitate the placement of guidewires to bypass occlusions, not to treat the underlying condition itself. Its function is mechanical-assistive for another therapeutic procedure.
No
The device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly details multiple hardware components including a guidewire, motor housing, control unit, shaping tool, and extension wire. It describes mechanical rotation and a battery-operated control unit, indicating a physical device with hardware functionality.
Based on the provided information, the TruePath CTO Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions." This describes a device used within the body for a therapeutic or interventional procedure, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details a steerable guidewire with an active tip for penetrating blockages in arteries. This is a medical device used for intervention, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used with biological samples (blood, urine, tissue, etc.), reagents, or for the purpose of providing diagnostic information about a patient's health status based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The TruePath CTO Device is clearly an interventional device used directly within the patient's vascular system.
N/A
Intended Use / Indications for 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.
Product codes
PDU
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral artery, carotid arteries (contraindicated)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Bench testing was performed to support a determination of substantial equivalence. 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. No new safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate devices.
The following in-vitro performance tests were completed:
Effective Length
Distal Shroud Detachment
Run Life II (operating at normal resistance)
Baseline Motor Current
Motor Housing Detachment
Run Life III (operating at increased resistance)
Key Metrics
Not Found
Predicate Device(s)
ReVascular Therapies Chronic K101599 Total Occlusion (RVT CTO) Device
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
APR 1 6 2014
510(k) Summary
.
per 21 CFR §807.92
| Submitter's
Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311 | | | |
|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------|--|
| Contact Name
and
Information | Carol Tiffany
Senior Regulatory Affairs Specialist
Phone: 763-494-1106
Fax: 763-494-2222
e-mail: carol.tiffany@bsci.com | | | |
| Date Prepared | 04 February 2014 | | | |
| Proprietary
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
Device(s) | ReVascular Therapies Chronic K101599 18 January 2011
Total Occlusion (RVT CTO) Device
(marketed as TruePath CTO Device) | | | |
| 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. | | | |
| Intended
Use/Indications
for 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. | | | | |
| Comparison of
Technological
Characteristics | The TruePath CTO Device incorporates substantially equivalent device
materials, device configuration, packaging, fundamental technology,
manufacturing processes, sterilization process and intended use as those
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.
Two additional components to the motor housing. | | |
| | Materials | Same with exception of the motor housing components. | | |
| | Packaging | Same packaging materials and configuration. | | |
| | Sterilization
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
Data | Bench testing was performed to support a determination of substantial
equivalence. 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. No new safety or performance
issues were raised during the testing and, therefore, these devices may be
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
resistance) | | Run Life III (operating at
increased resistance) | |
| Conclusion | Based on the indications for use, technological characteristics, safety and | | | |
1
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.
.
:
2
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.
3
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
4
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