(138 days)
Not Found
No
The document describes a physical medical device (microcatheter and guidewires) used for delivering materials in the peripheral vasculature. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The testing described focuses on physical and performance characteristics of the device itself.
No.
This device delivers diagnostic, embolic, or therapeutic materials but is not inherently therapeutic itself.
Yes
The "Intended Use / Indications for Use" section states: "The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel." This indicates that one of its intended uses is for diagnostic material infusion.
No
The device description clearly details physical components such as catheters, guidewires, coatings, markers, and adapters, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "peripheral vascular use" and for "controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel." This describes a device used within the body for interventional procedures, not for testing samples outside the body.
- Device Description: The description details a microcatheter and guidewires, which are instruments used for accessing and navigating blood vessels. This aligns with an in-vivo device, not an in-vitro diagnostic.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device is used to deliver substances or access anatomical locations.
In-vitro diagnostics are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
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.
Product codes
KRA
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, and J) 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
-
0.016 in (0.41 mm) diameter; 140 or 180 cm lengths
Transend 14/18 Steerable Guidewires -
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device. The Direxion Microcatheters met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing.
- OD/ID Dimensional Requirements
- Guide Catheter Compatibility ●
- Microcatheter Surface Defects ●
- Microcatheter Coating Length ●
- Distal Joint Integrity ●
- RO Marker band Tensile ●
- Embolic Coil Compatibility
- Initial Tip Shape
- Packaging Mandrel Removal Force ●
- Sterile Barrier Integrity ●
- Device Containment in Packaging ●
- Microcatheter System Removal from Packaging ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1210 Continuous flush catheter.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol consisting of three stylized human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 16, 2017
Boston Scientific Corporation Ms. Liz Johnston Regulatory Affairs Specialist Three Scimed Place Maple Grove, MN 55311
Re: K163701
Trade/Device Name: Direxion and Direxion HI-FLO Torqueable Microcatheters Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: April 17, 2017 Received: April 18, 2017
Dear Ms. Johnston:
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 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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" (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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Sincerely,
Fernand Aguel - S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K163701
Device Name
Direxion and Direxion HI-FLO Torqueable Microcatheters
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K163701 510(k) Summary
Per 21 CFR 807.92
| Submitter's Name and Address | Boston Scientific Corporation
Three Scimed Place
Maple Grove, MN 55311
USA |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contract Information | Liz Johnston
Regulatory Affairs Specialist
Phone: 763-494-1676
Fax: 763-494-2222
Email: Liz.Johnston@bsci.com |
| Date Prepared | 22 December 2016 |
| Proprietary Name | 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 |
| Common Name | Continuous Flush Catheters |
| Classification | Class II per CFR 870.1210 |
| Predicate Device | Boston Scientific Direxion Microcatheters:
• K142259, KRA, September 10, 2014 |
4
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, and J) 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
- 0.016 in (0.41 mm) diameter; 140 or 180 cm lengths
Transend 14/18 Steerable Guidewires
- 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.
5
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.
Comparison of Technological Characteristics
The Direxion and Direxion HI-FLO Torqueable Microcatheters are similar in fundamental design, function, materials, packaging, sterilization, operating principle, intended use / indication for use and fundamental technology as the predicate device. Modifications were made to the coating length, pre-shaped tips (Bern, J. Swan), and packaging of the Direxion Microcatheter.
Performance Data
The following testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device. The Direxion Microcatheters met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing.
- OD/ID Dimensional Requirements
- Guide Catheter Compatibility ●
- Microcatheter Surface Defects ●
- Microcatheter Coating Length ●
- Distal Joint Integrity ●
- RO Marker band Tensile ●
- Embolic Coil Compatibility
- Initial Tip Shape
- Packaging Mandrel Removal Force ●
- Sterile Barrier Integrity ●
- Device Containment in Packaging ●
- Microcatheter System Removal from Packaging ●
Conclusion
Boston Scientific has demonstrated that the modifications to the Direxion Microcatheters are substantially equivalent in fundamental design, technology, function, materials, packaging, operating principle, and intended use / indication for use as the predicate device.