(27 days)
Not Found
No
The device description focuses on the physical characteristics and intended use of a microcatheter and guidewire system for peripheral vascular procedures. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is a microcatheter intended for the delivery of other materials (diagnostic, embolic, or therapeutic) into the vessel, rather than being a therapeutic device itself.
Yes
The "Intended Use / Indications for Use" section states that "The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel," explicitly mentioning diagnostic materials.
No
The device description clearly details physical components such as catheters, guidewires, coatings, markers, and adapters, indicating it is a hardware medical device.
Based on the provided text, 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 "selectively introduce and position the microcatheter in the peripheral vasculature" and "controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel." This describes a device used within the body for interventional procedures.
- Device Description: The description details a microcatheter, guidewires, and accessories used for navigating blood vessels.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided text does not mention any testing of samples or analysis of biological materials.
The device described is an interventional medical device used for accessing and treating conditions within the peripheral vasculature.
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 (comma separated list FDA assigned to the subject device)
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
§ 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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Spetember 10, 2014
Boston Scientific Corp. % Mark Lanz Principal of Regulatory Affairs One Scimed Place Maple Grove, MN 55311
Re: K142259
Trade/Device Name: Direxion Torqueable Microcatheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: August 13, 2014 Received: August 14, 2014
Dear Mr. Lanz,
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
1
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 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 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
2
| Form Approved: OMB No. 0910-0120 | |
|---|---|
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| 510(k) Number (if known) | K142259 |
|---|---|
| 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) |
|---|---|
| ------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
| FORM FDA 3881 (1/14) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 | EF |
|---|---|---|---|
| ---------------------- | ------------- | ---------------------------------------- | ---- |
3
510(k) Summary
Per 21 CFR §807.92
| Submitter's Name and
Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311
USA |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Contact Name and
Information | Mark Lanz
Principal of Regulatory Affairs
Phone: 763-494-2895
Fax: 763-494-2222
Email: mark.lanz@bsci.com |
| Date Prepared | August 13, 2014 |
| 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 21 CFR 870.1210
Continuous Flush Catheters
Product Code: KRA
Classification Panel: Cardiovascular |
| Predicate Device | Boston Scientific Direxion and Direxion HI-FLO Torqueable
Microcatheters (K132947, KRA, October 18, 2013) |
4
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
- 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, guidewire introducer and torque device.
5
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. The change to the Direxion Microcatheter increasing the flexibility of the proximal shaft by adding additional slots to the nitinol shaft which improves kink resistance.
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 met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing.
- Hub / Shaft Tensile Strength
- Proximal Shaft Pushability ●
- System Removal from Carrier Tube ●
- . Kink Resistance
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.