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 (K111485)

0.016 in (0.41 mm) diameter; 140 or 180 cm lengths

Transend 14/18 Steerable Guidewires (K971254 / K964611)

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for microcatheters. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical or AI-centric studies. Therefore, many of the requested categories (e.g., effect size of human readers with AI assistance, algorithm-only performance, training set size, ground truth for training set) are not applicable to this document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Microcatheter Luer Compatibility	Met predetermined acceptance criteria.
Microcatheter ID / OD Verification	Met predetermined acceptance criteria.
Catheter Usable Length	Met predetermined acceptance criteria.
Microcatheter Coating Integrity	Met predetermined acceptance criteria.
Particulate Evaluation	Met predetermined acceptance criteria.
Tensile Strength	Met predetermined acceptance criteria.
Corrosion Resistance	Met predetermined acceptance criteria.
Kink Resistance	Met predetermined acceptance criteria.
Distal Tip Flexibility	Met predetermined acceptance criteria.
Proximal Shaft Pushability	Met predetermined acceptance criteria.
Torsional Strength	Met predetermined acceptance criteria.
Maximum Infusion Pressure	Met predetermined acceptance criteria.
Freedom from Liquid Leakage	Met predetermined acceptance criteria.
Embolic Coil Compatibility	Met predetermined acceptance criteria.
PVA Particle and Embolic Sphere Compatibility	Met predetermined acceptance criteria.
Chemical Compatibility	Met predetermined acceptance criteria.
Guide Catheter Compatibility	Met predetermined acceptance criteria.
Guidewire Compatibility	Met predetermined acceptance criteria.
Torque Device Compatibility	Met predetermined acceptance criteria.
Y-Adapter / RHV Compatibility	Met predetermined acceptance criteria.
Shelf Life	Met predetermined acceptance criteria.
Packaging Testing	Met predetermined acceptance criteria.
Sterilization	Met predetermined acceptance criteria.
Biocompatibility	Met predetermined acceptance criteria.

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

The document mentions "bench testing was conducted for design elements and performance characteristics." However, it does not specify sample sizes for these tests, nor does it refer to a "test set" in the context of patient data or algorithm evaluation. Data provenance (e.g., country of origin, retrospective/prospective) is not applicable as this concerns bench testing of the physical device.

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

Not applicable. "Ground truth" in this context would refer to a benchmark for a diagnostic or AI device. This submission is for a physical medical device (microcatheter) where performance is evaluated through engineering and biocompatibility testing.

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

Not applicable. This concept belongs to studies where human experts or algorithms are evaluating data, typically for diagnostic accuracy.

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

Not applicable. This device is a microcatheter, not an AI-assisted diagnostic or treatment system.

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

Not applicable. This device is a microcatheter, not an AI algorithm.

7. The type of ground truth used

For the performance data listed, the "ground truth" is established through industry standards, engineering specifications, and validated test methods for material properties, functional performance (e.g., ID/OD dimensions, tensile strength, kink resistance, infusion pressure), compatibility, and biological safety.

8. The sample size for the training set

Not applicable. This device is a microcatheter, not an AI algorithm requiring a training set.

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

Not applicable. This device is a microcatheter, not an AI algorithm.

Summary

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K132947 p. 1 of 3

510(k) Summary

Per 21 CFR §807.92

Submitter's Name and Address

Contact Name and Information

Boston Scientific Corporation One Scimed Place Maple Grove, MN 55311 USA

Maureen Sundeen Principal of Regulatory Affairs 763-494-2903 Phone: 763-494-2222 Fax: Email: sundeenm@bsci.com

Date Prepared

Common Name

Classification

Predicate Device

Proprietary Name

September 18, 2013

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

Continuous Flush Catheters

Class II per 21 CFR 870.1210 Product Code: KRA Classification Panel: Cardiovascular

Boston Scientific Renegade HI-FLO Microcatheter (K100892, KRA, April 12, 2010)

OCT 1 8 2013

Page 1 of 3

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K132947 p. 2 of 3

Intended Use / Indications for Use

Device Description

The Direxion and Direxion HI-FLO Microcatheters are available with the following preloaded guidewires:

Fathom-16 Steerable Guidewire (K111485)

0.016 in (0.41 mm) diameter; 140 or 180 cm lengths

Transend 14/18 Steerable Guidewires (K971254 / K964611)

0.014 in (0.37 mm) or 0.018 in (0.47 mm) diameters; 135, 165 or 190 cm lengths

Accessories may include a RHV or Y-adapter, steam shaping mandrel, microcatheter introducer, quidewire introducer and torque device.

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K132947 p. 3 of 3

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, Renegade HI-FLO Microcatheter. The modifications from the predicate device include changes to catheter design and materials for added pushability, steerability, and torqueability in accessing the treatment site. In addition the microcatheters are provided with preloaded guidewires for physician convenience. A minor change was made to the packaging design to accommodate the preloaded guidewires.

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 including packaging met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing.

Microcatheter Luer Compatibility �
Microcatheter ID / OD Verification .
Catheter Usable Length .
. Microcatheter Coating Integrity
Particulate Evaluation ●
Tensile Strength .
Corrosion Resistance .
Kink Resistance o
Distal Tip Flexibility ●
Proximal Shaft Pushability .
Torsional Strength .
Maximum Infusion Pressure o
. Freedom from Liquid Leakage
Embolic Coil Compatibility .
PVA Particle and Embolic Sphere o Compatibility
Chemical Compatibility .
. Guide Catheter Compatibility
Guidewire Compatibility .
Torque Device Compatibility .
Y-Adapter / RHV Compatibility .
Shelf Life .
Packaging Testing .
Sterilization .
Biocompatibility .

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, Renegade HI-FLO Microcatheter.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, 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

October 18, 2013

Boston Scientific Corporation Ms. Maureen Sundeen Principal of Regulatory Affairs One Scimed Place Maple Grove, MN 55311

Re: K132947

Trade/Device Name: Direxion™ Torqueable Microcatheter and Direxion™ HI-FLO™

Torqueable Microcatheter

Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheters Regulatory Class: II Product Code: KRA Dated: September 18, 2013 Received: September 19, 2013

Dear Ms. Sundeen:

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

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Page 2 - Ms. Maureen Sundeen

forth in 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 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/ResourcesforYou/Industry/default.htm.

ﮧ ، ، ،

Sincerely vours.

Bram D. Zockerman -S

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Special 510(k) Premarket Notification Direxion Microcatheters

Indications for Use

510(k) Number (if known):

Device Name:

Direxion™ Torqueable Microcatheter Direxion™ HI-FLO™ Torqueable Microcatheter 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

Indications for Use:

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 Center for Devices and Radiological Health (CDRH)

Bram D. Zucker 2013.10.18 14

Page 1 of 1

Regulation Number and Section

§ 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).