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.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Direxion and Direxion HI-FLO Torqueable Microcatheters. It describes the device and claims substantial equivalence to a predicate device. However, it does not contain the kind of detailed information requested about a study to prove the device meets acceptance criteria, especially in the context of an AI/ML powered medical device.

The information provided is for a traditional medical device (microcatheter) and focuses on bench testing to demonstrate physical properties and equivalence to a predicate device, rather than performance metrics related to diagnostic or therapeutic efficacy that would typically be evaluated in an AI/ML study.

Therefore, most of the requested fields are not applicable or cannot be extracted from this document. I will fill in what can be gleaned from the text and note where information is missing or not relevant for an AI/ML study.

Here's a breakdown based on the provided text:

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

Acceptance Criteria (Bench Testing)	Reported Device Performance (Met Criteria)
Hub / Shaft Tensile Strength	Met predetermined acceptance criteria
Proximal Shaft Pushability	Met predetermined acceptance criteria
System Removal from Carrier Tube	Met predetermined acceptance criteria
Kink Resistance	Met predetermined acceptance criteria

Note: The specific qualitative or quantitative acceptance criteria for each test (e.g., "Tensile strength must be > X Newtons") are not detailed in this summary, nor are the exact measured performance values.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing described is bench testing of physical properties, not a clinical study involving patients or a test set of data points in the AI/ML sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not an AI/ML powered device, and the testing described does not involve expert adjudication of ground truth for a test set.

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

Not applicable.

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 is not an AI/ML powered device.

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

Not applicable. This is not an AI/ML powered device.

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

For the bench tests, the "ground truth" would be the engineering specifications and validated test methods (e.g., a certain force required to cause failure, or a certain degree of flex without kinking). The document states the device "met the predetermined acceptance criteria."

8. The sample size for the training set

Not applicable. This is not an AI/ML powered device.

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

Not applicable. This is not an AI/ML powered device.

Summary

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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

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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

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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.

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and review the collection of information. Send comments regarding this burden estimate or any other aspect
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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
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510(k) Summary

Per 21 CFR §807.92

Submitter's Name andAddress	Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311USA
Contact Name andInformation	Mark LanzPrincipal of Regulatory AffairsPhone: 763-494-2895Fax: 763-494-2222Email: mark.lanz@bsci.com
Date Prepared	August 13, 2014
Proprietary Name	Single Product ConfigurationsDirexion™ Torqueable Microcatheter
	Direxion™ HI-FLO™ Torqueable Microcatheter
	Preloaded Guidewire System Configurations Direxion™Fathom™-16 SystemPre-Loaded Torqueable Microcatheter
	Direxion™ Transend™-14 SystemPre-Loaded Torqueable Microcatheter
	Direxion™ HI-FLO™ Fathom™-16 SystemPre-Loaded Torqueable Microcatheter
	Direxion™ HI-FLO™ Transend™-18 SystemPre-Loaded Torqueable Microcatheter
Common Name	Continuous Flush Catheters
Classification	Class II per 21 CFR 870.1210Continuous Flush CathetersProduct Code: KRAClassification Panel: Cardiovascular
Predicate Device	Boston Scientific Direxion and Direxion HI-FLO TorqueableMicrocatheters (K132947, KRA, October 18, 2013)

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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

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

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

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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.

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).