The VIA™ Microcatheter is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media), or therapeutic agents into the neuro, peripheral and coronary vasculature.

Device Description

The VIA™ Microcatheter and VIA™ PLUS Microcatheter are designed to be introduced over a stcerable guidewire into the vasculature. The physician inserts the catheter into the vein or artery through the skin (percutaneous) using a sheath or guidewire. The device can then be navigated to the treatment site. Navigation is aided by the coated surface of the catheter which assists with manipulation while in the vasculature. Throughout the procedure the physician can obtain the position of the catheter by the tip marker using fluoroscopic techniques. Interventional devices and infusion of diagnostic and therapeutic agents can be delivered through the lumen of the catheter to the treatment site.

The VIA™ Microcatheter is a sterile single lumen device with a single distal tip marker designed to aid the physician in accessing distal vasculature when used with a guide catheter and steerable guidewire. Variable shaft stiffness ranging from a flexible tip to a semi-rigid proximal section aid the physician in tracking over selectively placed guidewires. The proximal end of the catheter incorporates a standard luer adapter to facilitate attachment of accessories. A single radiopaque marker positioned at the distal tip facilitates fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating which reduces friction during manipulation in the vessel. The inner lumen of the catheter has a PTFE liner which assists with delivery of interventional devices, such as an intraluminal flow diverter.

The VIA™ and VIA™ PLUS Microcatheter are available in effective lengths of 154 cm and 133 cm and inner diameters of 0.27 inches and 0.33 inches, respectively. For commercialization purposes the 0.027 inch diameter will be named the VIA™ Microcatheter and the 0.033 inch diameter will be named the VIA™ PLUS Microcatheter.

The VIA™ Microcatheter is presented in a tyvek pouch and is sterile, single-use only and nonpvrogenic.

Accessories: Each VIA™ Microcatheter is provided with a shaping mandrel to facilitate distal tip shaping.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the VIA™ Microcatheter based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Methodology	Applicable International Standard and/or Sequent Test Method (TM)	Acceptance Criteria	Reported Device Performance	Conclusion
Visual and Dimensional	Tests conformance to specified microcatheter dimensions and visual criteria.	ISO 10555-1:2009	Conformance to specified dimensions and visual criteria	Met performance specifications per standard and test method	Complete conformance to standard
Kink Resistance	Measures diameter at which microcatheter shaft sections and junctions will kink.	BS EN 13868:2002	Not explicitly stated (implied by "Met performance specifications")	Met performance specifications per standard and test method	Conformance to standard with the following deviations:Kink diameter determined based on mechanical kink (drop in compressive force) instead of 50% reduction in water flow. This method is appropriate as the Via is primarily used to deliver non-liquid devices.
Tip Buckling	Tests force required for tip to buckle.	Internal test method	Not explicitly stated (implied by "Met performance specifications")	Met performance specifications per test method	Complete conformance to Sequent TM
Tracking Force	Tests force required to advance an interventional device through the microcatheter lumen.	Internal test method	Not explicitly stated (implied by "Met performance specifications")	Met performance specifications per test method	Complete conformance to Sequent TM
Steam Shaping and Shape Retention	Tests that microcatheter can be steam shaped to a clinically relevant angle and can maintain a minimum % of the initial angle after simulated use.	Internal test method	Clinically relevant angle maintained, minimum % of initial angle retained	Met performance specifications per test method	Complete conformance to Sequent TM
Shaft Tensile	Measures the ultimate tensile strength of all Pebax and Vestamid junctions along the length of the catheter shaft.	ISO 10555-1:2009	Not explicitly stated (implied by "Met performance specifications")	Met performance specifications per standard and test method	Complete conformance to standard
Hub-Shaft Tensile	Measures the ultimate tensile strength of the hub to shaft junction	ISO 10555-1:2009	Not explicitly stated (implied by "Met performance specifications")	Met performance specifications per standard and test method	Complete conformance to standard
Burst	Measures peak pressure before microcatheter burst/liquid leakage.	ISO 10555-1:2009	Not explicitly stated (implied by "Met performance specifications")	Met performance specifications per standard and test method	Complete conformance to standard
Coating Friction and Coating Integrity	Measures the average peak coating friction/lubricity. Coating integrity uses dye to test that coating remains adhered to catheter after simulated use.	Harland Medical Systems Coating Friction and Dye Test Methods FDA Guidance Document, Class II Special Controls for PTCA Catheters (section 12) (Issued 2010)	Not explicitly stated (implied by "Met performance specifications")	Met performance specifications per standard and test method	Complete conformance to supplier test methods. In line with FDA guidance document on coating integrity.
Coating Adherence/Particulate	Measures particulate generated from the hydrophilic coating on exterior of microcatheter, as well as particulate generated from advancing an interventional device through the inner lumen of the microcatheter.	Internal test method FDA Guidance Document, Non-Clinical Engineering Tests for Intravascular Stents and Associated Delivery Systems (section 12) (Issued 2010) FDA Guidance Document, Class II Special Controls for PTCA Catheters (section 13) (Issued 2010)	Not explicitly stated (implied by "Met performance specifications")	Met performance specifications per standard and test method	Complete conformance to Sequent TM. In line with FDA guidance documents on particulate testing.
Hub Performance	Tests hub liquid and air leakage, as well as that the hub can withstand adequate forces. Tests that the hub meets general requirements for conical fittings.	ISO 594-1:1986 ISO 594-2:1998 Internal test method	Not explicitly stated (implied by "Met performance specifications")	Met performance specifications per standard and test method	Conformance to standard with the following deviations:Used an alternative ISO 594-2:1998 fitting to test hubs for Separation Force and Unscrewing Torque. The fitting used was measured to have a minor diameter greater than called for in the standard. This was deemed as worst case for these tests, therefore acceptable to use.Only short term stress cracking was inspected for on hubs. ISO 594-2:1998 calls for inspection after 48 hours. Intended use of Via microcatheter only requires RHV or syringes to be connected for short durations during delivery of implant, therefore long term testing is not applicable.

2. Sample Size Used for the Test Set and Data Provenance

The provided text only mentions "bench tests performed" and "simulated use testing in animals." It does not specify the sample size for the test set (number of catheters tested for each bench test) or the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This device is a microcatheter, and the evaluation relies on physical and functional bench testing, and simulated animal use, not on human interpretation of images or data requiring expert consensus or ground truth in the typical clinical AI context.

4. Adjudication Method for the Test Set

Not applicable, for the same reasons as #3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

No MRMC study was done. This is a medical device (microcatheter), not an AI algorithm for diagnostic interpretation. The evaluation focuses on the device's physical and functional performance, not on improving human reader performance.

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

This question is not applicable to a physical medical device like a microcatheter. The "standalone" performance here relates to the microcatheter's ability to perform its intended functions (e.g., track, burst pressure, kink resistance) as per its design specifications. The performance data presented in the table represents the standalone performance of the device against predefined technical specifications and standards.

7. The Type of Ground Truth Used

The ground truth for the performance testing is based on:

International Standards: ISO 10555-1:2009, BS EN 13868:2002, ISO 594-1:1986, ISO 594-2:1998.
FDA Guidance Documents: Class II Special Controls for PTCA Catheters (sections 12 & 13) and Non-Clinical Engineering Tests for Intravascular Stents and Associated Delivery Systems (section 12).
Supplier Test Methods: Harland Medical Systems Coating Friction and Dye Test Methods.
Sequent Medical Internal Test Methods (Sequent TM): For tests like Tip Buckling, Tracking Force, Steam Shaping and Shape Retention, Coating Adherence/Particulate, and Hub Performance.

Essentially, the "ground truth" is defined by the technical specifications, performance limits, and methodologies outlined in these various standards and internal protocols.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The term "training set" is relevant for AI models, not for traditional medical devices undergoing bench and simulated use testing.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

Summary

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DEC 2 0 2013

Section 5.

510(K) Summary

5. 510(K) SUMMARY

K13265Z

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92(c).

DATE PREPARED	11/15/2013
APPLICANT	Sequent Medical, Inc.11A ColumbiaAliso Viejo, CA 92656Tel: (949) 830-9600Fax: (949) 830-9658
OFFICIALCORRESPONDENT	Melanie Parravi11A ColumbiaAliso Viejo. CA 92656melaniep@sequentmedical.comTel: (949) 830-9600 x 130Fax: (949) 830-9568
TRADE NAME	VIATM Microcatheter
COMMON NAME	Continuous Flush catheter
DEVICECLASSIFICATION	Class II, 21 CFR §870.1210
PRODUCT CODES	DQY: Percutaneous CatheterKRA: Continuous Flush Catheter
PREDICATEDEVICES	Marksman Catheter (K091559)Excelsior XT-27 Microcatheter (K113778)
PRIOR SUBMISSION	There has been a prior submission for the subject deviceand approval was obtained under K123477 forperipheral and coronary indications
PURPOSE OFSUBMISSION	The purpose of this submission is to gain marketingclearance for an expansion of the Indications for Use toinclude use of the VIATM and VIATM PLUSMicrocatheters in the neuro vasculature. The submissionalso requests clearance to extend the shelf life from 6months to 1 year.

SUBSTANTIALLY EQUIVALENT TO:

The VIATM Microcatheter is substantially equivalent to the previously cleared Marksman™ Catheter (K091559), Excelsior XT-27 Microcatheter (K113778) and VIA™ Microcatheter (K123477).

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DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The VIA™ Microcatheter is presented in a tyvek pouch and is sterile, single-use only and nonpvrogenic.

Accessories: Each VIA™ Microcatheter is provided with a shaping mandrel to facilitate distal tip shaping.

INDICATIONS FOR USE:

The VIA™ Microcatheter is intended for the introduction of non-liguid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media), or therapeutic agents into the neuro, peripheral and coronary vasculature.

TECHNICAL CHARACTERISTICS:

The VIA™ Microcatheter incorporates variable shaft stiffness ranging from a flexible tip to a semi-rigid proximal section aid the physician in tracking over a selectively-placed guidewire. The inner lumen incorporates a PTFE liner to facilitate movement of devices through the catheter's lumen to the intended destination in the vasculature. The outer surface of the catheter is coated with a hydrophilic coating which reduces friction during manipulation in the vessel. The tip of the catheter can be steam-shaped by physician for proper adjustment to the anatomy prior to use.

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PERFORMANCE DATA:

Device performance testing confirms that the VIA™ Microcatheter can be used according to its intended use. The VIA™ Microcatheter has been verified and validated according to Sequent Medical's procedures for product design and development. Performance testing included:

Bench Testing .
. Sterilization Validation
Packaging and Shelf Life Testing .
Biocompatibility and Chemical Testing .
. Simulated Use Testing in Animals

This testing regime demonstrates that the subject device is substantially equivalent to the legally marketed predicate device (s) for its intended use in the introduction of non-liquid interventional devices, infusion of diagnostic and therapeutic agents into the neuro, coronary, and peripheral vasculature.

The information provided by Sequent Medical in this 510(k) application was found to be substantially equivalent to all the predicate devices, including the Marksman™ Catheter (K091559), the Excelsior XT-27 Microcatheter (K113778) and the VIA™ Microcatheter (K123477)

NONCLINICAL TESTS DISCUSSION:

The nonclinical tests included:

Physical characteristics unique to the VIA Microcatheter, such as visual and dimensional . tolerances, kink resistance, and catheter tip shape retention
Safety features such as burst pressure, tensile force, and coating adhesion .
. Functional characteristics such as navigation and track force in a worst-case model that incorporates two 360 degree loops, as well as interventional device retraction and catheter flow rate.

The following table lists the bench tests performed, the methodology/purpose of the test, the associated international standard (if applicable), and final results.

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SECTION 5.

510(K) Summar

Test	Methodology	Applicable International Standard and/or Sequent Test Method (TM)	Result	Conclusion
Visual and Dimensional	Tests conformance to specified microcatheter dimensions and visual criteria.	ISO 10555-1:2009	Met performance specifications per standard and test method	Complete conformance to standard
Kink Resistance	Measures diameter at which microcatheter shaft sections and junctions will kink.	BS EN 13868:2002	Met performance specifications per standard and test method	Conformance to standard with the following deviations:Kink diameter determined based on mechanical kink (drop in compressive force) instead of 50% reduction in water flow. This method is appropriate as the Via is primarily used to deliver non-liquid devices.
Tip Buckling	Tests force required for tip to buckle.	Internal test method	Met performance specifications per test method	Complete conformance to Sequent TM
Tracking Force	Tests force required to advance an interventional device through the microcatheter lumen.	Internal test method	Met performance specifications per test method	Complete conformance to Sequent TM
Steam Shaping and Shape Retention	Tests that microcatheter can be steam shaped to a clinically relevant angle and can maintain a minimum % of the initial angle after simulated use.	Internal test method	Met performance specifications per test method	Complete conformance to Sequent TM
Shaft Tensile	Measures the ultimate tensile strength of all Pebax and Vestamid junctions along the length of the catheter shaft.	ISO 10555-1:2009	Met performance specifications per standard and test method	Complete conformance to standard
Hub-Shaft Tensile	Measures the ultimate tensile strength of the hub to shaft junction	ISO 10555-1:2009	Met performance specifications per standard and test method	Complete conformance to standard
Test	Methodology	ApplicableInternationalStandard and/orSequent TestMethod (TM)	Result	Conclusion
Burst	Measures peak pressurebefore microcatheterburst/liquid leakage.	ISO 10555-1:2009	Met performancespecifications perstandard and testmethod	Complete conformance to standard
Coating Frictionand CoatingIntegrity	Measures the average peakcoating friction/lubricity.	Harland MedicalSystems CoatingFriction and DyeTest Methods	Met performancespecifications perstandard and testmethod	Complete conformance to supplier test methods
	Coating integrity uses dye totest that coating remainsadhered to catheter aftersimulated use.	FDA GuidanceDocument, Class IISpecial Controlsfor PTCA Catheters(section 12) (Issued2010)	Met performancespecifications perstandard and testmethod	In line with FDA guidance document on coating integrity
CoatingAdherence/Particulate	Measures particulategenerated from thehydrophilic coating onexterior of microcatheter, aswell as particulate generatedfrom advancing aninterventional devicethrough the inner lumen ofthe microcatheter.	Internal test methodFDA GuidanceDocument, Non-ClinicalEngineering Testsfor IntravascularStents andAssociatedDelivery Systems(section 12) (Issued2010)FDA GuidanceDocument, Class IISpecial Controls	Met performancespecifications perstandard and testmethod	Complete conformance to Sequent TMIn line with FDA guidance documents on particulatetesting
Test	Methodology	ApplicableInternationalStandard and/orSequent TestMethod (TM)	Result	Conclusion
Hub Performance	Tests hub liquid and airleakage, as well as that thehub can withstand adequateforces. Tests that the hubmeets general requirementsfor conical fittings.	for PTCA Catheters(section 13) (Issued2010)ISO 594-1:1986ISO 594-2:1998Internal test method	Met performancespecifications perstandard and testmethod	Conformance to standard with the following deviations:Used an alternative ISO 594-2:1998 fitting to test hubsfor Separation Force and Unscrewing Torque. The fittingused was measured to have a minor diameter greater thancalled for in the standard. This was deemed as worst casefor these tests, therefore acceptable to use.Only short term stress cracking was inspected for onhubs. ISO 594-2:1998 calls for inspection after 48 hours.Intended use of Via microcatheter only requires RHV orsyringes to be connected for short durations duringdelivery of implant, therefore long term testing is notapplicable.

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SECTION 5.

510(K) Summary

Page 5 of 7

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Section 5.

510(K) Summar

Page 6 of 7

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Nonclinical testing demonstrated that the VIA™ and VIA™ PLUS Microcatheter can perform as intended, and demonstrated substantial equivalence to the predicate devices: Marksman™ Catheter (K091559), Excelsior XT-27 Microcatheter (K113778) and VIA™ Microcatheter (K123477).

BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

A technological comparison, bench testing, and simulated use testing demonstrate the substantial equivalence of the VIA™ Microcatheter to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 20, 2013

Sequent Medical, Inc. Ms. Melanie Parravi, Vice President Quality Assurance and Regulatory Compliance 11A Columbia Aliso Viejo, CA 92656

Re: K132652

Trade/Device Name: VIA and VIA PLUS Microcatheters Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA, DQY Dated: September 23, 2013 Received: September 24, 2013

Dear Ms. Parravi:

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

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Page 2 – Ms. Melanie Parravi

CFR Part 807); labeling (21 CFR Part 801); medical device 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.

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.

Sincerely yours,

Joyce M. Whang -S

Carlos L. Peña, Ph.D. for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K132652

Device Name: VIA and VIA PLUS Microcatheter

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Joyce M. Whang -S

Page 1 of 1

Regulation Number and Section

§ 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).