VIA 21, 27, 33 - The VIA® Microcatheter is intended for the introduction of interventional devices (such as the WEB device/stents/flow diverters) and infusion of diagnostic agents (such as contrast media) into the neuro, peripheral, and coronary vasculature.

VIA 17, 17 Preshaped 45°, 17 Preshaped 90° - The VIA® Microcatheter is intended for the introduction of interventional devices (such as coils/stents) and infusion of diagnostic agents (such as contrast media) into the neuro, peripheral, and coronary vasculature.

Device Description

The VIA® Microcatheter is a single lumen catheter designed to be introduced over a steerable 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 radiopaque marker bands using fluoroscopic techniques (VIA17 Microcatheter has 2 radiopaque marker bands. VIA 21, 27 and 33 Microcatheters have one radiopaque tip marker band). Diagnostic and interventional devices can be delivered through the lumen of the catheter to the treatment site. The proximal end of the catheter incorporates a standard luer adapter to facilitate attachment of accessories.

AI/ML Overview

The provided FDA 510(k) summary for the VIA® Microcatheter does not contain the specific information required to answer all parts of your request, as it pertains to a medical device's 510(k) clearance rather than a diagnostic AI algorithm study. This document focuses on demonstrating substantial equivalence to a predicate device through performance testing (biocompatibility and bench testing), not on a clinical effectiveness study with human readers and AI assistance.

Therefore, for aspects related to AI performance, human expert adjudication, effect size with AI assistance, and large-scale training/test sets for an AI algorithm (questions 2-9), the information is not applicable or not provided in this document.

However, I can extract the acceptance criteria and reported performance for the device itself (the VIA® Microcatheter) based on the provided bench testing data.

Acceptance Criteria and Reported Device Performance (Based on Bench Testing)

Acceptance Criteria / Test	Reported Device Performance
Visual and Dimensional Inspection	Pass
Hub ISO 80369-7	Pass
WEB Retraction	Pass
Kink Resistance	Pass
Tensile	Pass
Tip Buckling	Pass
Steam Shaping / Shape Retention	Pass
Catheter Leakage and Static Burst	Pass
Coating Friction & Durability	Pass
Coating Particulate	Pass
Tracking Force	Pass

Note: Some tests (Coating Integrity, Catheter Torque Strength, Flow Rate, Dead Space) were reported "For characterization only," implying they were not subject to specific pass/fail acceptance criteria for this submission but were measured to understand device properties.

Study Details (for the VIA® Microcatheter, not an AI study)

A table of acceptance criteria and the reported device performance:
- See table above.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document does not specify exact sample sizes for each bench test. For biocompatibility tests, specific numbers of animals (e.g., 17 male Hartley Guinea Pigs, 3 female New Zealand White Rabbits, 20 female Albino Swiss Mice, 2 Canine) are mentioned, but these are for biological testing, not for evaluating an AI algorithm on a medical dataset.
- Data Provenance: Not applicable for device performance bench testing in the context of AI. The tests are laboratory-based.
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 study requiring expert ground truth for medical images.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not an AI study requiring expert adjudication.
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:
- No MRMC study was done. This document outlines the premarket notification for a physical medical catheter, not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biocompatibility testing, the "ground truth" is defined by biological responses in test organisms and in vitro systems, evaluated against established ISO standards and criteria for non-toxicity, non-sensitization, non-irritation, non-hemolysis, etc.
- For bench testing, the "ground truth" is adherence to predefined engineering and functional specifications or standards (e.g., ISO 10555-1:2014, ISO80369-7:2016).
The sample size for the training set:
- Not applicable. There is no training set for an AI algorithm in this document specific to the device's performance evaluation.
How the ground truth for the training set was established:
- Not applicable. There is no AI training set.

Summary

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December 24, 2019

MicroVention, Inc. Sapna Singh Associate Director, Regulatory Affairs 35 Enterprise Aliso Viejo, California 92656

Re: K192135

Trade/Device Name: VIA® Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, KRA Dated: November 22, 2019 Received: November 25, 2019

Dear Sapna Singh:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Xiaolin Zheng, Ph.D., M.S. Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192135

Device Name VIA® Microcatheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

I. SUBMITTER

MicroVention Inc. 35 Enterprise, Aliso Viejo, CA 92656 Phone: 714-247-8162 Fax: 714-439-1044 Contact Person: Sapna Singh Date Prepared: November 22, 2019

II. DEVICE

Name of Device	VIA® Microcatheter
Common Name	Catheter, Percutaneous
Classification Name	Percutaneous Catheter (21 CFR 870.1250)Continuous Flush Catheter (21 CFR 870.1210)
Regulatory Class	Class II
Classification Product Code	DQY
Subsequent Product Code	KRA

III. PREDICATE DEVICE

VIA® Microcatheter (K150894, K132652, K162565) manufactured by Sequent Medical Inc. (SMI).

IV. REFERENCE DEVICE

Headway Microcatheter (K101542, K110813) manufactured by MicroVention Inc. (MVI) Scepter C Balloon Catheter (K110741, K121785) manufactured by MicroVention Inc. (MVI)

V. DEVICE DESCRIPTON

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lumen of the catheter to the treatment site. The proximal end of the catheter incorporates a standard luer adapter to facilitate attachment of accessories.

VI. INDICATION FOR USE

Headway Microcatheter	SMI VIA Microcatheter	MVI VIAMicrocatheter
Reference Device	Predicate Device	Subject Device
Headway 17 Advanced(K101542) Headway 27(K110813)	VIA17 (K162565) VIA21(K150894) VIA27 & 33(K132652)
Intended Use The Headway Microcatheteris intended for generalintravascular use, includingthe peripheral, coronary andneuro vasculature for theinfusion of diagnostic agents,such as contrast media, andtherapeutic agents, such asocclusion coils.	VIA21, 27, 33: The VIACatheter is intended forthe introduction ofnonliquid interventionaldevices (such asstents/flow diverters) andinfusion of diagnostic(such as contrast media)or non-liquid therapeuticagents into the neuro,peripheral, and coronaryvasculature.	VIA 21, 27, 33 - TheVIA® Microcatheter isintended for theintroduction ofinterventional devices(such as the WEBdevice/stents/flowdiverters) and infusion ofdiagnostic agents (suchas contrast media) intothe neuro, peripheral, andcoronary vasculature.
	The VIA 17 Microcatheteris intended for theintroduction of non-liquidinterventional devices(such as coils/stents) andinfusion of diagnostic agents	VIA 17, 17 Preshaped45°, 17 Preshaped 90° -The VIA® Microcatheteris intended for theintroduction ofinterventional devices(such as coils/stents) and
	infusion of diagnosticagents (such as contrastmedia) neuro, peripheral,and coronary vasculature.	(such as coils/stents)and infusion ofdiagnostic agents (suchas contrast media) intothe neuro, peripheral,and coronaryvasculature.
DeviceClassification	Class II DQY21 CFR 870.125021 CFR 870.1210	Class II DQY, KRA21 CFR 870.125021 CFR 870.1210	Class II DQY, KRA21 CFR 870.125021 CFR 870.1210
CatheterBody	Outer layer of Pebax andGrilamid; inner layer PTFE.Between outer and innerlayer is stainless steel coil.	Outer layer of Pebax andVestamid; inner layerPTFE. Between outer andinner layer is stainlesssteel braid and coil.	Same as SMI VIAMicrocatheters
Marker	Platinum/Iridium	Platinum/Iridium	Same as SMI VIAMicrocatheters
Hub	Nylon	Polypropylene	Same as SMI VIAMicrocatheters
Strain Relief	Pebax	Polyolefin	Same as SMI VIAMicrocatheters
Introducer	Pebax	Pebax	Same as HeadwayMicrocatheters
ShapingMandrel	Stainless steel	Stainless steel	Same as HeadwayMicrocatheters
Catheter size(OD Distal)	Headway 17 Advanced:0.022"Headway 27: 0.034"	VIA17: 2.2F (0.029")VIA21: 2.5F (0.033")VIA27: 3.0F (0.039")VIA33: 3.4F (0.045")	Same as SMI VIAMicrocatheters
ID
	Headway 17 Advanced:0.017"Headway 27: 0.027"	VIA17: 0.0175"VIA21: 0.021"VIA27: 0.027"VIA33: 0.033"	Same as SMI VIAMicrocatheters
		OD Proximal Headway 17 Advanced:0.031"Headway 21: 0.040"	VIA17: 0.032"VIA21: 0.036"VIA27: 0.042"VIA33: 0.050"	Same as SMI VIAMicrocatheters
		EffectiveLength	150 cm	VIA17: 154 cmVIA21: 154 cmVIA27: 154 cmVIA33: 133 cm
Coating		Hydronic Acid (HydrophilicCoating) - 100cm	Polyvinylpyrrolidone(Hydrophilic Coating) -100 cm	Same as HeadwayMicrocatheters – 100 cm
TipConfiguration	Headway 17 Advanced:Straight & PreshapedHeadway 21: Straight	Straight	VIA17: Straight &PreshapedVIA21, 27, 33: Straight
GuidewireCompatibility	Headway 17 Advanced:0.014" OD or smallerHeadway 21: 0.018" OD orsmaller	VIA17: 0.014" OD orsmallerVIA21, 27, 33: 0.018" ODor smaller	Same as SMI VIAMicrocatheters
Accessories	Introducer sheath and shapingmandrel	Shaping mandrel	Same as HeadwayMicrocatheters
Method ofSupply	Sterile and single use	Sterile and single use	Same as SMI VIA &Headway Microcatheters
SterilizationMethod	Ethylene Oxide	Ethylene Oxide	Same as SMI VIA &Headway Microcatheters
PackagingConfiguration	Catheter placed into a HDPE dispenser coil. Introducers sheath and shaping mandrel placed on a polyethylene packaging card that is attached to the dispenser coil. Dispenser coil is inserted into a Tyvek® pouch. Pouch and IFU placed in bleached sulfate carton box.	Catheter placed into a HDPE dispenser coil. Shaping mandrel placed on a polyethylene packaging card that is attached to the dispenser coil. Dispenser coil is inserted into a Tyvek® pouch. Pouch and IFU placed in bleached sulfate carton box.	Same as HeadwayMicrocatheters

VII. TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE

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PERFORMANCE DATA VIII.

Biocompatibility testing

Biocompatibility evaluation for the VIA® Microcatheter was conducted in accordance with "Use of International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The microcatheter is considered a limited (<24hour) circulating blood contacting device.

The battery of testing for the device included the following tests.

Test Performed	Extract(s) & Test Systems	Extract Conditions	Results
Cytotoxicity(ISO Medium EluateMethod (MEM)Elution Test)	Eagle's MinimalEssential Medium (E-MEM) + 5% FetalBovine Serum (FBS)L929 MouseFibroblast Cell Line	6.0 cm²/mL Extractedat 37°C/24 hrs.	Non-cytotoxicThe test article isconsidered non-cytotoxic to cells.
Sensitization (ISOGuinea PigMaximizationSensitization Test)	Normal Saline andSesame Oil ExtractsHartley Guinea Pigs(17 Male )	6.0 cm²/mL Extractedat 70°C/24 hrs.	Non-sensitizingThe test article didnot elicit asensitizationresponse.
Irritation/IntracutaneousToxicity(ISO IntracutaneousIrritation Test)	Normal Saline andSesame Oil ExtractsNew Zealand WhiteRabbits (3 Female –non-pregnant andnulliparous)	6.0 cm²/mL Extractedat 70°C/24 hrs.	Non-irritantNo evidence ofirritation.
Acute SystemicToxicity(ISO Acute SystemicInjection Test)	Normal saline andSesame Oil ExtractsAlbino Swiss Mice(20 Female – non-pregnant andnulliparous)	6.0 cm²/mL Extractedat 70°C/24 hrs.	Systemically non-toxicNo weight loss,mortality, or evidenceof systemic toxicityfrom the extractexposure to the mice.
Material-MediatedPyrogenicity	Normal SalineNew Zealand WhiteRabbits (3 Female –non- pregnant andnulliparous)	6.0 cm²/mL Extractedat 70°C/24 hrs.	Non-pyrogenicAll individual rabbitsinjected with the testarticle showed a totalrise in temperature of< 0.5 °C and weredetermined to be non-pyrogenic.
Hemocompatibility(ASTM HemolysisAssay – DirectContact and IndirectContact)	Direct Contact SolidSample Exposure toRabbit BloodSubstrate andIndirect ContactExtracted inPhosphate BufferedSaline (PBS)Blood from 3 NewZealand WhiteRabbits	Direct Contact:6.0 cm²/mL exposureto Blood Substratethen incubated at37°C for 3 hours withapproximately 60RPM agitation.Indirect Contact:6.0 cm²/mL in PBSextracted at 70°C for24 hours then extractexposed to bloodsubstrate andincubated at 37°C for3 hours withapproximately 60RPM agitation.	Non-hemolyticThere were nosignificantdifferences betweenthe test articleextract/solid andnegative controlarticle results.
Hemocompatibility(PartialThromboplastin Time(PTT) with Sponsor-Supplied ComparisonArticle)	Solid SampleExposure to HumanPlasma	6.0 cm²/mLIncubated withhuman plasma at37°C for 15 minuteswith orbital shakingat approximately 60RPM.	No adverse effect onUnactivated PartialThromboplastin Timeof human plasma.The solid test articlewas determined to becompatible withblood and not affectcoagulation.
Hemocompatibility(ISO ComplementActivation C3a andSC5b-9 Assay withSponsor-SuppliedComparison Article)	Solid Sample andNormal HumanSerum (NHS) asexposure medium	6.0 cm²/mL of NHSat 37°C for 60minutes.	C3a and SC5b-9complement proteinswere considered to benon-activated ascompared to thecomparison article.
Hemocompatibility(Platelet andLeukocyte Countswith Sponsor-SuppliedComparison Article)	Solid Sampleexposure to WholeHuman Bloodmedium	12 cm²/mL wholeblood at 37°C for 60minutes withagitation atapproximately 60RPM.	Platelet count for thetest article exposedblood are notstatisticallysignificantly differentas compared toreference control orcomparison article.
Hemocompatibility(ThromboresistanceEvaluation)	Test and Controldevice surgicallyplaced at each jugularvein of the animal.2 Canine, Cross bredhound – Female:nulliparous and non-pregnant.	Direct Exposure for 4hours.	Non-thrombogenic
Genotoxicity(ISO BacterialMutagenicity Test -Ames Assay)	Normal SalineAndDimethylsulfoxide(DMSO)Ames Assy -Salmonella.typhimurium TA97a,TA98, TA100,TA1535, and E. coliWP2 uvr A underboth non-activatedand activatedSystems	6.0 cm²/mL Extractedat 70°C/24 hrs.	Non-mutagenic
Genotoxicity(ISO In Vitro MouseLymphoma withExtended Treatment	Normal SalineAndDimethylsulfoxide(DMSO)L5178Y mouselymphoma cells	6.0 cm²/mL Extractedat 70°C/24 hrs.Extracts contact withtest system for 4hours in non-activated andactivated conditions	Non-mutagenic andnon-clastogenic
		and 24 hours in non-
		activated condition.

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The biocompatibility of the VIA® Microcatheter accessories, introducer sheath and shaping mandrel are supported by information submitted for the cleared MicroVention Headway Microcatheter (K101542, K110813) and MicroVention Scepter C Balloon Catheter (K110741, K121785) devices. The VIA accessories are identical to the accessories included in the cleared Headway and Scepter devices.

Bench testing

Bench testing conducted for the VIA® Microcatheter included the following:

Test	Test Method Summary	Results
Visual and DimensionalInspection	This method measures inner diameter, outer diameter,catheter length, coated length, tip length, distancebetween marker bands (VIA17 only), preshaped tipangle (VIA17 Preshaped only), printing on strain relief,accessories, and unbraided length.	Pass
Hub ISO 80369-7	ISO80369-7:2016 & -20:2015	Pass
WEB Retraction	The method measures the distance that the VIAcatheter pulls back during interventional devicerecapture	Pass
Kink Resistance	The method measures the diameter at which the VIAshaft sections and junctions will kink	Pass
Tensile	The method tests the tensile strength of themicrocatheter shaft sections (each joint/transition testedindividually). This method aligns with the methoddescribed in ISO 10555-1:2014.	Pass
Tip Buckling	The method measures the catheter tip buckling force bypushing the catheter tip into a load cell until it buckles.	Pass
Steam Shaping / ShapeRetention	The method measures the ability of the VIA to besteam shaped using a shaping mandrel and the abilityof the VIA to hold the shape during use.	Pass
Catheter Leakage andStatic Burst	The method measures the leakage and static burstpressure of the VIA. This method aligns with themethod described in ISO 10555-1:2014.	Pass

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Coating Friction &Durability	The method measures the catheter coatingfriction/lubricity over multiple friction test cycles usingan automated friction tester. After cycling, catheter isdyed to verify coating adherence.	Pass
Coating Particulate	The method measures the particulate generated duringsimulated navigation and adjunct device delivery perUSP <788>.	Pass
Coating Integrity	Coating integrity uses dye to test that coating remainsadhered to catheter after simulated use through atortuous model.	Forcharacterizationonly.
Catheter TorqueStrength	The method measures how many complete rotations thecatheter can withstand before breaking.	Forcharacterizationonly.
Tracking Force	The method tests the force required to passinterventional devices through the VIA catheter.	Pass
Flow Rate	The method measures the flow rate through the VIA bypushing fluid through the catheter at a constant ratewhile pressure is being monitored.	Forcharacterizationonly.
Dead Space	The non-hydrated VIA is attached to a syringe pumpand slowly filled with controlled amounts of distilledwater. Once water is observed to be exiting the raisedtip of the catheter, the volume of liquid dispensed isrecorded.	Forcharacterizationonly

Animal Study

No animal study was conducted.

CONCLUSION IX.

The VIA® Microcatheter is substantially equivalent to the identified predicate regarding performance, intended use, design, materials, principle of operation and overall technological characteristics. The nonclinical data supports the substantial equivalence of the subject device and the verification and validation testing demonstrate that the subject device should perform as intended when used as instructed in the instructions for use.

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).