VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)

K192135 · MicroVention, Inc. · DQY · Dec 24, 2019 · Cardiovascular

Device Facts

• Record ID: K192135
• Device Name: VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)
• Applicant: MicroVention, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 24, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Single-lumen percutaneous catheter; navigated over steerable guidewire to treatment site in neuro, peripheral, or coronary vasculature. Physician-operated under fluoroscopic guidance using radiopaque marker bands. Proximal luer adapter facilitates accessory attachment. Delivers interventional devices (stents, coils, flow diverters) or diagnostic agents (contrast media) through lumen. Hydrophilic coating assists navigation. Benefits patient by enabling minimally invasive delivery of therapeutic devices to target vasculature.

Clinical Evidence

Bench testing only. No clinical or animal data provided. Biocompatibility testing (ISO 10993-1) confirmed non-cytotoxic, non-sensitizing, non-irritant, non-pyrogenic, and hemocompatible. Bench performance testing included visual/dimensional inspection, ISO 80369-7 hub testing, WEB retraction, kink resistance, tensile strength, tip buckling, shape retention, leakage/burst pressure, coating friction/particulate, and tracking force.

Technological Characteristics

Single-lumen catheter; outer layer Pebax/Vestamid, inner layer PTFE, stainless steel braid/coil reinforcement. Radiopaque Platinum/Iridium marker bands. Hydrophilic coating (Hydronic Acid or PVP). Dimensions: 2.2F-3.4F OD, 0.0175"-0.033" ID. Ethylene Oxide sterilization. Single-use. Manual operation.

Indications for Use

Indicated for introduction of interventional devices (e.g., WEB device, stents, flow diverters, coils) and infusion of diagnostic agents (e.g., contrast media) into neuro, peripheral, and coronary vasculature.

Regulatory Classification

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.

Predicate Devices

• VIA® Microcatheter (K162565, K150894, K132652)

Reference Devices

• Headway Microcatheter (K101542, K110813)
• Scepter C Balloon Catheter (K110741, K121785)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------|--|
| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |
| <div> <span> <span style="border: 1px solid black;">  </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | |

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## 510(K) SUMMARY

#### I. SUBMITTER

MicroVention Inc. 35 Enterprise, Aliso Viejo, CA 92656 Phone: [phone] Fax: [phone] 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)<br>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

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

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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

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.

| Headway Microcatheter | SMI VIA Microcatheter | MVI VIA<br>Microcatheter | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------|
| Reference Device | Predicate Device | Subject Device | | |
| Headway 17 Advanced<br>(K101542) Headway 27<br>(K110813) | VIA17 (K162565) VIA21<br>(K150894) VIA27 & 33<br>(K132652) | | | |
| Intended Use The Headway Microcatheter<br>is intended for general<br>intravascular use, including<br>the peripheral, coronary and<br>neuro vasculature for the<br>infusion of diagnostic agents,<br>such as contrast media, and<br>therapeutic agents, such as<br>occlusion coils. | VIA21, 27, 33: The VIA<br>Catheter is intended for<br>the introduction of<br>nonliquid interventional<br>devices (such as<br>stents/flow diverters) and<br>infusion of diagnostic<br>(such as contrast media)<br>or non-liquid therapeutic<br>agents into the neuro,<br>peripheral, and coronary<br>vasculature. | VIA 21, 27, 33 - The<br>VIA® Microcatheter is<br>intended for the<br>introduction of<br>interventional devices<br>(such as the WEB<br>device/stents/flow<br>diverters) and infusion of<br>diagnostic agents (such<br>as contrast media) into<br>the neuro, peripheral, and<br>coronary vasculature. | | |
| | The VIA 17 Microcatheter<br>is intended for the<br>introduction of non-liquid<br>interventional devices<br>(such as coils/stents) and<br>infusion of diagnostic agents | VIA 17, 17 Preshaped<br>45°, 17 Preshaped 90° -<br>The VIA® Microcatheter<br>is intended for the<br>introduction of<br>interventional devices<br>(such as coils/stents) and | | |
| | infusion of diagnostic<br>agents (such as contrast<br>media) neuro, peripheral,<br>and coronary vasculature. | (such as coils/stents)<br>and infusion of<br>diagnostic agents (such<br>as contrast media) into<br>the neuro, peripheral,<br>and coronary<br>vasculature. | | |
| Device<br>Classification | Class II DQY<br>21 CFR 870.1250<br>21 CFR 870.1210 | Class II DQY, KRA<br>21 CFR 870.1250<br>21 CFR 870.1210 | Class II DQY, KRA<br>21 CFR 870.1250<br>21 CFR 870.1210 | |
| Catheter<br>Body | Outer layer of Pebax and<br>Grilamid; inner layer PTFE.<br>Between outer and inner<br>layer is stainless steel coil. | Outer layer of Pebax and<br>Vestamid; inner layer<br>PTFE. Between outer and<br>inner layer is stainless<br>steel braid and coil. | Same as SMI VIA<br>Microcatheters | |
| Marker | Platinum/Iridium | Platinum/Iridium | Same as SMI VIA<br>Microcatheters | |
| Hub | Nylon | Polypropylene | Same as SMI VIA<br>Microcatheters | |
| Strain Relief | Pebax | Polyolefin | Same as SMI VIA<br>Microcatheters | |
| Introducer | Pebax | Pebax | Same as Headway<br>Microcatheters | |
| Shaping<br>Mandrel | Stainless steel | Stainless steel | Same as Headway<br>Microcatheters | |
| Catheter size<br>(OD Distal) | Headway 17 Advanced:<br>0.022"<br>Headway 27: 0.034" | VIA17: 2.2F (0.029")<br>VIA21: 2.5F (0.033")<br>VIA27: 3.0F (0.039")<br>VIA33: 3.4F (0.045") | Same as SMI VIA<br>Microcatheters | |
| ID | | | | |
| | Headway 17 Advanced:<br>0.017"<br>Headway 27: 0.027" | VIA17: 0.0175"<br>VIA21: 0.021"<br>VIA27: 0.027"<br>VIA33: 0.033" | Same as SMI VIA<br>Microcatheters | |
| | | OD Proximal Headway 17 Advanced:<br>0.031"<br>Headway 21: 0.040" | VIA17: 0.032"<br>VIA21: 0.036"<br>VIA27: 0.042"<br>VIA33: 0.050" | Same as SMI VIA<br>Microcatheters |
| | | Effective<br>Length | 150 cm | VIA17: 154 cm<br>VIA21: 154 cm<br>VIA27: 154 cm<br>VIA33: 133 cm |
| Coating | | Hydronic Acid (Hydrophilic<br>Coating) - 100cm | Polyvinylpyrrolidone<br>(Hydrophilic Coating) -<br>100 cm | Same as Headway<br>Microcatheters – 100 cm |
| Tip<br>Configuration | Headway 17 Advanced:<br>Straight & Preshaped<br>Headway 21: Straight | Straight | VIA17: Straight &<br>Preshaped<br>VIA21, 27, 33: Straight | |
| Guidewire<br>Compatibility | Headway 17 Advanced:<br>0.014" OD or smaller<br>Headway 21: 0.018" OD or<br>smaller | VIA17: 0.014" OD or<br>smaller<br>VIA21, 27, 33: 0.018" OD<br>or smaller | Same as SMI VIA<br>Microcatheters | |
| Accessories | Introducer sheath and shaping<br>mandrel | Shaping mandrel | Same as Headway<br>Microcatheters | |
| Method of<br>Supply | Sterile and single use | Sterile and single use | Same as SMI VIA &<br>Headway Microcatheters | |
| Sterilization<br>Method | Ethylene Oxide | Ethylene Oxide | Same as SMI VIA &<br>Headway Microcatheters | |
| Packaging<br>Configuration | 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 Headway<br>Microcatheters | |

### 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<br>(ISO Medium Eluate<br>Method (MEM)<br>Elution Test) | Eagle's Minimal<br>Essential Medium (E-<br>MEM) + 5% Fetal<br>Bovine Serum (FBS)<br><br>L929 Mouse<br>Fibroblast Cell Line | 6.0 cm²/mL Extracted<br>at 37°C/24 hrs. | Non-cytotoxic<br>The test article is<br>considered non-<br>cytotoxic to cells. | |
| Sensitization (ISO<br>Guinea Pig<br>Maximization<br>Sensitization Test) | Normal Saline and<br>Sesame Oil Extracts<br><br>Hartley Guinea Pigs<br>(17 Male ) | 6.0 cm²/mL Extracted<br>at 70°C/24 hrs. | Non-sensitizing<br>The test article did<br>not elicit a<br>sensitization<br>response. | |
| Irritation/<br>Intracutaneous<br>Toxicity<br>(ISO Intracutaneous<br>Irritation Test) | Normal Saline and<br>Sesame Oil Extracts<br><br>New Zealand White<br>Rabbits (3 Female –<br>non-pregnant and<br>nulliparous) | 6.0 cm²/mL Extracted<br>at 70°C/24 hrs. | Non-irritant<br>No evidence of<br>irritation. | |
| Acute Systemic<br>Toxicity<br>(ISO Acute Systemic<br>Injection Test) | Normal saline and<br>Sesame Oil Extracts<br><br>Albino Swiss Mice<br>(20 Female – non-<br>pregnant and<br>nulliparous) | 6.0 cm²/mL Extracted<br>at 70°C/24 hrs. | Systemically non-toxic<br><br>No weight loss,<br>mortality, or evidence<br>of systemic toxicity<br>from the extract<br>exposure to the mice. | |
| Material-Mediated<br>Pyrogenicity | Normal Saline<br><br>New Zealand White<br>Rabbits (3 Female –<br>non- pregnant and<br>nulliparous) | 6.0 cm²/mL Extracted<br>at 70°C/24 hrs. | Non-pyrogenic<br><br>All individual rabbits<br>injected with the test<br>article showed a total<br>rise in temperature of<br>< 0.5 °C and were<br>determined to be non-<br>pyrogenic. | |
| Hemocompatibility<br>(ASTM Hemolysis<br>Assay – Direct<br>Contact and Indirect<br>Contact) | Direct Contact Solid<br>Sample Exposure to<br>Rabbit Blood<br>Substrate and<br>Indirect Contact<br>Extracted in<br>Phosphate Buffered<br>Saline (PBS)<br><br>Blood from 3 New<br>Zealand White<br>Rabbits | Direct Contact:<br>6.0 cm²/mL exposure<br>to Blood Substrate<br>then incubated at<br>37°C for 3 hours with<br>approximately 60<br>RPM agitation.<br><br>Indirect Contact:<br>6.0 cm²/mL in PBS<br>extracted at 70°C for<br>24 hours then extract<br>exposed to blood<br>substrate and<br>incubated at 37°C for<br>3 hours with<br>approximately 60<br>RPM agitation. | Non-hemolytic<br><br>There were no<br>significant<br>differences between<br>the test article<br>extract/solid and<br>negative control<br>article results. | |
| Hemocompatibility<br>(Partial<br>Thromboplastin Time<br>(PTT) with Sponsor-<br>Supplied Comparison<br>Article) | Solid Sample<br>Exposure to Human<br>Plasma | 6.0 cm²/mL<br>Incubated with<br>human plasma at<br>37°C for 15 minutes<br>with orbital shaking<br>at approximately 60<br>RPM. | No adverse effect on<br>Unactivated Partial<br>Thromboplastin Time<br>of human plasma.<br>The solid test article<br>was determined to be<br>compatible with<br>blood and not affect<br>coagulation. | |
| Hemocompatibility<br>(ISO Complement<br>Activation C3a and<br>SC5b-9 Assay with<br>Sponsor-Supplied<br>Comparison Article) | Solid Sample and<br>Normal Human<br>Serum (NHS) as<br>exposure medium | 6.0 cm²/mL of NHS<br>at 37°C for 60<br>minutes. | C3a and SC5b-9<br>complement proteins<br>were considered to be<br>non-activated as<br>compared to the<br>comparison article. | |
| Hemocompatibility<br>(Platelet and<br>Leukocyte Counts<br>with Sponsor-<br>Supplied<br>Comparison Article) | Solid Sample<br>exposure to Whole<br>Human Blood<br>medium | 12 cm²/mL whole<br>blood at 37°C for 60<br>minutes with<br>agitation at<br>approximately 60<br>RPM. | Platelet count for the<br>test article exposed<br>blood are not<br>statistically<br>significantly different<br>as compared to<br>reference control or<br>comparison article. | |
| Hemocompatibility<br>(Thromboresistance<br>Evaluation) | Test and Control<br>device surgically<br>placed at each jugular<br>vein of the animal.<br><br>2 Canine, Cross bred<br>hound – Female:<br>nulliparous and non-<br>pregnant. | Direct Exposure for 4<br>hours. | Non-thrombogenic | |
| Genotoxicity<br>(ISO Bacterial<br>Mutagenicity Test -<br>Ames Assay) | Normal Saline<br>And<br>Dimethylsulfoxide<br>(DMSO)<br><br>Ames Assy -<br>Salmonella.<br>typhimurium TA97a,<br>TA98, TA100,<br>TA1535, and E. coli<br>WP2 uvr A under<br>both non-activated<br>and activated<br>Systems | 6.0 cm²/mL Extracted<br>at 70°C/24 hrs. | Non-mutagenic | |
| Genotoxicity<br>(ISO In Vitro Mouse<br>Lymphoma with<br>Extended Treatment | Normal Saline<br>And<br>Dimethylsulfoxide<br>(DMSO)<br><br>L5178Y mouse<br>lymphoma cells | 6.0 cm²/mL Extracted<br>at 70°C/24 hrs.<br><br>Extracts contact with<br>test system for 4<br>hours in non-<br>activated and<br>activated conditions | Non-mutagenic and<br>non-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 Dimensional<br>Inspection | This method measures inner diameter, outer diameter,<br>catheter length, coated length, tip length, distance<br>between marker bands (VIA17 only), preshaped tip<br>angle (VIA17 Preshaped only), printing on strain relief,<br>accessories, and unbraided length. | Pass |
| Hub ISO 80369-7 | ISO80369-7:2016 & -20:2015 | Pass |
| WEB Retraction | The method measures the distance that the VIA<br>catheter pulls back during interventional device<br>recapture | Pass |
| Kink Resistance | The method measures the diameter at which the VIA<br>shaft sections and junctions will kink | Pass |
| Tensile | The method tests the tensile strength of the<br>microcatheter shaft sections (each joint/transition tested<br>individually). This method aligns with the method<br>described in ISO 10555-1:2014. | Pass |
| Tip Buckling | The method measures the catheter tip buckling force by<br>pushing the catheter tip into a load cell until it buckles. | Pass |
| Steam Shaping / Shape<br>Retention | The method measures the ability of the VIA to be<br>steam shaped using a shaping mandrel and the ability<br>of the VIA to hold the shape during use. | Pass |
| Catheter Leakage and<br>Static Burst | The method measures the leakage and static burst<br>pressure of the VIA. This method aligns with the<br>method described in ISO 10555-1:2014. | Pass |

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| Coating Friction &<br>Durability | The method measures the catheter coating<br>friction/lubricity over multiple friction test cycles using<br>an automated friction tester. After cycling, catheter is<br>dyed to verify coating adherence. | Pass |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| Coating Particulate | The method measures the particulate generated during<br>simulated navigation and adjunct device delivery per<br>USP <788>. | Pass |
| Coating Integrity | Coating integrity uses dye to test that coating remains<br>adhered to catheter after simulated use through a<br>tortuous model. | For<br>characterization<br>only. |
| Catheter Torque<br>Strength | The method measures how many complete rotations the<br>catheter can withstand before breaking. | For<br>characterization<br>only. |
| Tracking Force | The method tests the force required to pass<br>interventional devices through the VIA catheter. | Pass |
| Flow Rate | The method measures the flow rate through the VIA by<br>pushing fluid through the catheter at a constant rate<br>while pressure is being monitored. | For<br>characterization<br>only. |
| Dead Space | The non-hydrated VIA is attached to a syringe pump<br>and slowly filled with controlled amounts of distilled<br>water. Once water is observed to be exiting the raised<br>tip of the catheter, the volume of liquid dispensed is<br>recorded. | For<br>characterization<br>only |

# 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.