VIA 17 Microcatheter

K162565 · Sequent Medical, Inc. · DQY · Feb 18, 2017 · Cardiovascular

Device Facts

• Record ID: K162565
• Device Name: VIA 17 Microcatheter
• Applicant: Sequent Medical, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Feb 18, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

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

Device Story

Sterile, single-lumen microcatheter; aids physician in accessing distal vasculature using guide catheter and steerable guidewire. Features variable shaft stiffness (flexible tip to semi-rigid proximal section) for tracking; PTFE inner liner facilitates device delivery; hydrophilic outer coating reduces friction. Physician shapes distal tip via steam and shaping mandrel. Used in clinical settings (neuro, peripheral, coronary). Output is physical access to target vasculature for delivery of interventional devices or diagnostic agents. Benefits include improved navigation and delivery of therapeutic/diagnostic materials in complex vascular anatomy.

Clinical Evidence

No human clinical data. Evidence based on bench testing (kink resistance, tip buckling, tracking force, tensile strength, burst pressure, flow rate, coating integrity) and simulated-use testing in animal models. All tests met acceptance criteria comparable to predicate devices.

Technological Characteristics

Single-lumen microcatheter; materials: PTFE, Pebax, Vestamid, stainless steel wire, polypropylene. Hydrophilic coating (polyvinylpyrrolidone). 154 cm length, 0.0175 inch ID. Radiopaque markers (90% Pt/10% Ir). Sterilized via Ethylene Oxide. Manual tip shaping. No software/electronics.

Indications for Use

Indicated for patients requiring introduction of non-liquid interventional devices (coils/stents) or infusion of diagnostic agents (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™ 21 Microcatheter (K150894)
• VIA™ and VIA™ PLUS Microcatheters (K132652)
• Headway 17 Advanced Microcatheter (K101542)

Submission Summary (Full Text)

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

February 18, 2017

Sequent Medical, Inc. Bethany Barrett Regulatory/Clinical Project Manager 11A Columbia Aliso Viejo, California 92656

Re: K162565

Trade/Device Name: VIA™ 17 Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, KRA Dated: January 26, 2017 Received: February 1, 2017

Dear Ms. Barrett:

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 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.

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Carlos L. Pena-S

Carlos L. Peña, PhD, MS 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): K162565

Device Name VIA™ 17 Microcatheter

Indications for Use (Describe)

The VIA™ 17 Microcatheter is intended for the introduction of non-liquid 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> <svg height="16" width="16"> <path d="M2 2h12v12H2z" fill="none" stroke="black" stroke-width="2"></path> <path d="M4 4l8 8M4 12L12 4" stroke="black" stroke-width="2"></path> </svg> </span> Prescription Use (Part 21 CER 801 Subpart D) </div> | <div> <span> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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### 510(K) SUMMARY

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

| DATE PREPARED | 2/17/2017 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| APPLICANT | Sequent Medical, Inc.<br>11A Columbia<br>Aliso Viejo, CA 92656<br>Tel: [phone]<br>Fax: [phone] |
| OFFICIAL<br>CORRESPONDENT | Bethany Barrett<br>11A Columbia<br>Aliso Viejo, CA 92656<br>[e-mail]<br>Tel: [phone] x 113<br>Fax: [phone] |
| TRADE NAME | VIA™ 17 Microcatheter |
| COMMON NAME | Percutaneous Catheter, Continuous Flush Catheter |
| DEVICE<br>CLASSIFICATION | Class II, 21 CFR §870.1250, §870.1210 |
| PRODUCT CODES | DQY: Percutaneous Catheter<br>KRA: Continuous Flush Catheter |
| PREDICATE<br>DEVICES | VIA™ 21 Microcatheter (K150894)<br>VIA™ and VIA™ PLUS Microcatheters (K132652)<br>Headway 17 Advanced Microcatheter (K101542) |

#### SUBSTANTIALLY EQUIVALENT TO:

The VIA™ 17 Microcatheter is substantially equivalent to the previously cleared VIA 21 Microcatheter (K150894), VIA (VIA 27) and VIA PLUS (VIA 33) Microcatheters (K132652), and Headway 17 Advanced Microcatheter (K101542).

#### DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The VIA™ 17 Microcatheter is a sterile single lumen device 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

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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 coils/stents.

The VIATM 17 Microcatheter is available in an effective length of 154 cm and an inner diameter of 0.0175 inches.

The VIA™ 17 Microcatheter is presented in a tyvek pouch and is sterile, single use only and non-pyrogenic.

Accessories: Each VIA™ 17 Microcatheter is provided with shaping mandrels to facilitate distal tip shaping.

In intravascular procedures, the device assists the physician in:

- Accessing the targeted vasculature to facilitate the delivery of interventional devices, such as coils and stents, and infusion of diagnostic agents such as contrast.
### INDICATIONS FOR USE:

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

#### TECHNICAL CHARACTERISTICS:

The VIA™ 17 Microcatheter incorporates variable shaft stiffness ranging from a flexible tip to a semi-rigid proximal section aid the physician in tracking over selectively placed guidewires. 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.

#### PERFORMANCE DATA:

Device performance testing confirms that the VIA™ 17 Microcatheter can be used according to its intended use. The VIA™ 17 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 Assessment
- Biocompatibility Assessment
- Simulated Use Testing in Animals ●

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This testing regime demonstrates that the subject device is substantially equivalent to the legally marketed predicate device, for its intended use in the introduction of interventional devices and infusion of diagnostic agents into the vasculature.

The information provided by Sequent Medical in this 510(k) application was found to be substantially equivalent to the predicate devices, the VIA 21 Microcatheter (K150894), VIA (VIA 27) and VIA PLUS (VIA 33) Microcatheters (K132652), and the Headway 17 Advanced Microcatheter (K101542).

## NONCLINICAL TESTS DISCUSSION:

The nonclinical tests included:

- Physical characteristics unique to the VIA™ 17 Microcatheter, such as visual and ● dimensional tolerances, kink resistance, and catheter tip shape retention.
- Safety features such as burst pressure, tensile force and coating adherence.
- Functional characteristics such as navigation and track force. Interventional ● device retraction and catheter flow rate.
- The full list of non-clinical tests are listed in Table 1 below: ●

| Test | Test Method Summary | Result |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Kink Resistance | This method measures the diameter at which the VIA shaft sections<br>and junctions will kink. Each catheter section is inserted into an<br>automated test fixture and kinked. The kink diameter is then<br>calculated based on shaft displacement at peak force. | All units passed<br>acceptance criteria.<br>Acceptance criteria<br>based on measured<br>Headway 17 kink<br>resistance.<br>Substantially<br>equivalent to<br>predicate. |
| Tip Buckling | This method measures the catheter tip buckling force by pushing the<br>catheter tip into a load cell until it buckles. The peak force is<br>measured and recorded. | All units passed<br>acceptance criteria.<br>Acceptance criteria<br>based on measured<br>Headway 17 tip<br>buckling. Substantially<br>equivalent to<br>predicate. |
| Tracking Force | This method tests the force required to pass interventional devices<br>through the VIA catheter. Each VIA is inserted into a tracking<br>fixture and the hard model tortuosity fixture. The interventional<br>device is pushed through the tortuosity fixture and VIA catheter. The<br>peak force required to push the device through the VIA is recorded. | All units passed<br>acceptance criteria.<br>Acceptance criteria<br>identical to VIA 21<br>and VIA 27/33.<br>Substantially<br>equivalent to<br>predicate. |
| Test | Test Method Summary | Result |
| Steam Shaping<br>and Shape<br>Retention | This method measures the ability of the VIA to be steam shaped<br>using a shaping mandrel and the ability of the VIA to hold the shape<br>during use. The VIA is shaped per the VIA IFU shaping instructions.<br>The tip angle is measured and must fall within the documented<br>specification. The VIA is then subjected to simulated use through a<br>guide catheter in 37° water. After guidewire insertion for a specified<br>time, the tip angle is measured again and shape retention is evaluated<br>per the specification. | All units passed<br>acceptance criteria.<br>Acceptance criteria<br>based on measured<br>Headway 17 shape<br>retention.<br>Substantially<br>equivalent to<br>predicate. |
| Microcatheter<br>Tensile Strength | This method tests the tensile strength of the microcatheter shaft<br>sections (each joint/transition tested individually). This method<br>aligns with the method described in ISO 10555-1:2014. | All units passed<br>acceptance criteria per<br>ISO10555-1:2014.<br>Substantially<br>equivalent to<br>predicate. |
| Catheter<br>Leakage and<br>Static Burst | This method measures the leakage and static burst pressure of the<br>VIA. This method aligns with the method described in ISO 10555-<br>1:2014. | All units passed<br>acceptance criteria.<br>Acceptance criteria<br>identical to VIA 21<br>and VIA 27/33.<br>Substantially<br>equivalent to<br>predicate. |
| Retraction | This method measures the distance that the VIA catheter pulls back<br>during interventional device recapture. This test is performed in a<br>simulated use model. The guide catheter and VIA Microcatheter are<br>inserted into the fixture. A worst case interventional device is<br>deployed through the VIA and recaptured. The displacement of the<br>catheter in the fixture is measured and recorded. | All units passed<br>acceptance criteria.<br>Acceptance criteria<br>identical to VIA 21<br>and VIA 27/33.<br>Substantially<br>equivalent to<br>predicate. |
| Coating Friction<br>and Coating<br>Integrity | Measures the catheter coating friction/lubricity over multiple friction<br>test cycles using an automated friction tester.<br>Coating integrity uses dye to test that coating remains adhered to<br>catheter after simulated use through a tortuous model. | All units passed<br>acceptance criteria.<br>Acceptance criteria<br>identical to VIA 21<br>and VIA27/33.<br>Substantially<br>equivalent to<br>predicate. |
| Coating<br>Adherence/<br>Particulate | This method measures the particulate generated during simulated<br>navigation and adjunct device delivery. The VIA is cycled through<br>the tracking fixture and the hard model tortuosity fixture. A worst<br>case interventional device is then cycled through the inner diameter<br>(ID) of the VIA while inside the tortuosity fixture. Both the ID of the<br>fixture and the ID of the VIA are flushed with particulate free water<br>and the collected fluid is tested for particulate using the light<br>obscuration method. | All units passed<br>acceptance criteria per<br>USP24 <788>.<br>Acceptance criteria<br>identical to VIA 21<br>and VIA27/33.<br>Substantially<br>equivalent to<br>predicate. |
| Flow Rate | This method measures the flow rate through the VIA by pushing<br>fluid through the catheter at a constant rate while pressure is being<br>monitored. | All units passed<br>acceptance criteria per<br>ISO10555-1:2014.<br>Flow rate was |
| Test | Test Method Summary | Result |
| | | determined and<br>documented in the<br>instructions for use.<br>Substantially<br>equivalent to<br>predicate. |
| Hub<br>Performance | This method tests hub liquid and air leakage, as well as that the hub<br>can withstand adequate forces. Tests that the hub meets general<br>requirements for conical fittings. Methods used are per ISO594-<br>1:1986 and ISO 594-2:1998. | Test results adopted<br>from VIA 27/VIA33<br>(K132652). All units<br>passed acceptance<br>criteria per ISO594-<br>1:1986 and ISO 594-<br>2:1998. Substantially<br>equivalent to<br>predicate. |
| Visual and<br>Dimensional | This method measures inner diameter, outer diameter, catheter<br>length, coated length, tip length, distance between marker bands, and<br>unbraided length. | All units passed<br>acceptance criteria.<br>Substantially<br>equivalent to<br>predicate. |
| Catheter Torque<br>to Failure | This method measures how many complete rotations the catheter can<br>withstand before breaking. The catheter is inserted through a<br>tortuous model inside a heated water bath. The distal end of the<br>catheter is secured in place and the proximal end is rotated until<br>failure. This test is performed in both clockwise and<br>counterclockwise directions. | Characterization only.<br>Results comparable to<br>VIA 21. Substantially<br>equivalent to<br>predicate. |

### Table 1. Non-Clinical Tests

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Nonclinical testing demonstrated that the VIA™ 17 Microcatheter can perform as intended, and demonstrated substantial equivalence to the predicate devices: VIA 21 Microcatheter (K150894), VIA (VIA 27) and VIA PLUS (VIA 33) Microcatheters (K132652), and Headway 17 Advanced Microcatheter (K101542).

## BIOCOMPATIBILITY AND CHEMICAL TESTING:

Biocompatibility and chemical testing was adopted from the testing performed on the VIA (VIA 27) Microcatheter. The full list of biocompatibility and chemical testing that was adopted can be found in Table 2 below:

#### Table 2. Biocompatibility and Chemical Testing

| Test | Applicable International<br>Standard | Result |
|----------------------------------------------|--------------------------------------|--------------------------------------|
| Materials Mediated Rabbit<br>Pyrogen Test | ISO10993-11:2006 | Non-pyrogenic - Pass |
| ISO Guinea Pig Maximization<br>Sensitization | ASTM F720-81 (2002) | Non-sensitization response -<br>Pass |

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| Test | Applicable International<br>Standard | Result |
|----------------------------------------------------------|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| ISO Acute Systemic Injection<br>Test | ISO10993-11:2006 | Non Toxic - Pass |
| ISO Intracutaneous Reactivity<br>Test | ISO10993-10:2010 | Non-irritant - Pass |
| Four Hour Thromboresistance<br>Evaluation in Dogs | ISO10993-4:2002 (2006) | Thromboresistance<br>characteristics of test group<br>similar to control - Pass |
| ASTM Hemolysis Assay Direct<br>Contact and Extract | ISO10993-4:2002 (2006)<br>ASTM F619-03<br>ASTM F756-08 | Non-hemolytic under direct and<br>extract test conditions - Pass |
| Complement Activation with<br>Comparison Article | ISO10993-4:2002 (2006) | Results of test group comparable<br>to control group - Pass |
| Partial Thromboplastin Time<br>with Comparison Article | ISO10993-4:2002 (2006)<br>ASTM F2382-04 | Results of test group comparable<br>to control group -both non-<br>activators of the intrinsic<br>coagulation pathway - Pass |
| Platelet and Leukocyte Counts<br>with Comparison Article | ISO10993-4:2002 (2006) | Results of test group comparable<br>to control group - Pass |
| ISO MEM Elution Assay with<br>L-929 Mouse Fibroblast | ISO10993-5:2009 | Non-toxic - Pass |
| Chemical Testing | | |
| Test | Applicable International<br>Standard | Result |
| Colorant Analysis Testing | 21 CFR 74.3045 (2012) | Elemental results meet<br>requirements of 21 CFR<br>74.3045 - Pass |

### BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

A technological comparison, as well as bench and simulated use testing demonstrate the substantial equivalence of the VIA™ 17 Microcatheter to the predicate devices. Table 3 below shows a summary of the VIA™ 17 technological characteristics as compared to the predicate devices.

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# Table 3. Substantial Equivalence Summary – Technological Characteristics

| Element | SUBJECT DEVICE<br>- VIATM 17<br>MICROCATHETER | VIATM 21<br>MICROCATHETER<br>(K150894) | VIATM (VIA 27) AND<br>VIATM PLUS (VIA 33)<br>MICROCATHETER<br>(K132652) | HEADWAY 17<br>ADVANCED<br>MICROCATHETER<br>(K101542) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Differences in Technological Characteristics | | | | |
| The subject and predicate devices are substantially equivalent with respect to design characteristics. The slight variations in<br>flexibility as well as differences in ID and OD are what differentiate these catheters. Each manufacturer optimizes these design<br>variations towards a more specific application (e.g. infusion of diagnostic and therapeutic agents) or for the introduction of specific<br>devices such as embolic agents, coils and stents. Devices are composed of similar materials, all of which have extensive clinical<br>history of safe use in medical devices | | | | |
| Design Features -<br>Equivalent ? | | | | |
| Materials | PTFE, Pebax, Vestamid,<br>Stainless Steel wire,<br>Polypropylene<br>Yes | PTFE, Pebax, Vestamid,<br>Stainless Steel wire,<br>Polypropylene<br>Yes | PTFE, Pebax, Vestamid,<br>Stainless Steel wire,<br>Polypropylene<br>Yes | PTFE, Pebax, Stainless<br>Steel wire, Nylon<br>Santoprene<br>Yes |
| Tip Shape | Straight tip configuration<br>and the physician has the<br>option to steam shape the<br>tip using the Shaping<br>Mandrel prior to use to<br>ensure proper adjustment<br>to the anatomy.<br>Yes | Straight tip<br>configuration and the<br>physician has the option<br>to steam shape the tip<br>using the Shaping<br>Mandrel prior to use to<br>ensure proper<br>adjustment to the<br>anatomy.<br>Yes | Straight tip configuration<br>and the physician has the<br>option to steam shape the<br>tip using the Shaping<br>Mandrel prior to use to<br>ensure proper adjustment<br>to the anatomy.<br>Yes | Straight tip<br>configuration and the<br>physician has the<br>option to steam shape<br>the tip prior to use to<br>ensure proper<br>adjustment to the<br>anatomy.<br>Yes |
| Element | SUBJECT DEVICE<br>- VIATM 17<br>MICROCATHETER | VIATM 21<br>MICROCATHETER<br>(K150894) | VIATM (VIA 27) AND<br>VIATM PLUS (VIA 33)<br>MICROCATHETER<br>(K132652) | HEADWAY 17<br>ADVANCED<br>MICROCATHETER<br>(K101542) |
| Effective<br>Lengths | Via 17: 154 cm<br>Yes | Via 21: 154 cm<br>Yes | Via 27: 154 cm<br>Via 33: 133 cm<br>Yes | 150 cm<br>Yes |
| Proximal/Distal<br>OD | Via 17: Proximal<br>2.5F/Distal 2.2F<br>Yes | Via 21: Proximal<br>2.8F/Distal 2.5F<br>Yes | Via 27: Proximal<br>3.2F/Distal 3.0F<br>Via 33: Proximal 3.8<br>F/Distal 3.4F<br>Yes | Proximal OD: 2.4F<br>Distal OD: 1.7F<br>Yes |
| ID | Via 17: 0.0175 inch/1.3F<br>Yes | Via 21: 0.021 inch/1.6F<br>Yes | Via 27: 0.027 inch/2.1F<br>Via 33: 0.033 inch/2.5F<br>Yes | ID: 0.017 inch<br>Yes |
| Hydrophilic<br>Coating Length | Via 17: 100 cm<br>Yes | Via 21: 100 cm<br>Yes | Via 27: 100 cm<br>Via 33: 100 cm<br>Yes | 102 cm (measured)<br>Yes |
| Tip Length | 1mm<br>Yes | 1mm<br>Yes | 1mm<br>Yes | 0.64 mm (measured)<br>Yes |
| Distal Tip<br>Length | Via 17: 10cm<br>Yes | Via 21: 5cm<br>Yes | Via 27:10cm<br>Via 33: 5 cm<br>Yes | 11cm<br>Yes |
| Element | SUBJECT DEVICE<br>- VIATM 17<br>MICROCATHETER | VIA TM 21<br>MICROCATHETER<br>(K150894) | VIATM (VIA 27) AND<br>VIA™ PLUS (VIA 33)<br>MICROCATHETER<br>(K132652) | HEADWAY 17<br>ADVANCED<br>MICROCATHETER<br>(K101542) |
| Tip Markers | 2 markers, 90%Pt-10%Ir<br>Yes | 1 marker, 90%Pt-10%Ir<br>Yes | 1 marker, 90%Pt-10%Ir<br>Yes | 2 markers, confirmed<br>to be radiopaque<br>Yes |
| Coating | Polyvinylpyrrolidone<br>Yes | Polyvinylpyrrolidone<br>Yes | Polyvinylpyrrolidone<br>Yes | Confirmed to be<br>lubricious<br>Yes |
| Method of<br>supply | Sterile, single-use, non-<br>pyrogenic<br>Yes | Sterile, single-use, non-<br>pyrogenic<br>Yes | Sterile, single-use, non-<br>pyrogenic<br>Yes | Sterile, single-use, non-<br>pyrogenic<br>Yes |
| Packaging | Primary package: Coiled<br>Hoop within a single<br>pouch<br>Secondary Package:<br>Chipboard unit carton<br>Yes | Primary package: Coiled<br>Hoop within a single<br>pouch<br>Secondary Package:<br>Chipboard unit carton<br>Yes | Primary package: Coiled<br>Hoop within a single<br>pouch<br>Secondary Package:<br>Chipboard unit carton<br>Yes | Primary package:<br>Coiled Hoop within a<br>single pouch<br>Secondary Package:<br>Chipboard unit carton<br>Yes |
| Sterilization | Ethylene Oxide<br>Sterilization<br>Yes | Ethylene Oxide<br>Sterilization<br>Yes | Ethylene Oxide<br>Sterilization<br>Yes | Ethylene Oxide<br>Sterilization<br>Yes |
| Element | SUBJECT DEVICE<br>- VIATM 17<br>MICROCATHETER | VIATM 21<br>MICROCATHETER<br>(K150894) | VIATM (VIA 27) AND<br>VIATM PLUS (VIA 33)<br>MICROCATHETER<br>(K132652) | HEADWAY 17<br>ADVANCED<br>MICROCATHETER<br>(K101542) |
| Indication for Use<br>- Equivalent ? | | | | |
| The Subject and<br>the comparison<br>devices maintain<br>similar indications | 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<br>agents (such as contrast<br>media) into the neuro,<br>peripheral, and coronary<br>vasculature.<br>Yes | The VIA Catheter is<br>intended for the<br>introduction of non-<br>liquid interventional<br>devices (such as<br>stents/flow diverters)<br>and infusion of<br>diagnostic (such as<br>contrast media) or non-<br>liquid therapeutic agents<br>into the neuro,<br>peripheral, and coronary<br>vasculature.<br>Yes | The VIA Catheter is<br>intended for the<br>introduction of non-liquid<br>interventional devices<br>(such as stents/flow<br>diverters) and infusion of<br>diagnostic (such as<br>contrast media) or<br>therapeutic agents into the<br>neuro, peripheral, and<br>coronary vasculature.<br>Yes | The Headway 21<br>Microcatheter is<br>intended to for general<br>intravascular use,<br>including the<br>peripheral, coronary<br>and neuro vasculature<br>for the infusion of<br>diagnostic agents, such<br>as contrast media, and<br>therapeutic agents, such<br>as occlusion coils.<br>Yes |
| Summary Statement of Substantial Equivalence | | | | |
| Use in a clinical setting was conducted in animals to show that no new risks were identified and that the safety and effectiveness<br>profile is similar to well-established comparison market-approved devices. Bench Testing was performed in models representing<br>the higher risk neurovascular anatomy which is the worst case representation of the cardiac and peripheral vascular anatomies. The | | | | |

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the higher risk neurovascular anatomy, which is the worst case representation of the earther and peripheral vascular anato
VIA™ 17 Microcatheter has equivalent performance ch