VIA 21 Microcatheter

K150894 · Sequent Medical, Inc. · DQY · Aug 28, 2015 · Cardiovascular

Device Facts

• Record ID: K150894
• Device Name: VIA 21 Microcatheter
• Applicant: Sequent Medical, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 28, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The VIA™ 21 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 non-liquid therapeutic agents into the neuro, peripheral, and coronary vasculature.

Device Story

VIA™ 21 Microcatheter is a sterile, single-lumen, percutaneous device used to access distal vasculature. Physician inserts catheter over a steerable guidewire; navigation is facilitated by a hydrophilic outer coating and variable shaft stiffness (flexible tip to semi-rigid proximal section). Position is monitored via a radiopaque distal tip marker under fluoroscopy. The inner lumen, featuring a PTFE liner, allows delivery of interventional devices (e.g., flow diverters) or infusion of diagnostic/therapeutic agents. The device is used in clinical settings (neuro, peripheral, coronary) by physicians. The distal tip can be steam-shaped using an included mandrel to match patient anatomy. The device assists in accessing targeted vasculature, enabling precise delivery of implants or agents, potentially improving clinical outcomes in interventional procedures.

Clinical Evidence

No human clinical data. Evidence consists of bench testing (visual/dimensional, kink resistance, tip buckling, tracking force, steam shaping, tensile strength, burst pressure, coating friction/integrity, flow rate, hub performance) and simulated use testing in animals. Biocompatibility and chemical testing (pyrogenicity, sensitization, systemic toxicity, irritation, thromboresistance, hemolysis, complement activation, PTT, platelet/leukocyte counts) were adopted from the VIA 27 predicate.

Technological Characteristics

Single-lumen microcatheter; 154 cm length; 0.021 inch ID. Materials: PTFE liner, Pebax/Vestamid shaft, stainless steel wire, polypropylene hub. Hydrophilic coating (polyvinylpyrrolidone). Radiopaque 90%Pt-10%Ir marker. Variable shaft stiffness. Sterilized via Ethylene Oxide. Manual tip shaping via mandrel.

Indications for Use

Indicated for patients requiring neuro, peripheral, or coronary vascular access for the delivery of non-liquid interventional devices (e.g., stents, flow diverters) or the infusion of diagnostic/therapeutic agents.

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™ (VIA 27) and VIA™ PLUS (VIA 33) Microcatheters (K132652)
• Headway 21 Microcatheter (K093160)
• Orion Microcatheter (K113289)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of a triple-profile silhouette of a human head, with flowing lines suggesting movement or progress. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

August 28, 2015

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

Re: K150894

Trade/Device Name: VIA™ 21 Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, KRA Dated: July 27, 2015 Received: July 29, 2015

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

{1}------------------------------------------------

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [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 yours,

Carlos L. Pena - SD/A

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

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K150894

Device Name VIA™ 21 Microcatheter

Indications for Use (Describe)

The VIA™ 21 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 non-liquid therapeutic agents into the neuro, peripheral, and coronary vasculature.

Type of Use (Select one or both, as applicable)

| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------|
| <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

#### 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 | 4/1/2015 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| 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™ 21 Microcatheter |
| COMMON NAME | Continuous Flush Catheter |
| DEVICE<br>CLASSIFICATION | Class II, 21 CFR §870.1250, 21 CFR §870.1210 |
| PRODUCT CODES | DQY: Percutaneous Catheter<br>KRA: Continuous Flush Catheter |
| PREDICATE<br>DEVICES | VIA™ (VIA 27) and VIA™ PLUS (VIA 33)<br>Microcatheters (K132652)<br>Headway 21 Microcatheter (K093160)<br>Orion Microcatheter (K113289) |
| PRIOR SUBMISSION | This is an original submission. There has been no prior<br>submission for the subject device. |

#### SUBSTANTIALLY EQUIVALENT TO:

The VIA™ 21 Microcatheter is substantially equivalent to the previously cleared VIATM (VIA 27) and VIA™ PLUS (VIA 33) Microcatheters (K132652), Headway 21 Microcatheter (K093160) and Orion Microcatheter (K113289).

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

The VIA™ 21 Microcatheter is 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

{4}------------------------------------------------

manipulation while in the vasculature. Throughout the physician can obtain the position of the catheter by the tip marker using fluoroscopic techniques. Diagnostic, therapeutic and interventional devices can be delivered through the lumen of the catheter to the treatment site.

The VIATM 21 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 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™ 21 Microcatheter is available in an effective length of 154 cm and an inner diameter of 0.021 inches.

The VIA™ 21 Microcatheter is presented in a tyvek pouch and is sterile, single use only and non-pyrogenic.

Accessories: Each VIA™ 21 Microcatheter is provided with a shaping mandrel 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 intraluminal flow diverters, infusion of diagnostic agents such as contrast and infusion of therapeutic agents.
### INDICATIONS FOR USE:

The VIA™ 21 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 non-liquid therapeutic agents into the neuro, peripheral and coronary vasculature.

#### TECHNICAL CHARACTERISTICS:

The VIA™ 21 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.

{5}------------------------------------------------

### PERFORMANCE DATA:

Device performance testing confirms that the VIA™ 21 Microcatheter can be used according to its intended use. The VIA™ 21 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

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, infusion of diagnostic and non-liquid therapeutic 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. VIA™ (VIA 27) and VIATM PLUS (VIA 33) Microcatheters (K132652), Headway 21 Microcatheter (K093160) and Orion Microcatheter (K113289).

#### NONCLINICAL TESTS DISCUSSION:

The nonclinical tests included:

- Physical characteristics unique to the VIA™ 21 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 | Methodology | Applicable<br>International<br>Standard and/or<br>Sequent Test<br>Method (TM) | Result | Conclusion |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Visual and Dimensional | Tests conformance to<br>specified microcatheter<br>dimensions and visual<br>criteria. | ISO 10555-1:2013<br>TM036 | Met performance<br>specifications<br>per DTM003 | Complete<br>conformance to<br>standard |
| Test | Methodology | Applicable<br>International<br>Standard and/or<br>Sequent Test<br>Method (TM) | Result | Conclusion |
| Kink Resistance | Measures diameter at<br>which microcatheter<br>shaft sections and<br>junctions will kink. | BS EN 13868:2002<br>TM035 | Met performance<br>specifications<br>per DTM003 | Conformance to<br>standard with the<br>following<br>deviations:<br>Kink diameter |
| | | | | determined based<br>on mechanical kink<br>(drop in<br>compressive force)<br>instead of 50%<br>reduction in water |
| | | | | flow. This method<br>is appropriate as<br>the Via 21 is<br>primarily used to<br>deliver non-liquid<br>devices. |
| Tip Buckling | Tests force required for<br>tip to buckle. | TM034 | Met performance<br>specifications<br>per DTM003 | Complete<br>conformance to<br>Sequent TM |
| Tracking Force | Tests force required to<br>advance an<br>interventional device<br>through the<br>microcatheter lumen. | TM032 | Met performance<br>specifications<br>per DTM003 | Complete<br>conformance to<br>Sequent TM |
| Steam Shaping and<br>Shape Retention | Tests that microcatheter<br>can be steam shaped to a<br>clinically relevant angle<br>and can maintain a<br>minimum % of the initial<br>angle after simulated<br>use. | TM038 | Met performance<br>specifications<br>per DTM003 | Complete<br>conformance to<br>Sequent TM |
| Shaft Tensile | Measures the ultimate<br>tensile strength of all<br>Pebax and Vestamid<br>junctions along the<br>length of the catheter<br>shaft. | ISO 10555-1:2013<br>TM031 | Met performance<br>specifications<br>per DTM003 | Complete<br>conformance to<br>standard |
| Hub-Shaft Tensile | Measures the ultimate<br>tensile strength of the<br>hub to shaft junction. | ISO 10555-1:2013<br>TM031 | Met performance<br>specifications<br>per DTM003 | Complete<br>conformance to<br>standard |
| Burst | Measures peak pressure<br>before microcatheter<br>burst/liquid leakage. | ISO 10555-1:2013<br>TM037 | Met performance<br>specifications<br>per DTM003 | Complete<br>conformance to<br>standard |
| Test | Methodology | Applicable<br>International<br>Standard and/or<br>Sequent Test<br>Method (TM) | Result | Conclusion |
| Coating Friction and<br>Coating Integrity | Measures the average<br>peak coating<br>friction/lubricity.<br>Coating integrity uses<br>dye to test that coating<br>remains adhered to<br>catheter after simulated<br>use. | Harland Medical<br>Systems Coating<br>Friction and Dye<br>Test Methods<br>FDA Guidance<br>Document, Class II<br>Special Controls for<br>PTCA Catheters<br>(section 12) (Issued<br>2010) | Met performance<br>specifications<br>per DTM003 | Complete<br>conformance to<br>Harland test<br>methods<br>In line with FDA<br>guidance document<br>on coating integrity |
| Coating<br>Adherence/Particulate | Measures particulate<br>generated from the<br>hydrophilic coating on<br>exterior of<br>microcatheter, as well as<br>particulate generated<br>from advancing an<br>interventional device<br>through the inner lumen<br>of the microcatheter. | TM042<br>FDA Guidance<br>Document, Non-<br>Clinical Engineering<br>Tests for<br>Intravascular Stents<br>and Associated<br>Delivery Systems<br>(section 12) (Issued<br>2010)<br>FDA Guidance<br>Document, Class II<br>Special Controls for<br>PTCA Catheters<br>(section 13) (Issued<br>2010) | Met performance<br>specifications<br>per DTM003 | Complete<br>conformance to<br>Sequent TM<br>In line with FDA<br>guidance<br>documents on<br>particulate testing |
| Flow Rate | Measures flow rates<br>through the<br>microcatheter at defined<br>injection rates using<br>saline and contrast. | ISO 10555-1:2013 | Met performance<br>specifications<br>per DTM003 | Complete<br>conformance to<br>standard |
| Hub Performance | Tests hub liquid and air<br>leakage, as well as that<br>the hub can withstand<br>adequate forces. Tests<br>that the hub meets<br>general requirements for<br>conical fittings. | ISO 594-1:1986<br>ISO 594-2:1998<br>TM043 | Test results<br>adopted from<br>VIA 27/VIA33<br>(K132652) | Conformance to<br>standard with the<br>following<br>deviations:<br>Used an alternative<br>ISO 594-2:1998<br>fitting to test hubs<br>for Separation<br>Force and<br>Unscrewing<br>Torque. The fitting<br>used was measured<br>to have a minor<br>diameter greater<br>than called for in |
| | | | the standard. This<br>was deemed as<br>worst case for these<br>tests, therefore<br>acceptable to use.<br>Only short term<br>stress cracking was<br>inspected for on<br>hubs. ISO 594-<br>2:1998 calls for<br>inspection after 48<br>hours. Intended use<br>of Via 21<br>microcatheter only<br>requires RHV or<br>syringes to be<br>connected for short<br>durations during<br>delivery of implant,<br>therefore long term<br>testing is not<br>applicable. | |

### Table 1. Non-Clinical Tests

{6}------------------------------------------------

# 510(K) SUMMARY

{7}------------------------------------------------

# 510(K) SUMMARY

{8}------------------------------------------------

Nonclinical testing demonstrated that the VIA™ 21 Microcatheter can perform as intended, and demonstrated substantial equivalence to the predicate devices: VIA™ (VIA 27) and VIA™ PLUS (VIA 33) Microcatheters (K132652), Headway 21 Microcatheter (K093160) and Orion Microcatheter (K113289).

### 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:

| Biocompatibility Testing | | |
|------------------------------------------------|-----------------------------------|---------------------------------------------------------------------------|
| Test | Applicable International Standard | Result |
| Materials Mediated Rabbit Pyrogen Test | ISO10993-11:2006 | Non-pyrogenic - Pass |
| ISO Guinea Pig Maximization Sensitization | ASTM F720-81 (2002) | Non-sensitization response - Pass |
| ISO Acute Systemic Injection Test | ISO10993-11:2006 | Non Toxic - Pass |
| ISO Intracutaneous Reactivity Test | ISO10993-10:2010 | Non-irritant - Pass |
| Four Hour Thromboresistance Evaluation in Dogs | ISO10993-4:2002 (2006) | Thromboresistance characteristics of test group similar to control – Pass |

## Table 2. Biocompatibility and Chemical Testing

{9}------------------------------------------------

| 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 with<br>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 L-<br>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 74.3045<br>- 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™ 21 Microcatheter to the predicate devices. Table 3 below shows a summary of the VIA™ 21 technological characteristics as compared to the predicate devices.

{10}------------------------------------------------

Table 3. Substantial Equivalence Summary - Technological Characteristics

| Element | SUBJECT DEVICE<br>- VIA™ 21<br>MICROCATHETER<br>(K150894) | VIA™ (VIA 27)<br>AND VIA™ PLUS<br>(VIA 33)<br>MICROCATHETER<br>(K132652) | HEADWAY 21<br>MICROCATHETER<br>(K093160) | ORION ™<br>MICROCATHETER<br>CATHETER (K113289)<br>AND CE0297) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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,<br>Stainless Steel wire,<br>Nylon Santoprene<br>Yes | PTFE, Pebax, Stainless<br>Steel hypotube, Nitinol<br>braid reinforcement,<br>polypropylene<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 configuration<br>and the physician has the<br>option to steam shape the tip<br>using the Shaping Mandrel<br>prior to use to ensure proper<br>adjustment 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 | 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 21<br>MICROCATHETER<br>(K150894) | VIATM (VIA 27)<br>AND VIATM PLUS<br>(VIA 33)<br>MICROCATHETER<br>(K132652) | HEADWAY 21<br>MICROCATHETER<br>(K093160) | ORION TM<br>MICROCATHETER<br>CATHETER (K113289)<br>AND CE0297) |
| Effective<br>Lengths | Via 21: 154 cm<br>Yes | Via 27: 154 cm<br>Via 33: 133 cm<br>Yes | 150 cm<br>Yes | 150 cm<br>Yes |
| Proximal/Distal<br>OD | 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: 2.5F<br>Distal OD: 2.0F<br>Yes | Proximal OD: 2.4F<br>Distal OD: 2.6F<br>Yes |
| ID | 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: 0.021 inch<br>Yes | ID: 0.021 inch<br>Yes |
| Hydrophilic<br>Coating Length | Via 21: 100 cm<br>Yes | Via 27: 100 cm<br>Via 33: 100 cm<br>Yes | 100cm (measured)<br>Yes | 85 cm (measured)<br>Yes |
| Tip Length | 1 mm<br>Yes | 1 mm<br>Yes | 0.66 mm (measured)<br>Yes | 0.70 mm (measured)<br>Yes |
| Element | SUBJECT DEVICE<br>- VIATM 21<br>MICROCATHETER<br>(K150894) | VIA™ (VIA 27)<br>AND VIA™ PLUS<br>(VIA 33)<br>MICROCATHETER<br>(K132652) | HEADWAY 21<br>MICROCATHETER<br>(K093160) | ORION TM<br>MICROCATHETER<br>CATHETER (K113289)<br>AND CE0297) |
| Distal Tip<br>Length | Via 21: 5cm<br>Yes | Via 27:10cm<br>Via 33: 5 cm<br>Yes | 15cm (measured)<br>Yes | 13.5 cm (measured)<br>Yes |
| Tip Markers | 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 | 2 markers, confirmed<br>to be radiopaque<br>Yes |
| Coating | Polyvinylpyrrolidone<br>Yes | Polyvinylpyrrolidone<br>Yes | Confirmed to be<br>lubricious<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,<br>non-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 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 | Primary package:<br>Coiled Hoop within a<br>single pouch<br>Secondary Package:<br>Chipboard unit carton<br>Yes |
| Sterilization | Ethylene Oxide<br>Sterilization | Ethylene Oxide Sterilization<br>Yes | Ethylene Oxide<br>Sterilization | Ethylene Oxide<br>sterilization |
| Element | SUBJECT DEVICE<br>- VIATM 21<br>MICROCATHETER<br>(K150894) | VIATM (VIA 27)<br>AND VIATM PLUS<br>(VIA 33)<br>MICROCATHETER<br>(K132652) | HEADWAY 21<br>MICROCATHETER<br>(K093160) | ORION TM<br>MICROCATHETER<br>CATHETER (K113289)<br>AND CE0297) |
| | Yes | Yes | Yes | Yes…