The Viradius™ Neurowire consists of a stainless steel wire core and a radiopaque platinum/tungsten coil on the distal tip. The distal section of the guidewire is coated with a hydrophilic coating and the proximal portion of the device is coated with a hydrophobic coating. The guidewire is inserted into a polyethylene hoop and then placed along with a torque device into a labeled poly/tyvek pouch and ethylene oxide sterilized. The pouch, along with an Instruction for Use paper insert is placed into a labeled shipping box.

AI/ML Overview

The Viradius™ Neurowire is a guidewire intended for selective placement of catheters within the neuro and peripheral vasculature. The information provided outlines the acceptance criteria and the studies conducted to demonstrate its substantial equivalence to a legally marketed predicate device (NeuroScout Steerable Guidewire, K100351).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Viradius™ Neurowire are generally that the device "meets acceptance criteria" or performs comparably to the predicate device or selected competitor guidewires, or that the results are adequate/acceptable. The reported device performance indicates that all devices met these criteria for all tested parameters.

Test / Performance Characteristic	Acceptance Criteria	Reported Device Performance
Bond and Joint Tensile Strength	The guidewire, including all joints, must not suffer damage when subjected to tensile force.	All devices met acceptance criteria.
Ultimate Torque Response	The guidewire must withstand a minimum complete rotations without physical damage.	All devices met acceptance criteria.
Torque Response	Distal tip rotation shall be equivalent to predicate guidewire.	All devices met acceptance criteria.
Tip Deflection	Tip deflection force shall be comparable to selected competitor guidewires.	All devices met acceptance criteria.
Push Track – Anatomical Model	Force required to advance guidewire through simulated tortuous neurovascular arteries shall be comparable to predicate device.	All devices met acceptance criteria.
Surface Integrity	Guidewire surface shall not have any particulate visible to the naked eye under close inspection without magnification.	All devices met acceptance criteria.
Guidewire Diameter	The diameter was measured and met specifications (implicitly, as it passed; also noted 0.012" distal, 0.014" proximal).	All devices met acceptance criteria.
Guidewire Length	The length was measured and met specifications (implicitly, as it passed; also noted 205 cm / 300 cm).	All devices met acceptance criteria.
Catheter Compatibility	Guidewire shall be compatible with microcatheters, distal access catheters, guide catheters, and fluids.	All devices met acceptance criteria.
Kink Resistance	Proximal shaft shall not kink when subjected to a bend radius.	All devices met acceptance criteria.
Flex Test	In accordance with ISO 11070:2014 8.5 the guidewire shall not fracture, loosen, or fail in such a manner that any section of the coil is left free to stretch, a sharp, or potentially traumatic fracture surface is exposed, any part of the device becomes separated such that it would not be removable by withdrawing the device from use, or coated guidewires show flaking of the coating.	All devices met acceptance criteria.
Distal Fracture Test	In accordance with ISO 11070:2014 8.4 the guidewire shall not fracture, loosen, or fail in such a manner that any section of the coil is left free to stretch, a sharp, or potentially traumatic fracture surface is exposed, or any part of the device becomes separated such that it would not be removable by withdrawing the device from use.	All devices met acceptance criteria.
Tip Bending and Retention	After insertion through a competitive microcatheter, the bend radius shall not degrade.	All devices met acceptance criteria.
Device Coating Adhesion	After simulated use, the guidewire coating shall not exhibit any scratches, flaking, or generate any loose coating material.	All devices met acceptance criteria.
Particulate Testing	The guidewire was evaluated for particulate generation under simulated use in a representative tortuous model, with an implicit acceptance criterion of an "adequate" number and size of particulates.	Number and size of particulates generated was adequate.
Corrosion Test	The guidewire shall not exhibit visual corrosion when immersed in sodium chloride solution.	All devices met acceptance criteria.
Biocompatibility (Cytotoxicity)	Pass	Pass
Biocompatibility (Sensitization)	Pass	Pass
Biocompatibility (Intracutaneous)	Pass	Pass
Biocompatibility (Systemic Tox)	Pass	Pass
Biocompatibility (Pyrogen)	Pass	Pass
Biocompatibility (Hemocompat.)	Pass	Pass
Sterilization (SAL)	SAL of 10^-6 in accordance with ISO 11135-1:2007.	Validated.
Shelf Life (1 year)	Product and packaging remain functional and maintain sterility for up to one year; packaging integrity, seal strength, and device functionality met all acceptance criteria.	Met all acceptance criteria through aging studies.

2. Sample Size and Data Provenance (Test Set)

The document does not explicitly state the sample sizes (number of units or iterations) used for each specific bench test mentioned. However, for all performance tests, it states that "All devices met acceptance criteria." This implies that a sufficient number of devices were tested to draw this conclusion based on the test methods used.

The data provenance for the test set is retrospective/bench (laboratory) data, generated from direct testing of the Viradius™ Neurowire and comparison to the predicate device or competitor guidewires. There is no indication of country of origin as it applies to clinical data, as no clinical studies were performed.

3. Number of Experts and Qualifications (Ground Truth for Test Set)

This section is not applicable. The studies described are primarily bench (laboratory) performance tests and biocompatibility testing, not studies that involve human interpretation of medical images or diagnoses requiring expert ground truth in the traditional sense. The "ground truth" for these tests is the objective physical and chemical properties and performance of the device relative to established standards or a predicate device.

4. Adjudication Method (Test Set)

This section is not applicable. As the studies were bench tests demonstrating physical performance and material safety, there was no adjudication method involving multiple human reviewers to establish a consensus or resolve discrepancies, which is typical for clinical or imaging studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was performed. The submission explicitly states: "No clinical studies were performed as there are no change to the indications for use or the fundamental scientific technology of the device." Therefore, there is no information on the effect size of human readers improving with or without AI assistance. This device is a medical instrument, not an AI or imaging diagnostic tool.

6. Standalone (Algorithm Only) Performance

No standalone performance study was done. This device is a medical guidewire, a physical instrument, not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not relevant to this submission.

7. Type of Ground Truth Used

The "ground truth" for the performance testing was based on:

Engineering/Performance Standards: Adherence to established ISO standards (e.g., ISO 11070:2014, ISO 11135-1:2007) and internal company specifications.
Comparison to Predicate Device: Performance (e.g., torque response, push track force) comparable to the NeuroScout Steerable Guidewire (K100351).
Objective Laboratory Measurements: Direct measurements of physical dimensions (diameter, length), visual inspection (surface integrity, corrosion), and chemical tests (biocompatibility).
Simulated Use Models: Performance in simulated anatomical models (e.g., push track test, particulate testing in tortuous model).

8. Sample Size for the Training Set

No training set was used. This device is a physical medical instrument, not a machine learning model or AI algorithm that requires a training set.

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

Not applicable, as no training set was used.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.

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

November 16, 2015

MIVI Neuroscience, Inc. Mr. Randy LaBounty Vice President Regulatory and Clinical Affairs 6545 City West Parkway Eden Prairie, Minnesota 55344

Re: K151825

Trade/Device Name: Viradius™ Neurowire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: October 13, 2015 Received: October 14, 2015

Dear Mr. LaBounty:

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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Carlos L. Pena =5//△

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K151825

Device Name ViradiusTM Neurowire

Indications for Use (Describe)

The Viradius™ Neurowire is intended for selective placement of catheters within the neuro and peripheral vasculature.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary – K151825

Manufacturer:	MIVI Neuroscience, Inc.6545 City West ParkwayEden Prairie, MN 55344
Contact Person:	Matt OglePresident and CEOTelephone: 952-944-3834
Date SummaryPrepared	October 12, 2015
Trade Name ofDevice:	Viradius™ Neurowire
Common Name ofDevice:	Guidewire
Classification ofDevice:	21 CFR 870.1330 - Class II
Product Code:	MOF - PrimaryDQX - Secondary
Predicate Device:	NeuroScout Steerable Guidewire, 510(k)#: K100351
Performance Data:	The following bench testing was performed in support of the ViradiusNeurowire and to establish substanstial equivalence to the NeuroScoutSteerable Guidewire:Bond and Joint Tensile StrengthTorque ResponseUltimate Torque ReponseTip DeflectionPush TrackSurface IntegrityGuidewire DiameterGuidewire LengthCatheter CompatibilityKink ResistanceFlex TestDistal Fracture TestTip Bending and RetentionDevice Coating Adhesion

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Corrosion Test
. Coating Integrity – Simulated Use

A Design Validation study was performed on the bench model to assess the usability of the Viradius Neurowire compared to the previously cleared NeuroScout Steerable Guidewire. Biocompatibility testing, sterilization and one year accelerated aging study was also performed. No clinical studies were performed as there are no change to the indications for use or the fundamental scientific technology of the device.

Conclusion: The Viradius Neurowire is substantially equivalent to the currently cleared NeuroScout Steerable Guidewire based on the successful completion of non-clinical bench and design validation testing as well as similar principles of design, operation and indications for use.

Device Description

Indication for Use

The Viradius™ Neurowire is intended for selective placement of catheters within the neuro and peripheral vasculature.

Device Comparison

The table below provides a comparision of the technological characteristics of the Viradius

	Viradius Neurowire	NeuroScout SteerableGuidewire (K100351)	Rationale forDifference (IfPresent)
Indication forUse	The ViradiusTMNeurowire is intendedfor selective placementof catheters within theneuro and peripheralvasculature.	The NeuroScoutSteerable Guidewire isintended for selectiveplacement ofmicrocatheters andother devices withinthe neuro andperipheral vasculature.	Similar indications,included devicestested with theViradius Neurowire.
Materials
Core Material	Stainless Steel	Stainless Steel	N/A
	Viradius Neurowire	NeuroScout SteerableGuidewire (K100351)	Rationale forDifference (IfPresent)
Coil Material	Platinum/Tungsten	Platinum/Tungsten	N/A
Coil to CoreBond Material	Silver Braze	Adhesive	Bench testingindicated similartensile strength.
Coating/Distal	Hydrophilic	Hydrophilic	The materials used forthe Viradius
Coating/Proximal	Polytetrafluoro-ethylene (PTFE)	Hydrophilic	Neurowire wereshown to bebiocompatible per ISO10993 testing.Materials of this typeare widely used insimilar medicaldevices.
Dimensions
Distal Diameter	0.012"	0.011"	Distal diameter needsto be equal or lessthan proximaldiameter for cathetercompatibility.
ProximalDiameter	0.014"	0.014"	N/A
Overall Length	205 cm / 300 cm	205 cm / 300 cm	N/A
Coil Length	18 cm	10 cm	Extension of theflexible coil length.
Other Device Comparisons
RadiopaqueMarker	No discrete markerPlatinum Coil atdistal tip	No discrete markerPlatinum Coil atdistal tip	N/A
Tip Shape/Configuration	Straight	Straight	N/A
Sterility Method	Ethylene Oxide	Ethylene Oxide	N/A
Package	Hoop placed inBreathable Pouch	Hoop placed inBreathable Pouch	N/A

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Sterilization and Shelf Life

The packaged Viradius Neurowire is sterilized using a validated ethylene oxide (EO) sterilization cycle. The sterilization cycle has been validated to ensure a sterility assurance level (SAL) of 10-6 in accordance with ISO 11135-1:2007.

Aging studies for the Viradius Neurowire have established the product and packaging remain functional and maintain sterility for up to one year. Aging studies for packaging integrity, seal strength and device functionality were performed and met all acceptance

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criteria.

Biocompatibility

Biocompatibility testing was performed in compliance with AAMI/ANSI/ISO 10993-1:2009. All studies were conducted in compliance with U.S. Food and Drug Administration Good Laboratory Practice (GLP) regulations set forth in 21 CFT part 58.

Test	Result
Cytotoxicity	Pass
Sensitization	Pass
Intracutaneous Reactivity	Pass
Systemic	Pass
Toxicity (Acute)	Pass
Material Medicated Pyrogen	Pass
Hemocompatibiity	Pass

Performance Testing - Bench

A summary of the pre-clinical bench testing performed on the Viradius Neurowire is presented in the table below.

Test	Method	Conclusion
Bond and JointTensile Strength	The guidewire, including all joints, must notsuffer damage when subjected to tensile force.	All devices metacceptance criteria.
Ultimate TorqueResponse	The guidewire must withstand a minimumcomplete rotations without physical damage.	All devices metacceptance criteria.
Torque Response	Distal tip rotation shall be equivalent to predicateguidewire.	All devices metacceptance criteria.
Tip Deflection	Tip deflection force shall be comparable toselected competitor guidewires.	All devices metacceptance criteria.
Push Track –AnatomicalModel	Force required to advance guidewire throughsimulated tortuous neurovascular arteries shall becomparable to predicate device.	All devices metacceptance criteria.
Surface Integrity	Guidewire surface shall not have any particulatevisible to the naked eye under close inspectionwithout magnification.	All devices metacceptance criteria.
GuidewireDiameter	The diameter was measured.	All devices metacceptance criteria.
GuidewireLength	The length was measured.	All devices metacceptance criteria.
CatheterCompatibility	Guidewire shall be compatible withmicrocatheters, distal access catheters, guidecatheters, and fluids.	All devices metacceptance criteria.
Kink Resistance	Proximal shaft shall not kink when subjected to abend radius.	All devices metacceptance criteria.
Flex Test	In accordance with ISO 11070:2014 8.5 theguidewire shall not fracture, loosen, or fail in sucha manner that any section of the coil is left free tostretch, a sharp, or potentially traumatic fracture	All devices metacceptance criteria.

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Distal FractureTest	surface is exposed, any part of the device becomesseparated such that it would not be removable bywithdrawing the device from use, or coatedguidewires show flaking of the coating.In accordance with ISO 11070:2014 8.4 theguidewire shall not fracture, loosen, or fail in sucha manner that any section of the coil is left free tostretch, a sharp, or potentially traumatic fracturesurface is exposed, or any part of the devicebecomes separated such that it would not beremovable by withdrawing the device from use.	All devices metacceptance criteria
Tip Bending andRetention	After insertion through a competitivemicrocatheter, the bend radius shall not degrade.	All devices metacceptance criteria
Device CoatingAdhesion	After simulated use, the guidewire coating shallnot exhibit any scratches, flaking, or generate anyloose coating material.	All devices metacceptance criteria
ParticulateTesting	The guidewire was evaluation for particulategeneration under simulated use in a representativetortuous model	Number and size ofparticulates generatedwas adequate
Corrosion Test	The guidewire shall not exhibit visual corrosionwhen immersed in sodium chloride solution	All devices metacceptance criteria

Performance Testing - Animal

No animal study was performed as there is no change to the indications for use or the fundamental scientific technology for the Viradius Neurowire. Substantial equivalence of the Viradius Neurowire has been established to the predicate device through the results of bench testing.

Performance Testing - Clinical

No clinical study was performed as there is no change to the indications for use or the fundamental scientific technology for the Viradius Neurowire. Substantial equivalence of the Viradius Neurowire has been established to the predicate device through the results of bench and design validation testing.

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.