(133 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a guidewire, with no mention of AI/ML technology or data processing.
No
The device is a guidewire intended for selective placement of catheters, which is a supportive role in a medical procedure, not directly providing therapy.
No
The device is a guidewire intended for selective placement of catheters, which is an interventional/surgical tool, not a diagnostic one. Its performance studies focus on physical characteristics and usability, not disease detection or diagnosis.
No
The device description clearly outlines physical components such as a stainless steel wire core, platinum/tungsten coil, coatings, and packaging, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for selective placement of catheters within the neuro and peripheral vasculature." This describes a device used in vivo (within the body) for a procedural purpose (guiding catheters).
- Device Description: The description details a physical guidewire with coatings and packaging, designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical/interventional tool used directly within the patient's body.
N/A
Intended Use / Indications for Use
The Viradius™ Neurowire is intended for selective placement of catheters within the neuro and peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
MOF, DQX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neuro and peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following bench testing was performed in support of the Viradius Neurowire and to establish substantial equivalence to the NeuroScout Steerable Guidewire:
Bond and Joint Tensile Strength, Torque Response, Ultimate Torque Reponse, Tip Deflection, Push Track, Surface Integrity, Guidewire Diameter, Guidewire Length, Catheter Compatibility, Kink Resistance, Flex Test, Distal Fracture Test, Tip Bending and Retention, Device Coating Adhesion, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
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 Parkway
Eden Prairie, MN 55344 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Matt Ogle
President and CEO
Telephone: 952-944-3834 |
| Date Summary
Prepared | October 12, 2015 |
| Trade Name of
Device: | Viradius™ Neurowire |
| Common Name of
Device: | Guidewire |
| Classification of
Device: | 21 CFR 870.1330 - Class II |
| Product Code: | MOF - Primary
DQX - Secondary |
| Predicate Device: | NeuroScout Steerable Guidewire, 510(k)#: K100351 |
| Performance Data: | The following bench testing was performed in support of the Viradius
Neurowire and to establish substanstial equivalence to the NeuroScout
Steerable Guidewire:
Bond and Joint Tensile StrengthTorque ResponseUltimate Torque ReponseTip DeflectionPush TrackSurface IntegrityGuidewire DiameterGuidewire LengthCatheter CompatibilityKink ResistanceFlex TestDistal Fracture TestTip Bending and RetentionDevice Coating Adhesion |
4
- 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
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.
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 Steerable
Guidewire (K100351) | Rationale for
Difference (If
Present) |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
Use | The ViradiusTM
Neurowire is intended
for selective placement
of catheters within the
neuro and peripheral
vasculature. | The NeuroScout
Steerable Guidewire is
intended for selective
placement of
microcatheters and
other devices within
the neuro and
peripheral vasculature. | Similar indications,
included devices
tested with the
Viradius Neurowire. |
| Materials | | | |
| Core Material | Stainless Steel | Stainless Steel | N/A |
| | Viradius Neurowire | NeuroScout Steerable
Guidewire (K100351) | Rationale for
Difference (If
Present) |
| Coil Material | Platinum/Tungsten | Platinum/Tungsten | N/A |
| Coil to Core
Bond Material | Silver Braze | Adhesive | Bench testing
indicated similar
tensile strength. |
| Coating/Distal | Hydrophilic | Hydrophilic | The materials used for
the Viradius |
| Coating/
Proximal | Polytetrafluoro-
ethylene (PTFE) | Hydrophilic | Neurowire were
shown to be
biocompatible per ISO
10993 testing.
Materials of this type
are widely used in
similar medical
devices. |
| Dimensions | | | |
| Distal Diameter | 0.012" | 0.011" | Distal diameter needs
to be equal or less
than proximal
diameter for catheter
compatibility. |
| Proximal
Diameter | 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 the
flexible coil length. |
| Other Device Comparisons | | | |
| Radiopaque
Marker | No discrete marker
Platinum Coil at
distal tip | No discrete marker
Platinum Coil at
distal tip | N/A |
| Tip Shape/
Configuration | Straight | Straight | N/A |
| Sterility Method | Ethylene Oxide | Ethylene Oxide | N/A |
| Package | Hoop placed in
Breathable Pouch | Hoop placed in
Breathable Pouch | N/A |
5
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
6
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 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. | All devices met |
| acceptance criteria. | ||
| Guidewire | ||
| Length | The length was measured. | 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 | All devices met | |
| acceptance criteria. |
7
| Distal Fracture
Test | 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.
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 evaluation for particulate
generation under simulated use in a representative
tortuous model | 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 |
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.