Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and performance of a guide catheter, with no mention of AI or ML.

Therapeutic

No
The device is a guide catheter, which is used to facilitate the insertion and guidance of microcatheters, not to treat a medical condition directly.

Diagnostic

No

This device is a guide catheter, which is used to facilitate the insertion and guidance of microcatheters. Its described function is interventional, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly details a physical guide catheter with a shaft, radiopaque markers, hydrophilic coating, and a luer hub. This is a hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for "facilitating the insertion and guidance of microcatheters into a selected blood vessel". This is an in vivo procedure, meaning it is performed within a living organism.
Device Description: The description details a physical catheter designed to be inserted into blood vessels.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.

IVD devices are used outside the body to analyze samples. This device is used inside the body to facilitate a medical procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The MIVI Mi-Axus™ Guide Catheter is indicated for use in facilitating the insection and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

Product codes

DQY

Device Description

The MIVI Mi-Axus 8F Guide Catheter consists of a single lumen, braided, variable stiffness shaft designed for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary, or neurovascular system. A radiopaque marker is included on the distal end for angiographic visualization. The catheter shaft has a hydrophilic coating to reduce friction during use. Additionally, the distal segment of the PEBAX shaft of the 8F device is impregnated with Barium Sulfate (BaS04) for increased radiopacity. A luer hub on the proximal end allows attachments for flushing, insertion of catheters, and aspiration. It is used in junction with a rotating hemostatic valve with side-arm adapter for flushing, catheter insertion and aspiration. The MIVI Mi-Axus Guide Catheter has a straight distal tip and is available in lengths of 80 or 90 cm and an 8F diameter.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral, coronary and neuro vascular systems.

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

Not Applicable - No clinical data was needed to demonstrate substantial equivalence to the predicate devices.

Key Metrics

Not Found

Predicate Device(s)

MIVI MI-AXUS 6F Guide Catheter - K140557, Penumbra Neuron™ MAX System - K111380

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right.

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

December 9, 2015

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

Re: K151396

Trade/Device Name: MIVI Mi-Axus™ Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: November 6, 2015 Received: November 9, 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 -SFD/公

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) K151396

Device Name MIVI Mi-Axus™ Guide Catheter

Indications for Use (Describe)

The MIVI Mi-Axus™ Guide Catheter is indicated for use in facilitating the insection and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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 PRAStaff(@fda.hhs.gov

"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."

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Image /page/3/Picture/0 description: The image is a logo for MIVI Neuroscience. The logo is in a rounded rectangle with the words "MIVI" in large, bold, blue letters. Below the word "MIVI" is the word "NEUROSCIENCE" in smaller, blue letters. To the right of the words is a blue silhouette of a human head with a brain inside.

510(k) SUMMARY

Date Prepared: 28-July-2015

Submitter's Name / Contact Person

Manufacturer

Contact Person

MIVI Neuroscience, INC 6545 City West Parkway Eden Prairie, MN 55344

Matthew Ogle President and CEO Phone: 612-381-7674 Email: mogle@mivineuro.com

General Information

Trade Name	MIVI Mi-Axus™ Guide Catheter
Common / Usual Name	Guide Catheter
Classification Name	Percutaneous Catheter (21 CFR 870.1250, Product Code DQY)
Regulatory Classification
Class	II
Panel	Division of Cardiovascular Devices (DCD)
Peripheral Interventional Devices Branch (PIDB)
Predicate Device(s)	MIVI MI-AXUS 6F Guide Catheter - K140557
Penumbra Neuron™ MAX System - K111380

Device Description

The MIVI Mi-Axus 8F Guide Catheter consists of a single lumen, braided, variable stiffness shaft designed for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary, or neurovascular system. A radiopaque marker is included on the distal end for angiographic visualization. The catheter shaft has a hydrophilic coating to reduce friction during use. Additionally, the distal segment of the PEBAX shaft of the 8F device is impregnated with Barium Sulfate (BaS04) for increased radiopacity. A luer hub on the proximal end allows attachments for flushing, insertion of catheters, and aspiration. It is used in junction with a rotating hemostatic valve with side-arm adapter for flushing, catheter insertion and aspiration. The MIVI Mi-Axus Guide Catheter has a straight distal tip and is available in lengths of 80 or 90 cm and an 8F diameter.

Intended Use / Indications

The MIVI Mi-Axus Guide Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

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Image /page/4/Picture/0 description: The image shows the logo for MIVI Neuroscience. The logo is in a rounded rectangle shape with the text "MIVI" in large, bold, teal letters on the left side. Below "MIVI" is the word "NEUROSCIENCE" in smaller teal letters. To the right of the text is a teal silhouette of a human head with a stylized brain inside.

Principle of Operation

The device will be utilized to endovascularly insert and guide microcatheters under fluoroscopy so that the microcatheters can deliver contrast agents or other devices during diagnostic and/or therapeutic procedures for patients with arterial disease or damage. The subject 8F device will incorporate Barium Sulfate (BaS04) into the distal segment of the PEBAX shaft in order to increase radiopacity.

Accessories

There are no accessories to the MIVI 8F Guide Catheters.

	Subject Device	Predicate Device	Predicate Device
Feature	MIVI Mi-Axus
8F, 80 or 90cm
Guide Catheter	MIVI Mi-Axus 6F
110cm Guide
Catheter	Penumbra Neuron
Max 8F, 80 or 90cm
Guide Catheter.
Inner diameter –
0.088"
Classification	II, DQY	II, DQY	II, DQY
Indications for
Use	The MIVI 8F
Guide Catheter is
indicated for use in
facilitating the
insertion and
guidance of
microcatheters into
a selected blood
vessel in the
peripheral,
coronary and neuro
vascular systems.	The MIVI 6F Guide
Catheter is indicated
for use in facilitating
the insertion and
guidance of
microcatheters into a
selected blood vessel
in the peripheral,
coronary and neuro
vascular systems.	The Neuron MAX
System is indicated
for the introduction
of interventional
devices into the
peripheral, coronary,
and neuro
vasculature.
Materials, Packaging and Sterilization
Shaft Materials	PTFE lined
PEBAX with
stainless steel
braid, PEBAX
impregnated
with Barium
Sulfate ( $BaSO_4$ )	PTFE lined PEBAX
with stainless steel
braid	Catheter Type -
Braid reinforced.
Proximal End
Configuration	Hub with female
luer conical fitting	Hub with female luer
conical fitting
	Subject Device	Predicate Device	Predicate Device
Feature	MIVI Mi-Axus
8F, 80 or 90cm
Guide Catheter	MIVI Mi-Axus 6F
110cm Guide
Catheter	Penumbra Neuron
Max 8F, 80 or 90cm
Guide Catheter.
Inner diameter –
0.088"
Packaging	Catheter
attached to an
SBS packaging
card inside
PET/PE/Tyvek
pouch, inside
SBS box	Catheter attached to
an SBS packaging
card inside
PET/PE/Tyvek
pouch, inside SBS
box
Sterilization	Ethylene Oxide	Ethylene Oxide
Dimensions
Usable Length	75 ± .5 or 85 ± .5
(cm)	105 ± .5
Outer Diameter	8F	6F	8F
Proximal ID (mm,
inches, F)	2.26mm
(0.089")
6.8F

or -
2.3mm
(0.089")
6.8F | 1.6mm
(0.063")
4.8F | |
| Proximal OD (mm,
inches, F) | 2.7mm
(0.108")
8F | 2.0mm
(0.079")
6F | |
| Distal ID when
hydrated (mm,
inches, F) | 2.26mm
(0.089")
6.8F
-or-
2.3mm
(0.089")
6.8F | 1.3mm
(0.053")
3.9F | |
| Distal OD when
hydrated (mm,
inches. F) | 2.7mm
(0.108")
8F | 1.8mm
(0.069")
5.3F | |
| Lumenal
Maximum Length | 83 or 93 | 113 | |
| Tip Shape
Radiopaque Shaft
Segment | Straight
Yes | Straight
No | Yes |
| | | | |

Comparison to Predicate Devices:

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Image /page/5/Picture/0 description: The image is a logo for MIVI Neuroscience. The logo features the word "MIVI" in large, bold, teal letters, with the word "NEUROSCIENCE" in smaller letters underneath. To the right of the text is a teal silhouette of a human head, with the brain visible inside. The entire logo is enclosed in a rounded teal border.

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Image /page/6/Picture/0 description: The image is a logo for MIVI Neuroscience. The logo is in a rounded rectangle shape with a blue border. The word "MIVI" is in large, bold, blue letters, and the word "NEUROSCIENCE" is in smaller, blue letters below it. To the right of the text is a blue silhouette of a human head with the brain visible.

Functional Testing:

Design verification testing of the MIVI 8F Guide Catheter consisted of:

Performance Test	Result
Surface Integrity	Met established criteria
Torque Response – Catheter	Met established criteria*
Catheter Kink Resistance - Proximal Section	Met established criteria
Catheter Kink Resistance and Coating Damage – Distal
Section	Met established criteria
Catheter – Coating Adhesion	Met established criteria
Catheter – Coating Uniformity	Met established criteria
System - Introduction	Met established criteria
Device Compatibility	Met established criteria
Push/Track - Catheter	Met established criteria
Tip Stiffness	Met established criteria

Deviation - The original protocol requirements stated that the torque response would be measured in the Tortuous Path Anatomical Model. Based on feedback from the initial FDA submission, the 8F MI-AXUS Catheter was tested using the Farlow's Glass Model as it is more representative of the distal tortuosity. The model used represents a more challenging condition and would be considered worst case.

Testing for the line extension of the subject MIVI 8F Guide Catheter was conducted in accordance with ISO 10555-1:2013 - Sterile, Single Use Intravascular Catheters.

Biocompatibility:

The predicate 6F MIVI Mi-Axus catheter of the Mi-Axus catheter assembly was previously demonstrated to be biologically safe. The 8F device uses the same materials and manufacturing processes as the predicate device, with the addition of Barium Sulfate (BaS02) which is impregnated into the PEBAX of the catheter shaft. Therefore, only a limited number of tests were considered necessary to determine the extractability of the BaS04.

Testing was conducted in accordance with EN ISO 10993-1. MIVI Mi-Axus 8F Guide Catheters have been classified according to EN ISO 10993-1:2009. Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing as follows:

Category: Externally Communicating Contact type: Circulating blood Contact Duration: Limited exposure (≤24 hours)

Based on this classification, tests relevant to the device described within this premarket notification were selected and conducted in accordance with EN ISO 10993-1 and its applicable sub-parts.

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Image /page/7/Picture/0 description: The image shows the logo for MIVI Neuroscience. The logo features the word "MIVI" in large, teal, sans-serif font, with the word "NEUROSCIENCE" in a smaller font size underneath. To the right of the text is a teal silhouette of a human head, with a stylized representation of the brain inside. The entire logo is enclosed in a rounded rectangle with a teal border.

The catheter component of the MIVI Mi-Axus 8F Guide Catheter assembly is the only part of the device that comes in contact with the patient, thus, this is the only item that was assessed. The component successfully passed the following biocompatibility tests:

| Test Method | ISO 10993-1
Test Category | Test Method Summary |
|-------------------------------------------------------------------|----------------------------------|---------------------|
| L929 MEM Elution Test – ISO | Cytotoxicity | Non-Cytotoxic |
| Hemolysis – Rabbit Blood
Direct and Indirect Contact –
ASTM | Hemocompatibility
(Hemolysis) | Non-Hemolytic |

The following was performed to assess the amount of Barium that could be extracted and whether it is within acceptable limits.

| Test Method | ISO 10993-18
Test Category |
|--------------------------------------------------------------|-------------------------------|
| Material Qualification in support of ISO 10993-18 – Non -GLP | Extraction |

A toxicological risk assessment was conducted to determine whether repeated patient exposure to the levels of extractables from the test article, could produce unacceptable human health risks.

The report concluded the following:

. Since all surfaces of the device were extracted under exaggerated conditions, the extraction conditions and ratios represented the worst case scenario with respect to the leachable chemicals.
Overall, test results indicated that the device is biocompatible. Specifically, cytotoxicity ● and hemocompatibility results met the specified requirements.
All extractables, including an unknown compound from the semi-volatile organic scan in hexane extract, were lower than their recommended or calculated tolerable intake (TI) levels, resulting in margins of safety (MOS) that are greater than one (i.e. at least 10-fold greater, as MFs varied, based on the applied uncertainty factors).
. The overall risk profile of the Guide Catheter 8FR with BaSO4 is considered to be acceptable for the intended patient population and duration of use.

Sterilization and Residuals:

The MIVI 8F Guide Catheter meets ethylene Oxide (EO) and ethylene chlorohydrin (ECH) residuals specified in EN ISO 10993-7:2008, Biological Evaluation of Medical Devices - Part 7:

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Image /page/8/Picture/0 description: The image is a logo for MIVI Neuroscience. The logo is teal and features the word "MIVI" in large, bold letters, with the word "NEUROSCIENCE" in smaller letters underneath. To the right of the text is a silhouette of a human head, with the brain and blood vessels visible. The entire logo is enclosed in a rounded rectangle.

Ethylene Oxide Sterilization Residuals. A sterility assurance level (SAL) of 106 will be demonstrated.

Summary of Clinical Performance Data

Not Applicable - No clinical data was needed to demonstrate substantial equivalence to the predicate devices.

Conclusion

MIVI Neurosciences has determined its 8F Guide Catheter to be substantially equivalent to the current legally marketed predicate devices because of the following:

1. Intended use and indications for use are the same as for the predicate devices.
1. There is no difference in the fundamental scientific technology of the devices.
1. The risk assessments and successful verification testing including testing to EN ISO 10555-1, raise no new questions of safety and effectiveness.