Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

No.
The device facilitates the insertion and guidance of microcatheters and is used as a diagnostic angiographic catheter, which are not considered therapeutic actions.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states, "It may also be used as a diagnostic angiographic catheter."

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical catheter with a shaft, radiopaque marker, hydrophilic coating, and luer hub. The performance studies also focus on physical characteristics and biocompatibility of a hardware device.

IVD (In Vitro Diagnostic)

No, 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" and "may also be used as a diagnostic angiographic catheter." These are procedures performed in vivo (within the living body).
Device Description: The description details a physical catheter designed to be inserted into blood vessels.
Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. This device does not perform any such analysis of specimens.

The term "diagnostic angiographic catheter" in the intended use refers to its ability to be used during angiography, which is a diagnostic imaging technique performed in vivo to visualize blood vessels. It doesn't mean the catheter itself is performing an in vitro diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The MiVi 6F Guide Catheter is indicated for use in facilitating the insertion and guidance of microcathers into a selected blood vessel in the peripheral, coronary and neuro vascular systems. It may also be used as a diagnostic angiographic catheter.

Product codes (comma separated list FDA assigned to the subject device)

DQY

Device Description

The MiVi 6F Guide Catheter consists of a single lumen, braided, variable stiffness shaft designed for use in facilitating the insertion and guidance 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. 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 6F Guide Catheter has a straight distal tip and is available in a 110 cm length and 6F 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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Design verification testing of the MiVi 6F Guide Catheter consisted of:

Push/Track: Met established criteria
Stent Crossing: Met established criteria
Tip Stiffness: Met established criteria
Torque Response: Met established criteria
Kink Resistance: Met established criteria
Tensile: Met established criteria
Luer Leakage: Met established criteria
Coating Adhesion: Met established criteria
Coating Uniformity: Met established criteria
Coating Thickness: Met established criteria
Surface Integrity: Met established criteria
Radiopacity: Met established criteria
System Introduction: Met established criteria
Device Compatibility: Met established criteria

Testing was conducted in accordance with ISO 10555-1:2013, ISO 10555-3:2013, AAMI TIR42:2010, ISO 594-1 and ISO 594-2 standards and FDA guidance: FDA Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters September 8, 2010.

Shelf Life Testing (Product and Packaging) and Distribution Shipping Challenge Conditioning and Testing were performed and the devices met established criteria.

Packaging Verification Testing complies with EN ISO 11607-1 and assessed the ability of finished packages to withstand the effects of anticipated hazards of the distribution environment on essential packaging characteristics and the ability of packaging to protect the device and to maintain sterility (sterile barrier testing).

Biocompatibility testing was conducted in accordance with EN ISO 10993-1. MiVi 6F 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.

The MiVi 6F Guide Catheter devices meet ethylene Oxide (EO) and ethylene chlorohydrin (ECH) residuals specified in EN ISO 10993-7:2008, Biological Evaluation of Medical Devices -Part 7: Ethylene Oxide Sterilization Residuals. A sterility assurance level (SAL) of 10-6 will be demonstrated.

Testing showed the device, including its packaging, to be biocompatible for its intended use as an externally communicating, circulating blood contacting device as classified under EN ISO 10993-1:2009. The MiVi 6F Guide Catheter successfully passed all of the following biocompatibility tests and was found to be safe and effective and substantially equivalent to the predicate device from a biocompatibility perspective.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Cytotoxicity - ISO MEM Elution Assay: The test article scored '0' at 24, 48, and 72 hours and is considered non-cytotoxic. Conclusions: Not cytotoxic.
Irritation or Intracutaneous Reactivity - ISO Intracutaneous Reactivity Test: Animals in the study showed no abnormal clinical signs, no significant dermal reactions at the injection and control sites at the 24, 48, and 72 hour observation period. Conclusions: Non-irritating.
Hemocompatibility Hemolysis - ASTM Hemolysis Direct Contact and Extract Methods: The test article had a blank corrected hemolytic index of 0.1% above the control in the direct contact test. The test article had a blank corrected hemolytic index of 0.0 % above the control in the extract test. Conclusions: Non-hemolytic.
Hemocompatibility Thrombosis - Four Hour Thromboresistance Evaluation in Dogs: The combined analysis of APTT, platelet counts, device weights, and clinical observations indicated that the animal's clotting abilities were not compromised after implantation of the devices. The test article had similar thromboresistance results to the predicate device so was found to be substantially equivalent to it. Conclusions: Similar thromboresistance characteristics as control Stryker Concentric Guide Catheter Predicate Device.
Hemocompatibility Complement Activation - Complement Activation C3a and SC5b-9): The test article concentrations of C3a was 1.0 and the predicate device was 3.2 and SC5b-9 was 0.0 and the predicate device was 1.1 so the test article was not found to be an activator of complements. The test article results were also comparable to the predicate device so was found to be substantially equivalent to it. Conclusions: Comparable to Stryker Concentric Guide Catheter predicate device for complement activation. Not an activator.
Pyrogenicity - Limulus Amebocyte Lysate (LAL) Limit Test: Both test articles contained

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 shows the logo for the U.S. Department of Health and 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 right, with flowing lines beneath them, possibly representing water or movement.

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

September 18, 2014

MiVi Neuroscience, LLC Ms. Michelle Straight VP of Quality & Regulatory 10900 73td Avenue North, Suite 150 Maple Grove, MN 55369

Re: K140557 Trade/Device Name: MiVi 6F Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 14, 2014 Received: August 15, 2014

Dear Ms. Straight,

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 (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 -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K140557

Device Name MiVi 6F Guide Catheter

Indications for Use (Describe)

The MiVi 6F Guide Catheter is indicated for use in facilitating the insertion and guidance of microcathers into a selected blood vessel in the peripheral, coronary and neuro vascular systems. It may also be used as a diagnostic angiographic catheter.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Carlos L. Pena -S

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:

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Image /page/3/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 and blood vessels visible. The entire logo is enclosed in a rounded teal rectangle.

10900 73rd Ave. North, Suite 150 Maple Grove, MN 55369

510(k) SUMMARY: K140557

Date Prepared: 3-Mar-2014

Submitter's Name / Contact Person

Manufacturer

MiVi Neuroscience, LLC 10900 73rd Ave N, Suite 150 Maple Grove, MN 55369

Contact Person

Michelle Straight Vice President of RA/QA Phone: 612-940-7240 Fax: 763-577-1044 Email: mstraight@mivi.neuro.com

General Information

Trade Name	MiVi 6F Guide Catheter
Common / Usual Name	Guide Catheter
Classification Name	Percutaneous Catheter (21 CFR 870.1250, Product Code DQY)
Regulatory Classification
Class	II
Panel	Neurodiagnostic and Neurotherapeutic Device (NNDB) Division of Neurological and Physical Medicine Devices (DNPMD)
Predicate Device(s)	Stryker Concentric ® Medical, Inc. K110483 Modified HD Guide Catheter Stryker Concentric ® Distal Access Catheters Models 90120, 90121, 90130, 90131, 90160, 90161 and 90162

Device Description

The MiVi 6F Guide Catheter consists of a single lumen, braided, variable stiffness shaft designed for use in facilitating the insertion and guidance 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. 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 6F Guide Catheter has a straight distal tip and is available in a 110 cm length and 6F diameter.

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Intended Use / Indications

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. It may also be used as a diagnostic angiographic catheter.

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.

Accessories

There are no accessories to the MiVi 6F Guide Catheters.

	Subject Device	Predicate Device	Predicate Device
Feature	MiVi 6F Guide
Catheter	Stryker Concentric®
Medical, Inc. K110483
Modified HD Guide
Catheter
Stryker Concentric
REF 90170 and 90171	Stryker Concentric®
Distal Access Catheters
REF 90120, 90121,
90130, 90131, 90160,
90161 and 90162
Classification	II, DQY	II, DQY	II, DQY
Indications for
Use	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 Modified HD Guide
Catheter is indicated for
facilitating the insertion
and guidance of an
occlusion catheter,
infusion catheter or
other appropriate
microcatheter into a
selected blood vessel in
the peripheral, coronary
and neuro vascular
systems. It may also be
used as a diagnostic
angiographic catheter.	The Distal Access
Catheter is indicated for
use in facilitating the
insertion and guidance of
an occlusion catheter,
infusion catheter or other
appropriate
microcatheter into a
selected blood vessel in
the peripheral, coronary
and neuro vascular
systems. It may also be
used as a diagnostic
angiographic catheter.
Shaft
Materials
Materials, Packaging and Sterilization	PTFE lined PEBAX
with stainless steel
braid	PTFE lined polymer
with stainless steel braid	PTFE lined polymer
with stainless steel braid
Proximal End	Hub with female luer	Hub with female luer	Hub with female luer
Configuration	conical fitting	conical fitting	conical fitting
Packaging	Catheter attached to an
SBS packaging card
inside PET/PE/Tyvek
pouch, inside SBS box	Catheter attached to SBS
packaging card inside
carton	Catheter attached to SBS
packaging card inside
carton
Sterilization	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide

Comparison to Predicate Devices:

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	Subject Device	Predicate Device	Predicate Device
Feature	MiVi 6F Guide
Catheter	Stryker Concentric®
Medical, Inc. K110483
Modified HD Guide
Catheter
Stryker Concentric
REF 90170 and 90171	Stryker Concentric®
Distal Access Catheters
REF 90120, 90121,
90130, 90131, 90160,
90161 and 90162
Dimensions
Effective
Length	107.3 cm	105 cm
120 cm	115 cm to 136 cm
Outer Diameter	6F	6.3F	3.9F to 5.2F
Inner Diameter	Distal: .054"
Proximal: .064"	.070"	.038" to .057"
Tip Shape	Straight	Straight	Straight

Design verification testing of the MiVi 6F Guide Catheter consisted of:

Performance Test	Result
Push/Track	Met established criteria
Stent Crossing	Met established criteria
Tip Stiffness	Met established criteria
Torque Response	Met established criteria
Kink Resistance	Met established criteria
Tensile	Met established criteria
Luer Leakage	Met established criteria
Coating Adhesion	Met established criteria
Coating Uniformity	Met established criteria
Coating Thickness	Met established criteria
Surface Integrity	Met established criteria
Radiopacity	Met established criteria
System Introduction	Met established criteria
Device Compatibility	Met established criteria

Testing was conducted in accordance with ISO 10555-1:2013, ISO 10555-3:2013, AAMI TIR42:2010, ISO 594-1 and ISO 594-2 standards and FDA guidance: FDA Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters September 8, 2010.

Shelf Life Testing (Product and Packaging) and Distribution Shipping Challenge Conditioning and Testing were performed and the devices met established criteria.

Packaging Verification Testing complies with EN ISO 11607-1 and assessed the ability of finished packages to withstand the effects of anticipated hazards of the distribution environment on essential packaging characteristics and the ability of packaging to protect the device and to maintain sterility (sterile barrier testing).

Biocompatibility testing was conducted in accordance with EN ISO 10993-1. MiVi 6F Guide Catheters have been classified according to EN ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing as follows:

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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.

The MiVi 6F Guide Catheter devices meet ethylene Oxide (EO) and ethylene chlorohydrin (ECH) residuals specified in EN ISO 10993-7:2008, Biological Evaluation of Medical Devices -Part 7: Ethylene Oxide Sterilization Residuals. A sterility assurance level (SAL) of 10-6 will be demonstrated.

Testing showed the device, including its packaging, to be biocompatible for its intended use as an externally communicating, circulating blood contacting device as classified under EN ISO 10993-1:2009. The MiVi 6F Guide Catheter successfully passed all of the following biocompatibility tests and was found to be safe and effective and substantially equivalent to the predicate device from a biocompatibility perspective.

Test	Results	Conclusions
Cytotoxicity - ISO MEM Elution
Assay	The test article scored '0' at 24, 48, and 72 hours and is
considered non-cytotoxic	Not cytotoxic
Irritation or Intracutaneous
Reactivity - ISO Intracutaneous
Reactivity Test	Animals in the study showed no
abnormal clinical signs, no
significant dermal reactions at the
injection and control sites at the
24, 48, and 72 hour observation
period.	Non-irritating
Hemocompatibility
Hemolysis - ASTM Hemolysis
Direct Contact and Extract
Methods	The test article had a blank
corrected hemolytic index of
0.1% above the control in the
direct contact test. The test
article had a blank corrected
hemolytic index of 0.0 % above
the control in the extract test.	Non-hemolytic
Hemocompatibility
Thrombosis - Four Hour
Thromboresistance Evaluation in
Dogs	The combined analysis of APTT,
platelet counts, device weights,
and clinical observations
indicated that the animal's
clotting abilities were not
compromised after implantation
of the devices. The test article
had similar thromboresistance
results to the predicate device so
was found to be substantially
equivalent to it.	Similar
thromboresistance
characteristics as control
Stryker Concentric
Guide Catheter
Predicate Device.

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Test	Results	Conclusions
Hemocompatibility
Complement Activation -
Complement Activation C3a and
SC5b-9)	The test article concentrations of
C3a was 1.0 and the predicate
device was 3.2 and SC5b-9 was
0.0 and the predicate device was
1.1 so the test article was not
found to be an activator of
complements. The test article
results were also comparable to
the predicate device so was found
to be substantially equivalent to
it.	Comparable to Stryker
Concentric Guide
Catheter predicate
device for complement
activation. Not an
activator
Pyrogenicity - Limulus
Amebocyte Lysate (LAL) Limit
Test	Both test articles contained