The Navien™ Intracranial Support Catheter is a single lumen, flexible, variable stiffness composite catheter which has a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. The Navien™ Intracranial Support Catheter has a marker on the distal tip that is visible under fluoroscopy. The dimensions are included in the Navien™ Intracranial Support Catheter inner lumen can accommodate guidewires up to 0.038 inches in diameter to aid in placement of the catheter system. The catheter has both straight and pre-shaped tips.

The proximal end of the Navier™ Intracranial Support Catheter has a Luer fitting to allow attachment of accessories and infusion of liquids through the system. The Catheter is offered in various sizes to accommodate physician preferences and anatomical variations. The catheter is provided sterile, nonpyrogenic, and is intended for single use only.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Navien™ Intracranial Support Catheter, focusing on demonstrating substantial equivalence to a previously cleared predicate device due to a coating change. The study primarily relies on non-clinical bench and design validation testing, with no clinical or animal studies performed for the new device.

Here's an analysis of the acceptance criteria and the study based on the provided document:

Acceptance Criteria and Device Performance

The device's acceptance criteria and reported performance are primarily presented in the "Performance Testing – Bench" subsection.

Test	Acceptance Criteria	Reported Device Performance
Dimensional Inspection	Usable length, proximal and distal inner and outer diameters must meet all inspection criteria.	All devices met acceptance criteria.
Torque to Failure	The catheter must withstand multiple revolutions without failure.	Torque to failure testing met acceptance criteria.
Coating Lubricity/Durability	Average Friction Force must be comparable to the predicate device.	Coating lubricity and durability testing met acceptance criteria.
Liquid Leakage	Catheter shall not leak per ISO 10555-1.	Liquid leakage met acceptance criteria.
Dynamic Burst	Catheter shall not burst or leak during a dynamic pressure test.	Dynamic burst testing met acceptance criteria.
Tip Buckling	Compressive load shall not be statistically significantly different to comparable and/or the predicate device.	Tip buckling force met acceptance criteria.
Particulate Testing	Particulate must be within limits per USP <788>.	Number of particulates generated met acceptance criteria.
Physician Usability Testing	Assess navigation of Navien™ with new coating to the ICA and comparing Navien™ with new to Navien™ with old coating with regards to tip atraumaticity.	All test results met the acceptance criteria.
Biocompatibility (various tests)	As outlined in the "Biocompatibility" table (e.g., non-cytotoxic, non-sensitizer, non-irritant, non-pyrogenic, non-hemolytic, acceptable thromboresistance, no adverse effect on platelet/leukocyte/prothrombin, non-mutagenic).	All biocompatibility tests passed and met their respective criteria.

Study Details

Sample Size used for the test set and the data provenance:
- The document does not explicitly state specific sample sizes for each bench test beyond "All device met acceptance criteria" or "All test results met the acceptance criteria."
- The data provenance is from bench testing and in-vitro biocompatibility studies, performed at Micro Therapeutics, Inc. d/b/a ev3 Neurovascular and related contracted laboratories (e.g., Sterigenics for sterilization validation). As this is a medical device subject to FDA regulation in the USA, the testing would be expected to adhere to US regulatory standards. The data is retrospective in the sense that it evaluates the manufactured device against pre-defined criteria, rather than collecting new patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the "Physician Usability Testing," the document states "The device was navigated through a tortuous benchtop model to assess accessibility and the tip atraumatic profile." It also mentions assessing navigation and tip atraumaticity.
- The document does not specify the number of physicians or their qualifications used for this usability testing. It just refers to "Physician Usability Testing."
- For other bench tests, the ground truth is established by objective engineering and analytical measurements against established standards (e.g., ISO, USP).
Adjudication method for the test set:
- The document does not describe an adjudication method in the context of expert review for the test set. Given the nature of the tests (bench and usability), outcomes are likely determined by direct measurement against criteria or consensus during usability observations, rather than a formal expert adjudication process typically used in clinical studies involving multiple readers.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This document pertains to a medical device (intracranial support catheter), not an AI diagnostic or assistance system. Therefore, the concept of human readers improving with or without AI assistance is not applicable here.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, this is not applicable. The device is a physical catheter, not an algorithm or AI system.
The type of ground truth used:
- For the bench testing, the ground truth is based on objective engineering measurements against established international standards (e.g., ISO 10555-1, USP <788>) and comparative performance relative to the predicate device.
- For biocompatibility testing, the ground truth is derived from standardized biological assays and chemical analysis against recognized guidelines (AAMI/ANSI/ISO 10993-1:2009, FDA Blue Book Memorandum G95-1, USP).
The sample size for the training set:
- Not applicable. This submission is for a physical medical device (catheter), not an AI or machine learning model that requires a "training set." The testing performed is to demonstrate the physical and biological characteristics of the manufactured device.
How the ground truth for the training set was established:
- Not applicable. As stated above, there is no "training set" in the context of this device submission.

Summary

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

October 12, 2016

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ms. Jennifer Correa Sr. Product Specialist/Regulatory Affairs 9775 Toledo Way Irvine, California 92618

Re: K161152

Trade/Device Name: Navien Intracranial Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 6, 2016 Received: September 8, 2016

Dear Ms. Correa:

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 -SA

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) K161152

Device Name

Navien™ Intracranial Support Catheter

Indications for Use (Describe)

The Navien™ Intracranial Support Catheter is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

510(k) Owner:	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular9775 Toledo WayIrvine, CA 92618Establishment Registration No. 2029214
Contact Person:	Jennifer CorreaSenior Regulatory Affairs SpecialistTelephone: (949) 297-9563E-mail: jennifer.l.correa@medtronic.com
Date Summary Prepared:	September 6, 2016
Trade Name of Device:	Navien™ Intracranial Support Catheter
Common Name of Device:	Catheter, Percutaneous
Classification of Device:	21 CFR 870.1250 – Class II
Product Code:	DQY
Predicate Device:	Navien™ Intracranial Support Catheter, 510(k)#: K110055Originally cleared under trade name: ReFlex™ Guide Catheter
Performance Data:	The following testing was performed to support the coating change to the Navien™ Intracranial Support Catheter with new coating to establish substantial equivalence to the Navien™ Intracranial Support Catheter with old coating:Visual/Dimensional Inspection Torque Strength Coating Lubricity Catheter Leakage Test (Liquid) Dynamic Pressure Test Distal Tip Buckling Particulate Testing Physician Usability Testing The following testing was leveraged from the predicate device due to sufficiency of the existing testing record and justification for adoption: System Dimensional- Length Kink Resistance Flow Rate During Continuous Flush (for information only) Leakage (Static Burst Test)

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Aspiration ●
Labeling ●
Catheter Hub (ISO 594-1) ●
Tensile Srength
Corrosion Resistance ●
Tip Configuration ●
Radiopacity ●

A Design Validation study was performed on a bench model to assess the substantial equivalence and usability of Navien™ Intracranial Support Catheter with new coating compared to the previously cleared Navien™ Intracranial Support Catheter with old coating. Biocompatibility testing, sterilization, and a 2-year accelerated aging study were also performed. No clinical studies were performed as there is no change to the indications for use or the fundamental scientific technology of the device.

The Navien™ Intracranial Support Catheter with new coating is Conclusion: substantially equivalent to the currently cleared Navien™ Intracranial Support Catheter with old coating based on the successful completion of non-clinical bench and design validation testing as well as identical principles of design, operation and indications for use.

Device Description:

Indications for Use:

The Navien™ Intracranial Support Catheter is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

Device Comparison

The table below provides a comparison of the technological characteristics of the Navien™ Intracranial Support Catheter with old coating and the currently cleared Navien™ Intracranial Support Catheter.

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	Navien™ Intracranial SupportCatheter with old coating(K110055)	Navien™ Intracranial SupportCatheter with new coating
Indication forUse	The Navien™ Intracranial SupportCatheter is indicated for theintroduction of interventional devicesinto the peripheral andneurovasculature.	Same
Catheter ShaftMaterials	PTFE lined polymeric catheter, withhydrophilic coating	Same
Catheter ShaftSupport	Nitinol	Same
Marker band	Platinum	Same
Usable Length	90 - 130 cm	Same
Distal ID	0.046" – 0.072"	Same
Distal OD	0.058"–0.084" max	Same
Proximal ID	0.046" – 0.072"	Same
Proximal OD	0.058"–0.084" max	Same
TipConfiguration	Single, straight flexible tip	Same
SterilizationMethod	Ethylene Oxide	Same
Packaging	Catheter in polyethylene hoopattached to packaging card insidePET/PE/Tyvek pouch inside SBScarton	Same

Sterilization and Shelf Life

The packaged Navien™ Intracranial Support Catheter with new coating is sterilized using a validated ethylene oxide (EO) sterilization cycle at the Sterigenics US; LLC facility located at 4900 Gifford Avenue, Los Angeles, CA. The sterilization cycle has been validated to ensure a sterility assurance level (SAL) of 10° in accordance with ISO 11135-1:2007, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

Aging studies for the Navien™ Intracranial Support Catheter with new coating device has established the product and packaging remain functional and maintain sterility for up to 24 months. Aging studies for packaging integrity, seal strength, and device functionality were performed and met all acceptance criteria.

Biocompatibility

Biocompatibility testing was performed in compliance with the FDA consensus standard, recognition number 2-156, AAMI/ANSI/ISO 10993-1: 2009, Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process and U.S. Food and Drug Administration (FDA)

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Blue Book Memorandum G95-1 (1995) guidelines. All studies were conducted in compliance with U.S. Food and Drug Administration Good Laboratory Practice (GLP) regulations set forth in 21 CFR Part 58.

Test	Result	Conclusion
Plastics (USP)	Meets USP Physicochemicalextraction parameters.	Passes physical chemicalcharacteristics.
L929 MEM Elution Test - ISO	The test article scored "0" at 24, 48and 72 ± 4 hours and is considerednon-cytotoxic under the conditionsof this test.	Non-cytotoxic
Klingman Maximization Test –ISO (Guinea Pig Sensitization)	Under the conditions of thisprotocol, the test article did notelicit a sensitization response.	Non-sensitizer
Intracutaneous Injection Test -ISO	The differences in the mean testand control scores of the extractdermal observations were less than1.0, indicating that the requirementsof the ISO IntracutaneousReactivity Test have been met bythe test article.	Non-irritant
Acute Systemic Injection Test –ISO	None of the test article extracttreated animals were observed withclinical signs consistent withtoxicity at any of the observationperiods.	Non-cytotoxic
Materials Mediated RabbitPyrogen - ISO	This response did not exceed theUSP limit and meets therequirements for this test. Thereforethese results indicate that the testarticle was determined to be non-pyrogenic.	Non-pyrogenic
Hemolysis: Direct Contact /Indirect Extract	There were no significantdifferences between the test articleextract and negative control articleresults. The test article isconsidered non-hemolytic	Non-hemolytic
Complement activation C3a andSC5b-9	The levels of C3a and SC5b-9 ofthe NavienTM catheter with newcoating are comparable to theNavienTM with old coating and lessthan that of the positive control.	Levels of the compliments C3aand SC5b complements weresimilar for Navien and controldevice
Thrombosis ( in vivo ) – Canine(Navien)	The thromboresistance propertiesof the NavienTM IntracranialSupport Catheters are acceptable inclinical use.	Acceptable, expected to beequivalent to Navien in clinicaluse
Test	Result	Conclusion
in vitro HemocompatibilityAssay	The Navien Guide Catheter did notresult in a decrease in any bloodcomponent as compared to thereference material. These resultsindicate that the cause of thrombi isnot related to the materials exposedto human blood during use.	No adverse effect on plateletand leukocyte counts
Partial Thromboplastin Time	Clotting times for the Navien(predicate device) test arms weresimilar to the negative control andthe reference material (HDPE),indicating that the device materialsare not an activator of the intrinsiccoagulation pathway.	No adverse effect onprothrombin coagulation timeof human plasma.
Ames bacterial Mutagenicity 4salmonella+1e. coli	Based on the criteria and conditionsof the study protocol, the test articleis considered non-mutagenic.	Non-mutagenic
in vitro Mouse Lymphoma Assaywith Extended Treatment	The test article is considered to benon-mutagenic (non-genotoxic andnon-clastogenic) in this test system.	Non-mutagenic
in vivo Mouse MicronucleusAssay	Based on the criteria of the assay,the test article is considered non-mutagenic in this test system.	Non-mutagenic

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Performance Testing – Bench

A summary of the pre-clinical bench testing performed for the Navien™ Intracranial Support Catheter is presented in the table below.

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Test	Method	Acceptance Criteria	Conclusions
Dimensional Inspection	The usable length,proximal and distal innerand outer diameters weremeasured and recorded.	Usable length, proximaland distal inner and outerdiameters must meet allinspection criteria	All device metacceptance criteria.
Torque to Failure	Device was tested for full-length torque strength todetermine number ofrotations to failure.	The catheter mustwithstand multiplerevolutions without failure	Torque to failure testingmet acceptance criteria.
CoatingLubricity/Durability	Device coating wasevaluated for averagefrictional force anddurability.	Average Friction Forcemust be comparable to thepredicate device	Coating lubricity anddurability testing metacceptance criteria.
Liquid Leakage	Device was tested for ISO10555-1, Annex C liquidleakage testing.	Catheter shall not leak perISO 10555-1	Liquid leakage metacceptance criteria.
Dynamic Burst	Device was tested underfull-length staticconditions to burst and atpressures experiencedduring worst-case dynamicinjections.	Catheter shall not burst orleak during a dynamicpressure test	Dynamic burst testingmet acceptance criteria.
Tip Buckling	Repeated distal tipbuckling force undercompressive load wasevaluated for stiffness.	Compressive load shall notbe statisticallysignificantly different tocomparable and/or thepredicate device	Tip buckling force metacceptance criteria.
Particulate Testing	Device was evaluated forparticulate generationunder simulated use in arepresentative tortuousanatomical model perUSP<788>	Particulate must be withinlimits per USP<788>	Number of particulatesgenerated metacceptance criteria.
Physician UsabilityTesting	The device was navigatedthrough a tortuousbenchtop model to assessaccessibility and the tipatraumatic profile.	Assess navigation ofNavien™ with newcoating to the ICA andcomparing Navien™ withnew to Navien™ with oldcoating with regards to tipatraumaticity.	All test results met theacceptance 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 new device. Substantial equivalence of the Navien™ Intracranial Support Catheter with new coating has been established to the predicate device through the results of bench testing.

Performance Testing – Clinical

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No clinical study was performed as there is no change to the indications for use or the fundamental scientific technology for the new devices. Substantial equivalence of the Navien™ Intracranial Support Catheter with new coating has been established to the predicate device through the results of bench and design validation testing.

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).