The Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter are indicated for the introduction of interventional devices into the peripheral and neurovasculature.

Device Description

The Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter are designed for the introduction of interventional devices into the peripheral and neurovasculature. The Arc™ Mini are a single lumen, flexible, variable stiffness composite catheters with a Nitinol structure. A radiopaque marker band on the distal tip of the devices is used for visualization under fluoroscopy. The distal sections of both catheters are coated with a hydrophilic coating, which is used to reduce the overall frictional force during intravascular use. The Arc™ and Arc™ Mini dimensions are included in the individual device label. The devices are supplied sterile and are intended for single-use only.

AI/ML Overview

This document is a 510(k) Pre-Market Notification for the Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter. It focuses on establishing substantial equivalence to a predicate device (ReFlex™ Guide Catheter) through non-clinical testing. Therefore, it does not involve AI/ML performance criteria, human reader studies, or training/test sets as commonly understood in AI device submissions.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implicit from "met acceptance criteria")	Reported Device Performance
Lumen Patency	Mandrel of required size must pass through total length of device from proximal hub to distal tip.	All devices met acceptance criteria.
Dimensional Inspection	Dimensions (usable length, proximal/distal inner/outer diameters) must meet specified values.	All devices met acceptance criteria.
Distal Tip Buckling	Distal tip buckling force must meet specified criteria for stiffness under compressive load.	Distal tip buckling force met acceptance criteria.
Catheter Injection Flow Rate	Injection flow rate must meet specified criteria (ISO 10555-1, Annex E methods).	Injection flow rate met acceptance criteria.
Catheter Suction Flow Rate	Suction flow rate must meet specified criteria (ISO 10555-1, Annex E methods).	Suction flow rate met acceptance criteria.
Vacuum Resistance	Device must be resistant to vacuum collapse under static conditions with a 60cc syringe.	Device was resistant to vacuum collapse under static conditions.
Hub Air Aspiration Leak	Must meet ISO 10555-1, Annex D hub air aspiration leak criteria.	Hub air aspiration test met acceptance criteria.
Shaft Peak Tensile Force	Shaft joint peak tensile strength must meet specified criteria (ISO 10555-1, Annex B methods).	Shaft joint peak tensile force met acceptance criteria.
Hub Peak Tensile Force	Hub-shaft joint peak tensile strength must meet specified criteria (ISO 10555-1, Annex B methods).	Hub-shaft joint peak tensile force met acceptance criteria.
Coating Integrity – Baseline	(Characterization of worst-case coating defects)	Baseline coating integrity characterized with worst-case defect images. Data collected as engineering reference. (No explicit "met" here, but indicates characterization was performed)
Coating Lubricity/Durability	Average frictional force and durability must meet specified criteria.	Coating lubricity and durability testing met acceptance criteria.
Particulate Testing	Number of particulates generated under simulated use must meet specified criteria.	Number of particulates generated met acceptance criteria.
Coating Integrity – Simulated Use	(Characterization of worst-case coating defects after simulated use)	Post-simulated use coating integrity characterized with worst-case defect images. (No explicit "met" here, but indicates characterization was performed)
Kink Resistance	Device must be resistant to kinking around small radii.	Device was resistant to kinking around small radii.
Liquid Leakage	Must meet ISO 10555-1, Annex C liquid leakage criteria.	Liquid leakage met acceptance criteria.
Static/Dynamic Burst	Burst strength and performance during worst-case dynamic injections must meet specified criteria.	Static/dynamic burst testing met acceptance criteria.
Torque to Failure	Number of rotations to failure must meet specified criteria.	Torque to failure testing met acceptance criteria.
Physician Usability Testing	Compatibility with accessories, device stability, ability to aspirate, ability to inject saline or contrast, and user's ability to navigate to the M1 and M2 segment of the MCA and retrieve a mechanical thrombectomy device must meet acceptance criteria in a tortuous benchtop model.	All test results met the acceptance criteria.

Biocompatibility Testing:

Test	Acceptance Criteria (Implicit from "Conclusion")	Result / Conclusion
Plastics (USP)	Meet USP Physicochemical extraction parameters.	Passes physical chemical characteristics.
L929 MEM Elution Test - ISO	Non-cytotoxic (score "0" at 24, 48, and 72 ± 4 hours).	Non-cytotoxic.
Klingman Maximization Test - ISO (Guinea Pig Sensitization)	No sensitization response.	Non-sensitizer.
Intracutaneous Injection Test - ISO	Differences in mean test and control scores for dermal observations less than 1.0.	Non-irritant.
Acute Systemic Injection Test - ISO	No clinical signs consistent with toxicity.	Non-cytotoxic.
Materials Mediated Rabbit Pyrogen - ISO	No pyrogenic response (does not exceed USP limit).	Non-pyrogenic.
Hemolysis: Direct Contact / Indirect Extract	No significant differences between test article extract and negative control.	Non-hemolytic.
Complement activation C3a and SC5b-9	Levels comparable to control device (ReFlex) and less than positive control.	Levels of the compliments C3a and SC5b complements were similar for Arc and control device.
Thrombosis (in vivo) — Canine (Arc / ReFlex)	Acceptable thromboresistance.	Acceptable, expected to be equivalent to ReFlex in clinical use.
in vitro Hemocompatibility Assay	No decrease in any blood component compared to reference material.	No adverse effect on platelet and leukocyte counts.
Partial Thromboplastin Time	Clotting times similar to negative control and reference material.	No adverse effect on prothrombin coagulation time of human plasma.
Ames bacterial Mutagenicity 4 salmonella+1e.coli	Non-mutagenic.	Non-mutagenic.
in vitro Mouse Lymphoma Assay with Extended Treatment	Non-mutagenic (non-genotoxic and non-clastogenic).	Non-mutagenic.
in vivo Mouse Micronucleus Assay	Non-mutagenic.	Non-mutagenic.

Regarding AI/ML-specific questions (2-9):

This document describes a traditional medical device submission (catheter) focused on demonstrating substantial equivalence through bench testing, design validation, and biocompatibility testing. It does not involve software with AI/ML components for which these specific questions would be relevant. Therefore, most of these questions are not applicable.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This is a hardware device submission. Bench testing involved samples of the catheters, but not in the context of "test sets" for AI/ML validation. The document does not specify exact sample sizes for each bench test, but implies sufficient samples were used to meet statistical validity for the stated conclusions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. No ground truth needed for AI/ML performance. Physician Usability Testing involved users, implied to be qualified, but not "experts establishing ground truth" as defined for AI/ML.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No adjudication for AI/ML performance.

5. 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

Not Applicable. No AI/ML component; therefore, no MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. No AI/ML algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not Applicable. Ground truth, in the context of an AI/ML device, does not apply here. The "ground truth" for this device's performance are the established standards and specifications for mechanical performance, material properties, and biocompatibility, against which the device was tested.

8. The sample size for the training set

Not Applicable. No AI/ML training set.

9. How the ground truth for the training set was established

Not Applicable. No AI/ML training set or ground truth establishment.

Summary

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

July 29, 2015

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ms. Phuong Chau Senior Regulatory Affairs Product Specialist 9775 Toledo Way Irvine, California 92618

Re: K150107

Trade/Device Name: Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: June 26, 2015 Received: June 29, 2015

Dear Ms. Phuong Chau:

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 device

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related 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.

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 நி/Δ

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) K150107

Device Name

ArcTM Intracranial Support Catheter and ArcTM Mini Intracranial Support Catheter

Indications for Use (Describe)

The Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter are indicated for the introduction of interventional devices into the peripheral and neurovasculature.

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

For Activities Related to CA SB1383 (Organic Waste)
For Other Composting Activities

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 – K150107

510(k) Owner:	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular9775 Toledo WayIrvine, CA 92618Establishment Registration No. 2029214
Contact Person:	Phuong ChauSenior Regulatory Affairs Product SpecialistTelephone: (949) 297-5487E-mail: phuong.chau@covidien.com
Date SummaryPrepared:	June 25, 2015
Trade Name ofDevice:	Arc™ Intracranial Support Catheter and Arc™ Mini IntracranialSupport Catheter
Common Name ofDevice:	Catheter, Percutaneous
Classification ofDevice:	21 CFR 870.1250 – Class II
Product Code:	DQY
Predicate Device:	ReFlex™ Guide Catheter, 510(k)#: K110055
Performance Data:	The following bench testing was performed in support of the Arc™ andArc™ Mini Intracranial Support Catheter and to establish substantialequivalence to the ReFlex™ Guide Catheter:
	• Lumen Patency
	• Dimensional Inspection
	• Distal Tip Buckling
	• Catheter Injection Flow Rate
	• Catheter Suction Flow Rate
	• Vacuum Resistance
	• Hub Air Aspiration Leak
	• Shaft Peak Tensile Force
	• Hub Peak Tensile Force
	• Coating Integrity – Baseline
	• Coating Lubricity/Durability

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. Particulate Testing
Coating Integrity Simulated Use .
. Kink Resistance
Liquid Leakage .
Static/Dynamic Burst .
. Torque to Failure

A Design Validation study was performed on a bench model to assess the usability of the Arc™ and ArcTM Mini Intracranial Support Catheter compared to the previously cleared ReFlex™ Guide Catheter. Biocompatibility testing, sterilization, and a 6-month 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.

Conclusion: The ArcTM Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter are substantially equivalent to the currently cleared ReFlex™ Guide Catheter based on the successful completion of nonclinical bench and design validation testing as well as similar principles of design, operation and indications for use.

Device Description:

Indications for Use:

The Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter are 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 Arc™ Intracranial Support Catheter and Arc M Mini Intracranial Support Catheter and the currently cleared ReFlex (M Guide Catheter.

	ReFlex™ GuideCatheter(K110055)	Arc™ IntracranialSupport Catheter	Arc™ MiniIntracranialSupport Catheter	Rationale forDifference (IfPresent)
Indication forUse	The ReFlex™Guide Catheter isindicated for theintroduction of	The Arc IntracranialSupport Catheter isindicated for theintroduction of	The Arc MiniIntracranial SupportCatheter is indicatedfor the introduction	N/A

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	ReFlex™ GuideCatheter(K110055)	Arc™ IntracranialSupport Catheter	Arc™ MiniIntracranialSupport Catheter	Rationale forDifference (IfPresent)
	interventionaldevices into theperipheral andneurovasculature.	interventionaldevices into theperipheral andneurovasculature.	of interventionaldevices into theperipheral andneurovasculature.
Materials
CatheterShaftMaterials	PTFE linedpolymeric catheter,with hydrophiliccoating	PTFE linedpolymeric catheter,with hydrophiliccoating	PTFE linedpolymeric catheter,with hydrophiliccoating	The material usedfor the Arc andArc Mini catheterswere shown to bebiocompatible perISO 10993 testing.Materials of thistype are widelyused in similarmedical devices.
CatheterShaftSupport	Nitinol	Same	Same	N/A
Markerband	Platinum	Same	Same	N/A
Dimensions
Usable Length	90 – 130 cm	132 – 135 cm	160 – 163 cm	Longer lengthsprovided foradditionalnavigabilityoptions to user.
Distal ID	0.046" – 0.072"	0.061"	0.035"	Smaller distal IDprovided forimprovedtrackability overguide wire tosmaller vessels.
Distal OD(Max)	0.058"–0.084" max	0.071" max	0.049"	Smaller distalID/OD providedfor improveddistal flexibility.
Proximal ID	0.046" – 0.072"	0.069"	0.044"	Smaller proximalID provided forimprovedtrackability overguide wire to

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	ReFlex™ GuideCatheter(K110055)	Arc™ IntracranialSupport Catheter	Arc™ MiniIntracranialSupport Catheter	Rationale forDifference (IfPresent)
				smaller vessels.
Proximal OD(Max)	0.058"–0.084" max	0.0825" max	0.0620"	N/A
TipConfiguration	Single, straightflexible tip	Same	Same	N/A
GuidewireCompatibility	Can be navigatedover a guidewirewith a maximumOD of 0.038 in.	Same	Can be navigatedover a guidewirewith a maximumOD of 0.032 in.	Largestcompatibleguidewire sizedependent onsmallest ID.
SterilizationMethod	Ethylene Oxide	Same	Same	N/A
Packaging	Catheter inpolyethylene hoopattached topackaging cardinsidePET/PE/Tyvekpouch inside SBScarton	Same	Same	N/A

Sterilization and Shelf Life

The packaged Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter are 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-s 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 Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter devices have established the product and packaging remain functional and maintain sterility for up to 6 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) 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.

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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 Dyson catheter are comparableto the ReFlex and less than that ofthe positive control.	Levels of the compliments C3aand SC5b complements weresimilar for Arc and controldevice
Thrombosis (in vivo) — Canine(Arc / ReFlex)	The thromboresistance propertiesof the Arc and Arc MiniIntracranial Support Catheters areacceptable in clinical use.	Acceptable, expected to beequivalent to ReFlex in clinicaluse
in vitro HemocompatibilityAssay	Neither the Arc nor the ReFlexGuide Catheter resulted in adecrease in any blood component	No adverse effect on plateletand leukocyte counts

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Test	Result	Conclusion
	as compared to the referencematerial. These results indicate thatthe cause of thrombi is not relatedto the materials exposed to humanblood during use.
Partial Thromboplastin Time	Clotting times for Arc and theReFlex (predicate device) test armswere similar to the negative controland the 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

Performance Testing – Bench

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

Test	Method	Conclusions
Lumen Patency	The total length of the devicemust pass a mandrel of therequired size from the proximalhub to distal tip.	All devices met acceptancecriteria.
Dimensional Inspection	The usable length, proximal anddistal inner and outer diameterswere measured and recorded.	All device met acceptancecriteria.
Distal Tip Buckling	Repeated distal tip buckling forceunder compressive load wasevaluated for stiffness.	Distal tip buckling force metacceptance criteria.
Catheter Injection Flow Rate	Device flow rate was measuredusing ISO 10555-1, Annex E testmethods with injection throughproximal hub.	Injection flow rate metacceptance criteria.
Test	Method	Conclusions
Catheter Suction Flow Rate	Device flow rate was measuredusing ISO 10555-1, Annex E testmethods with injection throughdistal tip.	Suction flow rate met acceptancecriteria.
Vacuum Resistance	Device was evaluated forresistance to vacuum collapseunder static conditions with a60cc syringe.	Device was resistant to vacuumcollapse under static conditions.
Hub Air Aspiration Leak	Device was tested for ISO10555-1, Annex D hub airaspiration leak.	Hub air aspiration test metacceptance criteria.
Shaft Peak Tensile Force	Shaft peak tensile strength wastested to failure for each jointusing ISO 10555-1, Annex B testmethods.	Shaft joint peak tensile force metacceptance criteria.
Hub Peak Tensile Force	Hub-shaft joint peak tensilestrength was tested to failureusing ISO 10555-1, Annex B testmethods	Hub-shaft joint peak tensile forcemet acceptance criteria.
Coating Integrity - Baseline	Fully assembled devices wereinspected under a minimum 2.5xmagnification for worst-casecoating defects.	Baseline coating integritycharacterized with worst-casedefect images. Data collected asengineering reference.
Coating Lubricity/Durability	Device coating was evaluated foraverage frictional force anddurability.	Coating lubricity and durabilitytesting met acceptance criteria.
Particulate Testing	Device was evaluated forparticulate generation undersimulated use in a representativetortuous anatomical model.	Number of particulates generatedmet acceptance criteria.
Coating Integrity - SimulatedUse	Fully assembled devices werepre-conditioned under simulateduse conditions in a representativetortuous anatomical model.Coating was inspected under aminimum 2.5x magnification andsubsequently tested for averagefrictional force.	Post-simulated use coatingintegrity characterized withworst-case defect images.
Kink Resistance	Device was wrapped around arod of known radius andinspected in-place for any kinks.	Device was resistant to kinkingaround small radii.
Liquid Leakage	Device was tested for ISO	Liquid leakage met acceptance
Test	Method	Conclusions
	10555-1, Annex C liquid leakagetesting.	criteria.
Static/Dynamic Burst	Device was tested under full-length static conditions to burstand at pressures experiencedduring worst-case dynamicinjections.	Static/dynamic burst testing metacceptance criteria.
Torque to Failure	Device was tested for full-lengthtorque strength to determinenumber of rotations to failure.	Torque to failure testing metacceptance criteria.
Physician Usability Testing	The device was navigatedthrough a tortuous benchtopmodel to assess compatibilitywith accessories, device stability,ability to aspirate, ability to injectsaline or contrast, and the user'sability to navigate to the M1 andM2 segment of the MCA andretrieve a mechanicalthrombectomy device.	All test results met theacceptance criteria.

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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 devices. Substantial equivalence of the Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter 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 new devices. Substantial equivalence of the Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter 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).