The Minjie Catheter System consists of the Minjie Catheter, Introducer Peel Away Tool and packaging hoop with Elbow Flush Luer. The Minjie Catheter is a single lumen. flexible, variable stiffness composite catheter with a Nitinol structure. A radiopaque marker band on the distal tip of the catheter is used for visualization under fluoroscopy. The distal section of the catheter is coated with a hydrophilic coating, to reduce friction during intravascular use. The Minjie Catheter System dimensions are included in the individual device label. The devices are supplied sterile and are intended for single use only.

AI/ML Overview

The provided FDA 510(k) summary for the Minjie Catheter System does not contain acceptance criteria or reported device performance in the format requested for AI/algorithm-based devices. This document describes a medical device (a catheter system) and its performance through non-clinical (bench and animal) testing to demonstrate substantial equivalence to a predicate device, rather than the performance of an AI algorithm.

Therefore, many of the requested fields related to AI algorithm evaluation (sample sizes for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable to the information provided in this document.

However, I can extract information related to the device's non-clinical testing and its conclusions, which serve as the "proof" that the device meets some form of acceptance criteria for medical devices of this type.

Here's a summary based on the provided document, adapting the requested structure where possible for a non-AI device:

Acceptance Criteria and Study for the Minjie Catheter System

The Minjie Catheter System is a physical medical device (catheter) and its performance is evaluated against engineering specifications, biocompatibility standards, and functional capabilities rather than AI algorithm metrics. The studies performed are non-clinical, including bench testing and an animal study, to demonstrate substantial equivalence and safety/effectiveness for its intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "All devices met acceptance criteria" for each bench test, but it does not explicitly define the numeric acceptance criteria themselves. The reported performance is therefore a qualitative statement of compliance.

Test Name	Test Method Summary	Acceptance Criteria (Implied)	Reported Device Performance
Catheter Visual Inspection	Inspection for dents, kinks, cracks, damage, or anomalies.	No damage or anomalies affecting function.	All devices met acceptance criteria.
Coating Integrity	Inspection under magnification for coating defects before and after simulated use and particulate testing.	No coating defects.	All devices met acceptance criteria.
Particulate Testing	Evaluation for particulate generation under simulated use in a tortuous anatomical model.	Meets particulate generation limits.	All devices met acceptance criteria.
Simulated Use	Repeated navigation through a tortuous benchtop model to assess compatibility with accessories, stability, and navigation to M1 and M2 segments of MCA.	Successful navigation, compatibility, and stability.	All devices met acceptance criteria.
Coating Frictional Forces / Durability	Evaluation of frictional forces and durability via repeated navigation through simulated use test model.	Acceptable frictional forces and durability.	All devices met acceptance criteria.
Distal Tip Buckling	Testing distal tip under compressive loads at 5mm, 10mm, and 20mm to evaluate stiffness.	Meets specified stiffness requirements.	All devices met acceptance criteria.
Kink Resistance	Wrapping device around mandrels of clinically relevant diameters and inspecting for kinks.	No kinks.	All devices met acceptance criteria.
Liquid Leakage under Pressure	Tested per ISO 10555-1, Annex C.	No liquid leakage.	All devices met acceptance criteria.
Hub Air Aspiration Leak	Tested per ISO 10555-1, Annex D.	No hub air aspiration leak.	All devices met acceptance criteria.
Torque to Failure	Tested in a simulated use model to determine number of rotations to failure.	Withstands specified torque without failure.	All devices met acceptance criteria.
Manual Injection / Peak Pressure	Tested with manual syringe injection of worst-case contrast media after simulated use.	Withstands generated pressures.	All devices met acceptance criteria.
Static / Dynamic Burst	Tested under full-length static conditions to burst per ISO 10555-1, Annex F.	Meets burst pressure requirements.	All devices met acceptance criteria.
Luer Hub Compatibility	Tested per ISO 80369-7 and ISO 80369-20.	Compatible with luer hubs.	All devices met acceptance criteria.
Dimensional Inspection	Measurement of usable length, proximal/distal inner/outer diameters.	Meets specified dimensional tolerances.	All devices met acceptance criteria.
Lumen Patency	Mandrel of required size must pass from proximal hub to distal tip.	Mandrel passes freely.	All devices met acceptance criteria.
Shaft Peak Tensile Force	Tested to failure at distal tip section and each joint per ISO 10555-1, Annex B.	Withstands specified tensile forces.	All devices met acceptance criteria.
Hub Peak Tensile Force	Tested to failure per ISO 10555-1, Annex B.	Withstands specified tensile forces.	All devices met acceptance criteria.
Physician Usability Testing	Navigated through a tortuous benchtop model to assess compatibility, stability, injection ability, and navigation to M1/M2 segments of MCA.	Usable and effective for intended functions.	All devices met acceptance criteria.

Biocompatibility Test Name	Test Results Conclusion
Cytotoxicity	Non-cytotoxic
Sensitization	Non-sensitizer
Intracutaneous Irritation	Non-irritant
Acute Systemic Toxicity	No acute systemic toxicity
Material Mediated Pyrogen	Non-pyrogenic
Hemocompatibility (Hemolysis)	Non-hemolytic
Hemocompatibility (Complement Activation)	Non-activator of the complement system
Hemocompatibility (PTT)	Non-activator of coagulation
Hemocompatibility (Platelet & Leukocyte Counts)	Non-activator of platelet and leukocyte

Sterilization/Shelf-Life Test	Acceptance Criteria (Implied)	Reported Performance
EO Sterilization Validation	SAL of 10^-6 per ISO 11135:2014.	Achieved SAL of 10^-6.
Endotoxin Testing	Meets FDA guidance for pyrogen and endotoxins.	Compliant.
Packaging Integrity	Maintains sterility and integrity for 24 months.	Met all acceptance criteria.
Product Stability (Aging)	Device remains functional for 24 months.	Met all acceptance criteria.

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

Bench Testing: The document does not specify the exact sample size for each bench test (e.g., "All devices met acceptance criteria" implies multiple devices were tested). There is no explicit mention of data provenance (e.g., country of origin). This is non-clinical, prospective testing.
Biocompatibility Testing: Not specified for individual tests.
Sterilization and Shelf-Life: Not specified, but validation studies would involve multiple units.
Animal Testing: The document states "An animal study was performed," but does not specify the number of animals used. Data provenance is not specified.

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)

This is not applicable as this is a physical device and not an AI algorithm requiring expert ground truth for image interpretation or diagnosis. Bench testing results are typically objective measurements against engineering specifications. Animal study evaluations would be performed by qualified veterinary and pathology staff, but specific numbers and qualifications are not provided.

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

Not applicable for physical device testing.

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. This is not an AI-assisted diagnostic or therapeutic device.

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

Not applicable.

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

For this physical device:

Bench Testing: Engineering specifications, industry standards (e.g., ISO), and defined performance parameters serve as the "ground truth" or acceptance criteria.
Biocompatibility Testing: Established biological response parameters outlined in ISO 10993 series and FDA guidance.
Animal Testing: Angiographic and histological evaluations, which are considered objective medical findings.

8. The sample size for the training set

Not applicable. This is not an AI algorithm requiring a training set.

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

Not applicable. This is not an AI algorithm.

Summary

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June 2, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Kai Medtech, LLC Ricardo Olivo Senior Director, Quality and Reguatory Affairs 22651 Lambert Street, Suite 107 Lake Forest, California 92630

Re: K212288

Trade/Device Name: Minjie Catheter System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: April 29, 2022 Received: May 3, 2022

Dear Ricardo Olivo:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212288

Device Name Minjie Catheter System

Indications for Use (Describe)

The Minjie Catheter System is indicated for the introduction of interventional devices into the peripheral and neruovasculature.

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

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 K212288

This 510(k) Summary for the Minjie Catheter System is submitted in accordance with the requirements of 21 CFR Part 807.92 and following the recommendations outlined in FDA guidance, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]," issued on July 28, 2014.

Submitter

Submitter:	Kai Medtech, LLC22651 Lambert Street, Suite 107Lake Forest, CA 92630 USA
Contact Person:	Ricardo OlivoSenior Director, Quality and Regulatory Affairs+1 (949) 767-8960, Extension 109ricardo.olivo@kaimtgroup.com
Date Prepared:	June 01, 2022

Device Name and Details

Trade Name of Device:	Minjie Catheter System
Common Name ofDevice:	Distal Access Catheter
Device Classification:	Class II
Device ClassificationName:	Percutaneous Catheter
Regulation Number/Description:	21 CFR 870.1250, Percutaneous Catheter
ClassificationProduct Code:	Primary Product Code: QJPSecondary Product Code: DQY
Review Panel:	Neurology

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510(k)Number	ProductCode	Trade Name of Device	Device Manufacturer
Predicate Device
K150107	DQY	Arc™ Intracranial SupportCatheter and Arc™ MiniIntracranial SupportCatheter	Micro Therapeutics, Inc.d/b/a ev3 Neurovascular
Reference Devices
K161152	DQY	Navien Intracranial SupportCatheter	Micro Therapeutics, Inc.d/b/a ev3 Neurovascular
K140080	DQY	ENVOY® Distal Access (DA)Guiding Catheter	Codman & Shurtleff, Inc.

Table 1: Legally Marketed Predicate and Reference Devices

Device Description

Indications for Use Statement

The Miniie Catheter System is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

Comparison of Technological Characteristics with the Predicate Device

A comparison of the technological characteristics of the subject device (Minjie Catheter System) and predicate device (Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter) demonstrates that the technological characteristics of the subject Minjie Catheter System are substantially equivalent to the technological characteristics of the predicate Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter previously cleared under K150107. Refer to Table 2 below for a comparison between the Minjie Catheter System and Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter.

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	Predicate Device, ArcTMIntracranial Support Catheterand ArcTM Mini IntracranialSupport Catheter (K150107)	Subject Device, Minjie CatheterSystem (K212288)	Comparison
Regulation	DQY (21 CFR 870.1250)	QJP, DQY (21 CFR 870.1250)	Similar
Indications for UseStatement	The ArcTM IntracranialSupport Catheter and ArcTMMini Intracranial SupportCatheter are indicated forthe introduction ofinterventionaldevices into the peripheraland neurovasculature.	The Minjie Catheter System isindicated for the introduction ofinterventional devices into theperipheral and neurovasculature.	Same
Function /Principle of Operation	Facilitate introduction andselective placement ofinterventional devices into targetblood vessels in the peripheraland neuro vasculature.	Facilitate introduction andselective placement ofinterventional devices intotarget blood vessels in theperipheral and neurovasculature	Similar
Catheter ShaftMaterials	PTFE lined polymeric catheterwith hydrophilic coating	PTFE lined polymeric catheterwith hydrophilic coating	Similar
Catheter ShaftSupport	Nitinol	Nitinol	Similar
Marker Band	Platinum	Platinum/Iridium	Testingdemonstratedthat thedifference doesnot raise newquestions ofsafety andeffectiveness.
Usable Length	132cm - 135cm	115cm - 131cm	Similar
Coating Length	40cm - 45cm	60cm	Testingdemonstratedthat thedifference doesnot raise newquestions ofsafety andeffectiveness.
Distal Inner Diameter(ID)	0.061"	0.068" (1.73mm)	Testingdemonstratedthat thedifference doesnot raise newquestions ofsafety andeffectiveness.
Distal Outer Diameter(OD) (Max)	0.071"	0.081" (2.06mm)	Testingdemonstratedthat the

Proximal ID	0.069"	0.068" (1.73mm)	Similar
Proximal OD (Max)	0.082"	0.083" (2.11mm)	Similar
Shaft	Progressively softer from proximal end to distal tip	Progressively softer from proximal end to distal tip	Similar
Tip Configuration	Single, straight flexible tip	Single, straight flexible tip	Similar
GuidewireCompatibility	Can be navigated overguidewire with maximum ODof 0.038"	Can be navigated overguidewire with maximumOD of 0.035"	Testingdemonstratedthat thedifference doesnot raise newquestions ofsafety andeffectiveness.
Packaging	Catheter in polyethylene hoopattached to packaging card insidePET / PE / Tyvek pouch insideSBS carton	Catheter in polyethylene hoopattached to packaging cardinside PET / PE / Tyvek pouchinside SBS carton	Similar
Accessories	Introducer Tool	Introducer Peel Away Tool	Testingdemonstratedthat thedifference doesnot raise newquestions ofsafety andeffectiveness.
Sterilization Method	Ethylene oxide (EO) gas	EO gas	Similar
			difference doesnot raise newquestions ofsafety andeffectiveness.

Table 2: Comparison between Minjie Catheter System and Arc™ Intracranial Support
Catheter and Arc™ Mini Intracranial Support Catheter.

Page 3 of 8

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Performance Data (Non-Clinical Testing)

Sterilization and Shelf-Life

The packaged Minjie Catheter System is sterilized using a validated EO sterilization cycle. The sterilization cycle has been validated to ensure a sterility assurance level (SAL) of 106 in accordance with ISO 11135:2014, "Sterilization of health care products - Ethylene oxide - Requirements for the development, validation, and routine control Endotoxin testing was conducted in accordance with FDA guidance, "Pyrogen and Endotoxins Testing: Questions and Answers," issued in June 2012.

Aging studies for the Minjie Catheter System have established that the product remains functional, and packaging maintains sterility for up to twenty-four months. Aging studies for packaging integrity and product stability (device functionality) were performed and met all acceptance criteria.

Biocompatibility Testing

Biocompatibility testing was performed in accordance with FDA guidance. "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part Page 4 of 8

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1: Evaluation and testing within a risk management process"," issued on September 4, 2020, and ISO 10993-1:2018, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process," for the Minjie Catheter System categorized as a limited exposure (< 24 hours), external communicating device contacting circulating blood. Refer to Table 3 below for summary of the test results.

Test Standard and StudyName	Test Results	Conclusions
Cytotoxicity per ISO 10993-5; ISO Elution Method	The test article extract met therequirements of the test becausethe grade was less than a grade 2(mild reactivity).	Non-cytotoxic
Sensitization per ISO 10993-10; ISO Guinea PigMaximization SensitizationTest	Animals tested with the test extractdid not show evidence of delayeddermal contact sensitization.	Non-sensitizer
Intracutaneous Irritation perISO 10993-10; ISOIntracutaneous Study inRabbits	Animals tested with the test extractexhibited similar edema anderythema scores compared to thenegative control.	Non-irritant
Acute Systemic Toxicity perISO 10993-11; ISO AcuteSystemic Toxicity Study inMice	No animals injected with the test articleshowed a significantly greaterbiological reaction than the animalstreated with the control article.	No acute systemictoxicity
Material Mediated Pyrogenper ISO 10993-11; USPRabbit Pyrogen Study,Material Mediated	No single animal showed atemperature rise of ≥ 0.5°C above itsbaseline temperature. Total rise ofrabbit temperatures during three (3)hour observation period was withinacceptable USP requirements. Thetest article met the requirements forthe absence of pyrogens.	Non-pyrogenic
Hemocompatibility perISO 10993-4; ASTMHemolysis Study	The hemolytic index for the test articlein direct contact with blood was 0.0%,and for test article extract was 0.7%.	Non-hemolytic
Hemocompatibility per ISO10993-4; SC5b-9Complement ActivationAssay	SC5b-9 Concentration of the testarticle was not statistically differentthan activated non-human serumcontrol.	Non-activator of thecomplement system
Hemocompatibility perISO 10993-4; ASTMPartial ThromboplastinTime (PTT) with SponsorProvided Control	Inactivated partial thromboplastin timetest was conducted, and the resultsshowed no different compared to thereference device, ENVOY ® DistalAccess (DA) Guiding Catheter,K140080.	Non-activator ofcoagulation
Platelet and LeukocyteCounts (Platelet Adhesion)	The leukocyte and platelet counts thatwere exposed to the negative control	Non-activator ofplatelet and
per ISO 10993-4: 2017	subject device and predicate device (ArcTM Intracranial Support Catheter, K150107) extracts did not show difference.	leukocyte

Table 3: Summary of Biocompatibility Testing Results

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Bench Testing

A summary of the non-clinical bench testing performed for the Minjie Catheter System is presented in Table 4 below.

Test Name	Test Method Summary	Results
Catheter VisualInspection	Fully assembled devices were inspected with anunaided eye for dents, kinks, cracks or otherdamage or anomalies that may impact function ofdevice.	All devices metacceptance criteria.
CoatingIntegrity	Fully assembled devices were inspected under aminimum 40X magnification before and aftersimulated use and particulate testing, for coatingdefects.	All devices metacceptance criteria.
ParticulateTesting	The device was evaluated for particulate generationunder simulated use in a representative tortuousanatomical model.	All devices metacceptance criteria.
Simulated Use	The device was repeatedly navigated through atortuous benchtop model to assess compatibilitywith accessories and interventional devicesincluding guidewire, guide catheter, microcatheterand stent retriever, and assess device stability andability to navigate to the M1 and M2 segments ofthe middle cerebral artery (MCA).	All devices metacceptance criteria.
CoatingFrictionalForces /Durability	Device coating was evaluated for frictional forces,and durability via repeated navigation throughsimulated use test model.	All devices metacceptance criteria.
Distal TipBuckling	Tip buckling was evaluated, including testing thedistal tip under compressive loads at 5 mm, 10 mmand 20 mm from the distal tip, to evaluate stiffnessof the distal tip.	All devices metacceptance criteria.
Kink Resistance	The device was wrapped around several mandrels ofclinically relevant diameters and inspected forkinks.	All devices metacceptance criteria.
Liquid Leakageunder pressure	The device was tested for liquid leakage underpressure per ISO 10555-1, Annex C.	All devices metacceptance criteria.
Hub AirAspiration Leak	The device was tested per ISO 10555-1, AnnexD for hub air aspiration leak.	All devices metacceptance criteria.
Torque toFailure	The device was tested in a simulated use test modelfor full-length torque strength to determine the	All devices metacceptance criteria.
Test Name	Test Method Summary	Results
	number of rotations to failure.
ManualInjection /Peak Pressure	The device was tested for full-length, aftersimulated use testing, using manual syringeinjection of worst-case contrast media, to verifythat device can withstand pressures that may begenerated during manual delivery of contrastmedia.	All devices metacceptance criteria.
Static / DynamicBurst	The device was tested under full-length staticconditions to burst using worst-case contrast mediaper ISO 10555-1, Annex F, and compared againstburst pressures exhibited during manual syringeinjection of contrast media.	All devices metacceptance criteria.
Luer HubCompatibility	Luer hub testing was performed per ISO 80369-7and ISO 80369-20.	All devices metacceptance criteria.
DimensionalInspection	The usable length, proximal and distal inner andouter diameters were measured and recorded.	All devices metacceptance criteria.
Lumen Patency	The total length of the device must allow to pass amandrel of the required size from the proximal hubto distal tip.	All devices metacceptance criteria.
Shaft PeakTensile Force	Shaft peak tensile strength was tested to failure atthe distal tip section, and each joint of the device,per ISO 10555-1, Annex B test methods.	All devices metacceptance criteria.
Hub PeakTensile Force	Hub-shaft joint peak tensile strength was tested tofailure, per ISO 10555-1, Annex B test methods.	All devices metacceptance criteria.
PhysicianUsabilityTesting	The device was navigated through a tortuousbenchtop model to assess compatibility withaccessories, device stability, ability to inject saline,and the user's ability to navigate to the M1 and M2segments of the MCA.	All devices metacceptance criteria.

Table 4: Summary of Bench Testing Results

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Animal Testing

An animal study was performed to verify the safety and validate the functionality of the Minijie Catheter System in comparison to the predicate device, ArcTM Intracranial Support Catheter. The Minjie Catheter System yielded acceptable usability criteria ratings to validate functionality. As confirmed by angiographic and histological evaluations, the Minije Catheter System was verified to be safe for its intended use.

Clinical Testing

No clinical testing was conducted. The differences in technological characteristics do not raise new questions of safety and effectiveness as demonstrated through nonclinical bench testing using well-established acceptable scientific methods.

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Conclusion

The Minjie Catheter System has the same intended use as the predicate device and the technological characteristics are similar to the predicate device. The differences do not raise new questions of safety and effectiveness. The information and testing presented in this 510(k) submission demonstrate that the Minjie Catheter System is substantially equivalent to the predicate device, Arc™ Intracranial Support Catheter, for use in the peripheral and neurovasculature.

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).