Minjie Catheter System

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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, LLC<br>22651 Lambert Street, Suite 107<br>Lake Forest, CA 92630 USA | |-----------------|--------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Ricardo Olivo<br>Senior Director, Quality and Regulatory Affairs<br>+1 (949) 767-8960, Extension 109<br>ricardo.olivo@kaimtgroup.com | | Date Prepared: | June 01, 2022 | ## Device Name and Details | Trade Name of Device: | Minjie Catheter System | |------------------------------------|----------------------------------------------------------| | Common Name of<br>Device: | Distal Access Catheter | | Device Classification: | Class II | | Device Classification<br>Name: | Percutaneous Catheter | | Regulation Number/<br>Description: | 21 CFR 870.1250, Percutaneous Catheter | | Classification<br>Product Code: | Primary Product Code: QJP<br>Secondary Product Code: DQY | | Review Panel: | Neurology | {4}------------------------------------------------ | 510(k)<br>Number | Product<br>Code | Trade Name of Device | Device Manufacturer | |--------------------------|-----------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------| | <b>Predicate Device</b> | | | | | K150107 | DQY | Arc™ Intracranial Support<br>Catheter and Arc™ Mini<br>Intracranial Support<br>Catheter | Micro Therapeutics, Inc.<br>d/b/a ev3 Neurovascular | | <b>Reference Devices</b> | | | | | K161152 | DQY | Navien Intracranial Support<br>Catheter | Micro Therapeutics, Inc.<br>d/b/a ev3 Neurovascular | | K140080 | DQY | ENVOY® Distal Access (DA)<br>Guiding Catheter | Codman & Shurtleff, Inc. | Table 1: Legally Marketed Predicate and Reference Devices ## Device Description 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. ## 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. {5}------------------------------------------------ | | Predicate Device, ArcTM<br>Intracranial Support Catheter<br>and ArcTM Mini Intracranial<br>Support Catheter (K150107) | Subject Device, Minjie Catheter<br>System (K212288) | Comparison | |--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------| | Regulation | DQY (21 CFR 870.1250) | QJP, DQY (21 CFR 870.1250) | Similar | | Indications for Use<br>Statement | The ArcTM Intracranial<br>Support Catheter and ArcTM<br>Mini Intracranial Support<br>Catheter are indicated for<br>the introduction of<br>interventional<br>devices into the peripheral<br>and neurovasculature. | The Minjie Catheter System is<br>indicated for the introduction of<br>interventional devices into the<br>peripheral and neurovasculature. | Same | | Function /<br>Principle of Operation | Facilitate introduction and<br>selective placement of<br>interventional devices into target<br>blood vessels in the peripheral<br>and neuro vasculature. | Facilitate introduction and<br>selective placement of<br>interventional devices into<br>target blood vessels in the<br>peripheral and neuro<br>vasculature | Similar | | Catheter Shaft<br>Materials | PTFE lined polymeric catheter<br>with hydrophilic coating | PTFE lined polymeric catheter<br>with hydrophilic coating | Similar | | Catheter Shaft<br>Support | Nitinol | Nitinol | Similar | | Marker Band | Platinum | Platinum/Iridium | Testing<br>demonstrated<br>that the<br>difference does<br>not raise new<br>questions of<br>safety and<br>effectiveness. | | Usable Length | 132cm - 135cm | 115cm - 131cm | Similar | | Coating Length | 40cm - 45cm | 60cm | Testing<br>demonstrated<br>that the<br>difference does<br>not raise new<br>questions of<br>safety and<br>effectiveness. | | Distal Inner Diameter<br>(ID) | 0.061" | 0.068" (1.73mm) | Testing<br>demonstrated<br>that the<br>difference does<br>not raise new<br>questions of<br>safety and<br>effectiveness. | | Distal Outer Diameter<br>(OD) (Max) | 0.071" | 0.081" (2.06mm) | Testing<br>demonstrated<br>that 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 | | Guidewire<br>Compatibility | Can be navigated over<br>guidewire with maximum OD<br>of 0.038" | Can be navigated over<br>guidewire with maximum<br>OD of 0.035" | Testing<br>demonstrated<br>that the<br>difference does<br>not raise new<br>questions of<br>safety and<br>effectiveness. | | Packaging | Catheter in polyethylene hoop<br>attached to packaging card inside<br>PET / PE / Tyvek pouch inside<br>SBS carton | Catheter in polyethylene hoop<br>attached to packaging card<br>inside PET / PE / Tyvek pouch<br>inside SBS carton | Similar | | Accessories | Introducer Tool | Introducer Peel Away Tool | Testing<br>demonstrated<br>that the<br>difference does<br>not raise new<br>questions of<br>safety and<br>effectiveness. | | Sterilization Method | Ethylene oxide (EO) gas | EO gas | Similar | | | | | difference does<br>not raise new<br>questions of<br>safety and<br>effectiveness. | Table 2: Comparison between Minjie Catheter System and Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter. Page 3 of 8 {6}------------------------------------------------ ### 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 {7}------------------------------------------------ 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 Study<br>Name | Test Results | Conclusions | |---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------| | Cytotoxicity per ISO 10993-<br>5; ISO Elution Method | The test article extract met the<br>requirements of the test because<br>the grade was less than a grade 2<br>(mild reactivity). | Non-cytotoxic | | Sensitization per ISO 10993-<br>10; ISO Guinea Pig<br>Maximization Sensitization<br>Test | Animals tested with the test extract<br>did not show evidence of delayed<br>dermal contact sensitization. | Non-sensitizer | | Intracutaneous Irritation per<br>ISO 10993-10; ISO<br>Intracutaneous Study in<br>Rabbits | Animals tested with the test extract<br>exhibited similar edema and<br>erythema scores compared to the<br>negative control. | Non-irritant | | Acute Systemic Toxicity per<br>ISO 10993-11; ISO Acute<br>Systemic Toxicity Study in<br>Mice | No animals injected with the test article<br>showed a significantly greater<br>biological reaction than the animals<br>treated with the control article. | No acute systemic<br>toxicity | | Material Mediated Pyrogen<br>per ISO 10993-11; USP<br>Rabbit Pyrogen Study,<br>Material Mediated | No single animal showed a<br>temperature rise of ≥ 0.5°C above its<br>baseline temperature. Total rise of<br>rabbit temperatures during three (3)<br>hour observation period was within<br>acceptable USP requirements. The<br>test article met the requirements for<br>the absence of pyrogens. | Non-pyrogenic | | Hemocompatibility per<br>ISO 10993-4; ASTM<br>Hemolysis Study | The hemolytic index for the test article<br>in direct contact with blood was 0.0%,<br>and for test article extract was 0.7%. | Non-hemolytic | | Hemocompatibility per ISO<br>10993-4; SC5b-9<br>Complement Activation<br>Assay | SC5b-9 Concentration of the test<br>article was not statistically different<br>than activated non-human serum<br>control. | Non-activator of the<br>complement system | | Hemocompatibility per<br>ISO 10993-4; ASTM<br>Partial Thromboplastin<br>Time (PTT) with Sponsor<br>Provided Control | Inactivated partial thromboplastin time<br>test was conducted, and the results<br>showed no different compared to the<br>reference device, ENVOY ® Distal<br>Access (DA) Guiding Catheter,<br>K140080. | Non-activator of<br>coagulation | | Platelet and Leukocyte<br>Counts (Platelet Adhesion) | The leukocyte and platelet counts that<br>were exposed to the negative control | Non-activator of<br>platelet 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 {8}------------------------------------------------ ## 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 Visual<br>Inspection | Fully assembled devices were inspected with an<br>unaided eye for dents, kinks, cracks or other<br>damage or anomalies that may impact function of<br>device. | All devices met<br>acceptance criteria. | | Coating<br>Integrity | Fully assembled devices were inspected under a<br>minimum 40X magnification before and after<br>simulated use and particulate testing, for coating<br>defects. | All devices met<br>acceptance criteria. | | Particulate<br>Testing | The device was evaluated for particulate generation<br>under simulated use in a representative tortuous<br>anatomical model. | All devices met<br>acceptance criteria. | | Simulated Use | The device was repeatedly navigated through a<br>tortuous benchtop model to assess compatibility<br>with accessories and interventional devices<br>including guidewire, guide catheter, microcatheter<br>and stent retriever, and assess device stability and<br>ability to navigate to the M1 and M2 segments of<br>the middle cerebral artery (MCA). | All devices met<br>acceptance criteria. | | Coating<br>Frictional<br>Forces /<br>Durability | Device coating was evaluated for frictional forces,<br>and durability via repeated navigation through<br>simulated use test model. | All devices met<br>acceptance criteria. | | Distal Tip<br>Buckling | Tip buckling was evaluated, including testing the<br>distal tip under compressive loads at 5 mm, 10 mm<br>and 20 mm from the distal tip, to evaluate stiffness<br>of the distal tip. | All devices met<br>acceptance criteria. | | Kink Resistance | The device was wrapped around several mandrels of<br>clinically relevant diameters and inspected for<br>kinks. | All devices met<br>acceptance criteria. | | Liquid Leakage<br>under pressure | The device was tested for liquid leakage under<br>pressure per ISO 10555-1, Annex C. | All devices met<br>acceptance criteria. | | Hub Air<br>Aspiration Leak | The device was tested per ISO 10555-1, Annex<br>D for hub air aspiration leak. | All devices met<br>acceptance criteria. | | Torque to<br>Failure | The device was tested in a simulated use test model<br>for full-length torque strength to determine the | All devices met<br>acceptance criteria. | | Test Name | Test Method Summary | Results | | | number of rotations to failure. | | | Manual<br>Injection /<br>Peak Pressure | The device was tested for full-length, after<br>simulated use testing, using manual syringe<br>injection of worst-case contrast media, to verify<br>that device can withstand pressures that may be<br>generated during manual delivery of contrast<br>media. | All devices met<br>acceptance criteria. | | Static / Dynamic<br>Burst | The device was tested under full-length static<br>conditions to burst using worst-case contrast media<br>per ISO 10555-1, Annex F, and compared against<br>burst pressures exhibited during manual syringe<br>injection of contrast media. | All devices met<br>acceptance criteria. | | Luer Hub<br>Compatibility | Luer hub testing was performed per ISO 80369-7<br>and ISO 80369-20. | All devices met<br>acceptance criteria. | | Dimensional<br>Inspection | The usable length, proximal and distal inner and<br>outer diameters were measured and recorded. | All devices met<br>acceptance criteria. | | Lumen Patency | The total length of the device must allow to pass a<br>mandrel of the required size from the proximal hub<br>to distal tip. | All devices met<br>acceptance criteria. | | Shaft Peak<br>Tensile Force | Shaft peak tensile strength was tested to failure at<br>the distal tip section, and each joint of the device,<br>per ISO 10555-1, Annex B test methods. | All devices met<br>acceptance criteria. | | Hub Peak<br>Tensile Force | Hub-shaft joint peak tensile strength was tested to<br>failure, per ISO 10555-1, Annex B test methods. | All devices met<br>acceptance criteria. | | Physician<br>Usability<br>Testing | The device was navigated through a tortuous<br>benchtop model to assess compatibility with<br>accessories, device stability, ability to inject saline,<br>and the user's ability to navigate to the M1 and M2<br>segments of the MCA. | All devices met<br>acceptance criteria. | Table 4: Summary of Bench Testing Results {9}------------------------------------------------ ### 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. {10}------------------------------------------------ ## 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.