Who is the manufacturer of SOFIA EX Intracranial Support Catheter?

MicroVention, Inc. filed the 510(k) submission for SOFIA EX Intracranial Support Catheter (K182602).

What is the FDA product code for SOFIA EX Intracranial Support Catheter?

DQY. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for SOFIA EX Intracranial Support Catheter?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SOFIA EX Intracranial Support Catheter?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SOFIA EX Intracranial Support Catheter

Q: What are the predicate devices for SOFIA EX Intracranial Support Catheter?

SOFIA® Distal Access Catheter (K131482).

K182602 · MicroVention, Inc. · DQY · May 15, 2019 · Cardiovascular

Device Facts

Record ID	K182602
Device Name	SOFIA EX Intracranial Support Catheter
Applicant	MicroVention, Inc.
Product Code	DQY · Cardiovascular
Decision Date	May 15, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2

Indications for Use

The SOFIA® EX Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA® EX Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA® EX Catheter is not intended for use in coronary arteries.

Device Story

Single-lumen, flexible intracranial support catheter; used to navigate neuro/peripheral vasculature; facilitates delivery of diagnostic/therapeutic devices. Input: manual manipulation by physician under fluoroscopic guidance. Transformation: catheter tracks over guidewire/microcatheter through tortuous anatomy; radiopaque marker provides visualization. Output: delivery of interventional devices to target site. Used in clinical settings (e.g., neuro-interventional suites) by physicians. Benefits: provides stable support for delivery of braided devices/stent-retrievers; enables access to distal vasculature; improves procedural efficiency through enhanced torque response and tip stability.

Clinical Evidence

No human clinical data. Evidence includes extensive bench testing (dimensional, tip stability, burst, leakage, tensile, torque, lubricity, particulate, kink, corrosion) and biocompatibility testing (ISO 10993). Acute animal study (porcine model, n=3) compared SOFIA® EX to Navien; demonstrated equivalent tracking, no dissection/perforation, no thrombus, and no safety issues.

Technological Characteristics

Single-lumen catheter; outer layer: polyolefin elastomer, Pellethane, Pebax, Grilamid; inner layer: stainless steel braid, Nitinol coil, PTFE liner. Radiopaque marker (platinum/iridium). Hydrophilic coating. Dimensions: 5F, 105-115cm length. Sterilization: Ethylene Oxide. Standalone device; manual operation.

Indications for Use

Indicated for general intravascular use in neuro and peripheral vasculature to facilitate introduction of diagnostic or therapeutic devices. Not for use in coronary arteries.

Regulatory Classification

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.

Predicate Devices

SOFIA® Distal Access Catheter (K131482)

Reference Devices

Navien Intracranial Support Catheter (K161152)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 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" in blue, and the word "ADMINISTRATION" in a smaller font size below. May 15, 2019 MicroVention, Inc. Tina Ariaee Sr. Manager, Regulatory Affairs 1311 Valencia Avenue Tustin, California 92780 Re: K182602 Trade/Device Name: SOFIA® EX Intracranial Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: April 15, 2019 Received: April 16, 2019 Dear Tina Ariaee: 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 {1}------------------------------------------------ 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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Carlos L. Peña, PhD, MS Director 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) K182602 Device Name SOFIA® EX Intracranial Support Catheter #### Indications for Use (Describe) The SOFIA® EX Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA® EX Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA® EX Catheter is not intended for use in coronary arteries. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | <div> ☑ </div> | |----------------------------------------------|------------------------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | <div> ☐ </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > 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}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for MicroVention TERUMO. The logo features a stylized graphic to the left of the text. The text "MicroVention" is in a blue sans-serif font, with the word "TERUMO" in a smaller, bolder, blue sans-serif font directly underneath. # 510(k) Summary K182602 ### l. Submitter MicroVention, Inc. 1311 Valencia Avenue Tustin, CA 92780 Establishment Registration No: 2032493 Contact Person: Tina Ariaee Senior Manager, Regulatory Affairs Telephone: (714) 247-8000 Ext. 8366 Email: tina.ariaee@microvention.com #### Date Prepared: May 12, 2019 #### II. Device | Name of Device | SOFIA® EX Intracranial Support Catheter | |------------------------|-----------------------------------------| | Common Name | Intracranial Support Catheter | | Classification Name | Percutaneous Catheter (21 CFR 870.1250) | | Regulatory Class | Class II | | Product Code | DQY | ## III. Predicate Device | Predicate Device | SOFIA® Distal Access Catheter (K131482) | |------------------|------------------------------------------------| | Reference Device | Navien Intracranial Support Catheter (K161152) | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for MicroVention TERUMO. The logo features a stylized, abstract graphic to the left of the text. The text "MicroVention" is in a combination of blue and gray, with "Micro" in blue and "Vention" in gray. Below "MicroVention" is the word "TERUMO" in blue, presented in a bold, sans-serif font. #### IV. Device Description The SOFIA® EX Catheter is a single-lumen, flexible catheter equipped with the coil and the braid reinforcement. The distal segment is designed to facilitate vessel selection with 55-65cm of distal shaft hydrophilic coating for navigation through the vasculatures. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. The device is provided sterile and for single use. The catheter is placed in a dispenser tube (HDPE) and is placed on a packaging card (polyethylene) that is provided in a sterile barrier tyvek pouch and placed in a carton box. #### V. Indications for Use The SOFIA® EX Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA® EX Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA® EX Catheter is not intended for use in coronary arteries. ## VI. Comparison of Technological Characteristics with the Predicate Device | | Medtronic Navien Intracranial Support Catheter (K161152) | SOFIA® Distal Access Catheter (K131482) | SOFIA® EX Catheter | |------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Reference Device | Predicate Device | Subject Device | | Intended Use | The Navien Intracranial Support Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature. | The SOFIA® Distal Access Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic and therapeutic agents. It is not intended for use in coronary arteries. | The SOFIA® EX Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA® EX Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA® EX Catheter is not intended for use in coronary arteries. | | Device Classification | Class II DQY 21 CFR 870.1250 | Class II DQY, DQO 21 CFR 870.1250 21 CFR 870.1200 | Class II DQY 21 CFR 870.1250 | | | Medtronic Navien Intracranial Support Catheter (K161152) | SOFIA® Distal Access Catheter (K131482) | SOFIA® EX Catheter | | | Reference Device | Predicate Device | Subject Device | | Catheter Body | PTFE lined polymeric catheter, with hydrophilic coating and Nitinol Support. | Outer layer of polyurethane elastomer (Polyblend and Pellethane), polyether block amide (Pebax) and polyamide (Grilamid); inner layer of stainless steel braid/coil, PTFE and polyolefin elastomer. | Outer layer of polyolefin elastomer, polyurethane elastomer (Pellethane), polyether block amide (Pebax) and polyamide (Grilamid); inner layer of stainless steel braid, Nitinol coil, and PTFE. | | Marker | Platinum | Platinum/Iridium | Same as SOFIA® DAC (K131482) | | Hub | | Nylon | Same as SOFIA® DAC (K131482) | | Strain Relief | | Polyurethane | Same as SOFIA® DAC (K131482) | | Introducer | | Pebax | Same as SOFIA® DAC (K131482) | | Shaping Mandrel | none | Stainless steel | None | | Catheter size | 5F | 5F | Same as SOFIA® DAC (K131482) and Navien (K161152) | | ID | 0.058 inch (1.5 mm) | 0.055 inch (1.4 mm) | Same as Navien (K161152) | | OD | 0.070" Max. | 0.068 inch (1.7 mm) | 0.071 inch (1.8 mm) | | Effective Length | 105,115,125,130cm | 115, 125 cm | 105, 115 cm | | Coating | Hydrophilic coating | Hydrophilic coating | Same as SOFIA® DAC (K131482) | | Tip Construction and Material | | Outer layer of polyurethane elastomer, inner layer of stainless steel braid (entire shaft)/stainless steel coil (except for distal 2cm), and polyolefin elastomer. | Outer layer of polyolefin elastomer, inner layer of stainless steel braid (except for distal 2cm)/ Nitinol coil (entire shaft), and PTFE. | | Average Tip Stiffness (2cm length) | 44 gf | 16 gf | 31gf | | | | | | | | Medtronic Navien Intracranial Support Catheter (K161152) | SOFIA® Distal Access Catheter (K131482) | SOFIA® EX Catheter | | | Reference Device | Predicate Device | Subject Device | | Guidewire Compatibility | 0.038 inch | 0.035 or 0.038 inch | Same as SOFIA® DAC (K131482) | | Accessories | Introducer Sheath | Introducer sheath and shaping mandrel | Introducer sheath | | Method of Supply | Sterile and single use | Sterile and single use | Same as SOFIA® DAC (K131482) | | Sterilization Method | Ethylene Oxide | Ethylene Oxide | Same as SOFIA® DAC (K131482) | | Packaging Configuration | Catheter in polyethylene hoop attached to packaging card inside PET/PE/Tyvek pouch inside SBS carton. | Catheter placed into a HDPE dispenser tube. Dispenser tube, introducer and shaping mandrel placed on a polyethylene packaging card that is inserted into a Tyvek® pouch. Pouch and IFU placed in bleached sulfate carton box. | Same as SOFIA® DAC (K131482). No shaping mandrel. | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logos for MicroVention and Terumo. The MicroVention logo is on the top line and is in blue. The Terumo logo is on the second line and is also in blue. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image features the logo for MicroVention, a company owned by Terumo. The MicroVention logo is in a blue sans-serif font, with the "®" symbol next to it. Below MicroVention is the word "TERUMO" in a larger, bold, blue sans-serif font. To the left of the text is a circular graphic with three curved lines in shades of gray and blue. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for MicroVention TERUMO. The logo features a stylized, abstract graphic on the left, resembling a series of curved lines in shades of gray and blue. To the right of the graphic, the word "MicroVention" is written in a blue, sans-serif font, with the word "TERUMO" in a bolder, blue font below it. # VII. Performance Data The following performance data were provided in support of the substantial equivalence determination. # Bench Study | Test | Test Method Summary | Results | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Dimensional Inspection | The usable length, proximal and distal outer diameters, distal length and inner diameters were measured and recorded. | Device met acceptance criteria for length, inner and outer diameters. The device size (5F) comparable to the 5F predicate and reference devices. The inner diameter is larger than the predicate device, while the outer diameter is larger, but still compatible with tested 6F guiding sheaths. | | | Catheter Tip Stability | Simulated use of the delivery of a braided device is performed in a tortuous anatomical benchtop model and the movement of the subject device is measured and recorded. | Device met acceptance criteria for tip stability. The device is able to support the delivery of braided devices and stent-retrievers without losing distal tip position. The stability of the distal tip was better (less movement) than the predicate device. | | | Simulated Use and Physician Simulated Use | The device is put through simulated use. The device is navigated through a tortuous benchtop model to assess preparation, introduction, tracking, and support of the device. | Device met acceptance criteria | | | Dynamic Burst Testing | Device hub is connected to a pressure control machine and was tested under pressures experienced during worst-case dynamic injections. | Device met acceptance criteria and was able to withstand pressures experienced during worst-case dynamic injections. | | | Liquid Leakage | Device was tested per ISO 10555-1, Annex C liquid leakage testing. Device is connected at hub and is pressurized with fluid and maintains the pressure for a specified duration of time. | Device met acceptance criteria | | | Liquid Leakage at Rated Burst Pressure | Device was tested per ISO 10555-2 Annex A, liquid leakage testing. Device is connected at hub and is pressurized with fluid | Device met acceptance criteria and does not leak fluids at rated burst pressure. | | | | and maintains rated burst pressure for a specified duration of time. | | | | Air Leakage | Device was tested per ISO 594- 2. Device is connected at hub and subjected to negative pressure and any air leaking into the device is recorded. | Device met acceptance criteria. Device does not allow air to leak into the device when subjected to negative pressure. | | | Static Burst | Device was connected at hub and tested under full-length static conditions to burst. | Device met acceptance criteria. All devices burst above the rated burst pressure and had better results than the predicate device. | | | Tensile Strength | Device was tested per ISO 11070. The device is tensile tested to failure and the force at break is measured and recorded. | Device met acceptance criteria. | | | Tip Buckling | Distal tip buckling force under compressive load was evaluated for stiffness. | Device met acceptance criteria. Device has a softer distal tip than the reference device. | | | Torque Response | Device was tested for full-length torque response. The device is tracked through a tortuous benchtop model and the proximal hub is turned, the distal tip torque response is measured and recorded. | Device met acceptance criteria. Device has better torque response than the reference device. | | | Radio-detectability | Device is put under fluoroscope to assess visibility. | Device met acceptance criteria. Device is visible under fluoroscopy. | | | Coating Lubricity and Durability | Device coating was evaluated for frictional force and durability. | Device met acceptance criteria. Average friction is comparable to predicate device. | | | Particulate Testing | Device was evaluated for particulate generation under simulated use in a representative tortuous anatomical model per USP<788>. | Number of particulates generated met acceptance criteria and is within the limits per USP<788> and is comparable to the predicate and reference devices. | | | Kink Resistance | Device is evaluated for kink resistance by subjecting the device to bending experienced in tortuous anatomy. | Device met acceptance criteria. Results matched results of the predicate device. | | | Corrosion Resistance | Device is tested per ISO 10555- 1, Annex A and ISO 11070, Annex B to evaluate corrosion resistance. | Device met acceptance criteria. Device is resistant to corrosion. | | | Test | Test Method Summary | | Results | | | Extract(s) & Test Systems | Extract Conditions | | | Cytotoxicity (ISO Medium Eluate Method (MEM) Elution Test) | 1x CMEM Cell Growth Medium (MEM supplemented with 10% fetal bovine serum extract) L929 Mouse Fibroblast Cell Line | 6.0 cm²/mL (exposed surface area to extraction medium volume ratio), extracted at 37°C/24 hrs. | Non-cytotoxic The test article is considered non-cytotoxic to cells. | | Sensitization (ISO Kligman Maximization Test in Guinea Pigs Sensitization Test) | Normal Saline and Vegetable (Cottonseed) Oil Extracts Hartley Guinea Pigs | 6.0 cm²/mL (exposed surface area to extraction medium volume ratio), extracted at 50°C/72 hrs. | Non-sensitizing The test article did not elicit a sensitization response. | | Irritation/ Intracutaneous Toxicity (ISO Intracutaneous Injection Test in Rabbits) | Normal Saline and Vegetable (Cottonseed) Oil Extracts | 6.0 cm²/mL (exposed surface area to extraction medium volume ratio), extracted at 50°C/72 hrs. | Non-irritant No evidence of irritation. | | Systemic Toxicity (ISO Systemic Injection Test in Mice) | Normal Saline and Vegetable (Cottonseed) Oil Extracts Albino Swiss Mice | 6.0 cm²/mL (exposed surface area to extraction medium volume ratio), extracted at 50°C/72 hrs. | Non-cytotoxic No weight loss, mortality, or evidence of systemic toxicity from the extract exposure to the mice. | | Systemic Toxicity (ISO Rabbit Pyrogen (Material-Mediated) Test) | Normal Saline New Zealand White Rabbits (2 Male and 2 Female - non-pregnant and nulliparous) | 6.0 cm²/mL (exposed surface area to extraction medium volume ratio), extracted at 50°C/72 hrs. | Non-pyrogenic All individual rabbits for both the test article and negative control showed a total rise in temperature of < 0.5°C and were determined to be non- pyrogenic. | | Hemocompatibility (ASTM Hemolysis Test - Rabbit Blood - Direct and Indirect Contact Methods) | Direct Contact Solid Sample Exposure to Rabbit Blood Substrate and Indirect Contact Extracted in Phosphate Buffered Saline (PBS) New Zealand White Rabbits | Both Direct and Indirect Contact Methods Direct Contact: 6.0 cm²/mL (exposed surface area to extraction medium volume ratio), exposure to Blood Substrate then | Non-hemolytic There were no significant differences between the test article extract/solid and negative control article results. | | | | Incubated at 37°C for 3 hours. Indirect Contact: 6.0 cm2/mL (exposed surface area to extraction medium volume ratio) in PBS. Extracted at 50°C for 72 hours then Extract Exposed to Blood Substrate and Incubated at 37°C for 3 hours. | | | Hemocompatibility (ISO Unactivated Partial Thrombinplastin Time (UPTT) Test – Direct Contact Method) | Solid Sample Exposure to Human Plasma | 6.0 cm²/mL (exposed surface area to extraction medium volume ratio). Incubated with human plasma at 37°C for 15 minutes. | No adverse effect on Unactivated Partial Thrombinplastin Time of human plasma The solid test article was determined to be compatible with blood and not affect coagulation. | | Hemocompatibility (ISO Complement Activation (C3 and SC5b-9) Test - Direct Contact) | Solid Sample and Normal Saline Extract then Exposure to Human Plasma | Direct Contact: 6.0 cm²/mL (exposed surface area to extraction medium volume ratio). Exposure to Human Plasma then Incubated at 37°C for 90 Minutes. | C3a and SC5b-9 complement proteins were considered to be non-activated as compared to the negative control | | Hemo-compatibility (ISO In Vitro Hemocompatibility Test – Direct Contact Method) | Solid Sample Exposure to Human Plasma | 6.0 cm²/mL (exposed surface area to extraction medium volume ratio). Incubated with human plasma at 37°C for 60 minutes. | Hemocompatible The test article was determined to be hemocompatible with direct exposure to human blood for the blood parameters (WBC, RBC, HgB, Hct, MCV, MCH, MCHC, and Plt). | | Hemo-compatibility (Large Animal Thrombogenicity Test) | Final Devices Used in a Simulated Clinical Application tested on Female Yorkshire pigs | Direct Exposure | Non-thrombogenic. No significant thrombus was observed on any of the SOFIA® EX Catheter devices and the device was determined to not show thrombogenic potential. | | Genotoxicity - Gene Mutation (ISO In Vitro Ames Test - Salmonella typhimurium and Escherichia coli Reverse Mutation Genotoxicity Test) | Normal Saline and Vegetable (Cottonseed) Oil Extracts Salmonella. typhimurium TA98, TA100, TA1535, TA1537, and E. coli WP2 uvr A under both Non-Activated and Activated Systems | 6.0 cm²/mL (exposed surface area to extraction medium volume ratio). Extracted at 50°C/72 hrs. | Non-mutagenic Based on the acceptance criteria under the experimental conditions utilized, the test article extracts were both deemed non-mutagenic in all strains under both non-activated and activated conditions. | | Genotoxicity - Chromosomal Aberration (In Vitro Chromosomal Aberration Genotoxicity Test) | Ham's F12 Cell Growth Medium and PEG 400 Chinese Hamster Ovary (CHO) Cells under both Non- Activated and Activated Systems | 6.0 cm²/mL (exposed surface area to extraction medium volume ratio). Extracted at 50°C/72 hrs. | Non-mutagenic Based on the criteria of the study protocol, the test article was considered to be non- mutagenic. | | Genotoxicity - Chromosomal Aberration (In Vivo Rodent Blood Micronucleus Genotoxicity Test) | Normal Saline and Vegetable (Cottonseed) Oil Albino Swiss Mice | 6.0 cm²/mL (exposed surface area to extraction medium volume ratio). Extracted at 50°C/72 hrs. | Non-mutagenic Based on the criteria of the study protocol, the test article was considered to be non- mutagenic. | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image contains the logo for MicroVention, a company specializing in neurovascular products. The logo features a stylized graphic to the left of the company name, "MicroVention," which is written in a blue sans-serif font. Below "MicroVention" is the word "TERUMO," also in blue, indicating that MicroVention is associated with Terumo Corporation, a medical device company. The overall design is clean and professional, reflecting the medical and technological nature of the company. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image contains the logo for MicroVention TERUMO. The logo features a stylized, abstract graphic to the left, resembling a series of curved lines or orbits. To the right of the graphic, the word "MicroVention" is written in a blue, sans-serif font. Below "MicroVention", the word "TERUMO" is written in a similar blue font, but with a slightly bolder typeface. # Biocompatibility Study {10}------------------------------------------------ Image /page/10/Picture/0 description: The image contains the logo for MicroVention, a company that is part of Terumo. The logo features a stylized graphic of swirling lines on the left, followed by the company name "MicroVention" in a blue sans-serif font. Below "MicroVention" is the word "TERUMO" in a bolder, blue sans-serif font, indicating the parent company. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image contains the logo for MicroVention TERUMO. The logo features a stylized, abstract graphic on the left, resembling a series of curved lines in shades of gray and blue. To the right of the graphic, the word "MicroVention" is written in a blue, sans-serif font. Below "MicroVention", the word "TERUMO" is written in a bolder, blue, sans-serif font. ## Animal Study An acute animal testing was conducted in accordance with FDA GLP Regulation (21 CFR Part 58) comparing the SOFIA® EX Catheter to the Medtronic Navien Intracranial Support Catheter. The testing was intended to demonstrate clinical efficacy for catheter tip stability and safety in a porcine model. Three female Yorkshire pigs were chosen given the vessel sizes of the pig model allow for insertion and navigation of standard-sized devices used in humans and have diameters that are comparable with that of the human peripheral vasculature. The tracking results demonstrated that the SOFIA® EX and Navien devices performed equally in tracking over the microcatheter/quidewire. No dissection/perforation, thrombus formation or distal emboli were noted after the tracking procedures. Similar degrees of vasospasm and luminal narrowing were noted in the vessels instrumented with both devices. During explant there were no remarkable gross findings for any of the vessel samples for both the candidate and reference devices. All vessels appeared intact with no visible wall disruptions, ectasia, or aneurysmal dilation. Overall, the histologic findings were consistent with routine catheterization procedures, which are commonly observed with guide wires alone in the porcine safety models. The results of the present study did not raise any safety issues with either the control Navien or test SOFIA® EX catheter. Both devices are deemed equivalent. {12}------------------------------------------------ Image /page/12/Picture/0 description: The image contains the logo for MicroVention TERUMO. The logo features a stylized graphic on the left, resembling a swirling vortex or a stylized eye, with shades of gray and blue. To the right of the graphic, the text "MicroVention" is written in a combination of blue and gray, with "Micro" in blue and "Vention" in gray. Below "MicroVention", the word "TERUMO" is written in bold, blue letters. # VIII. Conclusions MicroVention concludes through a review of the benchtop and non-clinical animal assessments, the comparison of the device classification, indications for use, operating principle, technological characteristics, sterility and biocompatibility that the SOFIA® EX Catheter is substantially equivalent to the predicate SOFIA® Distal Access Catheter and the reference device Navien Intracranial Support Catheter. Any differences between the subject device and the predicate and reference device do not raise different questions of safety and effectiveness.

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SOFIA EX Intracranial Support Catheter

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