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 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.

AI/ML Overview

The provided document is a 510(k) premarket notification for the SOFIA® EX Intracranial Support Catheter. It describes the device, its intended use, comparison to predicate devices, and performance data used to demonstrate substantial equivalence.

Here's the breakdown of the acceptance criteria and the study proving the device meets them, as extracted from the document:

1. A table of acceptance criteria and the reported device performance:

The document presents the performance data in a table format under section "VII. Performance Data" (pages 7-8). Each "Test" listed implicitly defines an acceptance criterion (e.g., "Device met acceptance criteria"). Because the document is a 510(k) summary, the specific quantitative acceptance criteria values are not explicitly stated, but the results confirm that the "Device met acceptance criteria" for each test.

Test Name	Test Method Summary	Reported Device Performance
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 and maintains rated burst pressure for a specified duration of time.	Device met acceptance criteria and does not leak fluids at rated burst pressure.
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.
Cytotoxicity (ISO Medium Eluate Method)	1x CMEM Cell Growth Medium (MEM supplemented with 10% fetal bovine serum extract) L929 Mouse Fibroblast Cell Line (Extracted at 37°C/24 hrs, 6.0 cm²/mL)	Non-cytotoxic. The test article is considered non-cytotoxic to cells.
Sensitization (ISO Kligman Maximization Test)	Normal Saline and Vegetable (Cottonseed) Oil Extracts Hartley Guinea Pigs (Extracted at 50°C/72 hrs, 6.0 cm²/mL)	Non-sensitizing. The test article did not elicit a sensitization response.
Irritation/Intracutaneous Toxicity	Normal Saline and Vegetable (Cottonseed) Oil Extracts (Extracted at 50°C/72 hrs, 6.0 cm²/mL)	Non-irritant. No evidence of irritation.
Systemic Toxicity (ISO Systemic Injection Test)	Normal Saline and Vegetable (Cottonseed) Oil Extracts Albino Swiss Mice (Extracted at 50°C/72 hrs, 6.0 cm²/mL)	Non-cytotoxic (sic, likely meant non-toxic per the test type). No weight loss, mortality, or evidence of systemic toxicity from the extract exposure to the mice.
Systemic Toxicity (ISO Rabbit Pyrogen Test)	Normal Saline New Zealand White Rabbits (2 Male and 2 Female - non-pregnant and nulliparous) (Extracted at 50°C/72 hrs, 6.0 cm²/mL)	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)	Direct Contact Solid Sample Exposure to Rabbit Blood Substrate and Indirect Contact Extracted in Phosphate Buffered Saline (PBS) New Zealand White Rabbits (Direct Contact: 6.0 cm²/mL at 37°C for 3 hours; Indirect Contact: 6.0 cm2/mL in PBS, extracted at 50°C for 72 hours, then extract exposed to Blood Substrate at 37°C for 3 hours)	Non-hemolytic. There were no significant differences between the test article extract/solid and negative control article results.
Hemocompatibility (ISO Unactivated Partial Thrombinplastin Time (UPTT) Test)	Solid Sample Exposure to Human Plasma (6.0 cm²/mL, 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)	Solid Sample and Normal Saline Extract then Exposure to Human Plasma (Direct Contact: 6.0 cm²/mL, exposure to Human Plasma, 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.
Hemocompatibility (ISO In Vitro Hemocompatibility Test)	Solid Sample Exposure to Human Plasma (6.0 cm²/mL, 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).
Hemocompatibility (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)	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 (Extracted at 50°C/72 hrs, 6.0 cm²/mL)	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)	Ham's F12 Cell Growth Medium and PEG 400 Chinese Hamster Ovary (CHO) Cells under both Non-Activated and Activated Systems (Extracted at 50°C/72 hrs, 6.0 cm²/mL)	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)	Normal Saline and Vegetable (Cottonseed) Oil Albino Swiss Mice (Extracted at 50°C/72 hrs, 6.0 cm²/mL)	Non-mutagenic. Based on the criteria of the study protocol, the test article was considered to be non-mutagenic.

2. Sample size used for the test set and the data provenance:

Bench Studies: The document does not specify the exact sample sizes for each bench test (e.g., number of catheters tested for tensile strength). However, it implies that sufficient samples were tested to declare that the "Device met acceptance criteria" in each case. These are prospective tests conducted for the purpose of this submission. The origin is implicitly the manufacturing site (Tustin, CA, USA) or associated testing facilities.
Biocompatibility Studies: Again, the exact sample sizes for these in-vitro and in-vivo tests are generally not detailed in this summary, but the materials and test systems are provided (e.g., L929 Mouse Fibroblast Cell Line, Hartley Guinea Pigs, Rabit Blood, Human Plasma, Albino Swiss Mice, New Zealand White Rabbits). These are prospective studies.
Animal Study:
- Sample Size: Three female Yorkshire pigs were used.
- Data Provenance: The study was conducted in a porcine model, which is an animal study (not human data). It was an acute study performed specifically for this submission, making it prospective. The country of origin is not explicitly stated, but it was conducted in accordance with FDA GLP Regulation (21 CFR Part 58), suggesting it was designed to meet US regulatory standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Bench and Biocompatibility Tests: The ground truth for these tests is established by objective measurements and laboratory standards (e.g., ISO standards, ASTM standards, USP guidelines). It is not dependent on expert consensus or human interpretation in the same way clinical image analysis would be. Therefore, there's no mention of a number of experts or their qualifications in this context.
Animal Study: The document states that the testing was intended to "demonstrate clinical efficacy for catheter tip stability and safety" and notes that "histologic findings were consistent with routine catheterization procedures." While implicit that veterinarians, pathologists, and interventionalists (or researchers with similar expertise) observed and assessed the animal study outcomes, the number and specific qualifications of experts involved in the evaluation of the animal model are not explicitly stated in this 510(k) summary. The ground truth here is derived from direct observation, histological analysis, and physiological assessments in the live animal model.

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

For the bench and biocompatibility tests, adjudication methods (like 2+1 or 3+1) are not applicable as the results are based on objective measurements and established scientific protocols rather than subjective human interpretation needing consensus.
For the animal study, no formal subjective adjudication method is described. The results mention "No dissection/perforation, thrombus formation or distal emboli were noted" and "All vessels appeared intact with no visible wall disruptions," implying direct observation and assessment by the research team conducting the animal study. Histological findings would be adjudicated by a veterinary pathologist.

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:

No, an MRMC comparative effectiveness study was not done. This device is an intracranial support catheter, a physical medical device, not an AI software. The studies conducted are related to its physical performance, safety, and biocompatibility, not its impact on human reader performance with or without AI assistance.

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

Not applicable. This submission is for a physical medical device, an intracranial support catheter, not an algorithm or AI software that would have a "standalone performance."

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

Bench Studies: Ground truth is based on engineering and physical performance measurements against established standards (e.g., ISO, ASTM, USP).
Biocompatibility Studies: Ground truth is based on biological and toxicological responses measured through standard in-vitro and in-vivo tests, assessed against established biological safety evaluation criteria.
Animal Study: Ground truth is established through direct observation of clinical efficacy and safety endpoints (e.g., catheter tip stability, absence of dissection/perforation, thrombus formation, distal emboli, vasospasm, luminal narrowing) and histological examination of vessel samples in a live animal model. This combines direct observation with pathological assessment.

8. The sample size for the training set:

Not applicable. This document describes the testing and approval of a physical medical device. It does not involve machine learning or AI models that require a "training set."

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

Not applicable. As a physical medical device, there is no training set for an AI model.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K182602

Device Name SOFIA® EX Intracranial Support Catheter

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)	☑
Over-The-Counter Use (21 CFR 801 Subpart C)	☐

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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
ClassificationName	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)

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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

V. Indications for Use

VI. Comparison of Technological Characteristics with the Predicate Device

	Medtronic NavienIntracranial SupportCatheter (K161152)	SOFIA® Distal AccessCatheter (K131482)	SOFIA® EX Catheter
	Reference Device	Predicate Device	Subject Device
Intended Use	The NavienIntracranial SupportCatheter is indicatedfor the introduction ofinterventionaldevices into theperipheral and neurovasculature.	The SOFIA® Distal AccessCatheter is indicated forgeneral intravascular use,including the neuro andperipheral vasculature. Itcan be used to facilitateintroduction of diagnosticand therapeutic agents. It isnot intended for use incoronary arteries.	The SOFIA® EX Catheteris indicated for generalintravascular use,including the neuro andperipheral vasculature.The SOFIA® EX Cathetercan be used to facilitateintroduction of diagnosticagents or therapeuticdevices. The SOFIA® EXCatheter is not intendedfor use in coronaryarteries.
DeviceClassification	Class IIDQY21 CFR 870.1250	Class IIDQY, DQO21 CFR 870.125021 CFR 870.1200	Class IIDQY21 CFR 870.1250
	Medtronic NavienIntracranial SupportCatheter (K161152)	SOFIA® Distal AccessCatheter (K131482)	SOFIA® EX Catheter
	Reference Device	Predicate Device	Subject Device
Catheter Body	PTFE linedpolymeric catheter,with hydrophiliccoating and NitinolSupport.	Outer layer of polyurethaneelastomer (Polyblend andPellethane), polyether blockamide (Pebax) andpolyamide (Grilamid); innerlayer of stainless steelbraid/coil, PTFE andpolyolefin elastomer.	Outer layer of polyolefinelastomer, polyurethaneelastomer (Pellethane),polyether block amide(Pebax) and polyamide(Grilamid); inner layer ofstainless 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 Constructionand Material		Outer layer of polyurethaneelastomer, inner layer ofstainless steel braid (entireshaft)/stainless steel coil(except for distal 2cm), andpolyolefin elastomer.	Outer layer of polyolefinelastomer, inner layer ofstainless steel braid(except for distal 2cm)/Nitinol coil (entire shaft),and PTFE.
Average TipStiffness (2cmlength)	44 gf	16 gf	31gf

	Medtronic NavienIntracranial SupportCatheter (K161152)	SOFIA® Distal AccessCatheter (K131482)	SOFIA® EX Catheter
	Reference Device	Predicate Device	Subject Device
GuidewireCompatibility	0.038 inch	0.035 or 0.038 inch	Same as SOFIA® DAC(K131482)
Accessories	Introducer Sheath	Introducer sheath andshaping mandrel	Introducer sheath
Method of Supply	Sterile and singleuse	Sterile and single use	Same as SOFIA® DAC(K131482)
Sterilization Method	Ethylene Oxide	Ethylene Oxide	Same as SOFIA® DAC(K131482)
PackagingConfiguration	Catheter inpolyethylene hoopattached topackaging cardinside PET/PE/Tyvekpouch inside SBScarton.	Catheter placed into aHDPE dispenser tube.Dispenser tube, introducerand shaping mandrelplaced on a polyethylenepackaging card that isinserted into a Tyvek®pouch. Pouch and IFUplaced in bleached sulfatecarton box.	Same as SOFIA® DAC(K131482). No shapingmandrel.

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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.

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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.

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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 anddistal outer diameters, distallength and inner diameters weremeasured and recorded.	Device met acceptance criteria forlength, inner and outer diameters.The device size (5F) comparable tothe 5F predicate and referencedevices. The inner diameter is largerthan the predicate device, while theouter diameter is larger, but stillcompatible with tested 6F guidingsheaths.
Catheter Tip Stability	Simulated use of the delivery ofa braided device is performed ina tortuous anatomical benchtopmodel and the movement of thesubject device is measured andrecorded.	Device met acceptance criteria for tipstability. The device is able tosupport the delivery of braideddevices and stent-retrievers withoutlosing distal tip position. The stabilityof the distal tip was better (lessmovement) than the predicatedevice.
Simulated Use andPhysician SimulatedUse	The device is put throughsimulated use. The device isnavigated through a tortuousbenchtop model to assesspreparation, introduction,tracking, and support of thedevice.	Device met acceptance criteria
Dynamic Burst Testing	Device hub is connected to apressure control machine andwas tested under pressuresexperienced during worst-casedynamic injections.	Device met acceptance criteria andwas able to withstand pressuresexperienced during worst-casedynamic injections.
Liquid Leakage	Device was tested per ISO10555-1, Annex C liquid leakagetesting. Device is connected athub and is pressurized with fluidand maintains the pressure for aspecified duration of time.	Device met acceptance criteria
Liquid Leakage at RatedBurst Pressure	Device was tested per ISO10555-2 Annex A, liquid leakagetesting. Device is connected athub and is pressurized with fluid	Device met acceptance criteria anddoes not leak fluids at rated burstpressure.
	and maintains rated burstpressure for a specified durationof time.
Air Leakage	Device was tested per ISO 594-2. Device is connected at huband subjected to negativepressure and any air leaking intothe device is recorded.	Device met acceptance criteria.Device does not allow air to leak intothe device when subjected tonegative pressure.
Static Burst	Device was connected at huband tested under full-lengthstatic conditions to burst.	Device met acceptance criteria. Alldevices burst above the rated burstpressure and had better results thanthe predicate device.
Tensile Strength	Device was tested per ISO11070. The device is tensiletested to failure and the force atbreak is measured andrecorded.	Device met acceptance criteria.
Tip Buckling	Distal tip buckling force undercompressive load was evaluatedfor stiffness.	Device met acceptance criteria.Device has a softer distal tip than thereference device.
Torque Response	Device was tested for full-lengthtorque response. The device istracked through a tortuousbenchtop model and theproximal hub is turned, the distaltip torque response is measuredand recorded.	Device met acceptance criteria.Device has better torque responsethan the reference device.
Radio-detectability	Device is put under fluoroscopeto assess visibility.	Device met acceptance criteria.Device is visible under fluoroscopy.
Coating Lubricity andDurability	Device coating was evaluatedfor frictional force and durability.	Device met acceptance criteria.Average friction is comparable topredicate device.
Particulate Testing	Device was evaluated forparticulate generation undersimulated use in arepresentative tortuousanatomical model perUSP<788>.	Number of particulates generatedmet acceptance criteria and is withinthe limits per USP<788> and iscomparable to the predicate andreference devices.
Kink Resistance	Device is evaluated for kinkresistance by subjecting thedevice to bending experiencedin tortuous anatomy.	Device met acceptance criteria.Results matched results of thepredicate device.
Corrosion Resistance	Device is tested per ISO 10555-1, Annex A and ISO 11070,Annex B to evaluate corrosionresistance.	Device met acceptance criteria.Device is resistant to corrosion.
Test	Test Method Summary		Results
	Extract(s) & TestSystems	Extract Conditions
Cytotoxicity(ISO Medium EluateMethod (MEM) ElutionTest)	1x CMEM Cell GrowthMedium (MEMsupplemented with 10%fetal bovine serumextract)L929 Mouse FibroblastCell Line	6.0 cm²/mL (exposedsurface area toextraction mediumvolume ratio),extracted at 37°C/24hrs.	Non-cytotoxicThe test article isconsidered non-cytotoxicto cells.
Sensitization(ISO KligmanMaximization Test inGuinea PigsSensitization Test)	Normal Saline andVegetable (Cottonseed)Oil ExtractsHartley Guinea Pigs	6.0 cm²/mL (exposedsurface area toextraction mediumvolume ratio),extracted at 50°C/72hrs.	Non-sensitizingThe test article did notelicit a sensitizationresponse.
Irritation/Intracutaneous Toxicity(ISO IntracutaneousInjection Test inRabbits)	Normal Saline andVegetable (Cottonseed)Oil Extracts	6.0 cm²/mL (exposedsurface area toextraction mediumvolume ratio),extracted at 50°C/72hrs.	Non-irritantNo evidence of irritation.
Systemic Toxicity(ISO Systemic InjectionTest in Mice)	Normal Saline andVegetable (Cottonseed)Oil ExtractsAlbino Swiss Mice	6.0 cm²/mL (exposedsurface area toextraction mediumvolume ratio),extracted at 50°C/72hrs.	Non-cytotoxicNo weight loss, mortality,or evidence of systemictoxicity from the extractexposure to the mice.
Systemic Toxicity(ISO Rabbit Pyrogen(Material-Mediated)Test)	Normal SalineNew Zealand WhiteRabbits (2 Male and 2Female - non-pregnantand nulliparous)	6.0 cm²/mL (exposedsurface area toextraction mediumvolume ratio),extracted at 50°C/72hrs.	Non-pyrogenicAll individual rabbits forboth the test article andnegative control showeda total rise in temperatureof < 0.5°C and weredetermined to be non-pyrogenic.
Hemocompatibility(ASTM Hemolysis Test- Rabbit Blood - Directand Indirect ContactMethods)	Direct Contact SolidSample Exposure toRabbit Blood Substrateand Indirect ContactExtracted in PhosphateBuffered Saline (PBS)New Zealand WhiteRabbits	Both Direct andIndirect ContactMethodsDirect Contact: 6.0cm²/mL (exposedsurface area toextraction mediumvolume ratio),exposure to BloodSubstrate then	Non-hemolyticThere were no significantdifferences between thetest article extract/solidand negative controlarticle results.
		Incubated at 37°C for3 hours.Indirect Contact: 6.0cm2/mL (exposedsurface area toextraction mediumvolume ratio) in PBS.Extracted at 50°C for72 hours then ExtractExposed to BloodSubstrate andIncubated at 37°C for3 hours.
Hemocompatibility(ISO UnactivatedPartial ThrombinplastinTime (UPTT) Test –Direct Contact Method)	Solid Sample Exposureto Human Plasma	6.0 cm²/mL (exposedsurface area toextraction mediumvolume ratio).Incubated withhuman plasma at37°C for 15 minutes.	No adverse effect onUnactivated PartialThrombinplastin Time ofhuman plasmaThe solid test article wasdetermined to becompatible with bloodand not affectcoagulation.
Hemocompatibility(ISO ComplementActivation (C3 andSC5b-9) Test - DirectContact)	Solid Sample andNormal Saline Extractthen Exposure toHuman Plasma	Direct Contact:6.0 cm²/mL (exposedsurface area toextraction mediumvolume ratio).Exposure to HumanPlasma thenIncubated at 37°C for90 Minutes.	C3a and SC5b-9complement proteinswere considered to benon-activated ascompared to the negativecontrol
Hemo-compatibility(ISO In VitroHemocompatibility Test– Direct ContactMethod)	Solid Sample Exposureto Human Plasma	6.0 cm²/mL (exposedsurface area toextraction mediumvolume ratio).Incubated withhuman plasma at37°C for 60 minutes.	HemocompatibleThe test article wasdetermined to behemocompatible withdirect exposure to humanblood for the bloodparameters (WBC, RBC,HgB, Hct, MCV, MCH,MCHC, and Plt).
Hemo-compatibility(Large AnimalThrombogenicity Test)	Final Devices Used in aSimulated ClinicalApplication tested onFemale Yorkshire pigs	Direct Exposure	Non-thrombogenic. Nosignificant thrombus wasobserved on any of theSOFIA® EX Catheterdevices and the devicewas determined to notshow thrombogenicpotential.
Genotoxicity - GeneMutation(ISO In Vitro AmesTest - Salmonellatyphimurium andEscherichia coliReverse MutationGenotoxicity Test)	Normal Saline andVegetable (Cottonseed)Oil ExtractsSalmonella. typhimuriumTA98, TA100, TA1535,TA1537, and E. coliWP2 uvr A under bothNon-Activated andActivated Systems	6.0 cm²/mL (exposedsurface area toextraction mediumvolume ratio).Extracted at 50°C/72hrs.	Non-mutagenicBased on the acceptancecriteria under theexperimental conditionsutilized, the test articleextracts were bothdeemed non-mutagenicin all strains under bothnon-activated andactivated conditions.
Genotoxicity -ChromosomalAberration(In Vitro ChromosomalAberration GenotoxicityTest)	Ham's F12 Cell GrowthMedium and PEG 400Chinese Hamster Ovary(CHO) Cellsunder both Non-Activated and ActivatedSystems	6.0 cm²/mL (exposedsurface area toextraction mediumvolume ratio).Extracted at 50°C/72hrs.	Non-mutagenicBased on the criteria ofthe study protocol, thetest article wasconsidered to be non-mutagenic.
Genotoxicity -ChromosomalAberration(In Vivo Rodent BloodMicronucleusGenotoxicity Test)	Normal Saline andVegetable (Cottonseed)OilAlbino Swiss Mice	6.0 cm²/mL (exposedsurface area toextraction mediumvolume ratio).Extracted at 50°C/72hrs.	Non-mutagenicBased on the criteria ofthe study protocol, thetest article wasconsidered to be non-mutagenic.

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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.

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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

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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.

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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.

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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.

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).