Who is the manufacturer of SOFIA 88 Catheter?

MicroVention, Inc. filed the 510(k) submission for SOFIA 88 Catheter (K214024).

What is the FDA product code for SOFIA 88 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 88 Catheter?

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

Who can help prepare an FDA 510(k) submission like SOFIA 88 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 88 Catheter

Q: What are the predicate devices for SOFIA 88 Catheter?

Sofia 6F PLUS/Distal Access Catheters (K150366).

K214024 · MicroVention, Inc. · DQY · Sep 12, 2022 · Cardiovascular

Device Facts

Record ID	K214024
Device Name	SOFIA 88 Catheter
Applicant	MicroVention, Inc.
Product Code	DQY · Cardiovascular
Decision Date	Sep 12, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The SOFIA 88 Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA 88 Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA 88 Catheter is not intended for use in coronary arteries.

Device Story

SOFIA 88 Catheter is a non-tapered, single-lumen, flexible catheter with coil and braid reinforcement; features 60 cm distal-shaft hydrophilic coating for navigation; includes radiopaque marker for fluoroscopic visualization. Used by clinicians in neuro/peripheral vascular procedures to facilitate delivery of diagnostic/therapeutic agents. Device is inserted into vasculature; clinician monitors position via fluoroscopy. Provides a conduit for interventional devices; benefits patient by enabling minimally invasive access to target vascular sites. Single-use, sterile, EtO-sterilized.

Clinical Evidence

No human clinical data. Bench testing included dimensional verification, lubricity/durability, simulated use in tortuous models, burst pressure, leakage, tensile strength, flexural fatigue, particulate testing, kink resistance, torque strength, radiodetectability, and corrosion resistance. GLP-compliant porcine animal study (n=not specified) compared tracking and tip stability to predicate; results showed equivalent performance with no adverse histological findings (hemorrhage, necrosis, edema). Biocompatibility testing (cytotoxicity, irritation, sensitization, systemic toxicity, pyrogenicity, hemocompatibility) confirmed safety.

Technological Characteristics

Single-lumen catheter; coil/braid reinforcement; outer layer: polyurethane elastomer, polyether block amide, polyamide; inner layer: metal braid/coil, PTFE, polyolefin elastomer. Hydrophilic coating. 8F size. EtO-sterilized. Radiopaque marker (Platinum/Iridium).

Indications for Use

Indicated for general intravascular use in neuro and peripheral vasculature to facilitate introduction of diagnostic agents 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 6F PLUS/Distal Access Catheters (K150366)

Reference Devices

TracStar™ Large Distal Platform (K203764)
ZOOM™ 88 Large Distal Platform (K203764)
ZOOM™ 88-T Large Distal Platform (K203764)

Submission Summary (Full Text)

{0}------------------------------------------------ September 12, 2022 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. MicroVention, Inc. Alick Tan, Ph.D. Senior Regulatory Affairs Specialist 35 Enterprise Aliso Viejo, California 92656 ### Re: K214024 Trade/Device Name: SOFIA 88 Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, QJP Dated: August 12, 2022 Received: August 12, 2022 ### Dear Alick Tan: 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-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) K214024 Device Name SOFIA 88 Catheter Indications for Use (Describe) The SOFIA 88 Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA 88 Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA 88 Catheter is not intended for use in coronary arteries. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------| | <div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </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 shows the logo for MicroVention TERUMO. The logo features a stylized, abstract graphic on the left, resembling a series of concentric arcs in shades of blue and gray. To the right of the graphic is the word "MicroVention" in a blue sans-serif font, with "TERUMO" in a smaller, bolder blue font directly underneath. ### K214024 510(k) Summary | 510(k) Owner | MicroVention, Inc. 35 Enterprise Aliso Viejo, CA 92656 Establishment Registration No: 3013556777 | |--------------------------|------------------------------------------------------------------------------------------------------------------------| | Contact Person | Alick Tan, PhD Senior Regulatory Affairs Specialist Telephone: 949-615-2603 Email: alick.tan@microvention.com | | Date summary Prepared | September 12, 2022 | | Trade Name | SOFIA 88 Catheter | | Common Name | Catheter, Percutaneous, Neurovasculature | | Classification | Class II, DQY, QJP | | Regulation | 21 CFR 870.1250 | | Predicate Device | Sofia 6F PLUS/Distal Access Catheters (K150366) | | Reference Device | TracStar™ Large Distal Platform; ZOOM™ 88 Large Distal Platform; ZOOM™ 88-T Large Distal Platform (K203764) | ### Device Description The SOFIA 88 Catheter is a non-tapered, single-lumen, flexible catheter equipped with coil and braid reinforcement. The distal seqment is designed to facilitate vessel selection with 60 cm of distal-shaft hydrophilic coating for navigation through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. #### Indications for Use The SOFIA 88 Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA 88 Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA 88 Catheter is not intended for use in coronary arteries. #### Comparison of Indications for Use and Technological Characteristics Substantial equivalence of the SOFIA 88 Catheter to the predicate Sofia 6F PLUS/Distal Access Catheters (SOFIA 6F DAC) and to the reference device TracStar Large Distal Platform; ZOOM 88 Large Distal Platform; ZOOM 88-T Large Distal Platform (ZOOM 88) was established through an evaluation of the intended use, indications for use, principles of operation, device design, materials of construction, and an assessment of usability, safety, and effectiveness via bench and animal studies. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for MicroVention TERUMO. The logo features a stylized, abstract graphic to the left, resembling a circular or orbital design with varying shades of gray and blue. To the right of the graphic, the word "MicroVention" is written in a combination of blue and gray lettering, with "Micro" in blue and "Vention" in gray. Below "MicroVention", the word "TERUMO" is written in blue, in a slightly smaller and bolder font. The data presented in this submission demonstrates the technological similarity and equivalency of the SOFIA 88 Catheter compared with the predicate device SOFIA 6F DAC (K150366) and the reference device ZOOM 88 (K203764). The devices: - . have the same intended use, - . use the same principle of operation, - incorporate the same basic design, - use similar construction and material, and ● - are ethylene oxide (EtO)-sterilized and packaged using the same processes. ● ### Device Comparison Table | | ZOOM 88 (K203764) | SOFIA 6F DAC (K150366) | SOFIA 88 Catheter | |----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Reference Device | Predicate Device | Subject Device | | Indications for Use | The ZOOM 88 and ZOOM 88-T Large Distal Platform are indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. | The SOFIA PLUS/Distal Access Catheters are 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 88 Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA 88 Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA 88 Catheter is not intended for use in coronary arteries. | | Device Classification | Class II QJP, DQY 21 CFR 870.1250 | Class II DQY, DQO 21 CFR 870.1250 21 CFR 870.1200 | Class II DQY, QJP 21 CFR 870.1250 | | ZOOM 88 (K203764) | SOFIA 6F DAC (K150366) | SOFIA 88 Catheter | | | Reference Device | Predicate Device | Subject Device | | | Catheter Body | Commonly used medical grade plastics & metals with hydrophilic coating | Outer layer of polyurethane elastomer, polyether block amide, and polyamide; inner layer of metal braid/coil, PTFE, and polyolefin elastomer | Outer layer of polyurethane elastomer (different polyurethane formulation), polyether block amide, and polyamide; inner layer of metal braid/coil, PTFE, and polyolefin elastomer | | Marker | - | Platinum/Iridium | Same as SOFIA 6F DAC (K150366) | | Hub | - | Nylon | Same as SOFIA 6F DAC (K150366) | | Strain Relief | - | Polyurethane | Same as SOFIA 6F DAC (K150366) | | Introducer | None | Pebax® | Fluorinated ethylene propylene | | Shaping Mandrel | None | Stainless steel | None | | Catheter size | 8F | 6F | 8F, Same as ZOOM 88 (K203764) | | ID | 0.088 in (2.2 mm) | 0.070 in (1.8 mm) | 0.0875 in (2.22 mm) min | | OD | 0.110 in (2.79 mm) max | 0.0825 in (2.10 mm) | Proximal: 0.108 in (2.74 mm) max | | | | | Distal: 0.102 in (2.59 mm) max | | Effective Length | 80–110 cm | 115, 125, 131, 135 cm | 115 cm | | Coating | Hydrophilic coating | Hydrophilic coating | Same as SOFIA 6F DAC (K150366) | | Tip Configuration | Beveled distal edge, soft, flexible, atraumatic tip | Straight | Same as SOFIA 6F DAC (K150366) | | Guidewire Compatibility | ≤ 0.038 in | 0.035 in | ≤ 0.038 in | | Accessories | Rotating hemostasis valve (RHV) | Introducer sheath and shaping mandrel | Introducer sheath | | | ZOOM 88 (K203764) | SOFIA 6F DAC (K150366) | SOFIA 88 Catheter | | | Reference Device | Predicate Device | Subject Device | | Condition Supplied | Sterile and single use | Sterile and single use | Same | | Sterilization Method | EtO | EtO | Same | | Packaging Configuration | The catheters are placed in a protective polyethylene tube, mounted with accessory RHV onto a polyethylene packaging card, placed into a pouch, sealed and labeled. The sealed pouch and IFU are placed in a labeled shelf carton box. | 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. | Catheter placed into a HDPE dispenser tube. Dispenser tube and introducer placed on a polyethylene packaging card that is inserted into a Tyvek pouch. Pouch and IFU placed in bleached sulfate carton box. | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for MicroVention, a company that specializes in neurovascular products. The logo features a stylized graphic of interconnected blue and gray circles on the left. To the right of the graphic is the company name "MicroVention" in blue, with the registered trademark symbol. Below the company name is the word "TERUMO" in blue, which is the parent company of MicroVention. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for MicroVention TERUMO. The logo features a circular graphic on the left side, composed of overlapping curved lines in shades of gray and blue, creating a sense of motion or rotation. To the right of the graphic, the word "MicroVention" is written in a blue sans-serif font, with a small registered trademark symbol next to it. Below "MicroVention", the word "TERUMO" is written in a larger, bolder blue sans-serif font. ## Performance Testing Performance testing was conducted to demonstrate the substantial equivalence of the SOFIA 88 Catheter to the predicate device. The following testing data were provided to evaluate the performance of the SOFIA 88 Catheter. | Test | Test Method Summary | Results | |--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Dimensional Verification | Dimensional specifications were verified by measuring the catheter length, proximal and distal outer diameters, and distal inner diameter. | Pass | | Coating Lubricity and Durability | The hydrophilic coating was evaluated for frictional force and durability. | Pass | | Simulated Use | Performance was evaluated under simulated use in a tortuous anatomical model to assess preparation, introduction, tracking, and support of the device. | Pass | | Dynamic and Static Burst Pressure | Device was subjected to rated burst pressures to test catheter integrity. | Pass | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for MicroVention, a company that is part of Terumo. The logo features a stylized graphic of three curved lines that resemble a swirl or a vortex. To the right of the graphic is the word "MicroVention" in a blue sans-serif font. Below "MicroVention" is the word "TERUMO" in a smaller, bolder, blue sans-serif font. | Test | Test Method Summary | Results | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Air Leakage | Device was tested for air leakage requirements. | Pass | | Liquid Leakage | Device was tested for liquid leakage requirements. | Pass | | Tensile Strength | Device was tensile tested to failure, and recorded the force at breakage. | Pass | | Flexural Fatigue | Device was subjected to flexural fatigue from repeated bending during simulated use testing and flexural fatigue from repeated hoop stress on the catheter from pressure testing. | Pass | | Particulate Testing | The number and size of particulates generated during simulated use in a tortuous anatomical model were measured and results were compared with the predicate device. | Pass | | Kink Resistance | Device was evaluated for kink resistance after simulated use testing. | Pass | | Torque Strength | Device was evaluated for torque strength by measuring the number of catheter rotations until failure after tracking through a tortuous anatomical model. | Pass | | Radio Detectability | Device visibility was evaluated under fluoroscopy. | Pass | | Corrosion Resistance | Device corrosion was evaluated after immersion in saline. | Pass | | Small-bore Connector | The luer connector was evaluated for dimensional and performance requirements per reference standard. | Pass | | Stiffness Profile | The catheter stiffness profile along proximal and distal sections was compared to the reference device. | Pass | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image contains the logo for MicroVention TERUMO. The logo features a stylized, abstract graphic to the left, resembling interconnected circles or orbits in shades of gray and blue. To the right of the graphic is the word "MicroVention" in a blue sans-serif font, with "TERUMO" in a bolder, blue font positioned directly below it. # Biocompatibility Results | Test | Test Method Summary | | Results | |----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|---------------------------------------| | | Extract(s) & Test Systems | Extract Conditions | | | Cytotoxicity (ISO MEM Elution Test) | L-929 mouse fibroblast cells prepared using MEM Maintenance Growth Media with 5% FBS | 6.0 cm²/mL (exposed surface area to extraction medium volume ratio), extracted at 37 °C for 24 hrs | Non-cytotoxic | | Irritation Reactivity (ISO Intracutaneous Reactivity Test) | Normal saline and sesame seed oil (SSO) (tested separately) New Zealand White Rabbits | 6.0 cm²/mL (exposed surface area to extraction medium volume ratio), extracted at 50 °C for 72 hrs | Non-irritant | | Maximization (ISO Guinea Pig Maximization Test) | Normal saline and sesame seed oil (SSO) (tested separately) Guinea Pig | 6.0 cm²/mL (exposed surface area to extraction medium volume ratio), extracted at 50 °C for 72 hrs | Non-sensitizing | | Systemic Toxicity (ISO Acute Systemic Toxicity Test) | Normal saline and sesame seed oil (SSO) (tested separately) Albino outbred strain (ND4) mice | 6.0 cm2/mL (exposed surface area to extraction medium volume ratio), extracted at 50 °C for 72 hrs | Non-acute systemically toxic | | Pyrogenicity (ISO/USP Material Mediated Pyrogencity Test) | Normal saline New Zealand White Rabbits | 6.0 cm²/mL (exposed surface area to extraction medium volume ratio), extracted at 50 °C for 72 hrs | Non-pyrogenic | | Test | Test Method Summary | | Results | | | Extract(s) & Test Systems | Extract Conditions | | | Hemocompatibility In-Vitro Blood Loop Assay (ISO In-vitro Blood Loop Assay with Comparison Article) | A loop system circulated with freshly drawn sheep blood | The test article is exposed to the circulating blood that fills to the capacity of the loop at 37 °C for 4 hrs | Thromboresistant | | Hemocompatibility Hemolysis Assay (ISO ASTM Hemolysis Assay) | PBS – Phosphate Buffered Saline Blood - Three New Zealand White Rabbits | 6.0 cm²/mL (exposed surface area to extraction medium volume ratio), extracted at 50 °C for 72 hrs | Non-hemolytic | | Hemocompatibility Complement Activation Assay (ISO Hemocompatibility: Complement Activation Assay (SC5b-9)) | Normal Human Serum (NHS) | 6.0 cm²/mL (exposed surface area to extraction medium volume ratio), extracted at 37 °C for 60 min | Non-activator of complement system | | Hemocompatibility Partial Thromboplastin (ISO Hemocompatibility: Partial Thromboplastin Time (PTT) Assay) | Human Plasma Freshly Drawn Human Plasma | 6.0 cm²/mL (exposed surface area to extraction medium volume ratio), extracted at 37 °C for 15 min | No effect on the PTT | | Test | Test Method Summary | | Results | | | Extract(s) & Test Systems | Extract Conditions | | | Hemocompatibility Heparinized Blood Platelet and Leukocyte | Human Blood | 12 cm²/mL (exposed surface area to extraction medium volume ratio), extracted at 37 °C for 60 min | Pass | | | Freshly Drawn Human Blood | | | | (Hemocompatibility: Heparinized Blood Platelet and Leukocyte Count Assay) | | | | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image contains the logo for MicroVention, a Terumo company. The logo features a stylized, abstract graphic to the left of the text "MicroVention". Below "MicroVention" is the word "TERUMO", indicating that MicroVention is associated with Terumo Corporation. The text is in a blue font. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for MicroVention TERUMO. The word "MicroVention" is written in a combination of blue and gray letters, with "Micro" in blue and "Vention" in gray. To the left of the word is a circular graphic made of curved lines in shades of gray and blue. Below "MicroVention" is the word "TERUMO" in blue, in a smaller, bolder font. # Animal Study Acute animal testing was conducted in accordance with FDA Good Laboratory Practice (GLP) Regulation (21 CFR Part 58) comparing the SOFIA 88 Catheter to the SOFIA 6F DAC. The testing was intended to assess preclinical safety and efficacy for catheter tracking and tip stability in a porcine model. The porcine model was chosen since the vessel sizes of the pig model allow for insertion and navigation of standard-sized devices used in humans; porcine vessel diameters are comparable with human vasculature. The tracking results demonstrated that the SOFIA 88 Catheter and SOFIA 6F DAC devices performed equally. Catheter tip stability was found to be comparable for both devices. No dissection/perforation was noted for the test-article- and controltreated vessels. Similar degrees of vasospasm were noted in the vessels instrumented with both devices. During postmortem examination there were no remarkable gross findings for any of the vessel samples for both the test and control devices. There was no hemorrhage, necrosis, or edema in test article-treated and control article-treated arterial sections. Overall, the histologic findings were consistent with routine catheterization procedures, which are commonly observed after interventional procedures in porcine safety models. The results of the present study did not raise any safety issues with either the test SOFIA 88 Catheter or control SOFIA 6F DAC. The devices are deemed equivalent. ## Conclusion MicroVention concludes through a review of the benchtop testing, non-clinical animal study assessments, the comparison of the device classification, indications for use, operating principles, technological characteristics, sterility, and biocompatibility testing that the SOFIA 88 Catheter is substantially equivalent to the predicate SOFIA 6F DAC. Any differences between the subject device and the predicate device do not raise different questions of safety and effectiveness.

SOFIA 88 Catheter

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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SOFIA 88 Catheter

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

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Predicate Devices

Reference Devices

Submission Summary (Full Text)

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