Who is the manufacturer of SOFIA EX Intracranial Support Catheter?

MicroVention, Inc. filed the 510(k) submission for SOFIA EX Intracranial Support Catheter (K230775).

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

QJP. 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 EX Intracranial Support Catheter (K182602).

K230775 · MicroVention, Inc. · QJP · Sep 14, 2023 · Cardiovascular

Device Facts

Record ID	K230775
Device Name	SOFIA EX Intracranial Support Catheter
Applicant	MicroVention, Inc.
Product Code	QJP · Cardiovascular
Decision Date	Sep 14, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2

Intended Use

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

Device Story

Single-lumen, flexible intracranial support catheter; coil and braid reinforced; distal shaft hydrophilic coating for navigation; radiopaque platinum/iridium marker at distal end for fluoroscopic visualization. Used in neuro and peripheral vasculature; facilitates introduction of diagnostic agents or therapeutic devices. Operated by physicians in clinical settings. Device provides a pathway for interventional procedures; supports navigation through tortuous anatomy. Benefits patient by enabling access to target vasculature for diagnostic or therapeutic intervention.

Clinical Evidence

Bench testing only. Evaluated simulated use in tortuous anatomical models, kink resistance, and particulate generation. Results met all acceptance criteria and were comparable to the predicate device. No animal or clinical studies conducted.

Technological Characteristics

Materials: polyolefin elastomer, polyurethane elastomer (Pellethane), polyether block amide (Pebax), polyamide (Grilamid), stainless-steel braid, Nitinol coil, PTFE, platinum/iridium marker, nylon hub. 5F size; 0.058 in. ID; 0.071 in. OD. Hydrophilic coating. Sterilization: Ethylene Oxide.

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 EX Intracranial Support Catheter (K182602)

Reference Devices

Benchmark Intracranial Access System (K212838)

Related Devices

K150366 — SOFIA 6F Catheter · MicroVention, Inc. · Mar 27, 2015
K202752 — AXS Vecta 46 Intermediate Catheter · Stryker Neurovascular · Aug 27, 2021
K161152 — Navien Intracranial Support Catheter · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Oct 12, 2016
K234115 — APRO 55 Catheter · Alembic, LLC · Mar 15, 2024
K250962 — APRO 55 Intermediate Catheter · Alembic, LLC · Apr 29, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ September 14, 2023 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. MicroVention, Inc. Miranda Beach Regulatory Affairs Specialist 35 Enterprise Aliso Viejo, California 92656 Re: K230775 Trade/Device Name: SOFIA EX Intracranial Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: August 15, 2023 Received: August 16, 2023 # Dear Miranda Beach: 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 -S 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) K230775 Device Name SOFIA EX Intracranial Support Catheter #### Indications for Use (Describe) The SOFIA EX Intracranial Support Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA EX Intracranial Support Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA EX Intracranial Support Catheter is not intended for use in coronary arteries. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><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 graphic of overlapping curved lines in shades of gray and blue on the left. To the right of the graphic is the text "MicroVention" in a blue sans-serif font, with "TERUMO" in a smaller, bolder blue font underneath. # 510(k) Summary K230775 | 510(k) Owner | MicroVention, Inc. 35 Enterprise Aliso Viejo, CA 92656 Establishment Registration No: 3013556777 | |---------------------|-----------------------------------------------------------------------------------------------------------| | Contact Person | Miranda Beach Regulatory Affairs Specialist Email: Miranda.Beach@microvention.com | | Date of Preparation | September 12, 2023 | | Trade Name | SOFIATM EX Intracranial Support Catheter | | Common Name | Catheter, Percutaneous, Neurovasculature | | Classification | Class II, QJP, DQY | | Regulation | 21 CFR 870.1250 | | Predicate Device | SOFIA EX Intracranial Support Catheter (K182602) | | Reference Device | Benchmark Intracranial Access System (K212838) | # Device Description The SOFIA™ EX Intracranial Support Catheter is a single-lumen, flexible catheter equipped with coil and braid reinforcement. The distal segment is designed to facilitate vessel selection with 55-65cm 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. 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. # Indications for Use The SOFIA EX Intracranial Support Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA EX Intracranial Support Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA EX Intracranial Support Catheter is not intended for use in coronary arteries. #### Comparison of Indications for Use and Technological Characteristics The subject device is identical in its indication for use, technology, principle of operation, materials, sterilization method, and performance to the predicate device SOFIA™ EX Intracranial Support Catheter (K182602). The only difference between the subject and predicate devices are additional instructions added to the instructions for use (IFU) for the subject device {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for MicroVention TERUMO. The logo consists of a circular graphic on the left, with the text "MicroVention" in blue to the right of the graphic. Below "MicroVention" is the word "TERUMO", also in blue. The circular graphic is made up of curved lines in shades of gray and blue. related to radial access use. A comparison of the technological characteristics of the subject device and the predicate device is summarized in Table 1 below. | | SOFIA™ EX Intracranial Support Catheter (K182602) | SOFIA™ EX Intracranial Support Catheter | |----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Predicate Device | Subject Device | | 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. | The SOFIA EX Intracranial Support Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA EX Intracranial Support Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA EX Intracranial Support Catheter is not intended for use in coronary arteries. | | Device Classification | Class II DQY 21 CFR 870.1250 | Class II QJP, DQY 21 CFR 870.1250 | | Catheter Body Materials | 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. | Same | | Marker | Platinum/Iridium | Same | | Hub | Nylon | Same | | Strain Relief | Polyurethane | Same | | Introducer | Pebax | Same | | Catheter Size | 5F | Same | | Inner Diameter (ID) | 0.058 in. | Same | | | SOFIA™ EX Intracranial Support Catheter (K182602) | SOFIA™ EX Intracranial Support Catheter | | | Predicate Device | Subject Device | | Outer Diameter (OD) | 0.071 in. | Same | | Effective Length | 105 cm, 115 cm. | 115 cm. | | Coating | Hydrophilic Coating | Same | | Tip Configuration | Straight | Same | | Guidewire Compatibility | $\leq$ 0.038 in. OD | Same | | Accessories | Introducer Sheath | Same | | Method of Supply | Sterile and Single Use | Same | | Sterilization Method | Ethylene Oxide | Same | | Packaging Configuration | 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. | Same | # Table 1: Technological Characteristics Comparison {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for MicroVention TERUMO. The logo features a circular graphic on the left side, followed by the text "MicroVention" in a blue, sans-serif font. Below "MicroVention" is the word "TERUMO" in a smaller, bold, blue font. The overall design is clean and professional. # Performance Testing The following bench testing data were provided to evaluate the performance and support the substantial equivalence of the SOFIA™ EX Intracranial Support Catheter. | Test | Test Method Summary | Results | |----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------| | Simulated Use and Physician Simulated Use | The simulated use of the device is evaluated in a tortuous anatomical benchtop model to assess tracking and hydrophilic coating lubricity of the device. Physician simulated use is conducted with subject the | Device met acceptance criteria. | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for MicroVention TERUMO. The MicroVention part of the logo is in blue, with the word TERUMO in a smaller, bolder font below it. To the left of the text is a graphic of three overlapping circles in shades of gray and blue. | Kink Resistance | Device is subjected to bending experienced in tortuous anatomy. | Device met acceptance criteria. | |---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | 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. | Number of particulates generated are comparable to the predicate device. | # Biocompatibility The subject device, SOFIA™ EX Intracranial Support Catheter is categorized as a limited exposure (≤ 24 hours), externally communicating device with circulating blood contact in accordance with ISO 10993-1. The design and manufacturing of the subject device, SOFIA™ EX Intracranial Support Catheter use identical materials, processing, and sterilization method as the predicate device, SOFIA™ EX Intracranial Support Catheter (K182602) for which MicroVention has already successfully conducted biocompatibility testing per ISO 10993-1. Therefore, no additional biocompatibility testing is required. # Performance Data - Animal, Clinical No animal or clinical studies were conducted because bench testing was determined sufficient for verification and validation purposes. # Conclusions The subject SOFIA™ EX Intracranial Support Catheter is substantially equivalent to the predicate device SOFIA™ EX Intracranial Support Catheter. The subject device has the same indications for use as the predicate device. The 510(k) Summary demonstrates that the subject device is substantially equivalent to the predicate device regarding operating principle, design, fundamental technology, and the device performs as intended. The changes to the instructions for use do not raise new questions of safety and effectiveness.