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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the MicroVention, Inc. SOFIA EX Intracranial Support Catheter:

Summary of Acceptance Criteria and Device Performance for SOFIA EX Intracranial Support Catheter (K230775)

The provided document describes the SOFIA EX Intracranial Support Catheter as being substantially equivalent to its predicate device (SOFIA EX Intracranial Support Catheter, K182602). This means that the acceptance criteria and performance are largely benchmarked against the predicate device, implying similar performance expectations.

The document focuses on bench testing to demonstrate this equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied by equivalence to predicate)	Reported Device Performance
Simulated Use and Physician Simulated Use	Successful tracking and adequate hydrophilic coating lubricity in a tortuous anatomical model. Performance comparable to predicate device.	Device met acceptance criteria.
Kink Resistance	Ability to withstand bending experienced in tortuous anatomy without kinking or failure. Performance comparable to predicate device.	Device met acceptance criteria.
Particulate Testing	Number and size of particulates generated during simulated use should be comparable to the predicate device.	Number of particulates generated are comparable to the predicate device.
Biocompatibility	Should be biocompatible for limited exposure (≤ 24 hours), externally communicating device with circulating blood contact, per ISO 10993-1, with identical materials, processing, and sterilization as the predicate device.	No additional biocompatibility testing required as materials, processing, and sterilization are identical to the predicate which previously met these criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each specific bench test (e.g., number of catheters tested for simulated use, kink resistance, or particulate testing). The data provenance is bench testing, meaning it was conducted in a laboratory setting, not on patient data. No country of origin for the data is specified, but it can be assumed to be related to MicroVention, Inc.'s operations, likely within the US, given the FDA submission. The nature of the testing is prospective in the sense that new samples of the subject device were manufactured and tested according to a predefined protocol.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable (N/A) for this submission. The ground truth for these bench tests is based on objective measurements and predefined engineering specifications, not expert interpretation of diagnostic data.

4. Adjudication Method for the Test Set

Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation or agreement on outcomes. Bench tests rely on precise measurements and adherence to specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "No animal or clinical studies were conducted because bench testing was determined sufficient for verification and validation purposes." Therefore, no MRMC study was performed, and no human reader improvement effect size is available.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

Not Applicable (N/A). This device is a medical catheter, a physical product, not an AI algorithm. Therefore, the concept of "standalone algorithm performance" does not apply.

7. Type of Ground Truth Used

The ground truth for the bench tests is based on objective engineering measurements and predefined specifications. For example:

Simulated Use/Lubricity: Successful navigation through a tortuous model, visual inspection for damage, and measurement of friction/lubricity metrics.
Kink Resistance: Mechanical testing to observe and quantify resistance to kinking under specified bending conditions.
Particulate Testing: Quantitative measurement of particle count and size using standard laboratory methods.
Biocompatibility: Demonstrated through adherence to ISO 10993-1 standards, which were previously met by the predicate device (same materials, processing, sterilization).

8. Sample Size for the Training Set

Not Applicable (N/A). This is a medical device, not an AI/ML algorithm. There is no "training set" in the context of this submission. The device's design is based on engineering principles and validated through bench testing, not machine learning.

9. How the Ground Truth for the Training Set Was Established

Not Applicable (N/A). As there is no training set for an AI/ML algorithm, this question does not apply.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K230775

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 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 EnterpriseAliso Viejo, CA 92656Establishment Registration No: 3013556777
Contact Person	Miranda BeachRegulatory Affairs SpecialistEmail: 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

Indications for Use

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

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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 IntracranialSupport Catheter (K182602)	SOFIA™ EX IntracranialSupport Catheter
	Predicate Device	Subject Device
Indications for Use	The SOFIA EX Catheter isindicated for generalintravascular use, including theneuro and peripheral vasculature.The SOFIA EX Catheter can beused to facilitate introduction ofdiagnostic agents or therapeuticdevices. The SOFIA EX Catheteris not intended for use incoronary arteries.	The SOFIA EX IntracranialSupport Catheter is indicated forgeneral intravascular use,including the neuro andperipheral vasculature. TheSOFIA EX Intracranial SupportCatheter can be used to facilitateintroduction of diagnostic agentsor therapeutic devices. TheSOFIA EX Intracranial SupportCatheter is not intended for use incoronary arteries.
Device Classification	Class IIDQY21 CFR 870.1250	Class IIQJP, DQY21 CFR 870.1250
Catheter BodyMaterials	Outer layer of polyolefinelastomer, polyurethaneelastomer (Pellethane), polyetherblock amide (Pebax) andpolyamide (Grilamid); inner layerof stainless-steel braid, Nitinolcoil, 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 IntracranialSupport Catheter (K182602)	SOFIA™ EX IntracranialSupport 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
GuidewireCompatibility	$\leq$ 0.038 in. OD	Same
Accessories	Introducer Sheath	Same
Method of Supply	Sterile and Single Use	Same
Sterilization Method	Ethylene Oxide	Same
PackagingConfiguration	Catheter placed into a HDPEdispenser tube. Dispenser tubeand introducer placed on apolyethylene packaging card thatis inserted into a Tyvek pouch.Pouch and IFU placed inbleached sulfate carton box.	Same

Table 1: Technological Characteristics Comparison

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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 andPhysician Simulated Use	The simulated use of thedevice is evaluated in atortuous anatomical benchtopmodel to assess tracking andhydrophilic coating lubricityof the device.Physician simulated use isconducted with subject the	Device met acceptancecriteria.

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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 tobending experienced intortuous anatomy.	Device met acceptancecriteria.
Particulate Testing	The number and size ofparticulates generated duringsimulated use in a tortuousanatomical model weremeasured and results werecompared with the predicatedevice.	Number of particulatesgenerated are comparable tothe 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.

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).