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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.

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K Number

K182602

Device Name

SOFIA EX Intracranial Support Catheter

Manufacturer

Micro Vention Inc.

Date Cleared

2019-05-15

(236 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K161152,K131482

Intended Use

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

Device 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.	Number of particulates generated met acceptance criteria and is within the limits per USP 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

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