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510(k) Data Aggregation
(177 days)
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.
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.
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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