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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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(236 days)
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 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.
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<788>. | Number of particulates generated met acceptance criteria and is within the limits per USP<788> 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 < 0.5°C and were determined to be non-pyrogenic. |
| Hemocompatibility (ASTM Hemolysis Test) | Direct Contact Solid Sample Exposure to Rabbit Blood Substrate and Indirect Contact Extracted in Phosphate Buffered Saline (PBS) New Zealand White Rabbits (Direct Contact: 6.0 cm²/mL at 37°C for 3 hours; Indirect Contact: 6.0 cm2/mL in PBS, extracted at 50°C for 72 hours, then extract exposed to Blood Substrate at 37°C for 3 hours) | Non-hemolytic. There were no significant differences between the test article extract/solid and negative control article results. |
| Hemocompatibility (ISO Unactivated Partial Thrombinplastin Time (UPTT) Test) | Solid Sample Exposure to Human Plasma (6.0 cm²/mL, incubated with human plasma at 37°C for 15 minutes) | No adverse effect on Unactivated Partial Thrombinplastin Time of human plasma. The solid test article was determined to be compatible with blood and not affect coagulation. |
| Hemocompatibility (ISO Complement Activation (C3 and SC5b-9) Test) | Solid Sample and Normal Saline Extract then Exposure to Human Plasma (Direct Contact: 6.0 cm²/mL, exposure to Human Plasma, incubated at 37°C for 90 Minutes) | C3a and SC5b-9 complement proteins were considered to be non-activated as compared to the negative control. |
| Hemocompatibility (ISO In Vitro Hemocompatibility Test) | Solid Sample Exposure to Human Plasma (6.0 cm²/mL, incubated with human plasma at 37°C for 60 minutes) | Hemocompatible. The test article was determined to be hemocompatible with direct exposure to human blood for the blood parameters (WBC, RBC, HgB, Hct, MCV, MCH, MCHC, and Plt). |
| Hemocompatibility (Large Animal Thrombogenicity Test) | Final Devices Used in a Simulated Clinical Application tested on Female Yorkshire pigs (Direct Exposure) | Non-thrombogenic. No significant thrombus was observed on any of the SOFIA® EX Catheter devices and the device was determined to not show thrombogenic potential. |
| Genotoxicity - Gene Mutation (ISO In Vitro Ames Test) | Normal Saline and Vegetable (Cottonseed) Oil Extracts Salmonella. typhimurium TA98, TA100, TA1535, TA1537, and E. coli WP2 uvr A under both Non-Activated and Activated Systems (Extracted at 50°C/72 hrs, 6.0 cm²/mL) | Non-mutagenic. Based on the acceptance criteria under the experimental conditions utilized, the test article extracts were both deemed non-mutagenic in all strains under both non-activated and activated conditions. |
| Genotoxicity - Chromosomal Aberration (In Vitro Chromosomal Aberration) | Ham's F12 Cell Growth Medium and PEG 400 Chinese Hamster Ovary (CHO) Cells under both Non-Activated and Activated Systems (Extracted at 50°C/72 hrs, 6.0 cm²/mL) | Non-mutagenic. Based on the criteria of the study protocol, the test article was considered to be non-mutagenic. |
| Genotoxicity - Chromosomal Aberration (In Vivo Rodent Blood Micronucleus) | Normal Saline and Vegetable (Cottonseed) Oil Albino Swiss Mice (Extracted at 50°C/72 hrs, 6.0 cm²/mL) | Non-mutagenic. Based on the criteria of the study protocol, the test article was considered to be non-mutagenic. |
2. Sample size used for the test set and the data provenance:
- Bench Studies: The document does not specify the exact sample sizes for each bench test (e.g., number of catheters tested for tensile strength). However, it implies that sufficient samples were tested to declare that the "Device met acceptance criteria" in each case. These are prospective tests conducted for the purpose of this submission. The origin is implicitly the manufacturing site (Tustin, CA, USA) or associated testing facilities.
- Biocompatibility Studies: Again, the exact sample sizes for these in-vitro and in-vivo tests are generally not detailed in this summary, but the materials and test systems are provided (e.g., L929 Mouse Fibroblast Cell Line, Hartley Guinea Pigs, Rabit Blood, Human Plasma, Albino Swiss Mice, New Zealand White Rabbits). These are prospective studies.
- Animal Study:
- Sample Size: Three female Yorkshire pigs were used.
- Data Provenance: The study was conducted in a porcine model, which is an animal study (not human data). It was an acute study performed specifically for this submission, making it prospective. The country of origin is not explicitly stated, but it was conducted in accordance with FDA GLP Regulation (21 CFR Part 58), suggesting it was designed to meet US regulatory standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Bench and Biocompatibility Tests: The ground truth for these tests is established by objective measurements and laboratory standards (e.g., ISO standards, ASTM standards, USP guidelines). It is not dependent on expert consensus or human interpretation in the same way clinical image analysis would be. Therefore, there's no mention of a number of experts or their qualifications in this context.
- Animal Study: The document states that the testing was intended to "demonstrate clinical efficacy for catheter tip stability and safety" and notes that "histologic findings were consistent with routine catheterization procedures." While implicit that veterinarians, pathologists, and interventionalists (or researchers with similar expertise) observed and assessed the animal study outcomes, the number and specific qualifications of experts involved in the evaluation of the animal model are not explicitly stated in this 510(k) summary. The ground truth here is derived from direct observation, histological analysis, and physiological assessments in the live animal model.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- For the bench and biocompatibility tests, adjudication methods (like 2+1 or 3+1) are not applicable as the results are based on objective measurements and established scientific protocols rather than subjective human interpretation needing consensus.
- For the animal study, no formal subjective adjudication method is described. The results mention "No dissection/perforation, thrombus formation or distal emboli were noted" and "All vessels appeared intact with no visible wall disruptions," implying direct observation and assessment by the research team conducting the animal study. Histological findings would be adjudicated by a veterinary pathologist.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is an intracranial support catheter, a physical medical device, not an AI software. The studies conducted are related to its physical performance, safety, and biocompatibility, not its impact on human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This submission is for a physical medical device, an intracranial support catheter, not an algorithm or AI software that would have a "standalone performance."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Bench Studies: Ground truth is based on engineering and physical performance measurements against established standards (e.g., ISO, ASTM, USP).
- Biocompatibility Studies: Ground truth is based on biological and toxicological responses measured through standard in-vitro and in-vivo tests, assessed against established biological safety evaluation criteria.
- Animal Study: Ground truth is established through direct observation of clinical efficacy and safety endpoints (e.g., catheter tip stability, absence of dissection/perforation, thrombus formation, distal emboli, vasospasm, luminal narrowing) and histological examination of vessel samples in a live animal model. This combines direct observation with pathological assessment.
8. The sample size for the training set:
- Not applicable. This document describes the testing and approval of a physical medical device. It does not involve machine learning or AI models that require a "training set."
9. How the ground truth for the training set was established:
- Not applicable. As a physical medical device, there is no training set for an AI model.
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