(264 days)
The SOFIA 88 Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA 88 Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA 88 Catheter is not intended for use in coronary arteries.
The SOFIA 88 Catheter is a non-tapered, single-lumen, flexible catheter equipped with coil and braid reinforcement. The distal seqment is designed to facilitate vessel selection with 60 cm 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 provided document is a 510(k) summary for a medical device (SOFIA 88 Catheter), demonstrating its substantial equivalence to a predicate device. This type of regulatory submission primarily relies on performance (benchtop) and pre-clinical (animal) testing rather than clinical studies with human subjects or AI algorithm performance.
Therefore, many of the requested criteria (e.g., acceptance criteria for AI performance, sample size for test sets (human data), number of experts for ground truth, MRMC studies, standalone AI performance, training set details) are not applicable to this specific document as it pertains to a physical medical device (catheter) and not an AI/ML powered device.
However, I can extract the relevant information regarding the performance and equivalency testing conducted for the SOFIA 88 Catheter.
Device: SOFIA 88 Catheter
Type of Device: Percutaneous Catheter (physical medical device)
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are generally implied by the "Pass" result for each test, indicating that the device met the pre-defined standards for each physical and functional characteristic. The document doesn't explicitly state quantitative acceptance limits for each test but rather confirms successful completion.
| Test Title | Test Method Summary | Reported Device Performance |
|---|---|---|
| Dimensional Verification | Measured catheter length, proximal and distal outer diameters, and distal inner diameter. | Pass |
| Coating Lubricity and Durability | Evaluated hydrophilic coating for frictional force and durability. | Pass |
| Simulated Use | Evaluated performance under simulated use in a tortuous anatomical model to assess preparation, introduction, tracking, and support of the device. | Pass |
| Dynamic and Static Burst Pressure | Subjected device to rated burst pressures to test catheter integrity. | Pass |
| Air Leakage | Tested device for air leakage requirements. | Pass |
| Liquid Leakage | Tested device for liquid leakage requirements. | Pass |
| Tensile Strength | Tensile tested device to failure, recorded the force at breakage. | Pass |
| Flexural Fatigue | Subjected device to flexural fatigue from repeated bending during simulated use testing and from repeated hoop stress on the catheter from pressure testing. | Pass |
| Particulate Testing | Measured number and size of particulates generated during simulated use in a tortuous anatomical model and compared results with the predicate device. | Pass |
| Kink Resistance | Evaluated device for kink resistance after simulated use testing. | Pass |
| Torque Strength | Evaluated device for torque strength by measuring the number of catheter rotations until failure after tracking through a tortuous anatomical model. | Pass |
| Radio Detectability | Evaluated device visibility under fluoroscopy. | Pass |
| Corrosion Resistance | Evaluated device corrosion after immersion in saline. | Pass |
| Small-bore Connector | Evaluated luer connector for dimensional and performance requirements per reference standard. | Pass |
| Stiffness Profile | Compared catheter stiffness profile along proximal and distal sections to the reference device. | Pass |
| Biocompatibility Tests | ||
| Cytotoxicity | L-929 mouse fibroblast cells (MEM) with 6.0 cm²/mL at 37°C for 24 hrs. | Non-cytotoxic |
| Irritation Reactivity | Normal saline and sesame seed oil (SSO) on New Zealand White Rabbits with 6.0 cm²/mL at 50°C for 72 hrs. | Non-irritant |
| Maximization | Normal saline and sesame seed oil (SSO) on Guinea Pigs with 6.0 cm²/mL at 50°C for 72 hrs. | Non-sensitizing |
| Systemic Toxicity | Normal saline and sesame seed oil (SSO) on Albino outbred strain (ND4) mice with 6.0 cm²/mL at 50°C for 72 hrs. | Non-acute systemically toxic |
| Pyrogenicity | Normal saline on New Zealand White Rabbits with 6.0 cm²/mL at 50°C for 72 hrs. | Non-pyrogenic |
| Hemocompatibility (Blood Loop) | Loop system circulated with freshly drawn sheep blood; test article exposed to circulating blood at 37°C for 4 hrs. | Thromboresistant |
| Hemolysis Assay | PBS – Phosphate Buffered Saline / Blood from Three New Zealand White Rabbits; 6.0 cm²/mL at 50°C for 72 hrs. | Non-hemolytic |
| Complement Activation Assay | Normal Human Serum (NHS); 6.0 cm²/mL at 37°C for 60 min. | Non-activator of complement system |
| Partial Thromboplastin Time (PTT) Assay | Human Plasma / Freshly Drawn Human Plasma; 6.0 cm²/mL at 37°C for 15 min. | No effect on the PTT |
| Heparinized Blood Platelet and Leukocyte Count Assay | Human Blood / Freshly Drawn Human Blood; 12 cm²/mL at 37°C for 60 min. | Pass |
| Animal Study | ||
| Acute Animal Testing | Comparison of SOFIA 88 Catheter to SOFIA 6F DAC for catheter tracking and tip stability in a porcine model. GLP-compliant. Examined for dissection/perforation, vasospasm, hemorrhage, necrosis, edema. | Performed equally (SOFIA 88 Catheter and SOFIA 6F DAC). Found comparable. No issues noted. |
2. Sample size used for the test set and the data provenance
- Benchtop Testing: While specific sample sizes for each benchtop test are not provided in this summary, these tests generally involve a statistically significant number of device units (e.g., n=3, 5, or more depending on the test and standard requirements) to ensure reproducibility and reliability. The provenance is internal laboratory testing by MicroVention, Inc. and its contracted labs.
- Biocompatibility Testing: Sample sizes are mentioned for some tests (e.g., New Zealand White Rabbits for irritation/pyrogenicity, Guinea Pigs for maximization, ND4 mice for systemic toxicity, sheep blood for blood loop assay, three rabbits for hemolysis, human serum/plasma for others). The provenance is laboratory testing conducted according to ISO and USP standards.
- Animal Study: The document refers to "a porcine model" without specifying the exact number of animals. It's an acute animal study. The provenance is internal or contracted laboratory animal testing (conducted in accordance with FDA GLP Regulation 21 CFR Part 58).
All data provenance is internal R&D and pre-clinical testing, not human clinical retrospective or prospective data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the ground truth for a physical medical device like a catheter is established through objective physical and chemical measurements (benchtop tests) and observed physiological responses in animal models, not through expert human interpretation of medical images or data requiring "ground truth" establishment in the context of an AI algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no human interpretation or subjective judgment that would require an adjudication method in the context of this device's testing. Measurements are objective and pass/fail criteria are pre-defined.
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
This is not applicable. This device is a physical catheter, not an AI application, so no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established via objective engineering and material science measurements (e.g., dimensions, pressure, force), validated laboratory biological assays (e.g., cytotoxicity, hemolysis), and observed physiological responses and pathological findings in an animal model. It is not derived from expert consensus, pathology, or outcomes data in the sense of clinical diagnostic accuracy.
8. The sample size for the training set
This is not applicable as this is a physical medical device, not an AI/ML powered device that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the reason stated above.
§ 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).