(2 days)
The Surefire Infusion System is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.
The modified Surefire Infusion System is a 0.027" lumen coaxial microcatheter with the Surefire Expandable Tip at the distal end. The Surefire Infusion System has a female luer lock hub on the proximal end of the catheter and has a catheter shaft length of 150 cm.
The modified Surefire Infusion System serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. It is compatible with standard 0.018" guide wires, infusion syringes, rotating hemostatic valves (RHVs/Tuohy Borsts), and embolic hydrogel particles 700um or less in size and glass microspheres 190um or less in size. The Surefire Infusion System, serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. The Surefire Infusion System has a Teflon inner liner to provide a lubricious surface for passage of physician-specified agents and other accessory devices. The device is hydrophilically coated. The soft, pliable, funnel-shaped Surefire Expandable Tip is sized for use in vessels of 4 mm to 6 mm.
The Surefire Infusion System has an outer sheath to facilitate expanding and collapsing the Surefire Expandable Tip. There are three radiopaque markers located just proximal and distal to the Surefire Expandable Tip. The Tip can be expanded or collapsed for re-positioning during an interventional procedure by simply retracting or advancing the inner microcatheter while holding the outer sheath stationary. When expanded, the Expandable Tip is designed to improve infusion efficiency of compatible embolic agents while maintaining antegrade flow in the vessel.
The Surefire Infusion System is provided sterile (EtO) for single patient use.
This document is a 510(k) summary for the Surefire Infusion System, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria in the context of AI/diagnostic performance.
Therefore, many of the requested fields are not applicable or cannot be extracted from this type of regulatory document.
However, based on the provided text, I can infer information relevant to performance testing and equivalence for a physical medical device, not an AI system. The "acceptance criteria" here refer to meeting performance specifications for design verification/validation tests, not diagnostic accuracy metrics.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding numerical performance metrics. Instead, it states that the device "meets the same performance specifications and acceptance criteria as the predicate device" for a list of tests. It then concludes that "the modified Surefire Infusion System was found to be acceptable in all evaluated categories, met the defined user needs, and performed comparably to the predicate device."
Types of Performance Tests Conducted (without specific numerical acceptance criteria or reported device performance values):
| Performance Test | Reported Device Performance |
|---|---|
| Visual/Dimensional Inspections | Found acceptable / meets specifications of predicate |
| Pull Force | Found acceptable / meets specifications of predicate |
| Infusion Efficiency | Found acceptable / meets specifications of predicate |
| Particulates | Found acceptable / meets specifications of predicate |
| Device Compatibility | Found acceptable / meets specifications of predicate |
| Kink Resistance | Found acceptable / meets specifications of predicate |
| Antegrade Flow | Found acceptable / meets specifications of predicate |
| Torque Resistance | Found acceptable / meets specifications of predicate |
| Trackability | Found acceptable / meets specifications of predicate |
| Biocompatibility Tests | |
| Cytotoxicity | Did not indicate any significant biological reaction |
| Sensitization | Did not indicate any significant biological reaction |
| Irritation/Intracutaneous Reactivity | Did not indicate any significant biological reaction |
| Systemic Toxicity | Did not indicate any significant biological reaction |
| Hemocompatibility | Did not indicate any significant biological reaction |
| Thrombogenicity (Animal Study) | Did not indicate any significant biological reaction |
| Animal Study | Acceptable in all evaluated categories, met user needs, performed comparably to predicate |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified for individual bench tests. For the animal study, the sample size is not explicitly stated, only "An animal study was performed."
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be prospective testing (bench tests and animal study specifically conducted for this submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a physical catheter, not a diagnostic AI system requiring expert-established ground truth for a diagnostic test set. The animal study was evaluated by "physicians in a simulated clinical environment," but the number or specific qualifications are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a diagnostic AI study.
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
Not applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance tests, "ground truth" would be engineering specifications, material properties, and visual/dimensional standards. For biocompatibility, it's established ISO/ASTM standards and biological reaction assessments. For the animal study, it was performance evaluation by physicians against "defined user needs" and comparison to a predicate device.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).