(8 days)
The Surefire Precision 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 Surefire Precision Infusion Systems are coaxial microcatheters with a female luer lock hub at the proximal end, and the Surefire Expandable Tip at the distal end that is sized for use in various sized vessels. The Surefire Precision Infusion System, serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. It is compatible with standard guide wires up to 0.018", and embolic hydrogel particles ≤500μm, and glass microspheres ≤110μm (0.021" lumen) or
The Surefire Precision Infusion System is a medical device and the provided text describes its 510(k) summary, focusing on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" and "device performance" are not presented in the context of a diagnostic AI algorithm with specific metrics like accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" are the performance specifications and the "device performance" refers to the results of the verification and validation tests, which show the device meets these specifications and performs comparably to the predicate.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a medical device (intravascular catheter) and not an AI algorithm, the "acceptance criteria" refer to established performance specifications for device function, and "reported device performance" refers to the successful demonstration that the device met these specifications during testing. The document does not provide a quantitative table of specific numerical acceptance criteria and their corresponding results but rather states that the device "meets the same performance specifications and acceptance criteria as the predicate device" and that "performance is comparable to the predicate device."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Did not indicate any significant biological reaction that would affect the patient due to contact with materials. Thrombogenicity testing was also performed and found acceptable. |
| Design Verification/Validation (Material Modifications) | Met the same performance specifications and acceptance criteria as the predicate device for all tests performed, including: Tensile (Pull) Strengths (distal tip), Kink Radius, Torque Resistance, Infusion Efficiency, Antegrade Flow, Particulates, Embolic Agent Compatibility, Burst Pressure, Coating Durability and Uniformity, Frictional Force, Base Catheter Insertion/Retraction Force, Visual and Dimensional, EtO Residuals. |
| Comparative Acute Performance (Animal Study) | Acceptable in all evaluated categories, met defined user needs, and performed comparably to the predicate device in a simulated clinical environment. |
| Substantial Equivalence | Found to be substantially equivalent in intended use, design, and technology/principles of operation to the predicate device. Differences do not raise issues of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The "test set" here refers to the samples used in the performance testing and animal study for the physical device, not a dataset for an AI model.
- Sample Size: The document does not specify the exact numerical sample sizes for each performance test (e.g., number of catheters tested for burst pressure). It only generically states that various tests were performed. For the animal study, the sample size (number of animals) is not disclosed.
- Data Provenance: The biocompatibility testing was conducted by NAMSA (Northwood, OH), indicating US-based data. The performance testing (bench testing) was likely conducted in-house or by a contracted lab. The animal study was also performed to assess comparative acute performance. The general provenance is therefore related to device manufacturing and testing processes, not patient data from a specific country or whether it was retrospective/prospective in the AI sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not directly applicable in the context of this traditional medical device submission. Ground truth, in the sense of expert consensus on diagnostic imaging, is not relevant here. The "ground truth" for the device's performance is established by objective engineering and biological testing against predefined specifications and comparison to the predicate device's established performance.
However, for the animal study, it notes that the performance was "as defined by physicians in a simulated clinical environment." This implies that physicians (experts) observed and evaluated the device's performance in the animal model. The number and qualifications of these physicians are not specified.
4. Adjudication Method for the Test Set
Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in AI studies where disagreements among experts need to be resolved. This is not applicable to a traditional medical device's performance testing. Device performance is determined by objective measurements and observations against acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI algorithm on human reader performance, which is not the subject of this 510(k) submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, this question is not applicable as the Surefire Precision Infusion System is a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
For this physical device, the "ground truth" is defined by:
- Objective Performance Specifications: These are engineering standards and safety requirements that the device must meet (e.g., tensile strength, burst pressure, coating durability).
- Predicate Device Performance: The "ground truth" for comparative performance is the established safe and effective performance of the legally marketed predicate device. The new device must demonstrate comparable performance.
- Biocompatibility Standards: Compliance with ISO 10993 series standards establishes the biological "ground truth" for material safety.
- Physician Assessment (Animal Study): In the animal study, the "ground truth" for acceptability and comparability was a qualitative assessment by physicians based on "defined user needs" in a simulated clinical environment.
8. The Sample Size for the Training Set
This question is not applicable as the Surefire Precision Infusion System is a physical medical device and does not involve AI model training.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the Surefire Precision Infusion System is a physical medical device and does not involve AI model training or a training set.
§ 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).