(25 days)
The Surefire Infusion System 021 is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.
The Surefire Infusion System 021 is a 0.021" lumen coaxial microcatheter with the Surefire Expandable Tip at the distal end. It has an outer sheath to facilitate expanding and collapsing the Surefire Expandable Tip. The Surefire 021, 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 500um or less in size and glass microspheres 110um or less in size. The Surefire 021 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 1.5mm to 4 mm.
There are two radiopaque markers located just proximal and distal to the Surefire Expandable Tip. The Tip can be expanded or collapsed up to 3 times for re-positioning 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 various size vessels.
The Surefire Infusion System 021 is provided sterile (EtO) for single patient use.
The document provided is a 510(k) premarket notification letter and summary for the Surefire Infusion System 021. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.
Based on the provided text, the device is the Surefire Infusion System 021, and the study described is a comparison to a predicate device (Surefire Infusion System, K121677) to demonstrate substantial equivalence, rather than a study defining specific acceptance criteria for a novel AI or diagnostic algorithm and its performance against those criteria. Therefore, much of the requested information regarding acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies for an AI/diagnostic device is not directly applicable or available in this document.
However, I can extract the information that is relevant to the performance testing and comparison made in this submission.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal, quantitative table of acceptance criteria with specific thresholds for performance metrics. Instead, it states that the device "meets its specified performance requirements" and "is comparable to the performance of the predicate device."
| Criterion Category | Acceptance Criteria (general statement) | Reported Device Performance (general statement) |
|---|---|---|
| Design Verification | Meets specified performance requirements. | "demonstrated that the Surefire Infusion System 021 meets its specified performance requirements, and is equivalent to the performance of the predicate device." |
| Mechanical Strength & Performance | Comparable to the predicate device. | "The Surefire Infusion System 021 meets its specifications and is comparable in mechanical strength and performance to the predicate Surefire Infusion System." |
| Acute Performance (Clinical Simulation) | Acceptable performance, comparable to the predicate device. | "The Surefire Infusion System 021 was found to have acceptable performance. Additionally, the Surefire Infusion System 021 was found to have comparable performance to the predicate device." (from animal study) |
| Biocompatibility | No significant biological reaction that would affect the patient. | "The results of all of the biocompatibility testing did not indicate any significant biological reaction that would affect the patient due to contact with the materials used in the device construction." (leveraging predicate device testing, and additional thrombogenicity testing) |
2. Sample size used for the test set and the data provenance
- Test Set Description: The "test set" in this context refers to the samples used for design verification (bench testing) and the animal study.
- Bench Testing: No specific sample sizes are provided for the various bench tests (visual/dimensional inspection, lubricity, wear, particulates, burst pressure, tensile strength, kink resistance, torque resistance, trackability, infusion/embolic agent compatibility, antegrade flow, infusion efficiency). The document only states "Design verification testing was performed."
- Animal Study: The document states "An animal study was performed," but does not provide the number of animals or specifically state the country of origin.
- Data Provenance: Not explicitly stated for either bench or animal testing, beyond "NAMSA (Northwood, OH)" for biocompatibility (which was leveraged from the predicate device). The animal study involved a "simulated clinical environment," suggesting a controlled experimental setting rather than retrospective patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This document does not describe the use of "experts" to establish ground truth in the context of diagnostic performance for a test set. The animal study assessed "comparative acute performance... as defined by physician's in a simulated clinical environment," implying physician observation and assessment, but no specific number or qualifications are given for these "physicians."
4. Adjudication method for the test set
- No adjudication method is described. The performance assessments are generally stated as being "met" or "comparable."
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 MRMC comparative effectiveness study was conducted. This device is an infusion system (catheter), not an AI or diagnostic imaging device that would typically involve human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (catheter) and does not involve an algorithm for standalone performance evaluation in the way an AI diagnostic device would.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the performance claims comes from:
- Bench Test Specifications: The device met its internal specified performance requirements.
- Predicate Device Performance: Performance was compared to that of the predicate device.
- Animal Study Observations: Physicians' assessments in a simulated clinical environment were used for acute performance.
8. The sample size for the training set
- Not applicable. This is a mechanical device, not an AI or machine learning algorithm. Therefore, there is no "training set."
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device.
In summary: This FDA submission focuses on demonstrating substantial equivalence for a physical medical device (catheter) through bench testing, biocompatibility testing (leveraging existing data), and an animal study. It does not involve the types of testing, acceptance criteria, or ground truth establishment typically associated with AI-powered diagnostic devices or software that require human expert review and large datasets.
§ 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).