(28 days)
The Drakon™ and SeQure® microcatheters are intended for the infusion of contrast media into all peripheral vessels. The Drakon™ and SeQure® microcatheters are also intended for drug infusion in intra-arterial therapy and infusion of embolic materials. The Drakon™ and the SeQure® microcatheters should not be used in cerebral vessels.
The Drakon™ and Sequre® microcatheters are single use microcatheters primarily comprised of a luer lock hub, a strain relief cover and tube, central shaft, and a distal tip with radiopaque markers for visualization. The two models differ only in the design of the distal tip. The Sequre®'s distal end has side holes and two radiopaque markers while the Drakon™'s distal end has no side holes and one radiopaque marker. These markers allow for the fluoroscopic visualization of the distal tip of the microcatheters. The inner lumen is made of PTFE (polytetrafluoroethylene), which allows for the smooth passage of fluids, embolic agents and devices such as guide wires. The distal section of the shaft in both models is coated in a hydrophilic polymer layer, which ensures high lubricity when wet with saline or blood. The Drakon™ and Sequre® microcatheters are sterile single lumen devices and are available in varying configurations of length (105 cm, 130 cm, 150 or 155 cm, 180 cm), diameters (1.7 Fr., 1.9 Fr., 2.4 Fr. 2.7 Fr., 2.8Fr. and 3.0 Fr.) and tip shape (straight, SP1, SP2).
The provided text is a 510(k) summary for the Drakon™ and Sequre® microcatheters, and it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving those criteria.
Specifically, this document describes a device modification (addition of sizes and tip shapes) to previously cleared predicate devices, rather than an initial market clearance study with detailed performance metrics against specific disease detection criteria. The performance data presented are bench tests conducted to demonstrate that the modified device remains substantially equivalent to the predicate device, not a formal clinical efficacy study in the sense typically associated with AI/diagnostic device performance.
Therefore, many of your questions, particularly those related to clinical performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies, cannot be effectively answered from this document.
However, I can extract the available information related to the acceptance criteria and the type of studies conducted:
1. A table of acceptance criteria and the reported device performance
The document states that the modified devices met "predetermined acceptance criteria" for various bench tests, but it does not explicitly list the quantitative acceptance criteria or detailed numerical results. It only reports that the devices "met the predetermined acceptance criteria."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | |
| Cytotoxicity (ISO 10993-5:2009) | Met predetermined acceptance criteria |
| Physical/Mechanical Performance | |
| Guidewire & Guide Catheter Compatibility | Met predetermined acceptance criteria |
| Dimensional and Visual Inspection (including Tip Shape Dimension) | Met predetermined acceptance criteria |
| Bead Compatibility Bench Test | Met predetermined acceptance criteria |
| Vessel Flow Dynamic Indication (Beads Reflux) Bench Test | Met predetermined acceptance criteria |
| Trackability Bench Test | Met predetermined acceptance criteria |
| Tensile Bench Test | Met predetermined acceptance criteria |
| Torque Transmission | Met predetermined acceptance criteria |
| Air Leakage Bench Test | Met predetermined acceptance criteria |
| Liquid Leakage Bench Test | Met predetermined acceptance criteria |
| Burst Pressure Bench Test | Met predetermined acceptance criteria |
| Power Injection Bench Test | Met predetermined acceptance criteria |
| Acute Particulate Matter Evaluation | Met predetermined acceptance criteria |
| Usability | Met predetermined acceptance criteria |
| Sterilization & Shelf Life | |
| Sterilization validation (ISO 11135-1 for SAL 10-6) | Performed in compliance |
| Shelf life and packaging testing | Performed to support labeled shelf life |
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: Not specified. The document lists "bench tests," which typically involve a set number of physical samples of the device. The specific number of devices tested for each bench test is not provided.
- Data Provenance: Not applicable in the context of clinical data. These are laboratory/bench tests, not patient data trials.
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. These are bench tests for a microcatheter, not an AI/diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. These are bench tests.
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 study was not done. This device is a microcatheter, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For bench tests, "ground truth" generally refers to validated measurement standards, engineering specifications, and established limits for physical properties (e.g., tensile strength, burst pressure, leak rates). The document implies that these standards were used for the "predetermined acceptance criteria."
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
§ 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).