(84 days)
In selective areas of peripheral and coronary vessels, the MicroSyringe II Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents that are indicated for delivery into the vessel wall or perivascular area. The MicroSyringe II Infusion Catheter is also intended for the infusion of diagnostic and therapeutic agents intraluminally.
The Mercator MicroSyringe II is a wire-guided endovascular catheter that consists of a perpendicular microneedle delivery port, which is sheathed by and consists of a semi rigid nolymor halless sollyery port, which is sheathed within a semi-rigid polymer balloon actuator with an integrated compliant low-pressure forcing balloon opposite the microneedle. The device is advanced over a 0.014" guidewire, using a single operator method. The device is advanced over a 0.014 guidewire, use the needle delivery port into the troutinent vossel and nythanically actualed to ctructures structures.
The provided text is a 510(k) summary for the Mercator MicroSyringe II Infusion Catheter and does not contain the detailed information requested regarding acceptance criteria and a specific study proving device performance against those criteria in the context of an AI/ML model.
This document describes a medical device clearance for an infusion catheter, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML performance, ground truth, expert review, training sets, and comparative effectiveness studies are not applicable or detailed in this submission.
However, I can extract the relevant information that is present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance | Met all required specifications for the tests. |
| Fluid Delivery Performance | Met all required specifications for the tests. |
| Biocompatibility | Met all required specifications for the tests. Materials used are suitable for this use and have been used in several previously cleared products. |
| Sterilization Validation | Met all required specifications for the tests. |
| In-vivo Safety | Met all required specifications for the tests. |
| Overall Safety and Effectiveness (vs. Predicates) | "The results of these tests demonstrated that the device is as safe and effective as the legally marketed predicate devices." This implies that the performance across the above categories was equivalent or superior to the predicate devices (Mercator MicroSyringe Infusion Catheter K040139, Dispatch Coronary Infusion Catheter K932616, Selective Infusion II Catheter K914751, Isolate Infusion Catheter System K913517). The specific quantitative metrics for "acceptance criteria" are not explicitly detailed beyond "met all required specifications." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes (e.g., number of units tested, number of in-vivo subjects) for the mechanical, fluid delivery, biocompatibility, sterilization, or in-vivo safety testing. It also does not state the provenance of the data (e.g., country of origin, retrospective or prospective).
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 is a medical device for infusion, not an AI/ML diagnostic or predictive device requiring expert-established ground truth in the context of image interpretation or similar. The "performance" assessment is based on engineering and biological testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device requiring human adjudication of performance outcomes in that context. Device performance was likely assessed against engineering specifications and possibly animal studies in a direct, objective manner.
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-assisted device, and no MRMC study information is provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance of this physical device would typically be defined by:
- Engineering specifications and standards for mechanical and fluid delivery performance.
- Relevant ISO standards and guidelines for biocompatibility and sterilization validation.
- Pre-clinical (in-vivo animal) study results for safety.
The document states that "All components, subassemblies and/or full devices met the required specifications for the tests," implying these specifications served as the ground truth or target.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML model.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI/ML model.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).