(27 days)
In selective areas of 2.5 mm diameter peripheral and coronary vessels, the uSyringe 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 uSyringe Infusion Catheter is also intended for the infusion of diagnostic and therapeutic agents intraluminally.
The EndoBionics uSyringe is a wire-gulded endovascular catheter that consists of a perpendicular microneedle delivery port, which is sheathed by and contained within a semi-rigid polymer balloon actuator. The device is advanced over a 0.014" guidewire, using a single operator method, into the treatment vessel and hydraulically actuated to move the needle delivery port into the vessel in order to deliver substances to 2.5 min vascular structures.
The acceptance criteria and device performance for the EndoBionics MicroSyringe Infusion Catheter are described by a series of engineering tests. The submission states that "The results of the above tests demonstrated that the device is as safe and effective as the legally marketed predicate devices. All components, subassemblies and/or full devices met the required specifications for the above tests."
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Balloon Minimum Burst Strength | Not explicitly stated, implied by "met all specifications" | Met required specifications |
| Balloon Compliance (Distensibility) | Not explicitly stated, implied by "met all specifications" | Met required specifications |
| Balloon Inflation/Deflation Performance | Not explicitly stated, implied by "met all specifications" | Met required specifications |
| Balloon Fatigue | Not explicitly stated, implied by "met all specifications" | Met required specifications |
| Bond Strengths | Not explicitly stated, implied by "met all specifications" | Met required specifications |
| Catheter Diameter and Balloon Profile | Not explicitly stated, implied by "met all specifications" | Met required specifications |
| Tip Pull Test | Not explicitly stated, implied by "met all specifications" | Met required specifications |
| Over-the-Arch Torque Strength Test | Not explicitly stated, implied by "met all specifications" | Met required specifications |
| Over-the-Arch Torque Response Test | Not explicitly stated, implied by "met all specifications" | Met required specifications |
| Balloon Preparation | Not explicitly stated, implied by "met all specifications" | Met required specifications |
| Catheter Body Burst Pressure | Not explicitly stated, implied by "met all specifications" | Met required specifications |
| Biocompatibility Testing | Not explicitly stated, implied by "met all specifications" | Met required specifications |
| In-vivo Safety | Not explicitly stated, implied by "met all specifications" | Met required specifications |
| Fluid Delivery Performance | Not explicitly stated, implied by "determine performance" | Performance determined, met required specifications |
| Integrity of Device Components | Not explicitly stated, implied by "determine performance" | Integrity determined, met 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 for any of the tests. The data provenance (country of origin, retrospective/prospective) is also not mentioned. These tests appear to be bench and in-vivo safety studies, which are typically 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)
This information is not applicable. The study involves engineering and biocompatibility testing, not clinical human-expert-based ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the tests are engineering performance and safety assessments, not expert-adjudicated clinical studies.
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
There is no mention of an MRMC comparative effectiveness study, nor is there any AI component described in the device or its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical infusion catheter and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the engineering and biocompatibility tests would be the established scientific and engineering principles for material properties, mechanical performance, and biological response, and the pass/fail criteria derived from regulatory standards, internal specifications, and predicate device performance. For the in-vivo safety testing, the ground truth would be determined through observation of biological responses and standard histopathological evaluations.
8. The sample size for the training set
This is not applicable as there is no mention of a training set for an algorithm.
9. How the ground truth for the training set was established
This is not applicable as there is no mention of a training set.
§ 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).