Search Results
Found 1 results
510(k) Data Aggregation
(14 days)
EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135
The EmboCath® Plus Infusion Microcatheter is intended for: infusion of various diagnostic, embolic and therapeutic agents into the body's peripheral vascular systems, guidewire exchange/support; and superselective angiography of the peripheral vasculatures.
The EmboCath® Plus Infusion Microcatheter, same as its predicate device EmboCath Hydrophilic Catheter (K003105) is sterile, biocompatible, single use, peripheral vascular catheter constructed of a tapered reinforced shaft, inner lubricious lined lumen, hydrophilic outer surface, radiopaque marker and a standard luer adapter at the proximal end.
The device will be provided in the following configurations:
- Inner Diameter: 0.028 in.
- Outer Diameters: 3 F proximally to 2.8 F distally
- Lengths: 100 cm and 135 cm as indicated on product label .
The EmboCath® Plus Infusion Microcatheter is a tapered 3.0-2.8F single lumen catheter designed to facilitate the access of distal vasculature over a guidewire. The catheter has a semi-rigid proximal shaft and becomes progressively more flexible toward the distal end. The shaft is reinforced, which provides improved torque transmission. The inner lumen is lined with a lubricious material to facilitate the movement of guidewires or other devices. The outer diameter of the catheter is coated with a hydrophilic surface to enhance the ability to navigate tortuous anatomy. The distal tip of the catheter has a single radiopaque marker to facilitate fluoroscopic visualization. The hub at the proximal end incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter lumen is 0.028 inches and guidewires measuring up to 0.025 inches (0.635 mm) in diameter are recommended.
This 510(k) summary describes a medical device, the EmboCath® Plus Infusion Microcatheter, and its substantial equivalence to a predicate device, the EmboCath Hydrophilic Catheter (K003105). The submission primarily focuses on functional equivalence rather than clinical performance or AI-driven diagnostic accuracy. Therefore, several of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, training set details) are not applicable or not provided in this document as they pertain to clinical or AI performance studies which were not conducted for this type of device submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not provide explicit quantitative "acceptance criteria" for clinical performance. Instead, it relies on demonstrating that the EmboCath® Plus Infusion Microcatheter performs equivalently to its predicate device through in-vitro design verification and validation testing, ensuring it meets its design and performance specifications. The "reported device performance" is essentially the successful completion of these tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device successfully passes in-vitro design verification and validation tests to demonstrate equivalence to predicate. | "In-vitro design verification and validation testing demonstrates that the EmboCath® Plus Infusion Microcatheter is equivalent to its predicate device and fulfills design and performance specifications." Tests performed include: Visual Inspection, Dimensional Inspection, Trackability Test (in simulated anatomy), Kink Resistance Test, Patency Test (for embolic patency), Coating Lubricity Test, Aspiration Test, Stiffness Test, Tensile Failure Load Test, Column Test, Leak/Burst Test (Static Pressure). |
| Meets specified physical dimensions (length, inner diameter, outer diameter). | Length: 100 cm and 135 cm (matches predicate). |
| Inner Diameter: 0.028 in. (matches predicate). | |
| Outer Diameter: 0.038 in. distal 30 cm, 0.039 in. proximal (65 cm and 70 cm) (matches predicate). | |
| Uses materials functionally equivalent to the predicate device. | Materials: Predominantly Pebax, Nylon12, Stainless Steel, Polyvinylpyrrolidone (PVP), Polyachrylamide. (Similar to predicate, with expanded description of PVP and inclusion of Polyacrylamide, but considered functionally equivalent.) |
| Intended Use and Indications for Use are substantially equivalent to the predicate, with minor modifications (e.g., specific vascular systems). | Intended Use is for infusion of various diagnostic, embolic and therapeutic agents into the body's peripheral vascular systems, guidewire exchange/support; and superselective angiography of the peripheral vasculatures. This is a narrowing of the predicate's use which included neuro, peripheral, and coronary systems. This change does not raise new questions of safety or effectiveness. |
| Substantially equivalent in terms of size, construction, performance characteristics, biocompatibility, packaging, and sterilization method. | The device is deemed substantially equivalent in all these aspects to EmboCath Hydrophilic Catheter (K003105). |
2. Sample size used for the test set and the data provenance
Not applicable. This submission describes in-vitro engineering tests (e.g., trackability, kink resistance, patency) rather than a clinical study involving a test set of patient data. The tests are benchtop evaluations of device characteristics. No data provenance in terms of country of origin or retrospective/prospective collection is relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of expert consensus, is not relevant for in-vitro engineering tests. The "ground truth" for these tests would be established by validated test methodologies and measurement equipment against engineering specifications.
4. Adjudication method for the test set
Not applicable. There was no clinical test set requiring expert adjudication.
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 device is a microcatheter, not an AI-driven diagnostic tool. No MRMC study was performed as no human reader interpretation of AI output is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance claims is derived from engineering specifications and established test methods for material properties and functional device performance during the in-vitro design verification and validation testing. For example, a "kink resistance test" would have predetermined acceptance criteria for the force or angle at which kinking occurs, and the device's performance is measured against these criteria.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI models, so 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 an AI model, no ground truth needed to be established for it.
Ask a specific question about this device
Page 1 of 1