(21 days)
The Tip-Shape Echelon™ Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
The Tip-shape Echelon Micro Catheter is an endhole, single-lumen catheter designed to be introduced over a steerable guidewire into the vasculature. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter has a semi-rigid proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated to increase lubricity.
The provided text describes a 510(k) premarket notification for a medical device, the Tip-Shape Echelon™ Micro Catheter. This is a submission for substantial equivalence to existing predicate devices, not typically a submission that would include a detailed study with acceptance criteria and AI performance metrics as these are more common for novel algorithms or AI/ML-driven devices.
Based on the provided information, I can extract the following:
1. A table of acceptance criteria and the reported device performance
The document lists "Testing" that was performed, which includes various in-vitro performance tests and biocompatibility verification. However, it does not explicitly state specific acceptance criteria (e.g., "Tip Tensile Strength > X N") or directly report quantitative device performance against these criteria. It only lists the types of tests conducted and concludes that biocompatibility was "verified."
| Acceptance Criteria (Implicit from "Testing" section) | Reported Device Performance |
|---|---|
| Dimensional and Visual Analysis | N/A (Not explicitly stated) |
| Tip Tensile Strength | N/A (Not explicitly stated) |
| Pressure Testing | N/A (Not explicitly stated) |
| Guidewire Friction | N/A (Not explicitly stated) |
| Coil Friction | N/A (Not explicitly stated) |
| Tip Reshape-ability and Retention | N/A (Not explicitly stated) |
| Tip offset distances measurement | N/A (Not explicitly stated) |
| Tip length measurement specification | N/A (Not explicitly stated) |
| Biocompatibility (in accordance with ISO 10993-1) | Confirmed biocompatibility |
2. Sample sizes used for the test set and the data provenance
The document does not mention sample sizes for any of the in-vitro performance tests. Data provenance is not applicable as this concerns physical device testing, not data generated by a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a submission for a physical medical catheter, not an AI/ML device requiring expert ground truth for image analysis or similar tasks.
4. Adjudication method for the test set
Not applicable, as this is related to expert consensus on ground truth, which is not relevant to this device submission.
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 not an AI-driven tool and therefore no MRMC study involving AI assistance would be performed or reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical catheter, not an algorithm.
7. The type of ground truth used
For the in-vitro performance tests, the "ground truth" would be the engineering specifications and tolerances for the device's physical properties. For biocompatibility, the ground truth is established by the results of tests conducted according to ISO 10993-1. These are physical measurements and biological assays, not expert consensus or diagnostic outcomes in the typical sense.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is a physical device, not an AI/ML model.
9. How the ground truth for the training set was established
Not applicable, as there is no 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).