(119 days)
The INNERCHANGE micro-introducer catheter is intended for use in accessing the vascular system through a small gauge needle stick and for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
The INNERCHANGE micro-introducer catheter combines a micro-introducer kit for obtaining vascular access with a hydrophilically coated diagnostic catheter. The INNERCHANGE catheter is designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures. The INNERCHANGE micro-introducer catheter is compatible with ≤0.038" / 965mm guidewires. Each INNERCHANGE micro-introducer catheter consists of the following components:
- . 21G percutaneous entry needle
- 0.018" guidewire .
- Dilator .
- Catheter with selected tip shape and attached stopcock .
The provided document is a 510(k) summary for the InnerChange Micro-Introducer Catheter. It describes the device, its intended use, a summary of non-clinical testing, and concludes with a statement of equivalence to a predicate device.
Crucially, this document does not describe the acceptance criteria or a study that proves the device meets specific performance criteria in the way typically associated with AI/ML-driven devices (e.g., sensitivity, specificity, AUC). Instead, it describes a medical device that undergoes engineering and biocompatibility testing.
Therefore, many of the requested fields are not applicable to the information contained in this submission. I will answer based on the information provided, explicitly stating when information is not present or not applicable.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Bench Test) | Reported Device Performance |
|---|---|
| Radiopacity | Confirmed suitability |
| Visual inspection (lubricious coating) | Confirmed suitability |
| Visual inspection of catheter/dilator | Confirmed suitability |
| Catheter Curve retention | Confirmed suitability |
| Dilator passage | Confirmed suitability |
| Dilator/catheter tapered tip assembly | Confirmed suitability |
| Guidewire passage | Confirmed suitability |
| Catheter Tortuosity test | Confirmed suitability |
| Hydrophilic coating inspection after tortuosity | Confirmed suitability |
| Flow rate with contrast | Confirmed suitability |
| Dynamic pressure test (catheter only) | Confirmed suitability |
| Kink radius | Confirmed suitability |
| Liquid leak test (catheter only) | Confirmed suitability |
| Proximal to distal shaft strength | Confirmed suitability |
| Biocompatibility assessments | Confirmed suitability |
| Shelf life testing | Confirmed suitability |
Note: The document states "The results of this testing confirmed the suitability of the InnerChange Micro-Introducer Catheter for its intended use." It does not provide specific quantitative acceptance criteria or raw performance data for each test, only that the device "confirmed suitability."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "testing conducted" but does not detail sample sizes for each bench test or data provenance. There is no mention of a "test set" in the context of clinical data, as no clinical testing was performed.
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/not provided. The device is a physical medical instrument, not an AI/ML diagnostic tool requiring expert-established ground truth for a test set. The evaluation was based on engineering bench tests and biocompatibility, not interpretations by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. As no clinical or expert-reviewed "test set" was used, no adjudication method was necessary or mentioned.
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, a multi-reader, multi-case comparative effectiveness study was not done. This document is for a physical medical catheter, not an AI/ML system, so this type of study is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable. For this type of medical device, the "ground truth" for the bench tests would be defined specifications, engineering standards, and biological compatibility requirements rather than clinical ground truth like pathology or outcomes data. The document states "The results of this testing confirmed the suitability of the InnerChange Micro-Introducer Catheter for its intended use," implying compliance with predefined engineering and safety standards.
8. The sample size for the training set
This information is not applicable/not provided. The device is a physical product. There is no concept of a "training set" as understood in machine learning. Design verification involved bench testing, not machine learning model training.
9. How the ground truth for the training set was established
This information is not applicable/not provided. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.
§ 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).