(162 days)
The ENABLER-P Catheter System is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.
The ENABLER-P Catheter System is comprised of the ENABLER-P Catheter, the ENABLER Pressure Control Unit (PCU), and accessories including a sterile cover, syringe, manifold and extension tube.
The ENABLER-P Catheter is a dual-lumen intravascular catheter intended for percutaneous use. It is designed for use in conjunction with a 0.035" guidewire to gain access to locations within the cardiovascular system that are remote from the site of insertion. Once accessed, guidewires may be exchanged within the catheter. In addition, the ENABLER-P Catheter, using a distal balloon, can provide distal anchoring and support the advancement of the guidewire.
The ENABLER Pressure Control Unit (PCU) an optional accessory used to automate the inflation and deflation of the catheter's balloon.
The provided 510(k) summary for the EndoCross ENABLER-P Catheter System describes a device intended for use in the peripheral vasculature. However, it does not include information about acceptance criteria or a study designed to prove the device meets specific performance criteria in the way that would typically be presented for an AI/ML medical device.
This document is for a traditional medical device (catheter system) and the regulatory pathway is focused on demonstrating "substantial equivalence" to predicate devices, rather than establishing performance against pre-defined metrics in a clinical study with a ground truth.
Therefore, many of the requested sections (acceptance criteria, reported performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types/establishment for training sets) are not applicable to this specific 510(k) submission.
Here's a breakdown based on the information provided and what is implied by a traditional medical device submission:
1. Table of acceptance criteria and the reported device performance
- Not Applicable. The submission emphasizes "substantial equivalence" to predicate devices rather than meeting specific quantifiable performance criteria like sensitivity, specificity, or accuracy that would be found in an AI/ML device submission. The performance assessment is qualitative, stating that "Performance test results indicate that the device satisfies functional performance requirements when used as indicated."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This device is a catheter system, and its performance is evaluated through bench testing and in vivo studies, not typically against a "test set" of clinical data in the way an AI/ML algorithm would be. The document mentions "in vitro bench studies, and in vivo studies" but does not provide specific sample sizes or data provenance for these studies in the context of a "test set."
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. Ground truth in the context of expert consensus on clinical data is not relevant for this type of traditional device submission. Performance is assessed through engineering tests and non-clinical studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods for a "test set" are not relevant here as the performance evaluation is not based on interpreting clinical data where human expert disagreement would need resolution.
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. MRMC studies are specific to evaluating diagnostic systems, particularly AI/ML-assisted ones. This is a catheter system, not a diagnostic AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device (catheter system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For a physical device like this, "ground truth" would relate to engineering specifications, material properties, and biological responses (e.g., biocompatibility). The document states: "Biocompatibility test results indicate that the device is biocompatible. Performance test results indicate that the device satisfies functional performance requirements when used as indicated." This suggests that the "ground truth" is defined by pre-determined engineering and biological standards.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
Summary of the Study (as described in the 510(k) document):
The submission for the ENABLER-P Catheter System relies on "Biocompatibility testing, in vitro bench studies, and in vivo studies" to demonstrate the device's characteristics. The primary argument for clearance is Substantial Equivalence to legally marketed predicate devices (ENABLER-P Catheter manufactured by Endocross, Medtronic Everest 20cc Inflation Device, and Angiometrx Metricath System). The rationale is that the device has the "same intended use" and "similar technological characteristics" as the predicates, and that "[a]ny differences in technological characteristics or principles do not raise new questions of safety or efficacy."
Therefore, the "study" proving the device meets its requirements is essentially the set of these non-clinical tests and the comparative analysis against the predicate devices to establish substantial equivalence under the 510(k) pathway. Specific performance metrics, acceptance criteria, or clinical study endpoints as would be required for an AI/ML device are not detailed as they are not typically part of this type of submission.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).