(150 days)
The ENABLER-P Catheter 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 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 can provide distal anchoring and support the advancement of the guidewire. The ENABLER-P Catheter is packaged in a Tyvek/Poly pouch to form a sterile barrier. The packaged catheter is sterilized by ethylene oxide gas. The ENABLER-P Catheter is provided "STERILE" and "Non-pyrogenic", and is intended for single use only.
The provided text describes the 510(k) summary for the EndoCross ENABLER-P Catheter. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical study with specific acceptance criteria related to disease detection or diagnosis based on imaging or other data.
Therefore, many of the requested categories for AI/diagnostic device studies are not applicable to this submission, as it concerns a physical medical device (a catheter) and its mechanical/biocompatibility performance, not an AI or diagnostic algorithm.
Here's an analysis based on the provided text, indicating where information is not applicable (N/A):
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Functional Performance Requirements) | Reported Device Performance |
|---|---|
| Biocompatibility (materials are safe for biological systems) | Biocompatibility test results indicate that the device materials are biocompatible. (Statement from "Biocompatibility And Performance Data") |
| Functional performance requirements (related to intended use: accessing peripheral vasculature, guidewire exchange, distal anchoring, support guidewire advancement) | Performance test results indicate that the device satisfies functional performance requirements when used as indicated. (Statement from "Biocompatibility And Performance Data") |
| Sterility | Provided "STERILE" (Implicitly meets sterility requirements) |
| Non-pyrogenicity | Provided "Non-pyrogenic" (Implicitly meets non-pyrogenicity requirements) |
| Mechanical performance (similar to predicate devices) | The ENABLER-P Catheter is similar in basic materials, design, construction and mechanical performance to a combination of the predicate devices. Performance data demonstrate that the ENABLER-P Catheter is substantially equivalent to the ENABLER-P Support Catheter and the Asahi Tornus Support Catheter. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for performance testing. The text mentions "in vitro bench studies and animal studies" but does not quantify the sample sizes for these studies.
- Data Provenance: Not explicitly stated. The applicant, EndoCross Ltd, is located in Israel, but the location of the studies is not specified. The studies are likely prospective, as they are conducted to evaluate the new device.
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)
- N/A. This device is a catheter, not a diagnostic or AI device that requires expert-established ground truth for interpretation. Performance is assessed through engineering bench tests, animal studies, and biocompatibility testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are typically for subjective assessments or discrepancy resolution in diagnostic studies. This is a physical device with objective performance metrics (e.g., tensile strength, burst pressure, maneuverability in a model, biocompatibility assay results).
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
- N/A. This is a physical medical device (catheter), not an AI or diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical medical device. "Standalone performance" in the context of AI applies to algorithms making decisions independently, which is not relevant for a catheter's performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance relies on objective measurements from in vitro bench testing (e.g., mechanical properties, functional operation in models) and biological responses observed in biocompatibility tests and animal studies. It's not a diagnostic ground truth like pathology.
8. The sample size for the training set
- N/A. There is no "training set" in the context of evaluating a physical medical device like a catheter. This term applies to machine learning algorithms.
9. How the ground truth for the training set was established
- N/A. As there is no training set, this is not applicable.
§ 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).