(147 days)
The M-CATH Microcatheter is intended to provide support to the guide wire while performing PCI (percutaneous coronary intervention) and to facilitate the exchange of guide wires while maintaining access to distal vasculature. The device is also intended to deliver radiopaque contrast media into the coronary vasculature.
M-CATH™ consists of a catheter shaft, a hypotube and a hub. The catheter shaft has reinforcing braided mesh with high torquability. The outer surface of the catheter is coated with a hydrophilic polymer with a high lubricity upon moistening, hence, enhancing maneuverability and patient comfort.
The microcatheter has one distal radiopaque marker proximal at the distal tip.
The shaft has a central guidewire lumen which permits the use of a guide wire with maximum diameter of 0.014" (0.36 mm). The guidewire lumen begins at the proximal luer port and ends at the distal tip. At the proximal end the catheter has a hub with one port. The catheter is compatible with any 5F guiding catheter.
The main materials are stainless steel, PTFE and Pebax (braided shaft), stainless steel and Teflon (hypotube), Makrolon (luer), and Pt/Ir alloy (radiopaque marker). The coating is hydrophilic, based on hyaluronic acid.
The provided text describes a 510(k) premarket notification for a medical device called the M-CATH Microcatheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's absolute safety and effectiveness through extensive clinical trials. Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, expert involvement, and ground truth establishment, especially in the context of AI/ML performance, is not directly applicable to this document.
However, I can extract the information that is present and indicate where certain details are not provided due to the nature of a 510(k) submission for this type of device.
Here's a breakdown based on the provided document:
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific quantitative acceptance criteria or a direct comparison of the M-CATH Microcatheter's performance against numerical targets. Instead, it states that "The in vitro bench tests demonstrated that M-CATH™ microcatheter met all acceptance criteria and performed similarly to the predicate devices."
The performance data mentioned relates to a series of bench tests. These tests are implicitly the basis for demonstrating that the device meets its design specifications and functional requirements for safe and effective use, thereby meeting "acceptance criteria" through a demonstration of substantial equivalence.
General Bench Test Categories Performed:
| Acceptance Criteria Category | Reported Device Performance (Summary Statement) |
|---|---|
| Dimensional Verification | Met all acceptance criteria and performed similarly to predicate devices. |
| Ancillary Device Compatibility Test | Met all acceptance criteria and performed similarly to predicate devices. |
| Pushability and Trackability Testing | Met all acceptance criteria and performed similarly to predicate devices. |
| Catheter Bond Strength | Met all acceptance criteria and performed similarly to predicate devices. |
| Tip Pull Test | Met all acceptance criteria and performed similarly to predicate devices. |
| Flexibility and Kink Test | Met all acceptance criteria and performed similarly to predicate devices. |
| Torque Strength Test | Met all acceptance criteria and performed similarly to predicate devices. |
| Coating Lubricity | Met all acceptance criteria and performed similarly to predicate devices. |
| Particulate Evaluation – Coating Integrity | Met all acceptance criteria and performed similarly to predicate devices. |
| Particulate Evaluation - Coating Integrity (Coating Inspection) | Met all acceptance criteria and performed similarly to predicate devices. |
| Radiopacity | Met all acceptance criteria and performed similarly to predicate devices. |
| Maximum Labeled Pressure | Met all acceptance criteria and performed similarly to predicate devices. |
| Media Flow Rate | Met all acceptance criteria and performed similarly to predicate devices. |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity/Irritation, Acute Systemic Toxicity, Hemocompatibility, Hematology: ASTM Hemolysis, Complement Activation Assay (Sc5b9), In vivo thromboresistance, Chemical Characterization) | Blood contacting materials were found to be biocompatible in accordance with ISO 10993 recommendations. |
2. Sample size used for the test set and the data provenance
The document states that "Bench testing was performed on the M-CATH™ microcatheter." However, it does not specify the sample size for each bench test performed. Given that these are bench tests for a physical medical device (a microcatheter) and not an AI/ML model, the concept of "data provenance" (country of origin, retrospective/prospective) in the context of clinical data is not applicable here. The data would have been generated from laboratory testing of manufactured catheter samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this 510(k) submission. The "ground truth" for the performance of a physical medical device like a microcatheter in bench testing is typically established by engineering specifications, accepted industry standards, and comparisons to legally marketed predicate devices, not by expert interpretation of data in the way one would assess AI/ML diagnostic performance. There is no mention of expert radiologists or similar qualifications being used to establish "ground truth" for these engineering tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable to this 510(k) submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or interpretations, especially when establishing ground truth for AI/ML validation. The document describes bench testing of a physical device.
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
This information is not applicable to this 510(k) submission. The M-CATH Microcatheter is a physical medical device (a microcatheter), not an AI/ML diagnostic or assistive device. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance would have been conducted or reported here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable to this 510(k) submission. As mentioned, this is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the M-CATH Microcatheter, the "ground truth" for its performance is established through adherence to engineering specifications, recognized national/international standards (e.g., ISO 10993 for biocompatibility), and comparability to the established performance characteristics of the predicate devices. This is demonstrated through objective bench testing. The concepts of expert consensus, pathology, or outcomes data related to diagnostic accuracy are not relevant here.
8. The sample size for the training set
This information is not applicable to this 510(k) submission. There is no "training set" in the context of a physical medical device. This term is relevant for AI/ML models.
9. How the ground truth for the training set was established
This information is not applicable to this 510(k) submission. (See response for #8).
§ 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).