(30 days)
The AcQGuide® Catheter Introducer Sets are indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
The AcQGuide Catheter Introducer Sets contain either a steerable introducer (AcQGuide FLEX) or fixed curve introducer (AcQGuide MINI), an integrated vessel dilator/transseptal needle (AcQCross Qx), guidewire, and electrocardiogram (ECG) and electrosurgical (ES) adapter cables. The sets are designed to facilitate vascular access to the heart and then provide variable catheter positioning within the cardiac anatomy.
The provided text is a 510(k) summary for the AcQGuide® FLEX and AcQGuide® MINI Introducers with AcQCross™ Qx dilator/transseptal needle. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of acceptance criteria and device performance in the typical sense of a clinical trial for AI/software-as-a-medical-device.
Based on the document, here's an analysis of the requested information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or a performance table for a device's diagnostic accuracy or efficacy in the way one might expect for an AI device. Instead, it describes performance data related to the safety and functionality of the device, particularly focusing on the changes made (ES adapter cable and hemostasis valve). The "performance" demonstrated is primarily about meeting existing standards and showing substantial equivalence to predicate devices.
| Area of Performance | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Materials meet biocompatibility standards for intended use (ISO 10993). | The AcQGuide Introducer Set devices are made of identical materials to predicate devices (Flextra K170373, Guider K171081), except for the hemostasis valve. The new silicone rubber valve material is identical to that evaluated in Acutus AcQRef Introducer Sheath (K192016), thus no new biocompatibility testing was required. |
| Sterilization | Achieve a Sterility Assurance Level (SAL) of 10⁻⁶. | The devices undergo the identical ethylene oxide (EO) sterilization process as predicate devices to meet SAL of 10⁻⁶. The addition of the ES adapter cable was adopted into the existing process per AAMI TIR28, requiring no further validation. Shelf-life testing leveraged from predicate devices. |
| Electrical Safety & EMC | Compliance with applicable sections of ES 60601-1, IEC 60601-1-2, IEC 60601-2-2. | Testing conducted showed compliance with applicable sections of ES 60601-1:2005, IEC 60601-1:2006+A12:2014, IEC 60601-1-2:2014, and IEC 60601-2-2:2017. This is consistent with reference device Baylis Medical's NRG Transseptal Needle (K073326). |
| ES Generator Compatibility | System connectivity, no loose biological particulate, no coring, no dilator damage. | Successfully passed ES Generator Compatibility testing, including system connectivity, visual inspection for biological particulate, coring, and dilator damage. |
| Packaging Performance | Meet packaging performance specifications after Distribution Cycle testing. | The identical packaging system to the predicate devices underwent Distribution Cycle testing, followed by visual inspection and electrical connectivity testing, with positive results implied. |
| Hemostasis Valve Performance | Maintain hemostasis as per ISO 11070 Annex E Leak Test. | The AcQGuide Catheter Introducer Sets with the new silicone rubber valve material were tested to the same ISO 11070 Leak Test as the predicate devices, demonstrating its ability to maintain hemostasis. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes bench testing for specific components and functionalities rather than a "test set" in the context of diagnostic performance evaluation for a machine learning model.
- Biocompatibility: No new testing was performed; leveraged prior biocompatibility data from predicate devices (K170373, K171081) and a similar device (K192016).
- Sterilization: Process adoption via AAMI TIR28, not new testing on a sample set.
- Electrical Safety & EMC: Testing was conducted on the AcQGuide Introducer Set devices with the new ES adapter cable. No sample size is explicitly given, but this would typically involve a small number of devices to demonstrate compliance with standards.
- Bench Testing (ES Compatibility, Packaging, Hemostasis): Testing was performed for these aspects. No specific sample sizes are mentioned, but for bench testing, these are typically conducted on a representative sample of devices, often in the range of 3-10 units, to demonstrate compliance with engineering specifications and standards.
The data provenance is not specified, but these are typically retrospective in the sense that they are engineering tests performed by the manufacturer, rather than prospective clinical trials. The country of origin for the data (testing lab location) is not provided.
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 question is not applicable. The product described is a medical device (catheter introducer set), not an AI/diagnostic software. Therefore, there is no "ground truth" to be established by medical experts in the context of diagnostic accuracy, nor a "test set" for expert review. The testing described is engineering compliance and performance testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for a hardware device undergoing engineering and compliance testing. Adjudication methods are relevant for interpretation of diagnostic images or clinical outcomes, typically in studies involving human readers or AI algorithms.
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 question is not applicable. The device is a physical medical instrument, not an AI system. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant to the information provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This question is not applicable. As explained in point 3, there is no "ground truth" in the context of diagnostic accuracy for this hardware device. The "truth" in these tests is compliance with engineering specifications, safety standards (e.g., biocompatibility limits, electrical safety thresholds), and functional performance parameters (e.g., hemostasis, mechanical integrity).
8. The sample size for the training set
This question is not applicable. There is no training set mentioned or relevant for this type of medical device submission.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).