(31 days)
The AcQGuide MAX Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The AcQGuide MAX deflection facilitates catheter positioning.
The AcQGuide® MAX Steerable Sheath, Model 900200 is a single use, percutaneous catheter introducer designed to provide additional maneuverability to interventional catheters that are advanced through the sheath and into the right or left chambers of the heart. The distal portion of the sheath is comprised of a composite structured single lumen shaft. At the proximal end, an ergonomic handle provides torque and active deflection, a hemostasis valve allows safe introduction of an interventional catheter, and a side port provides access for aspiration, fluid flushes and fluid/medication infusions. The dilator is designed to introduce the Steerable Sheath into the vasculature and into chambers of the heart. The dilator has a smooth tapered tip and provides a smooth transition to the round edge of the non-traumatic tip of the sheath. The dilator is able to track over a 0.035″ guidewire. The hub section is attached to the shaft. It is a standard female luer made of high-density polyethylene (HDPE) material.
This submission details the AcQGuide MAX ASteerable Sheath (Model 900200), a device for introducing catheters into the vasculature and heart chambers. The submission seeks to demonstrate substantial equivalence to a previously cleared predicate device (AcQGuide Steerable Sheath, Model 900002).
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in a formal table format. Instead, it describes general performance goals and confirms that testing was conducted to ensure the device "conformed to the design specifications" and "met its established performance specifications." The key performance attributes evaluated are listed, and the conclusion is that the device "meets the specifications necessary for consistent performance."
Thus, the acceptance criteria are implicitly tied to meeting design specifications and established performance specifications, as demonstrated by passing various nonclinical tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to design specifications | Collective results of nonclinical testing demonstrate the materials, manufacturing processes, and design meet necessary specifications for consistent performance. |
| Meeting established performance specifications | Device met established performance specifications, verified by dimensional testing, visual inspection, leak testing, functional and compatibility testing, mechanical testing, and handle torque testing. |
| Consistent performance during intended use | Collective results of nonclinical testing affirm consistent performance during intended use. |
| No potential impact on safety or effectiveness | Collective bench testing demonstrates no potential impact on safety or effectiveness for percutaneous catheter introduction into the vasculature and heart chambers, compared to the predicate device. |
| Packaging and shelf-life requirements met | Studies performed to confirm acceptable product performance and ability to withstand sterilization; shelf-life difference (12 months vs. 18 months for predicate) does not raise new safety/effectiveness questions. |
| Sterilization effective and safe | Technical review established the subject device can be adopted into the existing EtO processing cycle validated to a 10^6 sterility assurance level (SAL). Materials are suitable for EtO sterilization and not known to retain high EtO residual levels. |
| Biocompatibility in accordance with standards | Passed appropriate biocompatibility tests in accordance with ISO 10993-1:2018 and FDA Guidance. Categorized as an external communicating device with limited (≤24 hours) contact with circulating blood. |
| Non-pyrogenic | Performed material mediated pyrogenicity testing in New Zealand white rabbits per 21 CFR Part 58; considered non-pyrogenic per ISO 10993-11 guidelines. |
| Dimensional accuracy of components | Dimensional testing ensured all components met required dimensions per specifications. |
| Absence of defects | Visual inspection ensured all components were free of defects. |
| Packaging integrity | Leak testing ensured packaging meets its specifications. The packaging system does not adversely affect gas ingress or egress, nor does it pose a risk to product heating. |
| Functional and compatibility requirements met | Functional and compatibility testing ensured requirements are met. |
| Mechanical strength and durability | Mechanical testing ensured components can withstand expected forces. |
| Handle torque resistance | Handle torque testing ensured it can withstand expected torques. |
| Deflection and Reach (Identical to Predicate) | Maximum Deflection: 180 degrees; Reach: 5.0 cm at 90 degrees. |
| Guidewire compatibility (Identical to Predicate) | 0.035". |
| Radiopaque marker visibility (Identical to Predicate) | Distal sections visible with standard or low-level fluoroscopy. |
| Hemostasis valve function (Identical to Predicate) | Prevents air incursion and minimizes blood loss. The differences in hemostasis valve material do not raise new safety/effectiveness questions. |
| Flush port function (Identical to Predicate) | Provides ability to administer saline flush throughout procedure. |
| Sheath deflection (Identical to Predicate) | Facilitates accurate catheter positioning. |
| Usable with catheters up to 12 Fr (Improved from Predicate 10.5 Fr) | Facilitates use with catheters up to 12 Fr in diameter. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify exact sample sizes for each nonclinical test (e.g., how many units were tested for dimensional inspection, leak testing, etc.). It generally states that "All necessary testing was conducted" and "The necessary bench testing was performed."
- Data Provenance: The testing was conducted by or for Acutus Medical, Inc. in the U.S. (Carlsbad, CA). The studies are nonclinical bench tests and "Physician simulated use in an animal model." This would be considered prospective data for device verification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The "Physician simulated use in an animal model" implies expert involvement, but the number and qualifications of these physicians are not detailed. For bench testing, human experts typically set the specifications, but they don't "establish ground truth" for test outcomes in the same way clinical data is adjudicated.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving interpretation of medical images or outcomes where expert consensus is needed to establish ground truth. As this is a nonclinical bench testing and simulated animal model study, such adjudication methods would not be relevant.
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 is not applicable. This submission is for a medical device (steerable sheath), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
This is not applicable. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the nonclinical bench tests, the "ground truth" is defined by the design specifications and established performance specifications of the device. These are objectively measurable parameters (e.g., dimensions, force resistance, electrical properties, etc.). For biocompatibility and sterilization, the "ground truth" refers to meeting the requirements of established international standards (ISO 10993-1, ISO 11135:2014+A1:2019) and regulations (21 CFR Part 58), which are objectively tested against. The "Physician simulated use in an animal model" would likely have qualitative or quantitative outcomes based on the successful demonstration of the device's function in a physiological setting, but the specific metrics are not detailed here.
8. The sample size for the training set:
This is not applicable. This is a non-AI medical device; therefore, there is no "training set."
9. How the ground truth for the training set was established:
This is not applicable. As there is no training set, there is no ground truth for it.
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).