(22 days)
The RX ACCUNET™ 2 Embolic Protection System is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the portery at the site of filter basket placement should be between 3.25 mm and 7.0 mm.
The RX ACCUNET™ 2 Embolic Protection System is a filtration type embolic protection device, filtering distal to the interventional site. The System consists of the RX ACCUNET™ Delivery System and a second-generation RX ACCUNET™ 2 Recovery Catheter. The RX ACCUNET™ 2 Embolic Protection System is delivered via a Delivery Sheath with a flexible tip coil that facilitates movement of the Sheath through tortuous anatomy. Once across the lesion, the Filter Basket is expanded in the arterial lumen by peeling the Delivery Sheath from the guide wire using the torque device and peel away adapter. At the conclusion of the interventional procedure, the Filter Basket is collapsed inside the Recovery Catheter. Once collapsed, the entire system is removed as a single unit. The Recovery Catheter has a radiopaque tip to facilitate movement though tortuous anatomy
This document is a 510(k) summary for the RX ACCUNET™ 2 Embolic Protection System. It outlines the device's substantial equivalence to a predicate device and provides an overview of its intended use and technological characteristics.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in the format of a numerical target for specific performance metrics. Instead, it relies on the concept of substantial equivalence to a predicate device (RX ACCUNET™ Embolic Protection System, K024418).
The "performance" is implicitly deemed acceptable if the new device demonstrates similar safety and effectiveness to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and effectiveness comparable to predicate device | "The results of the in vitro bench tests and in vivo studies demonstrated the safety and effectiveness of the RX ACCUNET™ 2 Embolic Protection System." |
| Design, principles of operation, materials, and indications for use substantially equivalent to predicate device | Stated: "The RX ACCUNET™ 2 Embolic Protection System is substantially equivalent to the RX ACCUNET™ Embolic Protection Systems (K024418) with regard to device design, principals of operation, materials, and indications for use." |
| No new issues of safety or efficacy | "Any new issues of safety or efficacy were addressed through pre-clinical evaluation including functional, in vivo and in vitro testing." |
| Technological characteristics (materials, biocompatibility, performance properties, sterilization, packaging) equivalent to predicate device | "Comparisons of the new and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties, sterilization and packaging are substantially equivalent to the currently marketed predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify a numerical sample size for the "in vivo studies." It simply states "in vivo studies." It's common in 510(k) submissions for device modifications to refer to previous studies or a cumulative understanding rather than detailing new, large-scale clinical trials for minor changes.
- Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. It only mentions "in vitro bench tests and in vivo studies." Given the context of a 510(k) submission, these would typically be internal company studies or studies conducted under contract for the company.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the given text. The document refers to "in vivo studies" but does not detail the methodology for establishing ground truth, such as expert review, for these studies.
4. Adjudication Method for the Test Set:
This information is not provided in the given text.
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 to this document. The RX ACCUNET™ 2 Embolic Protection System is a medical device (filtration type embolic protection device), not an Artificial Intelligence (AI) or software as a medical device (SaMD) product. Therefore, MRMC studies and AI-assisted improvements for human readers are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable for the same reasons as point 5. It's a physical medical device, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The document does not explicitly state the type of ground truth used for the "in vivo studies." For an embolic protection system, "safety and effectiveness" in vivo would likely involve:
- Outcomes data: Such as rates of stroke, TIA, or other neurological events post-procedure, as well as the amount and type of embolic material captured by the filter.
- Imaging: Assessment of vessel patency and absence of new lesions.
- Histopathology: Analysis of captured embolic material (if possible and relevant to the study design).
However, the specific methods are not detailed. The phrase "demonstrated the safety and effectiveness" is a general conclusion.
8. The Sample Size for the Training Set:
This is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set. The "training" for such devices typically involves design iterations, bench testing, and potentially animal studies.
9. How the Ground Truth for the Training Set was Established:
This is not applicable for the same reasons as point 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).