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510(k) Data Aggregation
(27 days)
AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323
The Agilis™ NxT Steerable Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
The Agilis NxT Steerable Introducer consists of a steerable sheath, plastic dilator and stainless steel guidewire, which is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. It is an 11F asymmetrical bi-directional steerable introducer with a small and medium curl at the distal tip and a useable length of 71 cm. The proximal end of the device sheath is fitted with a hemostasis valve to minimize blood loss during catheter insertion and/or exchange over a guidewire. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. A handle is equipped with a rotating collar to deflect 90° in the counterclockwise direction and 180° in the clockwise direction. The sheath is filled with radiopaque material for visualization under fluoroscopy.
This 510(k) summary (K083402) describes a medical device, the Agilis™ NxT Steerable Introducer Catheter, which is a Class II device (21 CFR 870.1340, Product Code DYB) for introducing cardiovascular catheters into the heart. The regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device (Agilis™ NxT Steerable Introducer, K061363) rather than defining specific acceptance criteria and providing a detailed study report with performance metrics.
Therefore, the requested information elements related to device acceptance criteria and a study proving those criteria are largely not applicable in the context of this 510(k) submission as it is presented. This type of submission relies on the concept of substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device.
However, I can extract what is provided and explain why other sections are not present in this document.
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
Summary of Information Provided in the 510(k) Document:
This 510(k) submission for the Agilis™ NxT Steerable Introducer Catheter primarily relies on demonstrating substantial equivalence to a legally marketed predicate device (Agilis™ NxT Steerable Introducer, K061363). The core argument is that the new device has the same intended use and fundamental scientific technology as the predicate and that testing confirmed its design meets product specifications and intended use, implying equivalence to the predicate's performance. Specific quantitative acceptance criteria with corresponding device performance metrics for novel functionalities are not explicitly detailed in this summary.
The "acceptance criteria" and "device performance" in this context are implicitly tied to demonstrating that the modifications made to the predicate device do not negatively impact its safety and effectiveness, and that the device performs as expected for its intended use, comparable to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Safety and Effectiveness Equivalence: Demonstrated substantial equivalence to the predicate device in terms of safety and effectiveness. | "The Agilis™ NxT Steerable Introducer has the same intended use and fundamental scientific technology as the predicate device. All technological characteristics of the Agilis™ NxT Steerable Introducer are substantially equivalent to the predicate device including packaging, biocompatibility, sterilization, and labeling. Where dimensional differences exist between the proposed device and the predicate device, performance testing demonstrated that these differences do not adversely affect the safety and effectiveness." (Summary of Non-Clinical Testing and Statement of Equivalence sections) |
| Design Meeting Product Specifications: Device design meets its established product specifications for its intended use. | "Bench testing of the Agilis NxT Steerable Introducer was performed to verify the device modifications. Results of the testing demonstrate that the Agilis™ NxT Steerable Introducer design meets the product specification and intended use." (Summary of Non-Clinical Testing section) |
| Functional Performance (e.g., Steerability, Blood Loss, Visualization): The device functions as described, including 90° counterclockwise and 180° clockwise deflection, minimization of blood loss, and radiopaque visualization. | While specific quantitative performance metrics (e.g., precise deflection angles under load, quantified blood loss rates, visibility scores) are not provided in this summary, the device description outlines these functional characteristics. The "bench testing" mentioned in the non-clinical summary would have implicitly verified these functions to meet internal design specifications that ensure equivalence to the predicate. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not explicitly stated in this 510(k) summary. The "bench testing" performed would have involved a sample of manufactured devices.
- Data Provenance: Not explicitly stated. Bench testing is typically conducted internally by the manufacturer. It is not clinical data (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable. This submission describes a physical medical device, not an AI/software device requiring "ground truth" established by human experts for a test set in the same manner. The "ground truth" for a device like this is its performance against engineering specifications and its functional behavior in a simulated environment, typically evaluated by engineers and quality control personnel.
4. Adjudication Method for the Test Set
- Not Applicable. As above, this is not an AI/software device requiring a human-expert adjudication method for a test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is a physical medical device submission, not an AI/software device requiring MRMC studies to assess human reader improvement with AI assistance. The evaluation is focused on the device's physical and functional properties.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Engineering Specifications and Functional Performance Benchmarks. For a physical device, the "ground truth" is typically defined by:
- Design Specifications: Quantitative and qualitative requirements established during the device's design phase.
- Predicate Device Performance: The established performance characteristics of the legally marketed predicate device to which the new device is compared for substantial equivalence.
- Industry Standards: Relevant ISO or ASTM standards that might apply to introducer catheters (though not explicitly mentioned for this specific testing).
- Bench Test Results: Direct measurements and observations of the device's physical properties and functional behavior (e.g., deflection angles, material strength, flow rates).
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of a physical medical device submission unless it refers to process validation or manufacturing controls, which are not detailed in this 510(k) summary. This is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As above, there is no "training set" or "ground truth for a training set" as typically understood in AI/software device submissions.
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