(90 days)
The EnStylet™ EC0010/20 is intended for use in conjunction with the EnSite® EC1000 catheter during electrophysiologic mapping procedures using the EnSite 3000® System. The EnStylet™ is designed to provide deflection and positioning of the distal end of the catheter.
The EnStylet™ EC0010/20 is a pre-formed J-shaped or straight, ball-tipped, 0.027-inch diameter stainless steel wire designed to be used in conjunction with the EnSite® EC1000 catheter during electrophysiologic mapping procedures using the EnSite 3000® System.
The provided document is a 510(k) summary for the EnStylet™ Model EC0010/20, a catheter stylet. It focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and in vitro testing. Therefore, much of the requested information regarding clinical studies, expert-established ground truth, and AI-related evaluations is not applicable or not provided in this regulatory submission for a medical device of this type.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Non-Clinical Testing | Dimensional specifications | Met or exceeded |
| Non-Clinical Testing | Mechanical specifications | Met or exceeded |
| Non-Clinical Testing | Functional specifications | Met or exceeded |
| Overall Performance | Acceptable for intended use | Found to be acceptable |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "extensive in vitro testing" was performed, but no specific number of units or test runs is provided.
- Data Provenance: Not applicable. The data is from in vitro (bench) testing, not human subjects or real-world use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. The "ground truth" for in vitro testing of a physical device like a stylet is typically based on engineering specifications, material properties, and functional requirements, rather than expert clinical consensus or pathology of medical images/data. The testing would compare the device's physical and functional attributes against predefined engineering standards.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or clinical outcomes where there might be disagreement among evaluators. For in vitro engineering tests, results are generally objective and measured against established specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. This is not an AI-enabled device or an diagnostic imaging product where MRMC studies are typically conducted. The device is a physical tool (catheter stylet) used in conjunction with other medical systems, not a standalone diagnostic or interpretative tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No. This is not an algorithm or AI system. It is a physical medical device.
7. The Type of Ground Truth Used
- Engineering Specifications and Functional Requirements: The ground truth for this device's performance is based on its ability to meet predetermined dimensional, mechanical, and functional specifications established during the device's design and engineering phases. This would involve objective measurements (e.g., tensile strength, flexibility, dimensions) and functional tests (e.g., ability to deflect a catheter).
8. The Sample Size for the Training Set
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
Summary of Device Performance and Equivalence Claim:
The EnStylet™ Model EC0010/20 demonstrated substantial equivalence to predicate devices (Intermedics Stylets and Pacesetter Locator Steerable Stylet) based on:
- Similar technological characteristics (device design, materials, components).
- Similar indications for use.
- "Extensive in vitro testing" which showed the stylet "met or exceeded all dimensional, mechanical, and functional specifications" and its performance was "acceptable for its intended use."
The device is a Class II medical device, and its 510(k) clearance was based on these non-clinical, in vitro testing results demonstrating equivalence.
§ 870.1380 Catheter stylet.
(a)
Identification. A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.(b)
Classification. Class II (performance standards).