(31 days)
The esolution® Esophageal Retractor is indicated for use in patients undergoing percutaneous cardiac catheter ablation of atrial fibrillation to deviate the esophagus away from the ablation energy source and to reduce the risk of ablation-related esophageal injury.
The esolution® Esophageal Retractor is a sterile mechanical deviation device for esophageal protection during cardiac ablation procedures. This device is placed in the lumen of the esophagus to reduce the likelihood of esophageal injury or a specific adverse event during cardiac ablation procedures. The device uses mechanical means to deviate the esophagus away from the source of ablation energy. The esolution® Esophageal Retractor contains two main components: an Outer Sheath, which is placed in the esophagus prior to the initiation of the therapeutic ablation procedure and a Mechanical Deflection Device that is inserted into the Outer Sheath once the Outer Sheath has been positioned in the esophagus for the indicated atrial fibrillation ablation therapeutic care. The purpose of this 510(k) is to capture the modifications made to the esolution® Esophageal Retractor required for manufacturability including changes to materials and design.
This document is a 510(k) premarket notification summary for a medical device called the "esolution® Esophageal Retractor (Gen 2.1)". The purpose of the 510(k) submission is to demonstrate that the modified device (Gen 2.1) is substantially equivalent to a previously cleared predicate device (esolution®, DEN230006).
Acceptance Criteria and Device Performance for (esolution® Esophageal Retractor (Gen 2.1))
The document focuses on non-clinical performance data to establish substantial equivalence, primarily comparing the modified device to its predicate. The acceptance criteria are essentially the performance characteristics demonstrated by the predicate device and reproduced by the subject device.
Here's the breakdown of the acceptance criteria and reported device performance based on the provided text:
| Acceptance Criteria (Performance Requirement) | Reported Device Performance (esolution® Gen 2.1) | Comparison to Predicate (esolution®) |
|---|---|---|
| Intended Use | Indicated for use in patients undergoing percutaneous cardiac catheter ablation of atrial fibrillation to deviate the esophagus away from the ablation energy source and to reduce the risk of ablation-related esophageal injury. | Same |
| Principle of Operation | Mechanical esophageal retraction with suction. | Same |
| Major Components | Outer sheath and mechanical deflection device. | Same |
| Materials | ABS, Silicone, Stainless Steel 316, Polyvinyl chloride (PVC), Polypropylene, Nylon 12, Polycarbonate, Thermoplastic Elastomer. | Similar - new materials do not raise different questions of safety and effectiveness. |
| Single Use | Yes | Same |
| Sterilization Method | Electron Beam Radiation | Same |
| Sterilization Assurance Level (SAL) | 10^-6 | Same |
| Biocompatibility | Meets requirements of ISO 10993-1 and "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" guidance document including: Cytotoxicity, Irritation, Sensitization. | Same |
| Packaging | PETG Tray/Blister with a sealed Tyvek lid. | Similar - different packaging configuration does not raise questions of safety and effectiveness. |
| Device Insertion/Withdrawal from Cannula | Successful insertion/withdrawal from cannula. | Same |
| Tensile Strength | Minimum strength of 15N. | Same |
| Deflection | Deflect and exert 0.7 lbf. | Same |
| Vacuum Leak/Decay Test | Maintain at least 200 mm Hg Vacuum when 300mmHg is applied. | Same |
Analysis of the Study Proving Device Acceptance:
Based on the provided document, the study conducted to prove the device meets acceptance criteria is a non-clinical performance testing intended to demonstrate substantial equivalence to a predicate device.
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Sample Size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample size for each non-clinical test (e.g., number of units tested for tensile strength or deflection). It broadly states, "The esolution® (Gen 2.1) was tested for biocompatibility, tensile strength, deflection, and vacuum leak."
- Data Provenance: The data is generated from "non-clinical performance testing," which implies laboratory or bench testing. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting the testing was either conducted in the U.S. or at a facility whose data is accepted by the FDA for U.S. market approval. It is inherently prospective for the Gen 2.1 device, as the testing was performed to support this specific regulatory submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of non-clinical testing (biocompatibility, mechanical performance) does not typically involve human experts in the way clinical studies for AI algorithms do for ground truth establishment. The "ground truth" here is objective physical measurements and adherence to established engineering and biocompatibility standards (e.g., ISO 10993-1, specified mechanical strengths). Therefore, there is no mention of experts establishing ground truth in the context of diagnostic performance.
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Adjudication method for the test set:
- Not applicable as this is non-clinical mechanical and material testing, not a diagnostic or clinical study requiring adjudication of expert interpretations.
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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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) might be assisted by AI. The esolution® Esophageal Retractor is a mechanical device, not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical medical device, not a software algorithm. The "performance" here refers to its physical and material properties, not an algorithm's output.
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The type of ground truth used:
- The "ground truth" for the non-clinical tests are engineering specifications, material science standards (e.g., ISO), and predefined performance thresholds (e.g., minimum tensile strength of 15N, deflection of 0.7 lbf). These are objective, measurable outcomes rather than expert consensus, pathology, or clinical outcomes data.
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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. It is a manufactured mechanical device.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned or implied for this type of device.
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