(220 days)
The Aqua Medical RF Vapor System is indicated for use in the coagulation and ablation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus.
Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP). The device is to be used in adults only.
The Aqua RF Vapor Ablation System uses a catheter to deliver heated water vapor to the tissue surface undergoing treatment. The Aqua RF Vapor Ablation System is a catheter-based system for heating and coagulating tissue. The heat is delivered to the target tissue in the form of water vapor that is generated within the catheter tip using radiofrequency (RF) energy. Application of heat to the tissue results in coagulation and ablation of the tissues being treated. This technique avoids the need for direct RF energy application to heat the tissue. The Aqua Medical RF VaporAblation System consists of the following components:
- Aqua RF Vapor Generator: A software-controlled RF generator is operated through a graphical user interface (GUI) and incorporates a syringe pump that delivers saline to the catheter. Delivery of bipolar RF energy to the catheter is controlled either by an accessory foot pedal or a button incorporated in the disposable catheter.
- Aqua RF Vapor Catheters: disposable, sterile, single-use catheters with a diameter of 7F -(2.3 mm) with an outer catheter sheath that is 10.5F and a length between 145 cm and 210 cm. There are 3 types of RF Vapor catheters available. Catheters are designed to be used through an endoscope working channel diameter of 3.7mm.
- Saline Delivery Tubing and Syringe: Tubing and syringe (60cc) provide a means of delivering saline to the catheter during treatment.
The provided text is a 510(k) summary for the Aqua Medical RF Vapor Ablation System. It details the device's indications for use, its description, and the testing performed to demonstrate substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria and study results typically found in reports for AI/software devices, particularly those relating to clinical performance metrics based on a test set, human expert involvement, or comparative effectiveness studies.
The "Performance Data" section (Page 6-7) describes non-clinical testing for the device's hardware and a "Lean Beef Testing" experiment. This suggests that the device's performance relies primarily on its physical and functional attributes, rather than an AI component requiring a complex clinical validation study with extensively adjudicated ground truth, as would be typical for an AI-powered diagnostic or predictive device.
Therefore, many of the requested details about acceptance criteria and study proving performance (specifically for an AI/software component, human-in-the-loop, etc.) are not present in this document.
Based on the available information, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document does not provide a table of acceptance criteria or specific quantitative performance metrics in the way one would expect for an AI device (e.g., sensitivity, specificity, AUC). Instead, it mentions:
- Hardware Verification Testing:
- Acceptance Criteria (Implied): Catheter joint forces and sliding forces "passed the specification requirements." Fatigue cycle testing was completed to "validate the physical integrity and durability of the subject device."
- Reported Performance: "The catheter joint forces and sliding forces passed the specification requirements for the testing. The fatigue cycle testing was completed to validate the physical integrity and durability of the subject device under simulated-use conditions including extreme tortuosity, mechanical cycling, high-vapor output and temperature exposure." (No specific numbers provided).
- Lean Beef Testing:
- Acceptance Criteria (Implied): "Equivalent results between the previous time-based treatment when compared to the modified energy level-based treatment." And "Equally desired ablation depths (penetration of heat) will be produced by both systems." (Based on the conclusion below).
- Reported Performance: "The Lean Beef testing demonstrated equivalent results between the previous time-based treatment when compared to the modified energy level-based treatment. The test also demonstrated that the ablation depths for the modified Circumferential Delivery Catheters are substantially equivalent to those produced by the Predicate Circumferential Delivery Catheters through the dose ranges evaluated in the test. Equivalent ablation depths (penetration of heat) were produced by both systems supporting our substantial equivalency claim." (No specific quantitative values like mm or power settings are provided).
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any of the tests.
- Data Provenance: The "Lean Beef Testing" implies a laboratory, non-clinical setting (animal tissue model - "Lean Beef"). It is not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. The testing described (hardware, lean beef) does not involve human expert interpretation of clinical data to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. Adjudication methods are typically used for clinical image or data interpretation studies, which are not described here.
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:
- No, not performed. This device is an ablation system, not a diagnostic AI tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device generates vapor for ablation; its performance is not measured as an "algorithm only" in the context of diagnostic or predictive AI. The software controls the generator, but its performance is tied to the physical delivery system.
7. The type of ground truth used:
- For hardware testing: Mechanical and physical specifications.
- For Lean Beef Testing: Ablation depth and characteristics measured directly in the beef tissue. This is a physical/material measurement rather than a clinical ground truth like pathology or expert consensus.
8. The sample size for the training set:
- Not applicable. This document describes a physical medical device, not an AI model that undergoes a "training" phase with a dataset. The software mentioned is for control of the generator, not for learning from vast datasets.
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no "training set" in the context of an AI model for this device.
In summary, the provided FDA 510(k) summary focuses on the substantial equivalence of modifications to an existing physical medical device (RF vapor ablation system) through engineering and bench testing, rather than a clinical study evaluating an AI component's performance. The "performance data" section primarily refers to non-clinical tests demonstrating the device's physical and functional equivalency.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).