(30 days)
The Aqua Medical RF Vapor System is indicated for use in the coagulation of bleeding sites in the gastrointestinal tract including but not limited to the esophagus. 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 System uses a catheter to deliver heated water vapor to the tissue surface undergoing treatment. The Aqua RF Vapor 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 of the tissues being treated. This technique avoids the need for direct RF energy application to heat the tissue. The Aqua Medical RF Vapor System consists of the following components: Aqua RF Vapor Generator: A software-controlled RF generator is operated i through a graphical user interface (GUI) and incorporates a svringe 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 7 F (2.3 mm) and a lengths between145 cm and 210 cm. There are 4 types of RF Vapor catheters available. Saline Delivery Tubing and Syringe: Tubing and syringe (60cc) provide a means of delivering saline to the catheter during treatment.
The Aqua Medical RF Vapor System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract in adults. 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).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria in a quantitative manner (e.g., minimum percentage of coagulation, specific temperature achieved). However, it does describe the types of tests performed to demonstrate substantial equivalence to the predicate device. The performance data is presented as verification that the new catheter design performs as intended and is as safe and effective as the predicate.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Intended Use Equivalence | The Aqua Medical RF Vapor System has identical indications for use as the previously cleared Aqua RF Vapor System (predicate device). |
| Technological Equivalence | The new Aqua Medical Circumferential RF Vapor Ablation Catheter design was tested to ensure it performs as intended via hardware verification testing. Comparative simulated use bench model testing was conducted to support substantial equivalency and demonstrate that the new design functions in an equivalent manner as the previously cleared Aqua Medical Focal RF Vapor Catheters. |
| Safety and Effectiveness | Comparative validation testing and verification testing demonstrated that the additional catheter design is substantially equivalent to the previously cleared Aqua RF Focal Vapor Catheter. The device is considered as safe and effective as its predicate without raising any new safety and/or effectiveness concerns. This was supported by: Hardware Verification TestingSimulated tissue model testingBiocompatibility Testing (cytotoxicity, sensitization, and irritation)Packaging and shelf-life testingSterilization Validation |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for the simulated use bench model testing or other performance tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective, beyond stating "simulated tissue model" which implies a prospective, controlled lab setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide information regarding the number of experts, their qualifications, or their involvement in establishing ground truth for the test set.
4. Adjudication Method
The document does not describe any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or indicated in the provided text. The evaluation focuses on the device's technical performance and equivalence to a predicate, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance
The Aqua Medical RF Vapor System is a physical medical device (catheter-based system using RF energy for tissue coagulation), not an algorithm or AI-driven system. Therefore, a standalone (algorithm only) performance study is not applicable and was not mentioned.
7. Type of Ground Truth Used
Based on the description of "simulated tissue model" and various verification and validation tests, the ground truth for the performance evaluations likely involved established scientific and engineering standards for tissue coagulation, material properties, biocompatibility, and sterilization effectiveness. The "ground truth" would be objective measurements and observations against these standards, rather than expert consensus on medical images or patient outcomes.
8. Sample Size for the Training Set
Since this is a physical medical device and not an AI or machine learning algorithm, the concept of a "training set" in the context of data for model development is not applicable.
9. How the Ground Truth for the Training Set Was Established
As noted above, a training set is not applicable for this type of device.
§ 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).