(182 days)
The Aqua Medical RF Vapor System is indicated for use in the coagulation 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 System uses a catheter to deliver heat to the tissue surface undergoing treatment. The heat, which is created by the application of RF energy to a bipolar electrode pair located inside the catheter tip, is delivered to the tissue through heated water vapor generated inside the catheter. 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 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 Catheter: a disposable, sterile, single-use catheter with a diameter of 7 F (2.3 mm) and a length of 145 cm. It includes an integrated cable for attachment to the generator and a Luer-connector that facilitates connection to the saline delivery tubing.
- Saline Delivery Tubing and Syringe: Tubing and syringe (60cc) that 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, including the esophagus. This covers conditions such as Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE), and Radiation Proctitis (RP) in adults. The device was deemed substantially equivalent to its predicate, the Halo 90 System by Barrx Medical, Inc.
Here's an analysis of the acceptance criteria and study findings based on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or precise reported device performance metrics in a readily tables format as might be expected for a diagnostic AI device. Instead, the "acceptance criteria" appear to be demonstrating substantial equivalence to the predicate device, the HALO® System, through comparative testing. The performance is assessed in terms of its ability to achieve similar tissue coagulation effects.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility | All tests successfully conducted: Cytotoxicity, Hemolysis, Systemic Toxicity, Intracutaneous, Sensitization, Pyrogenicity. |
| Electrical Safety and EMC | Complied with IEC 60601-1:2005/EN 60601-1:2006 and IEC 60601-1-2:2007 standards. |
| Software V&V | Verification and validation testing conducted, documentation provided, considered "major" level of concern. |
| Bench Testing | HW Verification Testing, System Validation Testing, Distal Assembly Pull Test, Lesion Comparative testing successfully completed. |
| Animal Study (Tissue Coagulation Ability) | Demonstrated ability to create thermal coagulative tissue injury that penetrates in depth to the external muscularis of the esophagus in healthy swine. No pathological complications, esophageal perforation, significant hemorrhage, or clinical complications. Results showed substantial equivalence to HALO® system. |
| Substantial Equivalence to Predicate | The Aqua Medical RF Vapor System has the same indications for use and is substantially equivalent in technological and performance characteristics to the HALO® predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The "test set" in this context refers to the animal study conducted to demonstrate the therapeutic effect.
- Sample Size: A total of 6 animals (swine) were utilized in the animal study.
- 3 animals were treated and evaluated acutely (Day = 0).
- 3 animals were treated and evaluated subacutely (48 hours).
- Data Provenance: The study was conducted on healthy swine, suggesting a controlled, prospective animal study environment. The country of origin is not specified, but it's an industry-conducted study for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states, "The histopathological evaluation assessed acute thermal coagulation through the cross-sectional layers of the esophagus."
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: The text mentions "histopathological evaluation," which implies assessment by qualified pathologists. However, specific qualifications (e.g., years of experience, board certification) are not provided.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method for the histopathological evaluation. It states that the evaluation was conducted, but details on how agreement was reached among multiple potential evaluators (if more than one was involved) are absent. It's common for a single expert or a small group to provide the assessment in such studies without a formal adjudication process beyond standard peer review.
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, an MRMC comparative effectiveness study was not done.
- The device is a direct therapeutic device (RF vapor system for tissue coagulation), not a diagnostic AI device intended to assist human readers in image interpretation. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable to this type of medical device submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable in the context of the Aqua Medical RF Vapor System. This is a therapeutic device that physically treats tissue, not an AI algorithm. Its operation involves user interaction (choice of power settings, advancing the catheter), making "standalone algorithm performance" an irrelevant concept here.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for evaluating the device's performance in the animal study was based on histopathological evaluation. This involved assessing "acute thermal coagulation through the cross-sectional layers of the esophagus."
8. The Sample Size for the Training Set
- Not applicable. This device is a hardware and software system for therapy delivery, not an AI/machine learning model that undergoes a "training phase" on a dataset in the conventional sense. The software primarily controls the RF generator and syringe pump based on user input and predefined parameters.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" in the context of an AI/ML model for this device. The software verification and validation would have been performed against functional requirements and design specifications rather than against a ground truth dataset from a training set.
§ 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).