(140 days)
The Barry™ Channel RFA Endoscopic Catheter 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 subject device, the Barrx™ Channel RFA Endoscopic Catheter is a sterile single-use bipolar device that delivers radiofrequency (RF) energy to the treatment tissue within the gastrointestinal tract through a copper electrode. The catheter is used exclusively with the HALOFEN Energy Generator (cleared under 510(k) K092487).
The provided text describes a medical device, the Barrx™ Channel RFA Endoscopic Catheter, and its 510(k) summary for FDA clearance. However, it does not include detailed information about acceptance criteria or a specific study proving the device meets those criteria, as typically seen in AI/ML device submissions.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through technological characteristics, principles of operation, and various bench and safety tests.
Therefore, I cannot extract the requested information like sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC study details, or standalone algorithm performance, as these are not present in the provided text.
Based on the available text, here's what can be provided:
Acceptance Criteria and Device Performance
The document describes several types of tests performed for verification and validation, implying that the device was expected to meet certain performance standards in these areas. However, specific numerical acceptance criteria and their corresponding reported device performance values are not explicitly stated. The summary only lists the tests conducted.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bench Testing: | (Specific criteria and performance values not provided in document) |
| 1. Catheter length testing | Assumed to meet design specifications. |
| 2. Shaft revolution testing | Assumed to meet design specifications. |
| 3. Endoscope articulation testing | Assumed to meet design specifications for compatibility. |
| 4. Push force testing | Assumed to meet design specifications. |
| 5. Retraction force testing | Assumed to meet design specifications. |
| 6. Electrode deflection force testing | Assumed to meet design specifications. |
| 7. Torque force and stability testing | Assumed to meet design specifications. |
| 8. Bend radius testing | Assumed to meet design specifications for flexibility. |
| 9. Electrical insulation testing | Assumed to meet safety standards. |
| 10. Apposition testing | Assumed to demonstrate proper tissue contact. |
| 11. Simulated use testing | Assumed to perform as intended in simulated scenarios. |
| 12. Esophageal damage test | Assumed to demonstrate safe operation without unintended damage. |
| 13. Tensile force test | Assumed to meet durability requirements. |
| Biocompatibility Testing | Assumed to meet ISO 10993 standards. |
| Sterilization | Assumed to meet sterility assurance level (SAL). |
| Packaging Validation | Assumed to ensure product integrity during transport and storage. |
| Shelf Life Testing | Assumed to meet specified shelf life. |
| EMC and Electrical Safety Testing | Assumed to comply with relevant safety standards (e.g., IEC 60601 series). |
| User Validation | Assumed to be acceptable for intended user operation. |
Detailed Information (Not available in the provided text)
- Sample size used for the test set and the data provenance: Not specified in the document. The tests performed are primarily bench and engineering tests, not clinical studies with patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The document describes engineering and safety tests, not studies requiring expert ground truth in a diagnostic context.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable. This device is an electrosurgical catheter, not an AI-powered diagnostic or assistive tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device does not have a standalone algorithm component.
- The type of ground truth used: For the bench and safety tests, the "ground truth" would be established engineering specifications, material standards, and regulatory safety limits. For instance, in electrical insulation testing, the ground truth is that there should be no electrical leakage above a certain threshold.
- The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Conclusion from the document:
The provided document concludes that the Barrx™ Channel RFA Endoscopic Catheter is "substantially equivalent to legally marketed predicates" and that "The test results and compliance with applicable standards provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its indications for use." This indicates that the device met the internal and regulatory performance expectations, even if specific numerical criteria are not detailed in this summary.
§ 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).