(37 days)
The Barry™ RFA Self Sizing Balloon Catheter is indicated for use in the coagulation of bleeding sites in the gastrontestinal tract including, but not limited to, the esophagus. Indications include Esophageal Ucers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.
The Barrx™ RFA Self Sizing Balloon Catheter is a sterile, single-use device that delivers radiofrequency (RF) energy to the treatment tissue within the gastrointestinal tract. The catheter is used exclusively with the Barrx™ Flex RFA Energy Generator. The Barrx™ RFA Self Sizing Balloon Catheter design incorporates the functionality of the Barrx™ 360 RFA Balloon Catheter and the Barrx™ 360 Soft Sizing Balloon into a single device. The Barrx™ 360 Soft Sizing Balloon is used to size the esophageal diameter and assist the physician in determining the size of Barrx™ 360 RFA Balloon Catheter for ablation. The Barrx™ RFA Self Sizing Balloon Catheter design enables the device to fit the esophageal diameter and ablate tissue.
This document, a 510(k) summary for the Barrx™ RFA Self Sizing Balloon Catheter (K142364), focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study. Therefore, much of the requested information regarding detailed acceptance criteria and a specific study proving those criteria are met is not explicitly available within this provided text.
The document states: "Performance testing for the Barrx™ RFA Self Sizing Balloon Catheter consisted of in-vitro functional testing, biocompatibility testing, sterilization assessment, packaging validation, shelf life testing, electrical safety testing, and user validation." However, it does not provide the specific "acceptance criteria" for these tests, nor the detailed "reported device performance" against them in a measurable format.
Therefore, the following information is extracted and presented as much as possible, with notations where details are not provided in the submitted text.
1. Table of Acceptance Criteria and Reported Device Performance
As specific quantitative acceptance criteria and their corresponding reported performance for clinical efficacy are not detailed in this 510(k) summary, a table in the requested format cannot be fully generated. The document focuses on demonstrating substantial equivalence to predicate devices.
However, the "Performance Data" section broadly states: "Results of performance testing demonstrate performance equivalence for the Barrx™ RFA Self Sizing Balloon Catheter when evaluated against the predicate devices."
The types of performance testing mentioned are:
- In-vitro functional testing
- Biocompatibility testing
- Sterilization assessment
- Packaging validation
- Shelf life testing
- Electrical safety testing
- User validation
Without the specific criteria and results for each of these categories, a detailed table cannot be created. The qualitative outcome is "performance equivalence" to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical "test set" in the context of a study evaluating diagnostic performance (like a medical imaging AI). Instead, the performance testing mentioned (in-vitro functional, biocompatibility, etc.) would typically involve laboratory samples or measurements.
- Sample Size for Test Set: Not specified for any of the performance tests mentioned (in-vitro functional, biocompatibility, sterilization, etc.).
- Data Provenance: Not specified. Given the nature of the tests (in-vitro, benchtop, etc.), the "data provenance" would likely be laboratory or manufacturing test data, not patient data from a specific country. This is a pre-market submission for a device, not an AI diagnostic algorithm.
- Retrospective or Prospective: Not applicable in the context of the described performance testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. The device is a medical instrument (catheter), not a diagnostic AI system requiring expert-established ground truth on a test set (e.g., image annotation). The "ground truth" for its performance would be established through engineering specifications, material science, and safety standards.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document, as it pertains to expert disagreement resolution in diagnostic assessment, which is not the focus of this device's performance evaluation.
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
This information is not applicable and not provided in the document. The device is a radiofrequency ablation catheter, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided in the document. The device is a physical medical instrument requiring human operation, not a standalone algorithm.
7. The Type of Ground Truth Used
For the "performance testing" mentioned (in-vitro functional, biocompatibility, sterilization, etc.), the "ground truth" would be against established engineering standards, material specifications, and regulatory requirements (e.g., ISO standards for biocompatibility, sterility assurance levels). It is not expert consensus, pathology, or outcomes data in the sense of a clinical diagnostic study.
8. The Sample Size for the Training Set
This information is not applicable and not provided in the document. The device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided in the document, as there is no "training set" for this type of medical device submission.
Summary of the Study (as described in the document):
The document describes a submission for pre-market notification (510(k)) to demonstrate substantial equivalence of the Barrx™ RFA Self Sizing Balloon Catheter to legally marketed predicate devices. The "study" refers to a series of performance tests, rather than a single clinical trial or AI performance study.
- Objective: To demonstrate that the Barrx™ RFA Self Sizing Balloon Catheter is substantially equivalent to predicate devices (Barrx™ 360 RFA Balloon Catheter and Barrx™ 360 Soft Sizing Balloon).
- Methodology: Performance testing included in-vitro functional testing, biocompatibility testing, sterilization assessment, packaging validation, shelf life testing, electrical safety testing, and user validation.
- Results: The document states that "Results of performance testing demonstrate performance equivalence for the Barrx™ RFA Self Sizing Balloon Catheter when evaluated against the predicate devices." This equivalency is based on similar technological characteristics (sterile, single-use, circumferential catheter, EEPROMs, construction, materials, energy type, packaging, principles of operation, ablation depths, use with Barrx™ Flex RFA Energy Generator).
- Conclusion: Covidien LLC considers the device substantially equivalent, and the testing provides "reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its indications for use."
Note: This 510(k) summary serves to demonstrate substantial equivalence for regulatory clearance, not to publish detailed efficacy or performance data in a scientific publication format. Detailed specifics on acceptance criteria, sample sizes for individual tests, and quantitative results are typically retained by the manufacturer and FDA but are not always disclosed in the public 510(k) summary.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.