(175 days)
The Barrx™ Anorectal RFA Wand is indicated for use in the coagulation of bleeding and non-bleeding sites in the anal and rectum, including but not limited to, arteriovenous malformations, angiodysplasia, and radiation proctitis (RP).
The Barrx™ Anorectal RFA Wand is a sterile, single-use, bipolar device used to deliver radiofrequency (RF) energy to treatment tissue in the anal and rectum. The design of the Barrx™ Anorectal RFA Wand is a modification to the legally marketed Barrx ™ 60 RFA Focal Catheter predicate device. The Barrx™ Anorectal RFA Wand design has a rigid distal shaft with handle which allows for targeted use in the anal canal and rectum. The device is used exclusively with the Barrx™ Flex RFA Energy Generator (K092487).
This document is an FDA 510(k) summary for the Barrx™ Anorectal RFA Wand. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against defined acceptance criteria. Therefore, much of the requested information regarding specific acceptance criteria, study details, and clinical performance metrics is not present in this regulatory submission.
The document does not contain the following information typically found in a study proving device performance against acceptance criteria:
- A table of acceptance criteria and reported device performance (in terms of clinical efficacy or safety, beyond substantial equivalence to a predicate).
- Sample sizes used for a "test set" in a clinical trial or performance study.
- Data provenance (country of origin, retrospective/prospective) for a clinical performance study.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance (as this is a medical device, not an AI algorithm).
- Details on the type of ground truth used beyond technical equivalence.
- Sample size for a "training set" (as this is not an AI/machine learning device).
- How ground truth for a "training set" was established.
However, based on the provided text, here's what can be extracted and inferred regarding performance data and the demonstration of equivalence:
Acceptance Criteria and Device Performance (Demonstration of Equivalence)
The summary emphasizes demonstrating substantial equivalence to an existing predicate device, the Barrx™ 60 RFA Focal Catheter (K112454), rather than meeting specific quantifiable performance acceptance criteria in an independent clinical study for a novel device. The "performance data" described focuses on technical and safety aspects, confirming the new device functions similarly to the predicate.
Table 1: Technical Performance & Equivalence Demonstrated
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Barrx™ Anorectal RFA Wand) |
|---|---|
| Sterile | Sterile |
| Single-Use | Single-use |
| Bipolar device | Bipolar device |
| EEPROM connection to Barrx™ Flex RFA Energy Generator | EEPROM connection to Barrx™ Flex RFA Energy Generator |
| Similar construction | Similar construction |
| Similar energy type (RF energy) | Uses RF energy |
| Similar principles of operation | Same principle of operation |
| Similar ablation depths | Achieves similar ablation depths |
| Compatibility with Barrx™ Flex RFA Energy Generator | Used exclusively with Barrx™ Flex RFA Energy Generator |
| Functional per intended use | In-vitro functional testing demonstrated performance |
| Biocompatible | Biocompatibility testing demonstrated performance |
| Validated Sterilization | Sterilization assessment completed |
| Validated Packaging | Packaging validation completed |
| Validated Shelf Life | Shelf life testing completed |
| Electrical Safety | Electrical safety testing completed |
| User Validation | User validation completed |
Study Details:
The acceptance criteria listed above are implicitly met through a series of non-clinical performance tests designed to show the Barrx™ Anorectal RFA Wand functions safely and effectively, and is technologically equivalent to the predicate device.
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Sample size used for the test set and the data provenance: Not applicable in the context of a clinical performance study for this submission. The "test set" refers to the various samples and units of the device used for the in-vitro and engineering tests listed above (functional, biocompatibility, sterilization, packaging, shelf life, electrical safety, user validation). Specific sample numbers for each individual test are not provided in this summary. The data provenance is from Covidien LLC, the manufacturer, through their internal testing. This is a retrospective demonstration of equivalence based on existing predicate device characteristics and new device testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is based on engineering specifications, regulatory standards, and the established performance of the predicate device.
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Adjudication method for the test set: Not applicable. Performance was determined by meeting pre-defined engineering and safety specifications, and by demonstrating equivalence to the predicate device in in-vitro and mechanical testing.
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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 is not an AI/imaging device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device delivering RF energy.
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The type of ground truth used:
- Engineering specifications and regulatory standards: For tests like electrical safety, sterilization, biocompatibility.
- Performance of the predicate device: The Barrx™ 60 RFA Focal Catheter (K112454) served as the benchmark for technological characteristics, energy type, principles of operation, and ablation depths.
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The sample size for the training set: Not applicable. This is not an AI/machine learning device; there is no "training set" in the machine learning sense.
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How the ground truth for the training set was established: Not applicable, as there is no training set for an AI model.
In summary, this 510(k) submission focuses on demonstrating substantial equivalence to a previously cleared device through technical and safety performance testing, rather than presenting a clinical study with detailed efficacy acceptance criteria and outcomes.
§ 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.