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The Barrx™ Anorectal RFA Wand is indicated for use in the coagulation of bleeding sites in the anal canal and rectum including, but not limited to, arteriovenous malformations, angiodysplasia, radiation proctitis (RP), and anal intraepithelial neoplasia (AIN).

The Barrx™ Anorectal RFA Wand is a sterile, single-use, bipolar device used to deliver radiofrequency (RF) energy to treatment tissue in the anal canal and rectum. The Barrx™ Anorectal RFA Wand consists of a cap with electrode, EEPROM, a proximal shaft and a rigid distal shaft with handle. The device is used exclusively in connection with the Barrx™ Flex RFA Energy Generator (K092487). Once the device is connected, the EEPROM is read by the generator, recognizes the device, and determines the operation parameters.

This document is a 510(k) summary for the Barrx™ Anorectal RFA Wand, seeking to include Anal Intraepithelial Neoplasia (AIN) as a specific indication for use, with clinical information from three AIN-related studies. However, the document explicitly states that no performance testing was conducted for the device itself because it is technologically identical to a previously cleared predicate device (K150251) and a reference predicate device (K112454).

Therefore, I cannot provide information on acceptance criteria and a study proving the device meets those criteria, as such a study was not performed as part of this 510(k) submission for the device itself.

Instead, the submission relies on clinical studies demonstrating the use of the Barrx™ Anorectal RFA Wand for AIN, implying these studies serve as the basis for the extended indication. However, the document does not detail the methodology, acceptance criteria, or specific results of these AIN-related clinical studies. It only mentions their existence and that they support the substantial equivalence claim for the new indication.

Based on the provided text, I can answer some of your questions regarding the AIN-related clinical studies, but not for the device's technical performance validation:

Regarding the AIN-related clinical studies mentioned in the 510(k) submission:

1. A table of acceptance criteria and the reported device performance:

   • Not provided. The document states that clinical studies were referenced to demonstrate the device's use for AIN, but it does not detail any specific acceptance criteria or performance metrics for these studies.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not provided. The document mentions "three AIN related clinical studies" but does not specify their sample sizes, data provenance, or whether they were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not provided. The document does not describe how ground truth was established for the AIN-related clinical studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not provided.

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:

   • Not applicable. This device is an electrosurgical RFA wand, not an AI-based diagnostic or assistive device for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • Not provided. For the AIN-related clinical studies, the specific type of ground truth used (e.g., histological confirmation of AIN resolution, clinical improvement) is not detailed.

8. The sample size for the training set:

   • Not applicable / Not provided. The device is not an AI algorithm; therefore, it does not have a "training set" in the context of machine learning. If "training set" refers to data used to inform the design or understanding of the device's use for AIN, this information is not provided.

9. How the ground truth for the training set was established:

   • Not applicable / Not provided. As above, the concept of a training set ground truth, as typically defined for AI, does not apply here.

Summary regarding the device's technical performance:

• No new performance testing was conducted for the Barrx™ Anorectal RFA Wand for this submission.
• The manufacturer stated that the subject device is "technologically identical" to its predicate devices (K150251 and K112454).
• The basis for the new indication (AIN) relies on "clinical studies referenced within this submission" that "demonstrate the Barrx™ Anorectal RFA Wand may be used for anal intraepithelial neoplasia." However, the details of these clinical studies (methodology, results, acceptance criteria, sample sizes, etc.) are not included in this 510(k) summary.

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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

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.

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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