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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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The HALO® ULTRA Ablation Catheter (used with the HALOEEK Energy Generator, model 1190A-115A) 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, HALO® ULTRA Ablation Catheter (hereafter referred to as "modified ULTRA") is a sterile single-use bipolar device that delivers radiofrequency (RF) energy to the treatment tissue within the gastrointestinal tract through a copper electrode. It is used exclusively with HALOFES Energy Generator model 1190A-115A (cleared under K092487).

The provided text describes a 510(k) premarket notification for a medical device, the HALO90 ULTRA Ablation Catheter. It focuses on demonstrating substantial equivalence to predicate devices through technical characteristic comparisons and bench testing.

Therefore, the following information regarding acceptance criteria and a study proving the device meets these criteria cannot be extracted from the document, as it is a 510(k) submission, not a study report demonstrating clinical performance against specific acceptance criteria.

The 510(k) process is about demonstrating substantial equivalence to a legally marketed predicate device, not necessarily proving a device meets new performance acceptance criteria through clinical studies in the same way a PMA (Premarket Approval) would.

Here's why the requested information is absent:

• Acceptance Criteria & Reported Performance: The document doesn't define specific "acceptance criteria" for clinical performance (e.g., sensitivity, specificity, accuracy) that an AI device would typically have. It's comparing the technological characteristics and bench test results of the modified device to the predicate.
• Sample Size, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set: These are all concepts relevant to studies evaluating the clinical performance of a diagnostic or AI-driven device, particularly when assessing its ability to detect or diagnose conditions. This document is for an ablation catheter, which treats conditions, and its filing is based on demonstrating safety and efficacy through equivalence to existing devices, supported by bench testing of physical characteristics.

Specifically addressed, based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The submission is for substantial equivalence based on technological characteristics and bench testing (migration, deflection, catheter distal integrity, detachment). No clinical performance acceptance criteria are mentioned.
2. Sample sized used for the test set and the data provenance: Not applicable. The "test set" refers to bench testing, not a clinical data set. The document lists the specific bench tests performed without providing sample sizes as would be relevant for clinical data, nor does it discuss data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of clinical studies, refers to definitive diagnoses, often established by expert consensus or pathology. This document describes bench testing where "ground truth" would be engineering specifications or physical measurements, not expert clinical interpretation.
4. Adjudication method for the test set: Not applicable. Adjudication is used to resolve discrepancies in expert interpretation of clinical data. This is a bench test submission.
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 is for an ablation catheter, not an AI diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is for a physical medical device (catheter), not an algorithm.
7. The type of ground truth used: For the bench testing, the "ground truth" would be the expected physical properties and performance metrics of the catheter as measured against engineering standards. This is not explicitly detailed but is implied by the nature of bench tests like "Migration," "Deflection," "Catheter Distal Integrity," and "Detachment."
8. The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established: Not applicable. See point 8.

Summary of Device and Evidence Presented in the 510(k):

The HALO90 ULTRA Ablation Catheter is a modification of an existing device (original ULTRA). The submission aims to prove substantial equivalence to its predicate devices, not to establish new performance criteria through a de novo clinical study.

Evidence presented for substantial equivalence:

• Technological Characteristics: The modified ULTRA has the "same construction, principles of operation, materials and energy density" as the original ULTRA. The differences are described as "a slight change in the manufacturing process of the endoscope mounting strap, as well as dimensional modification on the pivot mechanism components."
• Bench Testing: The minor differences were evaluated via the following bench tests to ensure no new questions of safety and effectiveness were raised:
  1. Migration
  2. Deflection
  3. Catheter Distal Integrity
  4. Detachment

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