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The HALO® System (including HALO® Ablation Catheter model 90-9100 and HALO® Energy Generator model 90-9000) 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 HALO® Ablation Catheter model 90-9100 operates in conjunction with HALO® Energy Generator model 90-9000. There are no changes to the HALO® Ablation Catheter or HALO® Energy Generator implemented since the devices were cleared by K083737, K062723 and K062441. The product is also identical in principle of operation and energy density to the treatment site with the predicate devices HALO360 Ablation Catheter, Stellartech Coagulation Catheter. HALO® is substantially equivalent in construction with the predicate devices HALO360 Ablation Catheter, Stellartech Coagulation Catheter and Microvasive Gold Probe. The product is similar in performance with Olympus Heat Probe.

The provided 510(k) summary for BARRX's HALO System (K093008) indicates that no new performance testing was conducted for this submission.

The submission focuses on expanding the indications for use for the HALO® Ablation Catheter to include Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP) based on the substantial equivalence to previously cleared devices and existing clinical data.

Therefore, the following information cannot be extracted from the provided text as the study described is a review of existing clinical data, not a new performance study with acceptance criteria.

1. A table of acceptance criteria and the reported device performance: Not applicable, as no new performance testing was conducted.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for new performance testing. The clinical data supporting the expanded indications was "derived from publications and case studies." The provenance details are not specified.
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 applicable, as no new test set was created with expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI/device assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the expanded indications, the clinical data relied upon was from "publications and case studies" which demonstrated the safety and effectiveness of the device when used for GAVE and RP. This implies that outcomes data from these existing sources served as the basis for substantiating safety and effectiveness for these new indications.
8. The sample size for the training set: Not applicable, as no new training set was explicitly mentioned for algorithmic development in this submission.
9. How the ground truth for the training set was established: Not applicable.

Summary of the study that proves the device meets the acceptance criteria (expanded indications):

The submission argues for the substantial equivalence of the HALO® Ablation Catheter for the treatment of GAVE and RP by referencing:

• Technological Identity and Substantial Equivalence: The HALO® Ablation Catheter model 90-9100 is "technologically identical" to its cleared predicate (K083737, K062723). It also highlights substantial equivalence in principle of operation, energy density, construction, and performance with other predicate devices (HALO360 Ablation Catheter, Stellartech Coagulation Catheter, Microvasive Gold Probe, Olympus Heat Probe).
• Clinical Data Review: Clinical data was provided to FDA "to support the changes in the Instructions for Use associated with the use in the coagulation of bleeding sites for the HALO® Ablation Catheter for the treatment of GAVE and Radiation Proctitis." This data "demonstrated that, when used in accordance with those instructions, the HALO® Ablation Catheter used for the treatment of GAVE and Radiation Proctitis respectively is at least as safe and effective as the cleared HALO® Ablation Catheter for the treatment of bleeding sites in the gastrointestinal tract."
• Basis of Clinical Data: The clinical data supporting the additional indications (GAVE and RP) was "derived from publications and case studies" and facilitated "Physician's Instructions recommending specific treatment settings and selection criteria for the patients (Contraindications, Warnings and Cautions)."
• Similarity of Conditions: GAVE and RP are described as being similar to other already indicated bleeding conditions (esophageal ulcers, Mallory-Weiss tears, etc.) in that they are confined to the mucosal layer, associated with hemorrhage, and treated with coagulative therapy.

In essence, the "study" proving the device meets the acceptance criteria for expanded indications was a retrospective review of existing clinical data from publications and case studies, and an argument for substantial equivalence to previously cleared predicate devices for similar applications. No new pre-market performance study with defined acceptance criteria was conducted.

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The HALO366 Coagulation Catheter is intended for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract.

The HALO360 Coagulation 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, and Angiodysplasia.

The HALO360 Coagulation System consists of the HALO300 Energy Generator with a disposable single-use ablation catheter HALO360+ Coagulation Catheter and HALO360 Coagulation Catheter, a HALO300 Sizing Balloon, an output cable, and an optional footswitch. The HALO360 Coagulation Catheter comprises models 31041-XX and 32041-XX equivalent in performance and mode of operation. There are no changes to the design, principle of operations for any of the products included in the HALO360 System.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that Barrx Medical's HALO360 Coagulation Catheter and HALO360+ Coagulation Catheter meet such criteria.

The document is a 510(k) summary for a premarket notification to the FDA. It does contain:

• Device Name: HALO360 Coagulation Catheter and HALO360+ Coagulation Catheter.
• Intended Use/Indications for Use: Coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, including specific conditions like Esophageal Ulcers, Mallory-Weiss tears, etc.
• Technological Characteristics: Describes the system components (Energy Generator, disposable catheters, sizing balloon, cable, footswitch) and states no changes to design or principle of operations.
• Substantial Equivalence: The submission is primarily about Instructions for Use (IFU) changes (adding a contraindication for "Eosinophilic esophagitis" and clarifying instructions) for devices that did not undergo product or process changes. It asserts that these changes do not affect device use or performance and do not raise questions about safety and efficacy, thus concluding substantial equivalence to existing predicate devices (K071543 HALO360+ Coagulation Catheter and K062225 HALO360 Coagulation Catheter).
• FDA Clearance: The letter from the FDA confirms market clearance based on substantial equivalence.

The document explicitly states that the devices did not undergo any product or process changes and that the submission addresses only changes to the instructions for use. Therefore, there is no discussion of new acceptance criteria, performance studies, or data related to the device's technical specifications or clinical effectiveness to demonstrate meeting those criteria in this document.

For the information you requested regarding acceptance criteria and performance studies, you would typically need to refer to a different type of document, such as a PMA (Premarket Approval) submission, clinical trial results, or a more detailed technical report which are not present in this 510(k) summary.

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