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The HALO® Coagulation System intended use is for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract.

The HALO® Coagulation System 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 HALO® Coagulation System consists of the HALO90 Energy Generator model 90-9000 with a disposable single-use HALO® Coagulation Catheter, output cable, and a footswitch. The HALO® Coagulation System performance and mode of operation is substantially equivalent to the already cleared HALO® Coagulation System, HALO360 Coagulation System, and Stellartech Coagulation System 2.

The HALO® Energy Generator model 90-9000 is configured with an output cable (model 90-9010), a footswitch (model 90-9020) and a power cord.

The HALO® Coagulation Generator supplies up to 150 watts of radiofrequency power at 460 kHz in a bipolar mode under power control while continuously monitoring and displaying power density, and energy density. Energy density and power are displayed to allow homogeneous energy delivery equivalent to the HALO90 Energy Generator model 1100C-115C.

The provided text is a 510(k) summary for the BARRX Medical's HALO® Coagulation System. This type of submission focuses on establishing substantial equivalence to predicate devices rather than proving safety and effectiveness through clinical trials and detailed acceptance criteria studies.

Therefore, the document does not contain the information requested regarding acceptance criteria studies, such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes (for test or training sets), data provenance, number or qualifications of experts, or adjudication methods for establishing ground truth.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used or how it was established for training sets.

The submission primarily focuses on demonstrating that the technological characteristics of the new HALO90 Energy Generator are substantially equivalent to previously cleared predicate devices (HALO® Energy Generator model 1100C-115C, HALO360 Energy Generator model 1100C-115B, and Stellartech Coagulation System 2). The "study" mentioned is limited to bench testing to evaluate the differences in the new generator, such as:

• Simplification of the generator and elimination of unused pneumatic systems.
• Changes in hardware for optimum RF power output for the defined impedance range.
• Minor modification of generator software.
• Change of design and manufacturing facility.

The document explicitly states: "All these differences were evaluated on bench and did not raise questions regarding safety and efficacy. Thus the devices are equivalent."

Essentially, for a 510(k) submission, the "acceptance criteria" for the new device are that its performance, as demonstrated through bench testing (and sometimes limited clinical data if significant changes, though not explicitly detailed here), does not raise new questions of safety or effectiveness compared to the predicate device. The "study" proving this is often a comparison of technical specifications and performance characteristics through bench testing.

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