(26 days)
The HALO360 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 HALO360 Coagulation System consists of the HALO360 Coagulation Generator and with a disposable single-use HALO360 Coagulation Catheter, output cable, and optional footswitch.
This 510(k) submission (K062225) for the HALO360 Coagulation Catheter does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance against those criteria.
This document is a Summary of Substantial Equivalence, which focuses on demonstrating that a new device is "substantially equivalent" to one or more legally marketed predicate devices. It does not typically include detailed performance study results or acceptance criteria in the manner you've described for a device performance evaluation.
Here's a breakdown of what is and is not in the provided text:
- Acceptance Criteria and Reported Device Performance: This information is not present in the document. The document states that the performance and mode of operation are "substantially equivalent to the already cleared HALO®360 Coagulation Catheter and Stellartech Coagulation Catheter 2." This is a regulatory statement of equivalence, not a report of specific performance metrics against defined acceptance criteria.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and ground truth for training set: All of these details, which relate to a detailed performance study, are not provided in this 510(k) summary. The summary focuses on comparing technological characteristics to predicates and stating that the differences "do not raise questions regarding safety and efficacy."
In summary, the provided text establishes the substantial equivalence of the HALO360 Coagulation Catheter to existing predicate devices based on intended use, indications for use, technological characteristics, and principles of operation, but it does not contain the specific performance study details, acceptance criteria, or expert review information you are seeking.
§ 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.