(34 days)
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.
§ 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.