LogoFDA 510(k) Search
K Number
K062723
Device Name
HALO90 COAGULATION CATHETER
Manufacturer
BARRX MEDICAL, INCORPORATED
Date Cleared
2006-11-09

(58 days)

Product Code
GEI
Regulation Number
878.4400
Type
Special
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

Device Description

The HALO90 Coagulation System consists of the HALO90 Coagulation Generator with a disposable single-use HALO90 Coagulation Catheter model 90-9100, output cable, and an optional footswitch. The HALO90 Coagulation System performance and mode of operation is substantially equivalent to the already cleared HALO90 Coagulation System (with catheter model 1520F).

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for the HALO® Coagulation System, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting performance data against pre-defined acceptance criteria.

Therefore, I cannot populate the table or provide details for the requested questions as the necessary information is not present in the given text.

The document indicates:

  • The device is substantially equivalent to the already cleared HALO®90 Coagulation System (with catheter model 1520F).
  • The purpose of the 510(k) is to secure clearance to market based on this substantial equivalence, not based on meeting specific quantitative performance acceptance criteria from a new study.

There is no mention of:

  • Specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds).
  • A formal study designed to demonstrate performance against such criteria.
  • Sample sizes for test or training sets in the context of performance evaluation.
  • Expert involvement, adjudication methods, or ground truth establishment for a performance study.
  • MRMC studies or standalone algorithm performance.

§ 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.