(133 days)
The HALO® Ablation Catheter (used with the HALOFER Energy Generator, model 1190A-115A) 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® (subject device) is a single-use bipolar device that delivers radiofrequency energy to the treatment tissue within the gastrointestinal tract. It is used solely with the HALOFES Energy Generator (model 1190A-115A), which provides the radiofrequency energy.
The HALO60 Ablation Catheter is a modification of the HALO90 Ablation Catheter, primarily involving a reduction in the copper electrode surface area. The submission is a Special 510(k) as the modification does not change the intended use or alter the fundamental scientific technology.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific quantitative acceptance criteria or numerical performance metrics for the HALO60 Ablation Catheter. Instead, it focuses on demonstrating substantial equivalence to a predicate device (HALO90 Ablation Catheter) based on the absence of new questions of safety or effectiveness.
The "performance" is implicitly demonstrated through the modifications and the conclusion of substantial equivalence.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No new questions of safety or effectiveness raised by the modifications | The primary modification (dimensional reduction of copper electrode surface area from 2.6cm² to 1.5cm²) and secondary modifications (dimensional reduction of supporting components) do not raise new questions of safety or effectiveness. |
| Same intended use as predicate device | The HALO60 Ablation Catheter has the same intended use as the HALO90 Ablation Catheter. |
| Same fundamental scientific technology as predicate device | The HALO60 Ablation Catheter has the same fundamental scientific technology as the HALO90 Ablation Catheter. |
| Compatible with HALOFER Energy Generator | The HALO60 Ablation Catheter is compatible with the HALOFER Energy Generator. No changes were made to the generator's software for HALO60. |
| Materials remained unchanged | The materials used in the HALO60 Ablation Catheter are unchanged from the predicate device. |
| Amount of energy delivered remained unchanged | The amount of energy delivered by the HALO60 Ablation Catheter is unchanged from the predicate device. |
| Depth of tissue treated remained unchanged | The depth of tissue treated by the HALO60 Ablation Catheter is unchanged from the predicate device. |
| Design verification activities demonstrate meeting design input requirements | Design verification activities were conducted to demonstrate that the design outputs of the modified device meet the design input requirements. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific clinical "test set" with a sample size in the traditional sense of evaluating a new device's performance against clinical endpoints. The submission relies on design verification activities and a comparison to the predicate device's established safety and effectiveness.
- Sample Size for Test Set: Not applicable as a clinical test set for performance evaluation is not described.
- Data Provenance: Not applicable as a clinical test set for performance evaluation is not described. The document pertains to regulatory submission data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this submission. The document focuses on engineering and design verification rather than clinical outcomes requiring expert consensus for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable to this submission as a clinical test set requiring adjudication is not described.
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
This information is not applicable. The HALO60 Ablation Catheter is a medical device for radiofrequency energy delivery, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The HALO60 Ablation Catheter is a physical medical device, not an algorithm, and operates with human intervention during its use.
7. The Type of Ground Truth Used
The "ground truth" in this context is established through design verification activities against design input requirements, and based on the established safety and effectiveness of the predicate device (HALO90). The document highlights:
- Design Input Requirements: The modified device's design outputs were verified to meet these.
- Predicate Device's Established Performance: The HALO90's prior clearances (K093008, K083737, K062723) serve as the basis for demonstrating substantial equivalence.
- Failure Modes, Effects, and Criticality Analysis (FMECA): Used to analyze risks, implying that safety standards and risk mitigation served as a form of "ground truth" for design decisions.
8. The Sample Size for the Training Set
This information is not applicable. The HALO60 Ablation Catheter is a physical medical device; there is no "training set" of data in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reasons stated in point 8.
§ 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.