(49 days)
The HALO360+ Ablation Catheter intended use is for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract.
The HALO360+ Ablation 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 System consists of the following components:
- HALO360 Energy Generator model 1100C-115B and 1100C-230B . and accessories (output cable, and an optional footswitch).
- A single use HALO360 Sizing Balloon model 3441B,
- A single use HALO360+ Ablation Catheter model 32041-xx with an optional accessory HALO Cap
The HALO360 System performance and mode of operation did not change. This 510 (k) addresses the addition of the optional accessory HALO Cap.
There are no changes in construction, materials, principle of operation, intended use and indications for use, for the HALO360+ Ablation catheter model 32041-xx when compared with the predicate device HALO360+ Coagulation Catheter model 32041-xx. The following changes are subject to this 510k submission:
- Based on feedback received from the physician-user, BARRX Medical identified the need for an optional accessory HALO Cap for the use with HALO30 + Coagulation Catheter. This accessory will-facilitate removal of biological debris.after treatment and as result minimize the time;of the ¿ procedure.
- HALO360+ Coagulation Catheter model 32041-xx was marketed in Europe and Canada as HALO360+ Ablation Catheter, under the same indications for use for tissue coagulation. For unifying the international and domestic labeling we request FDA to allow the name change for HALO360+ Coagulation Catheter to HALO360+ Ablation Catheter. There are no changes associated with the intended use, indication for use or the principle of operation.
This 510(k) summary (K083711) for the BARRX Medical HALO360+ Ablation Catheter does not describe a study to prove acceptance criteria with specific performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices for a modified version of an existing device.
Here's an breakdown of why the requested information cannot be fully provided from this document and what can be extracted:
The primary purpose of this 510(k) submission is to:
- Introduce an optional accessory, the HALO Cap, for the HALO360+ Ablation Catheter to facilitate debris removal and reduce procedure time.
- Change the device name from "HALO360+ Coagulation Catheter" to "HALO360+ Ablation Catheter" for international and domestic labeling consistency.
The submission explicitly states: "All these differences were evaluated on bench and did not raise questions regarding safety and efficacy. Thus the devices are equivalent." This indicates that the regulatory pathway relied on demonstrating that the changes did not negatively impact the existing device's safety and efficacy, rather than conducting a new clinical study to establish performance against pre-defined acceptance criteria for the entire device.
Therefore, many of the requested details related to a clinical study (like sample size, ground truth, expert qualifications, adjudication, MRMC studies, or standalone performance) are not present in this document because such a study was not deemed necessary for this particular submission.
Here's what can be extracted and inferred from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not directly applicable. Since this 510(k) is for demonstrating substantial equivalence based on minor modifications (an accessory and a name change), there are no specific, quantitative acceptance criteria and corresponding performance metrics presented in this document for the device as a whole or for the new accessory's performance. The "acceptance criteria" here implicitly relate to demonstrating that the addition of the HALO Cap does not degrade the safety and effectiveness of the existing device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implicit: No adverse impact on existing safety and efficacy of the HALO360+ Ablation Catheter due to: | Claimed: "All these differences [inclusion of HALO Cap, name changes] were evaluated on bench and did not raise questions regarding safety and efficacy. Thus the devices are equivalent." |
| 1. Inclusion of optional HALO Cap accessory | Bench testing indicated no safety/efficacy concerns. |
| 2. Name change from "Coagulation Catheter" to "Ablation Catheter" | No change in intended use, indications for use, or principle of operation. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable/Not specified. The document states "evaluated on bench," implying non-clinical testing rather than patient-based clinical testing. No specific number of samples or tests is provided.
- Data Provenance: Not applicable. The evaluation was "on bench," suggesting laboratory or engineering testing, not data from human subjects or clinical settings, either retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable. No expert ground truth establishment for a test set is described. The evaluation was "on bench," likely performed by engineers or technical personnel rather than clinical experts establishing ground truth in a diagnostic context.
4. Adjudication Method for the Test Set
- Not applicable. No adjudication method is described, as there was no clinical test set requiring expert consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study was not conducted or mentioned. This type of study focuses on human reader performance with and without AI, which is not relevant to this submission for a physical device and its accessory.
6. If a Standalone (Algorithm Only) Performance Study Was Done
- No. This device is a physical electrosurgical catheter, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used
- Not applicable. Given that the evaluation was "on bench" for changes to a physical device and an accessory, the "ground truth" would likely relate to engineering specifications, material properties, electrical performance, and mechanical function, rather than clinical outcomes, pathology, or expert consensus. No specific type of "ground truth" (e.g., pathology, outcomes) is mentioned.
8. The Sample Size for the Training Set
- Not applicable. This submission is for a physical medical device and an accessory, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, no training set or associated ground truth establishment is relevant to this device submission.
§ 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.