(56 days)
The HALO® System (inclusive of the HALO® 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 HALO90 System consists of the following components:
- HALO" Energy Generator model 1100C-115C and 90-9100 and . accessories (output cable, and an optional footswitch).
- A single use HALO90 Ablation Catheter model 90-9100 .
The HALO® System performance and mode of operation did not change. This 510 (k) addresses the name change for the catheter.
There are no changes in construction, materials, principle of operation, intended use and indications for use, for the HALO® Ablation catheter model 90-9100 when compared with the predicate device HALO® Coagulation Catheter model 90-9100.
The following changes are subject to this 510k submission: HALO® Coagulation Catheter model 90-9100 was marketed in Europe and Canada as HALO90 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 HALO® Coagulation Catheter to HALO90 Ablation Catheter. There are no changes associated with the intended use, indication for use or the principle of operation.
There are no changes associated to the HALO® Energy Generator software, hardware and accessories.
The provided text describes a 510(k) submission for the BARRX Medical HALO® Ablation Catheter. However, it does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria.
The 510(k) summary explicitly states:
"The HALO® System performance and mode of operation did not change. This 510 (k) addresses the name change for the catheter."
and
"There are no changes in construction, materials, principle of operation, intended use and indications for use, for the HALO® Ablation catheter model 90-9100 when compared with the predicate device HALO® Coagulation Catheter model 90-9100."
and
"There are no differences were evaluated on bench and did not raise questions regarding safety and efficacy. Thus the devices are equivalent."
This submission is solely about a name change for an already cleared device ("HALO® Coagulation Catheter" to "HALO90 Ablation Catheter") to unify international and domestic labeling. Therefore, no new performance studies or acceptance criteria are presented for this specific submission as the device itself is considered identical to its predicate.
As a result, I cannot populate the requested table or provide information about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this data is not present in the provided document. The 510(k) relies on the substantial equivalence to the predicate device, K062723, which would have had such studies.
§ 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.