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HALO360 + Sizing Balloon model 3441C is indicated for 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+ Sizing Balloon model 3441C is used in conjunction with either the HALO360 Energy Generator models 1100C-115B (or 1100C-230B), or HALORLEX Energy Generator model 1190A-115A (or 1190A-230A) for assessing the size of the esophageal lumen, and facilitate the selection of the disposable single-use HALO360+ Coagulation Catheter. The HALO360+ Sizing Balloon model 3441C, like the predicate device HALO360 Sizing Balloon model 3441B is comprised of a sizing balloon, a catheter shaft with markings, and an electrical connector.

The HALO® System (including HALO® Ablation Catheter model 90-9100 and HALO® Energy Generator model 90-9000) 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® Ablation Catheter model 90-9100 operates in conjunction with HALO® Energy Generator model 90-9000. There are no changes to the HALO® Ablation Catheter or HALO® Energy Generator implemented since the devices were cleared by K083737, K062723 and K062441. The product is also identical in principle of operation and energy density to the treatment site with the predicate devices HALO360 Ablation Catheter, Stellartech Coagulation Catheter. HALO® is substantially equivalent in construction with the predicate devices HALO360 Ablation Catheter, Stellartech Coagulation Catheter and Microvasive Gold Probe. The product is similar in performance with Olympus Heat Probe.

The HALOFLEX Energy Generator is indicated for use for the coagulation of soft tissue. The HALOFLEX Energy Generator 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 HALOFLEX Energy Generator is a modification to the HALO360 Energy Generator and HALO® Energy Generators that have already been cleared by the Food and Drug Administration ("FDA" or the "Agency") for use in coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus (K051168 and K060169, K062441 respectively). The Generator has the same intended use and fundamental scientific technology as the cleared HALO360 and HALO90 Energy Generators. In addition, the intended use was expanded to include "coagulation of soft tissue", for this indication for use the predicate device is the RF 3000 Radiofrequency Generator (K000241). The design changes between the HALO360 and HALO® Energy Generators and the HALOFLEX Energy Generator do not affect the clinical parameters employed in the energy delivery or the safety mechanisms that control those parameters. The HALOFLEX Energy Generator has a limited number of design changes compared to the predicate devices. These changes are minor and do not raise no questions or effectiveness. Further, bench testing demonstrated comparable performance and safety. These modifications were as follows: - Add to the indications for use the "coagulation of soft tissue", to reflect the . general nature of the device. - Modification of the CPU board, for increased memory . - Consolidation of the Pressure Monitoring Board and RF MUX Board in the Hand Piece Interface Board - Integration on the HALO360 and HALO90 Energy Generators on the same . hardware platform as HALO360 Energy Generator - . Update the software codes to reflect the specific performance characteristics for each Energy Generator. - Optimization of components for reliability, and/or obsolescence

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 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.

The HALO360 Energy Generator intended use is for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract. The HALO360 Energy Generator 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 HALO360 Energy Generator model 1100C-115B with a disposable single-use HALO®60 Coagulation Catheter, output cable, and an optional footswitch. The HALO360 Coagulation System performance and mode of operation is substantially equivalent to the already cleared HALO360 Coagulation System, and Stellartech Coagulation System 2. There are no changes associated to the HALO360+ Coagulation Catheter. The HALO360 Energy Generator model 1100C-115B is configured with an output cable (model CCC-001B), an optional footswitch (model FS-100B), and a power cord. There are no changes to the hardware associated to HALO360 Energy Generator cleared by the 510(k) k050831 and k051168. There are minor changes implemented to the software version of the generator. This submission addresses software changes for HALO360 Energy Generator cleared by the 510(k) k050831 and k051168. These minor changes implemented to the software version of the generator did not raise any new questions of safety or efficacy.

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.

The HALO360+ Coagulation Catheter model 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 HALO460 Energy Generator with a disposable single-use HALO360+ Coagulation Catheter, a HALO300 Sizing Balloon, an output cable, and an optional footswitch. The HALO360 Coagulation System comprising catheter model 32041-XX performance and mode of operation is substantially equivalent to the already cleared HALO300 Coagulation System comprising catheter models 31041-XX and/or 31041-XXBR.

The HALO® Coagulation System intended use is for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract. 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.

The HALO® Coagulation System consists of the HALO90 Energy Generator model 90-9000 with a disposable single-use HALO® Coagulation Catheter, output cable, and a footswitch. The HALO® Coagulation System performance and mode of operation is substantially equivalent to the already cleared HALO® Coagulation System, HALO360 Coagulation System, and Stellartech Coagulation System 2. The HALO® Energy Generator model 90-9000 is configured with an output cable (model 90-9010), a footswitch (model 90-9020) and a power cord. The HALO® Coagulation Generator supplies up to 150 watts of radiofrequency power at 460 kHz in a bipolar mode under power control while continuously monitoring and displaying power density, and energy density. Energy density and power are displayed to allow homogeneous energy delivery equivalent to the HALO90 Energy Generator model 1100C-115C.

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.

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).