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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 provided 510(k) summary for BARRX's HALO System (K093008) indicates that no new performance testing was conducted for this submission.

The submission focuses on expanding the indications for use for the HALO® Ablation Catheter to include Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP) based on the substantial equivalence to previously cleared devices and existing clinical data.

Therefore, the following information cannot be extracted from the provided text as the study described is a review of existing clinical data, not a new performance study with acceptance criteria.

1. A table of acceptance criteria and the reported device performance: Not applicable, as no new performance testing was conducted.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for new performance testing. The clinical data supporting the expanded indications was "derived from publications and case studies." The provenance details are not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no new test set was created with expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable, as this is not an AI/device assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the expanded indications, the clinical data relied upon was from "publications and case studies" which demonstrated the safety and effectiveness of the device when used for GAVE and RP. This implies that outcomes data from these existing sources served as the basis for substantiating safety and effectiveness for these new indications.
8. The sample size for the training set: Not applicable, as no new training set was explicitly mentioned for algorithmic development in this submission.
9. How the ground truth for the training set was established: Not applicable.

Summary of the study that proves the device meets the acceptance criteria (expanded indications):

The submission argues for the substantial equivalence of the HALO® Ablation Catheter for the treatment of GAVE and RP by referencing:

• Technological Identity and Substantial Equivalence: The HALO® Ablation Catheter model 90-9100 is "technologically identical" to its cleared predicate (K083737, K062723). It also highlights substantial equivalence in principle of operation, energy density, construction, and performance with other predicate devices (HALO360 Ablation Catheter, Stellartech Coagulation Catheter, Microvasive Gold Probe, Olympus Heat Probe).
• Clinical Data Review: Clinical data was provided to FDA "to support the changes in the Instructions for Use associated with the use in the coagulation of bleeding sites for the HALO® Ablation Catheter for the treatment of GAVE and Radiation Proctitis." This data "demonstrated that, when used in accordance with those instructions, the HALO® Ablation Catheter used for the treatment of GAVE and Radiation Proctitis respectively is at least as safe and effective as the cleared HALO® Ablation Catheter for the treatment of bleeding sites in the gastrointestinal tract."
• Basis of Clinical Data: The clinical data supporting the additional indications (GAVE and RP) was "derived from publications and case studies" and facilitated "Physician's Instructions recommending specific treatment settings and selection criteria for the patients (Contraindications, Warnings and Cautions)."
• Similarity of Conditions: GAVE and RP are described as being similar to other already indicated bleeding conditions (esophageal ulcers, Mallory-Weiss tears, etc.) in that they are confined to the mucosal layer, associated with hemorrhage, and treated with coagulative therapy.

In essence, the "study" proving the device meets the acceptance criteria for expanded indications was a retrospective review of existing clinical data from publications and case studies, and an argument for substantial equivalence to previously cleared predicate devices for similar applications. No new pre-market performance study with defined acceptance criteria was conducted.

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The Stellartech Coagulation System 2 is indicated for use in the coagulation of bleeding and nonbleeding 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 Stellartech Coagulation System 2 consists of the following components.

• . Stellartech Coagulation Catheter 2
• Stellartech Coagulation Generator 2 .
• . Stellartech Catheter Connection Cable 2
• Optional Stellartech Sheath ●
• Optional Stellartech Footswitch 2. .
• Optional Stellartech Sizing Catheter 2 .
  The proximal end of the Stellartech Coagulation Catheter 2 connects through the Stellartech Catheter Connection Cable 2 to the Stellartech Coagulation Generator 2.

The provided text is a 510(k) Safety Summary for a medical device called the "Stellartech Coagulation System 2." This document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with detailed acceptance criteria and expert-adjudicated ground truth as would be typical for AI/ML device submissions.

Therefore, many of the requested categories cannot be filled as the information is not present in the provided text.

Here is an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) summary focuses on substantial equivalence rather than explicit performance metrics against pre-defined acceptance criteria for a new clinical study.

2. Sample size used for the test set and the data provenance

This information is not provided. The document does not describe a new clinical study or test set for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. As no new test set is described, there's no mention of ground truth establishment by experts.

4. Adjudication method for the test set

This information is not provided.

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 provided. The Stellartech Coagulation System 2 is an electrosurgical unit, not an AI/ML diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not provided. Given the device type, 'standalone algorithm performance' is not relevant.

7. The type of ground truth used

This information is not provided.

8. The sample size for the training set

This information is not provided. The document refers to prior predicate devices, implying that the "training" for this device would be based on the established clinical use and safety of those equivalent devices, not a computational training set.

9. How the ground truth for the training set was established

This information is not provided. Similar to point 8, the concept of "ground truth for a training set" as it applies to AI/ML is not relevant to this traditional medical device submission.

Summary of Device and Regulatory Context (from the provided text):

The Stellartech Coagulation System 2 is an electrosurgical unit and accessories used for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, including specific indications like Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, etc.

The device received 510(k) clearance by demonstrating substantial equivalence to a list of previously cleared Stellartech Coagulation System predicate devices (K013139, K023765, K032062, K0324552, K032721, K040240, K041383, K042909). The equivalence was based on its design, principles of operation, materials, and intended use. The 510(k) process in this context did not require a new clinical study with specific performance acceptance criteria or the establishment of ground truth as typically seen for novel diagnostic or AI-driven devices.

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The Stellartech 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 esophaqus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

The Stellartech Coagulation System consists of the following components.

• Stellartech Coagulation Catheter .
• Stellartech Coagulation Catheter Connection Module ●
• Stellartech Coagulation Generator .
• Stellartech Sheath .
• Optional Stellartech Footswitch. ◆
• Optional Stellartech Pressure Gauge
• Optional Stellartech Sizing Catheter .
• 후 Optional Stellartech Sizing Sheath
  The proximal end of the Stellartech Coagulation Catheter connects to the Stellartech Coagulation Catheter Connection Module. The proximal end of the Stellartech Coagulation Catheter Connection Module cable connects to the Stellartech Coagulation Generator.

The provided document is a 510(k) safety summary for the Stellartech Coagulation System. It focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.

Therefore, I cannot provide the requested information. The document pertains to a traditional medical device (electrosurgical unit), not an AI/ML device, and thus does not involve the types of studies and criteria typically associated with AI/ML performance evaluation.

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