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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

Here's an analysis of the provided text regarding the HALOFLEX Energy Generator, addressing the specific points requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for the HALOFLEX Energy Generator does not explicitly define quantitative acceptance criteria or provide specific numerical device performance metrics in the way one might expect for a diagnostic or AI-driven device.

Instead, the submission relies on the concept of substantial equivalence to predicate devices. This means the acceptance criteria are implicitly that the HALOFLEX Energy Generator performs at least as safely and effectively as the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of a clinical study with a defined sample size. The performance data mentioned refers to "bench testing" and compliance with standards rather than a clinical trial where patients or specific datasets are evaluated.

Therefore:

• Sample size for the test set: Not applicable/Not provided. The submission focuses on substantial equivalence through design and bench testing, not a clinical test set.
• Data provenance: Not explicitly stated as retrospective or prospective clinical data. The "bench testing" implies laboratory-based data, not patient data from a specific country of origin.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable/not provided. The submission does not describe a process of establishing ground truth by medical experts for a test set, as it is not a diagnostic device requiring such evaluation. The safety and effectiveness are established through comparison with predicate devices and bench testing.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. There is no described "test set" or clinical evaluation requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices (e.g., imaging software) to evaluate interpretative performance by human readers with and without AI assistance. The HALOFLEX Energy Generator is a therapeutic device (electrosurgical coagulation system), and its evaluation focuses on safety, fundamental scientific technology, and equivalent performance to existing devices, not on improving human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The concept of "standalone performance" for an algorithm is not applicable to the HALOFLEX Energy Generator. This device is an energy generator for electrosurgical coagulation, which is inherently a human-in-the-loop therapeutic procedure. Its performance is evaluated on its ability to deliver energy safely and effectively, not as an autonomous algorithm. The "performance data" mentioned refers to bench testing to ensure the device's functional integrity.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, expert consensus on imaging) is not directly applicable here. The "ground truth" for affirming the device's safety and effectiveness relies on:

• Bench testing results: Demonstrating compliance with engineering specifications and safety standards.
• Comparison to predicate devices: The established safety and effectiveness of the existing HALO360, HALO90, and RF 3000 generators serve as a de facto "ground truth" for what is considered safe and effective performance for this class of device.
• Regulatory standards: Compliance with international and domestic requirements acts as a standard for acceptable performance.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The HALOFLEX Energy Generator is a hardware device with embedded software, not a machine learning model that undergoes "training" on a dataset. The software updates mentioned are for "specific performance characteristics" and "optimization of components," not for an AI algorithm trained on a dataset.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided for the same reasons as point 8.

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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.

This 510(k) summary describes a device modification, not a study establishing new acceptance criteria or performance. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not present in the provided document.

The submission focuses on minor software changes to the HALO360 Energy Generator and demonstrates substantial equivalence to previously cleared devices. It confirms that "These minor changes implemented to the software version of the generator did not raise any new questions of safety or efficacy."

Here's a breakdown of what can be extracted from the document based on your request:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The submission states that the differences were evaluated on bench, implying functional testing was performed to ensure the software changes did not negatively impact performance, but specific acceptance criteria and detailed performance results are not reported. The primary claim is substantial equivalence based on the absence of new safety or efficacy questions.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "bench" evaluation, which typically involves laboratory testing rather than testing on a "test set" of patient data as might be relevant for AI/diagnostic devices.

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)

This information is not provided in the document. This is not applicable as the submission is about a software update for an electrosurgical generator, not a diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document and is not applicable for this type of device modification submission.

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 in the document and is not applicable. The device is an energy generator for coagulation, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not provided in the document. This is not directly applicable. The device is a hardware generator with software control, not a standalone algorithm. Its performance is demonstrated through its function, not through an "algorithm only" evaluation in the context of an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the document. The ground truth for such a device would typically be its ability to perform its intended coagulation function safely and effectively, which would be assessed through engineering and bench testing, not expert consensus or pathology in this context.

8. The sample size for the training set

This information is not provided in the document. This concept is not applicable as the device is not an AI algorithm that undergoes "training" on a dataset in the conventional sense. The "software changes" were likely developed and tested internally rather than trained on a distinct dataset.

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

This information is not provided in the document and is not applicable.

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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 provided text is a 510(k) summary for the BARRX Medical's HALO® Coagulation System. This type of submission focuses on establishing substantial equivalence to predicate devices rather than proving safety and effectiveness through clinical trials and detailed acceptance criteria studies.

Therefore, the document does not contain the information requested regarding acceptance criteria studies, such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes (for test or training sets), data provenance, number or qualifications of experts, or adjudication methods for establishing ground truth.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used or how it was established for training sets.

The submission primarily focuses on demonstrating that the technological characteristics of the new HALO90 Energy Generator are substantially equivalent to previously cleared predicate devices (HALO® Energy Generator model 1100C-115C, HALO360 Energy Generator model 1100C-115B, and Stellartech Coagulation System 2). The "study" mentioned is limited to bench testing to evaluate the differences in the new generator, such as:

• Simplification of the generator and elimination of unused pneumatic systems.
• Changes in hardware for optimum RF power output for the defined impedance range.
• Minor modification of generator software.
• Change of design and manufacturing facility.

The document explicitly states: "All these differences were evaluated on bench and did not raise questions regarding safety and efficacy. Thus the devices are equivalent."

Essentially, for a 510(k) submission, the "acceptance criteria" for the new device are that its performance, as demonstrated through bench testing (and sometimes limited clinical data if significant changes, though not explicitly detailed here), does not raise new questions of safety or effectiveness compared to the predicate device. The "study" proving this is often a comparison of technical specifications and performance characteristics through bench testing.

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