(88 days)
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 HALO® Coagulation Generator with a disposable single-use HALO® Coagulation Catheter, output cable, and an optional footswitch.
The provided text (K060169) for the BÂRRX Medical's HALO® Coagulation System is a 510(k) summary and not a comprehensive study report. Therefore, it does not contain detailed information regarding acceptance criteria, specific study designs, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or direct comparative effectiveness studies with human readers.
The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a standalone performance study with predefined acceptance criteria.
Here's an analysis based on the information available in the provided text, while acknowledging significant gaps due to the nature of the document:
Acceptance Criteria and Device Performance:
The document does not explicitly state numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy, or specific coagulation depth/width targets) or report performance against such criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices, implying that its performance is presumed acceptable if it functions similarly and addresses the same indications for use.
The "performance" described is largely about the technological characteristics and the assertion of substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Efficacy (via Substantial Equivalence) | HALO® Coagulation System has "same or similar intended use, indications for use, technological characteristics, and principles of operation" as predicate devices. |
| Technological Characteristics - Catheter Design | Uses an endoscope and pivot mechanism for electrode positioning. |
| Technological Characteristics - Sizing Balloon | Eliminates the sizing balloon and the need for custom catheter selection. |
| Technological Characteristics - Materials | Employs additional materials. |
| Technological Characteristics - Software Modifications | Minor modification of generator software to support catheter design changes. |
| Impact of Differences on Safety and Efficacy | "All these differences were evaluated on bench and did not raise questions regarding safety and efficacy." |
| Coagulation of Bleeding and Non-Bleeding Sites (Intended Use) | Indicated for "coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus." |
| Specific Indications (Intended Use) | Indicated for Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia. |
Detailed Study Information (Based on Available Text):
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not explicitly stated. The document refers to "bench" evaluations for the technological differences but does not provide details on sample size, data type, or provenance for these evaluations or any clinical studies.
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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 explicitly stated. The document does not describe a clinical study that would involve expert-established ground truth for a test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not stated. No clinical test set or adjudication method is described.
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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:
- No. This device is an electrosurgical coagulation system, not an AI-powered diagnostic or interpretive tool. Therefore, a MRMC study assessing human reader improvement with AI assistance is not relevant to this device and was not performed/reported.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not stated. This is a medical device for direct coagulation, not an algorithm. Its operation is inherently "standalone" in that it performs the coagulation directly, but its use involves a clinician (human-in-the-loop) for guidance and application. The document describes "bench" evaluations, but not a "standalone algorithm" performance study.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated. Given the nature of a coagulation system, "ground truth" for performance would likely relate to objective measurements of tissue ablation/coagulation effectiveness, depth, and safety parameters, potentially animal models or in-vitro tissue models for bench testing. However, the document does not specify these details.
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The sample size for the training set:
- Not applicable/Not stated. The device is not an AI/machine learning system that requires a training set in the conventional sense.
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How the ground truth for the training set was established:
- Not applicable/Not stated. No training set is described for this type of device.
Summary of Device Approval Process:
The document is a 510(k) Pre-market Notification, which is a process for demonstrating that a new device is "substantially equivalent" to an already legally marketed device (predicate device). In this case, BÂRRX Medical argued that the HALO® Coagulation System is substantially equivalent to:
- K051168 HALO360 Coagulation System (BÂRRX Medical Inc.)
- K050831 Stellartech Coagulation System 2 (Stellartech Research Corporation)
The "study" referenced is primarily a demonstration that the technological differences (endoscope/pivot vs. sizing balloon, additional materials, minor software modifications) were evaluated "on bench" and did not raise new questions of safety or efficacy compared to the predicate devices. This type of submission does not typically include detailed clinical studies with quantifiable acceptance criteria for diagnostic performance metrics.
§ 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.