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510(k) Data Aggregation
(89 days)
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.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety equivalent to predicate devices | Performance data demonstrated that, when used in accordance with the instructions, the HALOFLEX is at least as safe as the predicate devices (HALO360 and HALO90 Energy Generators). |
| Effectiveness equivalent to predicate devices | Performance data demonstrated that, when used in accordance with the instructions, the HALOFLEX is at least as effective as the predicate devices (HALO360 and HALO90 Energy Generators). |
| Technological characteristics equivalent to predicate devices | Same intended use, fundamental scientific technology, and principles of operation as predicate devices. Minor design changes do not affect clinical parameters or safety mechanisms. |
| No new issues of safety or effectiveness | Minor technological differences raise no new issues of safety or effectiveness. |
| Compliance with applicable international and domestic requirements | Performance testing conducted in compliance with applicable international and domestic requirements and certifications for harmonized standards. |
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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(41 days)
The RFA Medical InCircle™ Bi-Polar RF Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the thermal coagulation of soft tissues.
The RFA Medical InCircle™ Bi-Polar RF Ablation System is a sterile, disposable, bi-polar, Radio Frequency (RF), hand-held electrosurgical device that utilizes opposing sets of Electrodes to coagulate/ablate a region of soft tissue using bi-polar RF energy. The device is designed for in percutaneous, laparoscopic, and intraoperative surgical use procedures. The device is designed for use with standard FDA cleared generators, such as the Boston RF Scientific Corporation (RadioTherapeutics) RF3000 (K000241) and the RITA Medical Systems 1500X (K983214).
The provided text describes the "InCircle™ Bi-Polar RF Ablation System" and its 510(k) submission. However, it does not contain information about specific acceptance criteria for a study, a detailed study description, performance data, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked.
The document is a 510(k) summary for a medical device seeking clearance based on substantial equivalence. It focuses on:
- Device identification and contact information.
- Device description and intended use.
- Comparison to predicate devices.
- Statements about bench testing/functional testing to ensure substantial equivalence and safety/efficacy.
Therefore, I cannot answer the specific questions about acceptance criteria, study details, performance data, sample sizes, expert qualifications, or ground truth establishment based solely on the provided text.
The document states: "Bench testing/functional testing was performed on the RFA Medical InCircle™ Bi-Polar RF Ablation System to ensure that the product is substantially equivalent to the predicate device and to ensure that the new device does not raise new questions of safety and efficacy." This implies testing was done, but the details of those tests, their acceptance criteria, and specific results are not included in this summary.
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