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The HOTWIRE is indicated for creation of an atrial septal defect in the heart.

The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power in a monopolar mode to a distal electrode segment for the creation of an atrial septal defect in the heart. The HOTWIRE™ is intended to be used in conjunction with compatible third-party intravascular sheaths and/or dilators, and third-party RF electrosurgical generator(s). The HOTWIRE™ is comprised of a stainless steel core wire. The main body of the wire is jacketed with an insulating polymer that provides electrical insulation and facilitates smooth movement of the device through vascular dilators and/or sheaths. The floppy distal segment of the wire has an atraumatic tip with an uninsulated stainless-steel coil, which serves as an electrode, and also provides fluoroscopic and echogenic visualization. A tungsten marker coil at the tip provides additional radiopacity. The stiff body of the HOTWIRE™ provides support for advancing wire-guided devices into the left atrium after the distal segment has traversed the septum. The proximal insulated portion of the wire has visual markers that align the electrode tip with third-party transseptal sheaths and/or dilators. A portion of the proximal wire is uninsulated for placement of an included Adapter Pin that connects to hand pieces used with compatible third-party RF electrosurgical generators.

The HOTWIRE™ + Handpiece Kit is a sterile, single-use guidewire device that delivers radiofrequency (RF) power in a monopolar mode to a distal electrode segment for the creation of an atrial septal defect in the heart. The HOTWIRE™ + Handpiece Kit is intended to be used in conjunction with compatible third-party intravascular sheaths and/or dilators, and the HOTWIRE™ System RF Generator, which utilizes a commercially-available Patient Return Electrode (PRE) which is in compliance with IEC 60601-2-2, such as the Valleylab E7507DB (K822572). The HOTWIRE™ is comprised of a stainless steel core wire. The main body of the wire is jacketed with an insulating polymer that provides electrical insulation and facilitates smooth movement of the device through vascular dilators and/or sheaths. The floppy distal segment of the wire has an atraumatic tip with an uninsulated stainless-steel coil, which serves as an electrode, and also provides fluoroscopic and echogenic visualization. A tungsten marker coil at the tip provides additional radiopacity. The stiff body of the HOTWIRE™ provides support for advancing wire-guided devices into the left atrium after the distal segment has traversed the septum. The proximal insulated portion of the wire has visual markers that align the electrode tip with third-party transseptal sheaths and/or dilators. A portion of the proximal wire is uninsulated for placement of an included handpiece that connects with the HOTWIRE™ System RF Generator.

This FDA 510(k) clearance letter and summary describe a physical medical product, the HOTWIRE RF Guidewire, not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML system (which typically involves metrics like accuracy, sensitivity, specificity, AUC, and studies like MRMC with ground truth establishment) is not applicable here.

The document details the device's technical specifications, design, materials, and extensive non-clinical bench top and in vivo performance testing to demonstrate its safety and effectiveness and its substantial equivalence to a predicate device.

Key points from the document regarding the device's performance and testing:

• Acceptance Criteria & Performance (General): The document states: "All test requirements were met as specified by applicable standards and test protocols." and "The HOTWIRE™ met all specified criteria and did not raise new safety or performance questions." This implies that predefined performance criteria for each test were successfully achieved. While a specific table of quantitative acceptance criteria versus reported performance (like a sensitivity/specificity table for an AI) isn't provided, the text confirms successful completion of various engineering and in vivo tests.

• Study Type: The studies performed are primarily non-clinical benchtop testing and in vivo animal testing (porcine model). These are designed to verify the device's physical and functional properties, and its performance in a biological environment.

• Sample Size:

  • Test Set (In vivo): A "porcine model" was used for in vivo testing. The specific number of animals or trials is not explicitly stated.
  • Training Set (for manufacturing/design, not AI): Not applicable in the AI sense. The design and manufacturing process for the guidewire would be iterated and refined through various engineering tests and material evaluations.

• Data Provenance:

  • Benchtop Testing: Likely conducted in a lab environment.
  • In vivo Testing: Utilized a porcine (pig) model.
  • Retrospective/Prospective: Not applicable in the context of an AI study. These are experimental tests designed to evaluate hardware performance.

• Experts for Ground Truth / Adjudication / MRMC:

  • These concepts are not applicable for a physical medical device clearance. "Ground truth" for a physical device is established through engineering specifications, material properties, and direct measurement of its physical and functional performance (e.g., tensile strength, RF power delivery, ability to create a defect in a model).
  • MRMC studies are specifically for evaluating human reader performance (e.g., radiologists) with or without AI assistance in diagnostic tasks.

• Standalone Performance: The benchtop and in vivo tests can be considered a demonstration of the device's "standalone" performance, meaning its inherent functional capabilities independent of human interpretation or diagnostic aid. For example, the "Arc integrity test," "Tensile strength test," and "In vivo testing" directly assess the device's intended function and safety characteristics.

• Type of Ground Truth: For this device, the "ground truth" is based on:

  • Engineering Specifications: Defined parameters for dimensions, material strength, electrical insulation, etc.
  • Direct Measurement: Quantification of physical properties (e.g., tensile strength, torque strength).
  • Functional Validation: Assessment of the device's ability to perform its intended action (deliver RF power, create a defect) in a controlled environment (benchtop) and a biological model (in vivo).
  • Compliance with Standards: Meeting requirements of relevant industry and regulatory standards (e.g., IEC 60601-2-2 for the RF Generator, ASTM standards for packaging).

• How Ground Truth for Training Set was Established: N/A as this is not an AI/ML device. The "training" of the device itself refers to its design and manufacturing process, which is refined based on engineering principles and test results.

Summary of Relevant Performance Data from the document:

The document lists several categories of testing, highlighting that all requirements were met:

• RF Guidewire Testing:
  • Visual and dimensional inspection
  • Simulated use test
  • Arc integrity test
  • Tensile strength test
  • Torque strength test
  • Torquability test
  • Fracture resistance test
  • Flexing test
  • Tip flexibility test
• Handpiece Testing:
  • Cable flex test
  • Cable tensile strength test
  • EEPROM functionality test
  • Cable length dimensional inspection
  • Retention test
  • Activation button test
• In vivo Testing:
  • Utilized a porcine model.
  • Evaluated subject device design performance during normal intended use.
  • Included compatibility with commercially-available introducer sheaths, intracardiac echocardiography (ICE) catheters, and fluoroscopic visualization.
• Shelf life testing: Accelerated aging for 1 year, all acceptance criteria met.
• Packaging validation: Acceptance criteria met, ensuring protection and sterile barrier.
• Sterilization validation: Achieved an SAL of 10⁻⁶ using gamma radiation.

In conclusion, while the request's structure is tailored for AI/ML devices, the provided document outlines a comprehensive set of engineering and biological tests demonstrating the physical guidewire's safety and performance, affirming its substantial equivalence to a predicate device.

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