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The MALLINCKRODT DAR Heated Wire Breathing Circuit is intended to warm breathing gases for adults, children, and infants undergoing anesthesia or mechanical ventilation within a health care facility.

The MALLINCKRODT DAR Heated Wire Breathing Circuit consists of the existing smooth bore breathing circuits (K942392, Airway Connectors with Flex Tube) into which a resistor has been molded into the inside of the external rib. Heating is controlled by ventilation/anesthesia breathing heaters or heater/humidifiers to which the MALLINCKRODT DAR Heated Wire Breathing Circuits are electrically connected. Some HWBC configurations may include traps for collection of the condensed moisture from patient exhalation or from humidification. Devices will be available in a variety of configurations.

The provided document (K993268) describes a 510(k) premarket notification for the MALLINCKRODT DAR Heated Wire Breathing Circuit. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study data with acceptance criteria that would typically be seen for novel devices.

Therefore, the document does not contain information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or details of a test set.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the document states:

1. Acceptance Criteria and Device Performance:

The acceptance criteria are implicitly defined by the demonstration of "substantial equivalence" to the predicate devices. The performance of the device is assessed through compliance with designated voluntary standards and fulfillment of product specifications, rather than specific performance metrics against clinical acceptance criteria.

The document states:
"Biocompatibility, performance, electrical safety, and electromagnetic compatibility testing demonstrate that Mallinckrodt DAR HWBC comply with designated voluntary standards and fulfill product specifications."

No specific quantifiable performance metrics or acceptance thresholds are provided in the document. The substantial equivalence claim is based on:

• Intended Use: "The MALLINCKRODT DAR Heated Wire Breathing Circuit is intended to warm breathing gases for adults, children, and infants undergoing anesthesia or mechanical ventilation within a health care facility." This is consistent with the predicate devices.
• Design: Shared characteristics with predicate devices (e.g., smooth bore, standard airway connectors, various configurations).
• Operational Characteristics: Provides a heated gas pathway, used for anesthesia and respiratory therapy, compatible with humidifiers.
• Materials of Construction: "Same materials as standard breathing circuits."
• Performance: "Meets ASTM standards" (implying standard performance criteria rather than novel device-specific criteria).

The comparison table (Table 1) highlights shared characteristics with predicate devices across Use, Sterility, Design, Materials, and Performance, indicating that the new device meets similar functional and safety attributes as the legally marketed predicate devices without defining new performance acceptance criteria.

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