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The Hudson RCI Dri-Tech Breathing Circuits are intended for pediatric and adult patients in professional healthcare environments as a conduit of breathing gas between a patient and a ventilator and to maintain the temperature of humidified inspired gas.

The Hudson RCI® Dri-Tech Breathing Circuits are intended for pediatric and adult patients in professional healthcare environments as a conduit for respiratory gas between a patient and includes heated wire(s) for use with the Hudson RCI Neptune Heated Humidifier (K131912). The heated wires are intended to aid in maintaining the set patient temperature and minimize condensation in the ventilator tubing.

The Dri-Tech Breathing Circuits are designed to be used with various patient interfaces such as oral tracheal tubes, nasal tracheal tubes, endo-bronchial tubes, and masks (for noninvasive ventilation therapies such as CPAP, BiPAP, and Mask usage). As such, Dri-Tech Breathing Circuits are designed and will be manufactured to conform to the test requirements of ISO 5367:2014 "Anaesthetic and respiratory equipment -- Breathing sets and connectors".

The adult dual limb configuration consists of 19mm ID inspiratory limbs with 22mm connectors that are compliant to ISO 5356-1.2015 Anaesthetic and respiratory equipment – Conical connectors – Part 1: Cones and sockets. The adult circuits have a length of 1.7m on the inspiratory limb, and are kitted with the accessories described below:

• Tubing Adaptor: 22mm male to male adaptor for various connections as required.
• . Elbow Adaptor: Adaptor for connecting to the circuit wye to the patient interface to allow the circuit to exit the patient perpendicularly for optimal placement.
• . Tubing Hanger: Optional accessory for hanging the circuit to reduce pull on the patient interfaces and ventilator/humidifier connections.
• . Humidifier Limb: Required tubing and adaptors for connecting the ventilator inhalation port to the heated humidifier.

Optional Ventilator Accessory available for the Dri-Tech Dual Limb Breathing Circuit:

• . Dri-Tech Ventilator Accessory: Optional tee accessory capable of providing the 10 LPM flow required for the expiratory star lumen tubing. This ventilator accessory is comprised of male and female medical grade air DISS connectors to connect between the air hose and ventilator, a standard Christmas tree adaptor for connecting the tubing to, and an on/off valve to start and stop the flow.
  The adult single limb configuration is identical to the inspiratory limb of the dual limb configuration, however, is packaged with a different set of adaptors to facilitate connections and use with non-invasive therapies as described below:

• Humidifier Line: Optional tubing and adaptors for connecting the ventilator inhalation port to the heated humidifier.

• Exhalation Port Adaptor: Optional adaptor including an exhalation port and connector for the pressure monitoring line.

• Pressure Monitoring Line: Optional accessory tubing for use with units without an Airway Pressure Monitor.

• Pressure Monitoring Assembly: Optional accessory containing a tee and tubing for pressure monitoring on units with an Airway Pressure Monitor.

• 15mm Adaptor: Optional accessory required for connecting to certain patient interfaces.

• Male Luer: Optional accessory for required for certain setups to connect the pressure monitoring line.

• Tubing Hanger: Tubing hanger designed for single limb tubes and pressure monitoring lines to reduce pull on the patient interfaces and ventilator/humidifier connections.

• Bacterial/Viral Electrostatic Filter: Optional accessory in specific kit codes for user convenience.
  The Hudson RCI® Dri-Tech Breathing Circuits are sold non-sterile.

The provided document describes the FDA 510(k) premarket notification for the Hudson RCI Dri-Tech Breathing Circuits. This document outlines the device's characteristics, intended use, and a comparison with a predicate device, along with a summary of non-clinical testing performed to demonstrate substantial equivalence.

However, the document does not contain specific acceptance criteria in the form of numerical performance targets, nor does it detail a study that proves the device meets such criteria using a test set, expert adjudication, or MRMC/standalone performance metrics. The information provided heavily focuses on bench testing to established industry standards (e.g., ISO 5367:2014, ISO 80601-2-74:2017) and biocompatibility testing.

Therefore, I cannot provide a table of acceptance criteria and reported device performance as requested, because specific numerical acceptance criteria (e.g., a specific percentage for sensitivity or specificity) are not stated for AI/algorithm performance. The document describes a comparison to a predicate device and adherence to recognized standards, which are the basis for the FDA's substantial equivalence determination for this breathing circuit, not an AI-powered diagnostic device.

Similarly, other requested information such as sample size for the test set, data provenance, number and qualifications of experts, adjudication methods, MRMC study details, standalone performance, and ground truth establishment are not applicable to the type of device and testing described in this FDA submission. The device is a medical accessory, not an AI/ML-driven diagnostic or assistive tool.

Key takeaways from the document regarding "acceptance criteria" and "study":

• Acceptance Criteria (as implied by the regulatory submission): The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to a predicate device and meeting the requirements of recognized international standards for breathing circuits. These standards define performance characteristics such as resistance to flow, compliance, and leakage.

  • Resistance to Flow: Less than 1.8 cmH2O @ 30 LPM (per ISO 5367:2014)
  • Compliance: Less than 5 mL/cmH2O @ 60 cmH2O (per ISO 5367:2014)
  • Leakage: Less than 30 ml/min @ 60 cmH2O (per ISO 5367:2014)
  • Biocompatibility: Meeting the requirements of ISO 10993-1:2018 and ISO 18562-1:2017 for gas pathway evaluation (particulate matter, VOCs, leachables in condensate).
  • Safety: Meeting ISO 80601-2-74:2017 (Safety Testing), IEC 60601-1:2005 (Electrical Safety), and IEC 60601-1-2:2014 (EMC).
  • Useful Life: Meeting requirements for an intended 12-day useful life.

• Study That Proves the Device Meets the Criteria: The "study" described is a compilation of non-clinical bench testing.

  • Performance Testing (Bench): This included verification of features like length, leakage rate, compliance, resistance to flow (with and without bend), adaptor retention, circuit weight, ventilator accessory flow rate, expiratory star lumen tubing kink and crush resistance, moisture removal, and pressures.
  • Biocompatibility Testing: Evaluated cytotoxicity, irritation/intracutaneous reactivity, sensitization, genotoxicity, material mediated pyrogenicity, and extractables/leachables. Gas pathway evaluation included particulate matter and VOCs.
  • Electrical Safety and EMC Testing: Per IEC 60601-1 and IEC 60601-1-2.
  • Human Factors and Usability Testing: Summative testing was performed.

Therefore, I cannot populate the table or provide detailed responses to the AI/ML-specific questions as they are not relevant to the provided text.

In summary, based on the provided document:

1. A table of acceptance criteria and the reported device performance:
   • Acceptance Criteria (derived from standards):
     • Resistance to Flow:

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When used with a Neptune Heated Humidifier and Hudson RCI ventilator circuits, the ConchaSmart Column provides heated humidification for patients with and without an artificial airway in place.

The ConchaSmart Column is an accessory to the Neptune Heated Humidifier (K063758 and K131912). It is a single use, disposable humidifier cartridge which is intended for neonatal, infant, pediatric, and adult patients requiring heated humidification. The ConchaSmart Column is used by inserting the column into the center of the Neptune Heated Humidifier.

The provided document is a 510(k) summary for the ConchaSmart Column, a respiratory gas humidifier. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device.

Therefore, the requested information categories related to acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are largely not applicable to this type of regulatory submission. This document describes a medical device, but not an AI-powered one that would typically undergo the kind of performance evaluation requested.

However, I can extract the information that is present and indicate where the requested information is not applicable (N/A) or not provided in this document.

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

The document presents a comparison to a predicate device based on technological characteristics and performance specifications rather than explicit acceptance criteria and a study proving device performance against those criteria in the way an AI device would be evaluated. The "reported device performance" in this context refers to its specifications alongside those of the predicate.

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