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The HAMILTON-H900 humidifier is intended to add moisture and to warm breathing gases during invasive and non-invasive mechanical ventilation. The intended area of use is the intensive care ward or the recovery room.
The HAMILTON-H900 humidifier is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications for patients > 10 kg.
The HAMILTON-BC8022 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of adult and pediatric patients > 10 kg.
The HAMILTON-BC4022 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of adult and pediatric patients > 10 kg.
The HAMILTON-BC8010 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive mechanical ventilation of infants > 10 kg.
The HAMILTON-BC4010 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of infants > 10 kg.

The HAMILTON-H900 respiratory gas humidifier is designed to add heat and moisture to respiratory gases, which are then administered to patients who need invasive or noninvasive ventilation. The breathing gas is passed through a humidifier chamber, where the gas is heated and humidified using an external heat source.
The HAMILTON-H900 humidifier uses breathing circuits that are recognized automatically when connected to the humidifier. The humidifier uses two heating systems as heat sources:

• -A heating plate that has contact with the metal plate of a special humidifier chamber inserted into the base of the humidifier prior to application, thus heating the water contained inside the chamber.
• -The controlled heating within the breathing circuits.
  The respiratory gas exiting the humidifier chamber is continuously monitored using temperature sensors that are integrated into the humidifier base. Additionally, a temperature probe inside the breathing tube is used to measure the temperature of the gas delivered to the patient airway.
  The design of the breathing tubes offers heating performance over the entire length by providing constant heating of the entire tube wall, from the chamber exit to the patient connection. A float mechanism, together with detection of the water level inside the humidifier chamber and the autofill mechanism, keeps a constant water level.
  The HAMILTON-BC8022 and HAMILTON-BC8010 are single-use, dual-limb breathing circuits comprising heated inspiratory and heated expiratory tubes. The humidifier chamber uses a float mechanism to keep a constant water level inside the auto-feed chamber.
  The HAMILTON-BC4022 and HAMILTON-BC4010 are single-limb breathing circuits comprising a heated inspiratory tube. The humidifier chamber uses a float mechanism to keep a constant water level inside the auto-feed chamber.

This document is a 510(k) Summary for medical device clearance, specifically for the Hamilton-H900 respiratory gas humidifier and associated breathing circuits. It details the device's characteristics and compares them to predicate devices to establish substantial equivalence.

Based on the provided text, the document describes performance data regarding electrical safety, electromagnetic compatibility, mechanical testing, software verification and validation, biocompatibility, and a human factors/usability study. However, it does not contain information about studies involving human readers, ground truth established by experts, or specific acceptance criteria and performance data in a comparative table for an AI/human-in-the-loop system.

The document states:

• "Hamilton Medical has demonstrated the HAMILTON-H900 humidifier and the HAMILTON-BC-series breathing circuits to have adequate performance."
• "The following performance and nonclinical data were provided in support of the substantial equivalence determination."
• It then lists various technical tests meeting industry standards (IEC, ISO).

Therefore, I cannot directly answer your request for a table of acceptance criteria and reported device performance (in the context of an AI/human-in-the-loop system as implied by the prompt's follow-up questions) or any details related to expert ground truth, adjudication, MRMC studies, or multi-reader studies, as these concepts are not mentioned in this regulatory submission for a respiratory humidifier and its circuits. This document focuses on the technical performance and safety of hardware and software components against established engineering standards and predicate devices.

To answer your specific questions based only on the provided text:

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

   • The document provides several comparison tables for "Characteristic used for comparison" (e.g., flow range, accuracy displayed temperature, humidity performance, etc.) against predicate devices (Tables 1, 2, and 3). These characteristics can be interpreted as performance metrics, and the device's reported values are listed. However, explicit "acceptance criteria" for these values are not stated as pass/fail thresholds within these tables, but rather as performance characteristics matched or compared to predicates.
   • For the non-clinical tests (e.g., Electrical Safety, EMC, Mechanical Testing, Software V&V, Biocompatibility, Human Factors), the acceptance criterion is implicitly compliance with the stated industry standards (e.g., IEC 60601-1, ISO 8185, ISO 5367, ISO 5356-1, ISO 10993-1). The reported device performance is that it "complies with" these standards.

   Example (from various sections, not a single explicit table):

   Acceptance Criterion (Implied)	Reported Device Performance	Source Section
   Compliance with IEC 60601-1 (Electrical Safety)	The devices comply with the IEC 60601-1 standard for safety.	Electrical Safety and Electromagnetic Compatibility
   Compliance with ISO 8185 (Respiratory Gas Humidifiers)	The devices comply with the ISO 8185 standard for respiratory gas humidifiers.	Electrical Safety and Electromagnetic Compatibility
   Airway temperature control (Invasive mode)	33°C - 43°C	Table 1
   Humidity performance (Invasive mode)	>33 mg H2O/L at up to 60 L/min flow and 26°C ambient temp.	Table 1
   Software Validation (Level of Concern: Major)	All specified requirements have been implemented correctly and completely.	Software Verification and Validation Testing
   Biocompatibility (following ISO 10993-1)	Testing in accordance with ISO 10993-1 performed, including Cytotoxicity, Sensitization & Irritation, Systemic Toxicity, Genotoxicity, Implantation Testing, Extractables and Leachables.	Biocompatibility
   Compliance with ISO 5367 (Breathing Tubes)	The breathing circuits comply with the ISO 5367 standard for breathing tubes.	Mechanical Testing
   Human Factors / Usability	Conformance with "Applying Human Factors and Usability Engineering to Medical Devices, 2016" guidance.	Human Factors / Usability Study

2. Sample sizes used for the test set and the data provenance: Not specified in the document for the performance studies. The testing appears to be primarily lab-based performance and safety verification of the device hardware and software. It does not mention clinical trial data or patient data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document is not evaluating an AI system against expert consensus or ground truth derived from expert review. It's about a hardware medical device (humidifier) and its compliance with engineering standards.

4. Adjudication method: Not applicable (no expert review process described).

5. 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: Not applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm, but hardware and embedded software. The software V&V was done, but it's not a standalone AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the functional performance (e.g., temperature, humidity), the "ground truth" would be measurements from calibrated instruments and adherence to the specifications derived from the predicate devices and applicable standards. For other tests like electrical safety, EMC, and biocompatibility, the ground truth is compliance with the specified international standards. No expert consensus, pathology, or outcomes data is mentioned as ground truth.

8. The sample size for the training set: Not applicable. This document is about a finished medical device (hardware and embedded software), not a machine learning model that undergoes a separate training phase.

9. How the ground truth for the training set was established: Not applicable. (See #8).

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The Hybernite RT heated breathing circuits are intended to carry warmed/moistened gas from the humidifier to the patient's airways. The Hybernite RT breathing tubes are indicated for patient populations from neonates to adults. They may be used in the home or hospital environments. They are for single patient use only.

The Hybernite RT is a breathing system heater according to 21 CFR§ 868.5270. A breathing system heater is identified by the Food and Drug Administration (FDA) as a therapeutic device that is intended to warm breathing gases before they enter a patient's airway. The Device family "Hybernite RT" is the name for dual wire passive heated breathing circuits optimized for patient category and application. The Hybernite RT is optimized for 3 patient categories, adult, paediatric and neonatal. Within each patient category there is a dual limb and single limb version to accommodate the specific clinical application as tabulated below; the device is intended to act as a conduit for the breathing gasses delivered from the ventilator to the humidifier, from the humidifier to the patient and if applicable from the patient to the ventilator. The product family of Hybernite RT is defined as the combination of non- heated and heated breathing tubes intended to deliver the desire air temperature at the patient port when used in combination with a Humidifier. The Hybernite RT tubing has a range of tubing dimensions (Internal diameter from 10 mm to 22 mm and length from 0.3 meter to 2.4 meters) depending on the clinical application that can be connected to a humidifier. That means that the performance requirement in terms of desired patient port temperatures is controlled by the Humidifier. The Hybernite RT functions as a heating element. All members of this device family therefore share the same basic design and performance characteristics as related to the safety and efficacy of the device, the same intended use and function and device classification. The heated tubing comprises a single limb single lumen smooth bore tube containing 2 heater wires that are embedded in the tubing construction. The heating wires are physically separated from the lumen of the tubing. When a voltage is applied, a current flows through the heating wires. Due to the wire resistance, heat is dissipated through the wall of the tube construction into the air flow in the lumen of the tubing. As a result, the air passing through the tubing is warmed reducing or eliminating water condensation and/or pooling of water in the breathing circuit and the problems associated with such condensation. The nonheated tubing has the same construction as the heated tubing without the heating wires incorporated. The lead from the heated limb can be connected to the humidifier to supply the heating. The Hybernite RT does not have sensing functionality. However it is equipped with a flow probe port and a temperature probe port which connect with the sensors of the humidifier. Based on these readings the humidifier regulates the power supplied to the Hybernite RT. All the cuffs of the Hybernite RT breathing tubes are standard cuffs. As such, the Hybernite RT breathing tubes can be connected to ventilators and masks that have standard male/female outlet connectors. The Hybernite RT can be used in a hospital environment in combination with the Fisher & Paykel MR 850 Heated Humidifier.

The provided document is a 510(k) summary for the Hybernite RT, a heated breathing circuit. It describes the device, its intended use, and a comparison to predicate devices, along with non-clinical data and testing conducted.

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

The document does not explicitly state "acceptance criteria" with numerical targets for clinical performance that would typically be found in an AI/diagnostic device submission. Instead, it focuses on demonstrating substantial equivalence to predicate devices through compliance with established standards and comparable performance characteristics for a breathing system heater.

The performance characteristics evaluated are:

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of an AI/diagnostic algorithm using patient data. The testing described is primarily for engineering and safety performance of the physical device.

• Performance Testing: "Comparative performance testing has been done for the Hybernite RT and Intersurgical Predicate utilizing the Fisher & Paykel MR 850 Heated Humidifier." No specific sample size (e.g., number of circuits, number of test runs) is provided, nor is the provenance of this testing (e.g., conducted internally, by a third-party lab, country of origin).
• Biocompatibility Testing: "All materials utilized in the Hybernite RT circuits have been evaluated according to tests outlined in ISO 10993-1." This involves material samples, not a patient test set.
• Usability Study: "The device has been subject to a usability study according to IEC 62366." The number of participants or details of the study are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this submission. The device is a heated breathing circuit, and its performance and safety are evaluated against engineering standards and physiological parameters (e.g., temperature, flow resistance), not by expert interpretation of medical images or diagnostic data. Therefore, there is no "ground truth" in the sense of expert consensus on diagnostic findings.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As described above, there is no test set requiring expert adjudication for ground truth establishment.

5. 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

Not applicable. This is a submission for a physical medical device (heated breathing circuit), not an AI-powered diagnostic or assistive tool for human readers. There is no AI component, and thus no human-in-the-loop performance study or MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. There is no algorithm for this device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable in the typical sense for an AI/diagnostic device. For this physical device, "ground truth" for performance is established by objective measurements against harmonized standards (e.g., ISO, IEC) and internal specifications. For instance, temperature measurements are compared against a maximum allowable temperature (40°C), and resistance to flow is measured and compared against ISO 5367 requirements. Biocompatibility is assessed through standardized tests on materials.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. There is no training set or AI component.

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The Gründler HumiCare D900 system is intended to heat and humidify medical respiratory gases for patients. The device is for use during artificial ventilation or ventilatory support (e.g. invasive ventilation via tracheal tube or cannula), non-invasive ventilation, or respiratory therapy by means of a mask or other patient interface.

Heated breathing circuits are intended to provide warmed and/or humidified breathing gases before entering the patient airway reducing or eliminating water. They are accessories for the Gründler's HumiCare D900. The heated breathing circuits are used for flow rates greater than 3L/min.

The system is for use in hospital/institutional environment or in the home environment by medically trained healthcare users.

The HumiCare D900 system is a respiratory gas humidifier according to 21 CER §868.5450. A respiratory gas humidifier is identified by the Food and Drug Administration (FDA) as a therapeutic device that is intended to warm and add humidity.

The HumiCare D900 including heated air tubings is an active heated humidifier which employs a passover humidification via an enhanced surface area for gas/water. The huge gas/water sufface area is resulting in an output of gas with a temperature almost identical to that of the water with a relative humidity of 100%.

The principle HumiCare D900 is to direct the gas mixture from the ventilator's outlet into the humidifier's water chamber via air tubing. There it is heated and humidified by means of heated water. A heated inspiratory tube is used to transport the conditioned gas from the water chamber's outlet to the patient.

Depending on the patient interface an inspiratory tube or inspiratory and expiratory tubes can be used for the humidification with HumiCare D900. The inspiratory limb can further include an antibacterial filter with filter heater to reduce condensation. In order to minimize condensation (rain out), both inspiratory and expiratory air tubing can be actively heated therefore temperature sensors are included in the inspiratory and expiratory air tubing,

The HumiCare D900 system consists of a heater base with external power supply, connector cables, a 30day disposable water chambers, heated tubes (inspiratory), connection tube, antibacterial filter and filter heater. The 30day disposable water chamber and air tubing circuits are intended for single patient use, with the exception of when an antibacterial filter is incorporated into the circuit allowing multi-patient use of the chamber. The HumiCare D900 heater base and filter heater are intended for multi-patient re-use.

The HumiCare D900 is a respiratory gas humidifier. The provided text from the 510(k) summary (K122765) states that various design and verification activities were performed to ensure the device met predetermined acceptance criteria. These tests confirmed that the product met these criteria, specifically highlighting side-by-side testing for humidification performance and resistance.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "All tests confirmed the product met the predetermined acceptance criteria. In particular side-by-side testing demonstrated that the HumiCare D900 essential performance specifications (humidification performance, resistance of the humidifier) are Substantially Equivalent to the predicate devices."

However, specific numerical acceptance criteria or detailed performance reports are not provided in this summary. The summary only generally states that the device met the criteria and was substantially equivalent to predicate devices for "humidification performance" and "resistance of the humidifier."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the test set. It also does not define the data provenance (e.g., country of origin, retrospective or prospective) for the performance testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts or a ground truth established by them for the performance validation of the HumiCare D900. The testing appears to be of a technical/engineering nature, comparing the device's technical specifications and performance against predicate devices and relevant standards.

4. Adjudication Method for the Test Set

Since an expert-based ground truth is not mentioned, there is no adjudication method described in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document describes a medical device (a respiratory gas humidifier) and its engineering and performance validation. It does not involve human readers interpreting data or a multi-reader multi-case comparative effectiveness study in the context of AI assistance.

6. If a Standalone Performance Study Was Done

Yes, a standalone performance study was done in the sense that the device's performance was evaluated against predetermined acceptance criteria and compared to predicate devices. The text states: "All tests confirmed the product met the predetermined acceptance criteria. In particular side-by-side testing demonstrated that the HumiCare D900 essential performance specifications (humidification performance, resistance of the humidifier) are Substantially Equivalent to the predicate devices." This implies that the device (algorithm/system) was tested on its own to demonstrate its functionality and equivalence.

7. The Type of Ground Truth Used

The "ground truth" for the HumiCare D900's performance appears to be based on:

• Engineering specifications and pre-determined acceptance criteria for device functionality.
• The performance characteristics of legally marketed predicate devices, against which the HumiCare D900 was deemed "substantially equivalent."
• Compliance with recognized standards (e.g., ISO 8185:2009 for humidifiers, ISO 10993 series for biocompatibility, IEC 60601-1 for safety).

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here, as this device is a physical medical device (a humidifier) and not an AI/machine learning model that undergoes training on data.

9. How the Ground Truth for the Training Set Was Established

As mentioned above, the concept of a "training set" is not applicable to this device. Therefore, no ground truth for a training set was established.

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