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Intended Use HAMILTON-H900

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.

Intended Use HAMILTON-BC8010

The HAMILTON-BC8010 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of pediatric and neonatal patients.

Intended Use HAMILTON-BC4010

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 pediatric and neonatal patients.

HAMILTON-H900

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.

HAMILTON-BC8010

The HAMILTON-BC8010 is a single-use, dual-limb breathing circuit 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.

HAMILTON-BC4010

The HAMILTON-BC4010 is a single-imb breathing circuit comprising a heated inspiratory tube. The humidifier chamber uses a float mechanism to keep a constant water level inside the auto-feed chamber.

HAMILTON-HC322/HC310

The HAMILTON-HC322/HC310 are single-use humidifier chambers with a float mechanism to keep a constant water level inside the auto-feed chamber. The HAMILTON-HC322 humidifier chamber is part of the HAMILTON-BC8022/BC4022 breathing sets and the HAMILTON-HC310 humidifier chamber is part of the HAMILTON-BC8010/BC4010 breathing sets, as cleared in K152029.

This is a 510(k) summary for a medical device (respiratory gas humidifier and breathing circuits), not an AI/ML medical device. Therefore, the information requested about acceptance criteria, study details, and ground truth establishment, which are typical for AI/ML device submissions, are not primarily available or applicable in the provided text.

The document discusses substantial equivalence to predicate devices based on technological characteristics and performance, focusing on non-clinical data. It does not describe an AI/ML algorithm that predicts or diagnoses based on medical images or other data, nor does it detail a study that evaluates the performance of such an algorithm against a ground truth established by experts.

However, I can provide the acceptance criteria and performance as described for this specific device, based on the provided text, recognizing that it's not in the context of an AI/ML model.

Here's an analysis of the provided text, focusing on the closest equivalents to your requested information, understanding the context is a medical device, not an AI/ML diagnostic:

The provided text is a 510(k) summary for the Hamilton-H900 Humidifier and Hamilton-BC series breathing circuits. This document outlines the rationale for the device's substantial equivalence to previously cleared predicate devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and performance specifications and non-clinical testing, rather than the type of clinical performance study typically conducted for AI/ML diagnostic or predictive devices.

Therefore, many of the requested points (e.g., number of experts for ground truth, adjudication methods, MRMC study, standalone performance for an algorithm) are not applicable to this type of device submission.

Here is the information extractable from the document, focusing on performance characteristics and non-clinical testing rather than AI/ML specific criteria:

Acceptance Criteria and Reported Device Performance (Non-AI/ML Context)

The acceptance criteria are implied by the "Characteristic used for comparison" and the "HAMILTON-H900 (Subject device)" column in Table 1 for the humidifier and Table 2 for the breathing circuits. The "reported device performance" is the statement that the subject device meets these established characteristics, which are largely identical to the predicate device.

1. Table of Acceptance Criteria and the Reported Device Performance

For HAMILTON-H900 (Humidifier):

For HAMILTON-BC8010 / BC4010 (Breathing Circuits):

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The Fisher & Paykel HC550 System is designed for use with artificial ventilation systems. Portable volume ventilation systems, pressure support ventilation and Continuous Positive Airway Airway Pressure (CPAP) systems may incorporate an HC550 to provide therapeutic levels of warm humidified air to adult patients with artificial airways or through mask ventilation.

The operating flow range is 5 to 120L/min depending on the patient interface.

The HC550 is designed for use in long term care facilities or the home under the prescription of a qualified medical professional.

The Fisher & Paykel Healthcare HC550 System is designed to condition gases for patients by raising the delivered water vapor content (humidity) and temperature of the gases.

The HC550 System consists of the following components:

• . HC550 Respiratory Humidifier
• . Accessories:
  • a) Breathing circuit (compatible adult breathing circuits as cleared in K983112, K020332, K034026, K103767, K122432)
  • b) Humidification Chamber (as cleared in K9341401 and K913368)
  • c) Heaterwire Adaptor (as cleared in K073706)
  • d) Temperature/Flow Probe (as cleared in K983112)
  • RT008 Air Entrainer (optional oxygen therapy accessory) (as cleared in K953711) e)

The device consists of an electrically powered heat controller, utilizing a microprocessor with embedded software, to control a heating element that transfers heat to the water in a humidification chamber.

A dryline tube (part of the breathing circuit) transports respiratory gases from a flow source (e.g. ventilator) to the humidification chamber where the gases are heated and humidified.

The inspiratory limb of the breathing circuit transports the heated and humidified gases from the humidification chamber to the patient. The inspiratory tube may be electrically heated by means of a heater-wire placed internally to the tube, which is controlled by the HC550 respiratory humidifier.

The expiratory limb of the breathing circuit transports expired gas from patient. In the case of a dual-heated breathing circuit, this limb may also be heated in the same manner as the inspiratory limb.

If a heated breathing circuit is used, the heaterwire adaptor provides electrical energy from the respiratory humidifier to the heaterwire in the breathing circuit.

Temperature probes in the gas path provide feedback on temperature and flow of the gas to regulate temperature and humidity to the patient.

HC550 System Acceptance Criteria and Study Details

This document describes the acceptance criteria and corresponding study results for the HC550 System, a respiratory gas humidifier. The information is extracted from the provided 510(k) Notification K132017.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the HC550 System are based on compliance with the ISO 8185:2007 standard for humidification systems. The device's performance is compared to these requirements.

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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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