(29 days)
The HAMILTON-T1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics.
Intended areas of use:
- · In the intensive care ward or in the recovery room.
- · For emergency medical care or primary care.
- · During transport within and outside the hospital.
- · During transfer by rescue vehicles, jet or helicopter.
The HAMILTON-T1 ventilator 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.
The HAMILTON-T1 is designed for adults and pediatrics requiring invasive or noninvasive ventilation support. Due to its compact design, a fully-loaded weight of only 6.5 kg (14.3 lbs), a twin hot-swappable battery supply, and a built-in turbine; the HAMILTON-T1 can accompany a ventilated patient everywhere within the hospital or outside the hospital when transport is needed. The HAMILTON-T1 can run using AC or DC power. It does not need compressed air or O2 to drive the pneumatics, which reduces the weight load in the aircraft needed to operate the ventilator.
Since the HAMILTON-T1 has been tested and evaluated for flight and high-altitude environments, it can be also used during patient transfer by emergency rescue vehicles, fixed-wing aircraft, or helicopter. This makes the HAMILTON-T1 especially relevant for Aeromedical Evacuations and Medevac operations.
The HAMILTON-T1 ventilator uses the same graphical user interface (GUI) used by the HAMILTON-C2 and HAMILTON-G5, featuring a touchscreen "Ventilation Cockpit", this provides the exact information that the user needs and helps focus on what is important. In addition, the HAMILTON-T1 includes the ASV ventilation-mode which automatically applies lung-protective strategies, reduces the risk of operator error, and promotes early weaning.
The HAMILTON-T1's microprocessor system controls gas delivery and monitors the patient. The gas delivery and monitoring functions are cross-checked by an alarm controller. This cross-checking helps prevent simultaneous failure of these two main functions and minimizes the possible hazards of software failure.
The HAMILTON-T1 is intended as a transport ventilator, based on the existing HAMILTON-C2, with minor adaptations to make the HAMILTON-T1 capable of being used in highaltitude flight environments. The HAMILTON-T1's changes include the following:
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- The HAMILTON-T1 software is identical to the HAMILTON-C2's software, except that some of the options are not available with the HAMILTON-T1, (e.g. Neonatal Ventilation & nCPAP-PS). Other features like Trends & Loops, NIV, NIV-ST, APRV, and DuoPAP are standard with the C2, but are only optional with the HAMILTON-T1.
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- The HAMILTON-T1 has increased immunity from EMI, including >30 V/m. It also has extra safety features for the EMD, ESD, and RFI environments found on aircraft.
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- The unit is contained within an impact resistant case which protects the controls from damage and inadvertent manipulation. The enclosure for the HAMILTON-T1 has been ruggedized to withstand shock, vibrations, water ingress, and drops from >1 meter heights.
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- The HAMILTON-T1 was tested for use in fixed and rotary-wing aircraft.. Because mechanical ventilation can be challenging during air-medical transport, particularly due to the impact of changing barometric pressure with different altitude levels, the HAMILTON-T1 automatically compensates for altitude changes. Adjusting provided- and measured-patient volumes accordingly, thereby eliminating the need for manual calculation and reducing the risk of error.
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- The HAMILTON-T1 has a "lock-button" which prevents an inadvertent change of settings. If screen lock is active, the following items are inactive: Touchscreen. Power/Standby switch, Print-screen key, Press-and-turn knob. Active are Alarm Silence, Manual Breath, O2 enrichment, Nebulizer. To switch off power, the user must press the On/Off button for > 3 s.
Acceptance Criteria and Study for HAMILTON-T1 Ventilator
This document describes the acceptance criteria and the non-clinical study that demonstrates the HAMILTON-T1 ventilator meets these criteria, as presented in the provided 510(k) summary (K120670).
1. Table of Acceptance Criteria and Reported Device Performance
The HAMILTON-T1 is essentially a modified HAMILTON-TC1 (K112006) for use in high-altitude flight environments. Therefore, its performance is largely measured against established standards and its predicate device. The acceptance criteria are derived from these recognized standards and confirmed through a battery of non-clinical tests.
| Acceptance Criteria Category | Specific Criteria (Standard/Guidance Document) | HAMILTON-T1 Performance (Reported in 510(k) Summary) |
|---|---|---|
| Safety - General | IEC 60601-1: General Requirements for Safety | Non-clinical test results show device is safe. |
| Safety - Electromagnetic Compatibility (EMI) | IEC 60601-1-2: Electromagnetic Compatibility | Increased immunity from EMI, including >30 V/m. Meets RTCA/DO-160F, Section 21, Category M (maximum level of radiated radio frequency interference). |
| Safety - Software | IEC 60601-1-4: Programmable electrical medical systems; IEC 62304: Software life-cycle processes | Software verification and validation testing demonstrates all specified requirements implemented correctly and completely. Hazard analysis and traceability analysis performed. |
| Safety - Alarms | IEC 60601-1-8: Alarm Systems | Not explicitly detailed, but implied through general safety and predicate equivalence. |
| Safety - Critical Care Ventilators | IEC 60601-2-12: Critical Care Ventilators | Not explicitly detailed, but implied through general safety and predicate equivalence, and its basis on HAMILTON-C2. |
| Usability | IEC 62366: Application of usability engineering to medical devices; AAMI/ANSI HE75: Human factors engineering. Design of medical devices | Touchscreen "Ventilation Cockpit" provides exact information, helps focus. "Lock-button" prevents inadvertent changes. |
| Risk Management | EN ISO 14971: Application of risk management to medical devices | Hazard analysis performed. |
| Airborne Environmental Conditions | RTCA/DO-160F (Environmental Conditions and Test Procedures for Airborne Equipment), specific sections: 7 (Normal surge voltage), 8 (Low/Abnormal surge voltage, Voltage spikes), 16.6 (DC input power leads), 17 (Vibration), 18.3.1 (Operational Shocks and Crash Safety), 19.3.1 (Abnormal operating conditions), 20 (Magnetic field induced into equipment), 21 (Radio Frequency Susceptibility - Radiated & Conducted), 25 (Electrostatic Discharge & Radiated Electromagnetic Field) | Tested and evaluated for flight and high-altitude environments. Meets or exceeds all specified RTCA/DO-160F sections. Automatically compensates for altitude changes. |
| Road Ambulances | EN 1789: Medical vehicles and their equipment - Road ambulances | Unit ruggedized to withstand shock, vibrations, water ingress, and drops. |
| Air Ambulances | EN 13718-1: Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances | Tested for use in fixed and rotary-wing aircraft. Automatically compensates for altitude changes. |
| Mechanical Performance (Waveform) | ASTM F1100-90: Standard Specification for Ventilators Intended for Use in Critical Care (for waveform standard analysis) | Ventilator subjected to waveform performance testing. |
| Ruggedness/Durability | EN 794-3: Particular requirements for emergency and transport ventilators (Equal to EN 60068-2-6; -29; -64) | Unit contained in impact resistant case, ruggedized to withstand shock, vibrations, water ingress, and drops from >1 meter heights. |
| Input Power | IEC 62133: Battery Safety. Non-Spillable. | Twin hot-swappable battery supply. Runs using AC or DC power. |
| Software Equivalence | N/A | Software is identical to HAMILTON-C2's software, with some options unavailable. |
| Predicate Equivalence | N/A | Intended use, technological characteristics, and performance specifications are equivalent to HAMILTON-TC1 (K112006). |
2. Sample Sizes Used for Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of devices. The "test set" refers to the HAMILTON-T1 device itself being subjected to various non-clinical tests.
- Data Provenance: The testing was conducted by HAMILTON MEDICAL AG, a Swiss company. The tests are non-clinical, involving the device's physical and software performance under simulated conditions as per internationally recognized standards (e.g., IEC, ISO, RTCA/DO-160, ASTM, EN, MIL-STD). This is a prospective evaluation of the manufactured device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable for this submission. The "ground truth" for non-clinical performance refers to the established requirements and specifications outlined in the referenced standards (e.g., a certain level of EMI immunity, specific waveform characteristics). Compliance is measured against these objective, quantifiable standards, not against expert human interpretations of clinical data. Testing personnel performing these evaluations would be qualified engineers and technicians.
4. Adjudication Method for the Test Set
This section is not applicable for a non-clinical performance study. The adjudication method as described typically refers to how disagreements among human readers or expert reviewers are resolved in a clinical study where subjective interpretation is involved. Non-clinical tests against objective standards do not require such adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on non-clinical performance and equivalence to a predicate device, not on diagnostic or treatment efficacy evaluated through human-in-the-loop performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation of the device's engineering and software attributes was done through the extensive non-clinical testing described. This includes:
- Software verification and validation testing: To ensure specified requirements are implemented correctly and completely.
- Waveform performance testing: As described in ASTM F1100-90.
- EMI/EMC testing: Against IEC 60601-1-2 and RTCA/DO-160F.
- Environmental stress testing: For shock, vibration, water ingress, drops, and high-altitude/low-pressure conditions.
- Safety testing: Against a range of IEC 60601-1 series standards.
These tests evaluate the device's intrinsic functional and safety characteristics without direct human intervention in its operation for a clinical outcome.
7. The Type of Ground Truth Used
The ground truth used for this submission is engineering specifications and recognized international consensus standards. These include:
- Performance Specifications: Quantifiable parameters like FiO2 range, Tidal Volume, Peak Flow, which are compared against known requirements for ventilators.
- Safety Standards: Such as IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-1-8, IEC 60601-2-12, IEC 62304, IEC 62366, EN ISO 14971.
- Environmental and Transportation Standards: Such as RTCA/DO-160F, EN 794-3, EN 1789, EN 13718-1.
- Waveform Standards: ASTM F1100-90.
The device's performance in designated tests is measured against the limits and criteria defined by these standards.
8. The Sample Size for the Training Set
This refers to a machine learning context. Since the HAMILTON-T1 device is not described as utilizing a machine learning algorithm that requires a "training set" of data, this section is not applicable. The device's software is based on the HAMILTON-C2's software and verified through traditional software validation methods, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, this section is not applicable as there is no "training set" in the context of this device's development or evaluation.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).