(452 days)
The HAMILTON-C1 ventilator is intended to provide positive pressure ventilatory support or continuous flow of respiratory gases to adults and pediatrics, and optionally infants and neonates.
Intended areas of use:
· In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room
· During transfer of ventilated patients within the hospital
The HAMILTON-C1 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 ventilator is intended to provide positive pressure ventilatory support or continuous flow of respiratory gases to adults and pediatrics, and optionally infants and neonates.
Intended areas of use:
· In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room
- · For emergency medical care
- · During transport within and outside the hospital
- · During transfer by rescue vehicles, fixed wing aircraft, helicopter or ship
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-C1 and HAMILTON-T1 ventilators are designed for adults, pediatrics, infants and neonatal patients requiring invasive or non-invasive ventilation support. All ventilators cover a range of clinical requirements, including invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and Non-Invasive Ventilation.
The previously cleared ventilators, HAMILTON-C1 and HAMILTON-T1 (both K140939), have been bundled together in this 510(k) submission in order to add the following new features:
A modification to the software allows compatibility with the Nihon Kohden -SpO2 sensors to be used with HAMIILTON-C1 and HAMILTON-T1 ventilators. These ventilators are already compatible and cleared for use with Masimo SpO2 sensors (K140939).
- cFlow was added, which continuously delivers an air/gas mixture.
- -A modification to the software, which allows HAMILTON-C1/T1 ventilators to be compatible for use with speaking valves. A speaking valve allows tracheostomized adult and pediatric patients to communicate verbally.
The provided text describes the Hamilton-C1 and Hamilton-T1 ventilators and their clearance by the FDA. The submission focuses on adding new features to already cleared devices.
Here's an analysis of the provided information regarding acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria for the new features (cFlow, Speaking Valve, and Nihon Kohden SpO2 sensor compatibility) and their reported performance. Instead, it states that "the data provided from these tests was shown to be equivalent to the legally marketed devices." This implies that the acceptance criterion was equivalence to predicate/reference devices, and the reported performance met this criterion.
However, the "SUMMARY OF THE TECHNOLOGY AND PERFORMANCE SPECIFICATIONS COMPARISON WITH THE PREDICATED DEVICES" (Table 1 on pages 5-6) compares various parameters of the proposed HAMILTON-C1/T1 with the predicate HAMILTON-C1/T1 (K140939). For all listed parameters (Indications of Use, Control settings, Modes of ventilation, Alarms), the comparison states "Substantially Equivalent" or "Equivalent". While this table doesn't detail performance metrics for the new features, it confirms that the device, with its existing features, is considered equivalent to its predicate.
For the new features, the text mentions:
- cFlow: "cFlow was added, which continuously delivers an air/gas mixture." It later states, "The Nihon Kohden NKV-550 Series Ventilator System is used as a reference device for the proposed HAMILTON-C1/T1 as both the reference device and the proposed device are intensive care ventilators which have the O2 therapy/cFlow feature." This implies the cFlow feature in HAMILTON-C1/T1 is equivalent to that in the Nihon Kohden NKV-550.
- Nihon Kohden SpO2 sensors: "A modification to the software allows compatibility with the Nihon Kohden -SpO2 sensors to be used with HAMIILTON-C1 and HAMILTON-T1 ventilators." The document states, "The HAMILTON-C3 is used as a reference device for the proposed HAMILTON-C1/T1 as both the reference device and the proposed device are intensive care ventilators which can be used with Nihon Kohden SpO2 sensors and accessories." This suggests compatibility and performance with these sensors are equivalent to the HAMILTON-C3.
- Speaking Valve: "A modification to the software, which allows HAMILTON-C1/T1 ventilators to be compatible for use with speaking valves." "The Esprit Ventilator V200 with Speaking mode Option is used as a reference device for the proposed Speaking valve compatibility on the modified HAMILTON-C1/T1..." This indicates equivalence to the Esprit Ventilator V200's speaking mode.
Implicit Acceptance Criteria and Reported Performance for New Features:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| cFlow Feature: Performance and safety of continuous delivery of air/gas mixture should be equivalent to the reference device (Nihon Kohden NKV-550 Series Ventilator System). | "The data provided from these tests was shown to be equivalent to the legally marketed devices." (Referring to comparison testing with legally marketed devices for the new features). |
| Nihon Kohden SpO2 Sensor Compatibility: Successful compatibility and performance with Nihon Kohden SpO2 sensors should be equivalent to the reference device (HAMILTON-C3), which also supports these sensors. Compatibility with existing Masimo SpO2 sensors should be maintained. | "The data provided from these tests was shown to be equivalent to the legally marketed devices." (Referring to comparison testing with legally marketed devices for the new features). |
| Speaking Valve Compatibility: Safe and effective operation with speaking valves for tracheostomized adult and pediatric patients should be equivalent to the reference device (Esprit Ventilator V200 with Speaking mode Option) and maintain functionality in invasive modes. Waveform characteristics should be comparable to legally marketed devices. | "The data provided from these tests was shown to be equivalent to the legally marketed devices." Additionally, "waveform comparison testing was completed for the Speaking Valve Feature." and "The data provided from these tests was shown to be equivalent to the legally marketed devices." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify exact sample sizes (e.g., number of patients, number of test cases) used for the comparison testing of the new features. It only states that "Testing of the modified HAMILTON-C1/T1, with the new features, was conducted."
The provenance of the data (country of origin, retrospective/prospective) is also not mentioned. The non-clinical performance tests are generally bench testing and software validation, not human studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the document describes non-clinical performance tests for a ventilator, not diagnostic imaging or AI performance where human expert consensus would establish ground truth. The "ground truth" for these tests would be established through engineering specifications, validated test equipment, and established medical device standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The testing described is non-clinical performance and software validation, not a multi-reader clinical study requiring adjudication.
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 ventilation device, not a diagnostic AI tool, so no MRMC study or AI assistance improvement for human readers would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not entirely applicable in the context of a ventilator. However, the software validation and bench testing can be considered "standalone" in the sense that the device's technical performance and software functions were tested independently of a human operator making clinical decisions or interpreting results in a real patient scenario. The tests confirm the device operates as intended according to its design specifications and relevant standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical performance tests and software validation would be based on:
- Engineering Specifications: The defined functional requirements and performance limits of the device.
- International and National Standards: Compliance with standards like ANSI/AAMI ES60601-1, IEC 60601-1-2, ISO 80601-2-12, etc. (listed in Section IX) which define acceptable ranges and behaviors for critical care ventilators, electromagnetic compatibility, alarm systems, and usability.
- Predicate/Reference Device Performance: The established, legally marketed performance of the predicate HAMILTON-C1/T1 and the reference devices (Nihon Kohden NKV-550, HAMILTON-C3, Esprit Ventilator V200) for the new features. Equivalence to these cleared devices serves as a form of "ground truth" for substantial equivalence.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning product that requires a training set. The changes described are software modifications for compatibility and feature additions to a pre-existing ventilator design.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of medical device submission.
§ 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).