(509 days)
The HAMILTON-T1 ventilator is intended to provide positive pressure ventilatory support 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 ventilator is intended to provide positive pressure ventilatory support 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-C1 and HAMILTON-T1 are designed for adults, pediatrics, infants and neonatal patients requiring invasive or non-invasive ventilation support. Both ventilators cover a full range of clinical requirements: including invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and non-invasive ventilation.
The two previously cleared ventilators, the HAMILTON-T1 and the HAMILTON-C1, have been bundled together in this 510(k) submission, in order to add the following new features to both ventilators:
Neonatal patients with a minimum weight of 0.2 kg and a minimal tidal volume of 2 mL. The following two new modes for the neonatal patient group: nCPAP and nCPAP-PC; SpO2 monitoring with MASIMO PULSE OXIMETERS;
An increase in the battery duration from 5.5 hours on the HAMILTON-T1, to 9.25 hours (maximum) instead and an increased battery duration from 2 hours to 4.30 hours on the HAMILTON-C1.
Increased temperature range for the HAMILTON-T1 to 50°C [122°F] for adult and pediatric patients. Increased altitude operating condition for the HAMILTON-T1 from 15.091 ft to 25.000 ft for adult and pediatric patients.
This document is a 510(k) summary for the Hamilton-T1 and Hamilton-C1 ventilators, detailing their substantial equivalence to predicate devices and the performance data supporting this claim.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative table format with corresponding reported device performance for specific features. However, it implies that the devices meet a set of performance and safety standards, and that their performance on new features (neonatal ventilation, improved battery life, increased temperature/altitude range, SpO2 monitoring, and new modes) has been demonstrated to be "substantially equivalent" to legally marketed predicate devices.
The "Difference Status" column in the comparison tables (Table 1 for HAMILTON-T1 and Table 2 for HAMILTON-C1) implicitly acts as a form of "acceptance criteria met" by referencing substantial equivalence to specific predicate devices for each new or changed feature.
| Feature | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Neonatal Ventilation (HAMILTON-T1 & C1) | Must be substantially equivalent to the HAMILTON-C2 (K121225) for neonatal patient group. Minimum weight 0.2 kg, minimum tidal volume 2 mL. | Demonstrated substantial equivalence to HAMILTON-C2 (K121225). |
| nCPAP and nCPAP-PC modes (HAMILTON-T1 & C1) | Must be substantially equivalent to MAQUET Servo-I (K073179). | Demonstrated substantial equivalence to MAQUET Servo-I (K073179). New ventilation modes were subjected to waveform performance testing, as described in ASTM F1100-90, and data was shown to be substantially equivalent to legally marketed devices. |
| SpO2 monitoring (HAMILTON-T1 & C1) | Must be substantially equivalent to the HAMILTON-G5 (K131774) and ensure SpO2 and pulse rate values are not corrupted during communication between OEM system and host device. | Demonstrated substantial equivalence to HAMILTON-G5 (K131774). Testing demonstrated that SpO2 and pulse rate values calculated by the OEM system are not corrupted during communication to the HAMILTON-T1 or HAMILTON-C1 host device. |
| Battery Duration (HAMILTON-T1) | Maximal run time of 9.25 hrs (increased from 5.5 hrs). | Achieved a maximal run time of 9.25 hrs. |
| Battery Duration (HAMILTON-C1) | Maximal run time of 4.30 hrs (increased from 2 hrs). | Achieved a maximal run time of 4.30 hrs. |
| Temperature Range (HAMILTON-T1) | 5 to 50°C (41 to 122°F) for adults/pediatrics (increased from 5 to 40°C). | Components can withstand 50°C (122°F) in the adult/pediatric mode. |
| Altitude Operating Condition (HAMILTON-T1) | 1013 to 376 hPa (25.000 ft) for adults/pediatrics (increased from 1013 to 600 hPa). | Performance in high altitude has been increased for adult/pediatric patients to 376 hPa (25.000 ft). |
| O2 consumption monitoring (HAMILTON-T1) | Must be substantially equivalent to the Dräger Oxylog 3000 (K062267). | Demonstrated substantial equivalence to the Dräger Oxylog 3000 (K062267). |
| VOC and Particulate Matter | Output gas from the device must meet requirements for allowable levels of particulate matter for the most vulnerable patient population. | Gas sample analysis comprising VOC and particular matter testing has demonstrated that the output gas from the device meets the requirements. |
| General Safety and Performance | Compliance with relevant FDA guidelines and international standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, ISO 80601-2-12, IEC 60601-1-8, IEC 60601-1-6, IEC 62366, IEC 62304, ISO 80601-2-55). Software is a "major" level of concern. | Testing demonstrated compliance with all listed standards and guidelines. Software verification and validation testing were conducted as per FDA guidance for "major" level of concern software. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document extensively references "bench testing" and "waveform performance testing" for the new ventilation modes as described in ASTM F1100-90. It also mentions "gas sample analysis" for VOC and particulate matter.
- Sample Size: The document does not specify the sample size for the test sets used in these bench tests.
- Data Provenance: The data appears to be from bench testing conducted by the manufacturer, Hamilton Medical AG, located in Bonaduz, Grisons, Switzerland. The nature of these tests (laboratory-based performance evaluation) suggests they are prospective in relation to the submission.
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 information is not provided in the document. The testing described (bench testing, waveform performance testing, gas sample analysis) is focused on technical performance metrics against specified standards and predicate devices, rather than clinical ground truth established by medical experts for a diagnostic or treatment outcome.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided in the document. The tests described are objective engineering and performance evaluations, not subjective assessments requiring adjudication of ground truth by multiple human reviewers.
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
There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. This document is for a ventilator, not an AI-assisted diagnostic or therapeutic device requiring human interpretation of output. Therefore, information on differences in human reader improvement with or without AI assistance is not applicable and not provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a ventilator, which is a therapeutic medical device, not an algorithm for diagnosis or interpretation. The document describes the performance of the integrated device and its new features. Therefore, the concept of "standalone (algorithm only)" performance as typically applied to AI/ML devices is not directly applicable here. The performance data presented refers to the functionality of the device itself.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the technical performance evaluations, the "ground truth" implicitly refers to the established standards (e.g., ASTM F1100-90), technical specifications, and the performance characteristics of the identified predicate devices. For example, for waveform performance, the waveforms generated by the new modes would be compared against expected waveforms defined by the standard and/or predicate device performance. For VOC and particulate matter, the ground truth is the "requirements for allowable levels" of these substances. This is not clinical ground truth derived from human subjects or pathology.
8. The sample size for the training set
The document describes a mechanical ventilator with hardware and embedded software, not a machine learning or AI algorithm that typically has a "training set." Therefore, the concept of a "training set sample size" is not applicable and not provided. The software mentioned (considered "major" level of concern) undergoes verification and validation, but this is distinct from machine learning model training.
9. How the ground truth for the training set was established
As the concept of a "training set" for an AI/ML algorithm is not applicable to this device, the method for establishing its "ground truth" is also not relevant and not provided. The software verification and validation would follow established software engineering principles and regulatory guidance, ensuring the software performs its intended functions correctly and safely.
§ 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).