(114 days)
The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care. The HAMILTON-G5 ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician. The HAMILTON-G5 ventilator may be used for transport within a hospital or hospital type facility provided compressed gas is supplied.
The device is not to be used in the presence of flammable anesthetic agents or other iqnition sources. The ventilator is not to be used in an environment with magnetic resonance imaging (MRI) equipment. The device is not intended for transportation outside the hospital or for use in the home environment.
The HAMILTON-G5 is an electronically controlled pneumatic intensive care ventilator ventilation system. It uses oxygen and air or heliox to ventilate adults, pediatrics, infants, and neonates. It is powered by AC, and with battery backup in order to protect against power failure or unstable power and to facilitate intra-hospital transport. The HAMILTON-G5's pneumatics deliver gas -- while its electrical systems controls pneumatics, monitors alarms and distributes power. The user interface consists of a LCD-display with touch screen, keys, and a press-and- turn knob.
The HAMILTON-G5's new software version 2.30, includes a pulse oximetry function for continuous, non-invasive oxygen saturation monitoring (SpO2).
Volume targeting in the HAMILTON-G5 is now supported by a new ventilation mode, called the Volume Support mode (VS). It is a flow-cycled, volume targeted, and pressure-regulated mode.
The Volume Support (VS) mode is designed for spontaneously breathing patients. It provides support to patient-initiated breaths so as to deliver the desired tidal volume (V+), at a level appropriate to the patient's efforts. This mode allows the ventilator to change the support in response to changing patient conditions and inspiratory effort levels. To achieve this volume, the device decreases support when the patient's breathing activity increases or, conversely, increases support when the patient's inspiratory effort decreases.
Here's an analysis of the acceptance criteria and study information for the HAMILTON-G5 device, based on the provided document:
The document is a 510(k) summary for the HAMILTON-G5 ventilator, specifically for an updated version (SW 2.30) that includes a pulse oximetry function and a new Volume Support (VS) ventilation mode. It focuses on demonstrating substantial equivalence to previously cleared predicate devices.
1. Table of Acceptance Criteria & Reported Device Performance:
The document doesn't explicitly present a typical "acceptance criteria" table with specific quantitative thresholds. Instead, it describes compliance with recognized standards and uses qualitative statements of "substantial equivalence" for the new features.
| Feature | Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|---|
| New Volume Support (VS) Mode | Performance testing as described by the standard ASTM F1100-90. Demonstrated to be substantially equivalent to a legally marketed device (MAQUET Servo-i). | Substantially Equivalent: The new Volume Support mode was subjected to waveform performance testing, as described by the standard ASTM F1100-90. The data provided from these tests were shown to be substantially equivalent to a legally marketed device (MAQUET Servo-i - K073179). The HAMILTON-G5 (SW 2.30) includes the Volume Support mode while the predicate HAMILTON-G5 (SW 2.0) does not, but it is substantially equivalent to the mode in the MAQUET Servo-i. |
| Pulse Oximetry (SpO2) Function | Verification and Validation testing demonstrating that SpO2 and pulse rate values, calculated by the OEM system, are not corrupted during communication to the HAMILTON-G5 host device. Utilizes previously cleared devices (Masimo Rainbow Set Radical Pulse co-oximeter & accessories, Nihon Kohden SpO2 oximeter & accessories). | Substantially Equivalent: Verification and Validation testing demonstrated that the SpO2 and pulse rate values, calculated by the OEM system, are not corrupted during communication to the HAMILTON-G5 host device. No modifications were made to the previously cleared oximeter systems. The proposed HAMILTON-G5 includes both the Masimo (K100428) and Nihon Kohden Pulse Oximetry (K974292, K011918, K032749, K043517) components. |
| General Safety and EMC | Compliance with relevant IEC standards: IEC 60601-1 (General Requirements for Safety), IEC 60601-1-2 (Electromagnetic Compatibility), IEC 60601-2-12 (Critical Care Ventilators), IEC 60601-2-49 (Essential performance of multi-function monitoring equipment). Also "Draft Reviewer Guidance for Ventilators. 1995." (While not a standard, this guidance document outlines expectations for ventilator safety and performance.) | Substantially Equivalent: Safety testing of the HAMILTON-G5, with the new options, was conducted and shows that the device is substantially equivalent to the predicate devices for its intended use. The product's compliance with these standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-12, IEC 60601-2-49, and Draft Reviewer Guidance for Ventilators. 1995) is implicitly stated as part of demonstrating substantial equivalence. The document states, "The results of verification, validation, and testing activities demonstrate that the modified HAMILTON-G5 ventilator is substantially equivalent to the legally marketed devices identified above." |
| Software Verification and Validation | All specified requirements have been implemented correctly and completely for the new software version 2.30. | Verified and Validated: "The results of the software verification and validation testing demonstrate that all specified requirements have been implemented correctly and completely." This applies to the overall software update, including the new VS mode and SpO2 functionality. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify a "sample size" in terms of patient data or a number of test cases. The testing appears to be primarily bench testing (waveform performance, communication integrity) and compliance with standards rather than clinical trials with patient populations.
- Data Provenance: Not applicable as it's not a clinical study involving patient data. The testing mentioned (waveform testing per ASTM F1100-90, software V&V) is likely performed in a lab or simulate environment. The country of origin of the device manufacturer is Switzerland.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- This information is not provided in the document. The document describes compliance with engineered performance standards and internal verification/validation, not the establishment of ground truth by human experts for a test set.
4. Adjudication Method for the Test Set:
- This information is not provided as the testing described does not involve expert adjudication of a test set in the way a clinical study or diagnostic imaging study would.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC comparative effectiveness study was not done. This document is for a medical device (ventilator) seeking 510(k) clearance, which typically relies on
bench testing and substantial equivalence to predicates, not comparative effectiveness studies of human readers with vs. without AI assistance. The device itself is not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- This question is not directly applicable in the context of this device. The HAMILTON-G5 is a ventilator, a physical device with embedded software and functions. The new features (VS mode, SpO2) are integrated functionalities of the device. The "standalone performance" of these functions (e.g., the SpO2 calculation itself) is established by using previously cleared OEM components and by verifying their integration into the HAMILTON-G5, not as a separate, algorithm-only performance assessment like that for a diagnostic AI.
7. The Type of Ground Truth Used:
- The "ground truth" for the new functionalities would be established by:
- Engineering Specifications / Reference Devices: For the Volume Support mode, the "ground truth" for its performance is derived from the established performance characteristics and waveforms defined by the ASTM F1100-90 standard and comparison to the MAQUET Servo-i predicate device.
- Calibration & Known Standards: For the SpO2 function, the "ground truth" for oxygen saturation and pulse rate values would come from the calibrated performance of the OEM pulse oximeter systems (Masimo, Nihon Kohden) and ensuring these values are accurately transmitted and displayed by the HAMILTON-G5.
- Regulatory Standards: Overall safety and electromagnetic compatibility ("ground truth" for compliance) are established by fulfilling the requirements of the cited IEC standards.
8. The Sample Size for the Training Set:
- Not applicable. This document describes a medical device undergoing 510(k) clearance, not an AI or machine learning model that requires a "training set" in the conventional sense. The device's software (SW 2.30) is developed and verified through engineering processes, not by training on a dataset.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no "training set." The software development and verification process would involve testing against validated specifications and expected outputs based on engineering principles and regulatory standards.
§ 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).