(118 days)
The HAMILTON-G5 ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients, and optionally to infant and neonatal patients. The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care, including use as a patient bedside for intra-facility transport, provided compressed gas is supplied. 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 (optionally) heliox to ventilate adults, pediatrics, and optionally infants and neonates. It is powered by ac with battery backup to protect against power failure or unstable power and to facilitate intrahospital transport. The HAMILTON-G5's pneumatics deliver gas, and its electrical systems control pneumatics, monitor alarms, and distribute power. The user interface consists of a LCD-display with touch screen, keys, and a press-andturn knob. The CO2 option allows continuous mainstream monitoring of carbon dioxide.
The provided text describes a 510(k) summary for the HAMILTON-G5 continuous ventilator. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information regarding acceptance criteria and study details (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details) is not directly available or applicable in this document because the submission relies on non-clinical performance and equivalence.
However, I can extract the information that is present and explain why other details are missing based on the nature of a 510(k) submission.
Here's a breakdown of the available and missing information:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion/Test | "Acceptance Criteria" (Implied) | Reported Device Performance |
|---|---|---|
| Safety | Compliance with relevant IEC standards | "The test results show that the device is safe and effective for its intended use." (Based on IEC60601-1, IEC60601-1-2, IEC 60601-2-12 and other applicable standards) |
| Wave-form Performance | Substantial equivalence to a legally marketed device (as described in ASTM F1100-90) | "The data provided from these tests, were shown to be substantially equivalent to a legally marketed device." |
| Software Verification & Validation | All specified requirements implemented correctly and completely | "The results of the software verification and validation testing demonstrate that all specified requirements have been implemented correctly and completely." |
| Overall Equivalence | As safe, as effective, and performs as well as or better than legally marketed predicate devices | "The results of verification, validation, and testing activities demonstrate that the HAMILTON-G5 ventilator including the new options is as safe, as effective, and performs as well as or better than the legally marketed devices identified above." |
| Indended Use | Comparable to predicate devices | "The indication statements for the HAMILTON-G5 ventilator are comparable to those for the predicate devices." |
| Technological Characteristics & Performance Specifications | Substantially equivalent to predicate devices | "Technological characteristics and performance specifications of the HAMILTON-G5 ventilator are substantially equivalent to those of the predicate devices." |
| CO2 Option | Substantially equivalent to CO2 gas analyzer of predicate device Servo-i | "The Carbon dioxide gas analyzer is considered to be substantial equivalent to the CO2 gas analyzer of the currently marketed predicate device Servo-i." |
| Heliox Option | Comparable to option of predicate device AVEA ventilator | "The heliox option is comparable with the substantial equivalent option of the predicate device AVEA ventilator." |
| Neonate Ventilation Characteristics | Substantially equivalent to predicate devices Servo-i, Engström Carestation, and Evita XL | "The neonate ventilation characteristics are substantially equivalent to those of the predicate devices Servo-i, Engström Carestation, and Evita XL." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable/not provided. The submission refers to non-clinical performance tests (safety, waveform, software) rather than a clinical test set with patient data.
- Data Provenance: Not applicable. The tests appear to be laboratory-based and engineering evaluations, not involving patient data from specific countries or retrospective/prospective studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/not provided. Ground truth establishment with experts is typical for diagnostic algorithms, not for physical medical device performance testing in this context. The "ground truth" here is adherence to engineering standards and functional specifications.
4. Adjudication method for the test set
- Not applicable/not provided. Adjudication methods are typically associated with expert consensus in clinical studies, which are not described here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
- No, an MRMC comparative effectiveness study was not done. This type of study is common for diagnostic imaging AI, to evaluate how AI assists human readers. This submission focuses on the safety and performance of a physical ventilator.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The HAMILTON-G5 is a medical device (ventilator), not an algorithm in the AI sense. Its performance is evaluated through engineering tests and comparison to predicate devices, which can be considered "standalone" in that it performs its function without human intervention for the measurement of that function, but it's not an "algorithm-only" performance in the way an AI would be evaluated.
7. The type of ground truth used
- The "ground truth" for this ventilator device primarily constitutes:
- Compliance with International Standards: IEC60601-1, IEC60601-1-2, IEC 60601-2-12, ASTM F1100-90.
- Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices (HAMILTON-G5 K070513, MAQUET Servo-i K041223, Viasys AVEA ventilator K062093, Datex-Ohmeda Engström Carestation K062710, Dräger EvitaXL with NeoFlow Option K051263, K983219).
- Software Requirements: The specified requirements for the device's software.
8. The sample size for the training set
- Not applicable/not provided. The document describes a medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable/not provided for the same reason as point 8.
§ 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).