(237 days)
The Galileo Gold ventilator is intended to provide positive pressure ventilatory support to Adults, Pediatrics and Infants. The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care, including use as a patient bedside or for intra-facility transport, provided compressed gas is supplied. The device is not intended for transport, outside the hospital or for use in the home environment.
The Galileo ventilator is a legally marketed intensive care ventilator (K982910, K001686). The four modifications included in this application are purely software-related and do not change the hardware of the Galleo Gold ventilator. This application is for the following options to the Galileo Gold ventilator: DuoPAP and APRV modes, NIV mode, MMV+ mode, and TRC feature.
Here's a summary of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes modifications to an existing ventilator (GALILEO Gold) rather than a novel device requiring specific clinical performance metrics like sensitivity, specificity, or accuracy for a diagnostic task. Therefore, the "acceptance criteria" here relate to demonstrating substantial equivalence to predicate devices and ensuring the new software features do not introduce safety or effectiveness concerns. The performance is reported in terms of successful testing and comparison to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| DuoPAP & APRV Modes: | DuoPAP & APRV Modes: |
| - Automatic and regular switchover between two pre-set pressure levels functioning correctly | Yes (No difference to predicate devices: PB 840, Raphael) |
| - Ventilated patient can breathe freely at either pressure level | Yes (No difference to predicate devices) |
| - Spontaneous breaths may be pressure-supported if desired | Yes (No difference to predicate devices) |
| - "Control breaths" synchronized to spontaneous breaths | Yes (No difference to predicate devices) |
| NIV Mode: | NIV Mode: |
| - Underlying mode is Pressure Support | Yes (No differences to predicate device: Evita 4 NIV option) |
| - Inspiration is patient-triggered | Yes (No differences to predicate device) |
| - Inspiration is pressure-limited | Yes (No differences to predicate device) |
| - Inspiration is flow-cycled (first) and time-cycled (second) | Yes (No differences to predicate device) |
| - Indicated for spontaneously breathing patients only | Yes (No differences to predicate device) |
| - Apnea ventilation possible | Yes (No differences to predicate device) |
| TRC Feature: | TRC Feature: |
| - Minimizes additional Work of Breathing (WoB) caused by ET-tube or tracheostomy tube | Yes (No difference to predicate device: Evita 4 ATC option) |
| - Compensates resistance from ET-tube or tracheostomy tube | Yes (No difference to predicate device) |
| - Applies instantaneous opposite counter-force to offset the resistance | Yes (No difference to predicate device) |
| - Compensation works in inspiration and expiration phases | Yes (No difference to predicate device) |
| - Users must set up tube type, size, and compensation intensity | Yes (No difference to predicate device) |
| - Displays on-line a calculated intra-tracheal pressure curve | Yes (No difference to predicate device) |
| MMV+ Mode: | MMV+ Mode: |
| - User sets target minute ventilation | Yes (Matches Evita 4 MMV, Servo1, Servo 300A Automode) |
| - User sets target tidal volume | Yes (Matches Evita 4 MMV, Servo1, Servo 300A Automode) |
| - User sets target rate | Yes (Matches Evita 4 MMV - minimum mandatory rate only, Servo1, Servo 300A Automode) |
| - Regulated inspiratory pressure | Yes (Matches Servo1, Servo 300A Automode (PRVC & VS); Evita 4 MMV does not) |
| - Regulated respiratory rate | Yes (Matches Evita 4 MMV; Servo1, Servo 300A Automode does not) |
| - Assured minimum target minute ventilation | Yes (Matches Evita 4 MMV, Servo1, Servo 300A Automode) |
| - Switch between mandatory and spontaneous breaths | Yes (Matches Servo1, Servo 300A Automode; Evita 4 MMV does not) |
| Overall Software Safety & Performance: | Overall Software Safety & Performance: |
| - No performance deviations during modular, integration, and system testing | "As presented within the accompanying documentation, there were no performance deviations observed or documented during modular, integration and system testing." |
| - Compliance with ASTM Standard F1100-93 (Ventilator Performance) | "The ventilator performance has been further evaluated in accordance to the ASTM Standard F1100-93. The graphical analyses of the waveforms shows that there is no new question raised regarding safety and effectiveness of the complete instrument and its new features." |
| - No impact on microcomputer system (execution times, reaction times, overall load) | "The impact of the new software on the microcomputer system (execution times of the different communication processes, reaction times and the overal load) were tested and documented. As presented within the accompanying documentation, there were no performance deviations observed or documented during the testing." |
| - Substantial equivalence to predicate devices for each new mode/feature for intended use cases | "There are no significant differences between the new Galileo Gold features and its predicates." (This is the overarching conclusion drawn from the detailed feature comparison tables for each mode.) Found substantially equivalent by FDA (K040574). |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes software modifications to an existing device, and the testing focuses on functional verification and validation, rather than clinical trials with patient data.
- Test Set Sample Size: Not applicable in the traditional sense of a clinical trial test set. The "test set" consisted of various test cases, scenarios, and configurations for modular, integration, and system testing of the software features. Specific numbers of test cases or their characteristics are not provided in this summary.
- Data Provenance: The testing was conducted internally by Hamilton Medical AG (Switzerland) as part of the device modification and regulatory submission process. It is a prospective test in the sense that custom tests were designed and executed to verify the functionality of the new software. There is no indication of retrospective patient data being used.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable in the context of this type of device submission. Ground truth, in this context, would refer to the expected functional behavior and performance defined by engineering specifications, relevant standards (like ASTM F1100-93), and comparisons to legally marketed predicate devices. This is established through engineering design, regulatory standards, and comparison to existing, approved devices, not via expert consensus on clinical findings.
4. Adjudication Method for the Test Set:
Not applicable. The testing described is a verification and validation process against predefined specifications and predicate devices, not subjective clinical assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses how human readers perform with and without an AI assistant, which is relevant for diagnostic or interpretive AI devices. The GALILEO Gold ventilator modification is a software update for a therapeutic device, not a diagnostic AI system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, in a sense. The core of the testing involved evaluating the new software features in a standalone capacity (i.e., the algorithm/software's execution and its impact on the ventilator's function) without explicitly human-in-the-loop performance studies as would be conducted for AI diagnostic tools. The "System tests were executed with a complete instrument, i.e. the new software together with the existing Galileo Gold hardware," which assesses the algorithm's performance within the device itself.
7. Type of Ground Truth Used:
The "ground truth" for this submission is based on:
- Engineering Specifications and Design Requirements: The new software features were developed to specific engineering criteria.
- Performance Standards: Compliance with relevant standards, such as ASTM Standard F1100-93 for ventilator performance.
- Functional Equivalence to Predicate Devices: The detailed comparison tables demonstrate that the new features function equivalently and do not introduce significant differences compared to the predicate devices.
- Absence of Deviations: The successful completion of modular, integration, and system testing without observed or documented performance deviations.
8. Sample Size for the Training Set:
Not applicable. This device is a medical ventilator with software modifications, not a machine learning or AI algorithm that requires a training set of data for learning patterns. The software is programmed with specific logic and control algorithms.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device. The software's "logic" is established through conventional software engineering and ventilator control algorithms, based on physiological principles and intended clinical functionality.
§ 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).