(172 days)
The indication for FLOW-i Anaesthesia System is administering inhalation Anaesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment, by healthcare professionals trained in inhalation Anaesthesia administration.
FLOW-i (K102182 SE5/9/2011) is a high-performance Anaesthesia system designed to meet the many ventilatory challenges within Anaesthesia, as well as to provide inhalation Anaesthesia. It is intended to serve a wide range of patients from neonatal to adult.
FLOW-i is a software-controlled semi-closed system for inhalation Anaesthesia (Sevoflurane, Desflurane, Isoflurane and/or nitrous oxide).
The most important performance features of the FLOW-i Anaesthesia system are:
- o a ventilator whose functionality is based on ICU-ventilator technology,
- o the volume reflector technology,
- o the electronically controlled injector vaporizers and
- o the ergonomic design.
The proposed modification (K112114) includes two additional ventilation modes and a backup function:
- o PRVC, Pressure Regulated Volume Control
- O SIMV (VC and PC), Synchronized Intermittent Mandatory Ventilation
- o Pressure Support with Backup
In addition to the new ventilation modes the proposed modification includes a number of minor changes.
PRVC is a controlled mode of ventilation which combines the advantages of volume controlled and pressure controlled ventilation. FLOW-i assures that the preset tidal volume is delivered at the lowest possible pressure in order to protect the lungs. The flow during inspiration is decelerating and patient can trigger extra breaths.
SIMV is designed to improve synchronization of breaths which can decrease patient's tendency to fight against the Anaesthesia ventilator.
Backup functionality has been added to Pressure Support to add safety for the patient and improve the work flow for the users by minimizing apnea alarms.
The provided text describes modifications to the MAQUET FLOW-i Anaesthesia System (K112114) and claims substantial equivalence to a previously cleared version of the FLOW-i (K102182) and the GE Datex-Ohmeda, Aisys Anaesthesia System (K090233). Rather than outlining specific acceptance criteria and a detailed study proving performance against them, the document focuses on demonstrating that the updated device performs within its specifications and applied performance standards through various non-clinical tests.
Here's a breakdown of the requested information based on the provided text, highlighting what is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it lists areas where performance testing was conducted to ensure the device performs "within its specifications and within the limits of the applied performance standards."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technical data specifications | Performs within specifications |
| Measurement ranges | Performs within specified ranges |
| Measurement accuracy | Accuracy verified |
| Delivery accuracy | Accuracy verified |
| Construction | Verified |
| Features | Verified |
| Interfaces | Verified |
| Handling | Verified |
| Critical situations | Verified |
| Interventions | Verified |
| Electrical safety | Covered in evaluation |
| Mechanical safety | Covered in evaluation |
| Electromagnetic Compatibility | Covered in evaluation |
| Software Validation | Covered in evaluation |
| Usability | Covered in evaluation |
| Tightness | Covered in evaluation |
| Verification of Alarms | Covered in evaluation |
| Packaging | Covered in evaluation |
| Verification of Operating Data | Covered in evaluation |
| Biocompatibility | Covered in evaluation |
| Vaporizer filling system | Covered in evaluation |
| New Ventilation Modes (PRVC, SIMV) | Functionality equivalent to predicate device (Aisys) |
| Backup Functionality (Pressure Support) | Assessed for safety and workflow improvement |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in terms of a patient cohort or a dataset with a defined sample size for clinical evaluation. The testing described is non-clinical, focusing on device performance characteristics. Therefore, information on data provenance (country of origin, retrospective/prospective) is not applicable or provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study described is a non-clinical device performance and verification study, not a clinical study involving expert assessment of medical data.
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study is mentioned. The study is a non-clinical verification and validation of device performance against specifications and standards, not a comparison of human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is an anaesthesia system, which is inherently a human-in-the-loop system controlled by healthcare professionals. The concept of "standalone algorithm performance" as typically applied to AI/ML software is not relevant here. The performance testing focuses on the system's ability to deliver ventilation and anaesthesia as specified.
7. The Type of Ground Truth Used
For the non-clinical performance and verification testing, the "ground truth" would be established by the engineering and design specifications for the device, and compliance with recognized standards (e.g., electrical safety, EMC). It relies on objective measurements against these predefined acceptable ranges and behaviors. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this type of non-clinical evaluation.
8. The Sample Size for the Training Set
No training set is mentioned as this device is not an AI/ML algorithm that undergoes a "training" phase. The system is software-controlled, but the "validation" described is for the software's functionality and performance against design requirements, not statistical learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is mentioned.
§ 868.5160 Gas machine for anesthesia or analgesia.
(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).