Investigator information · development IB framework v0.1

AIRCHILL Investigator’s Brochure Framework

The Investigator’s Brochure (IB) is a required core document for the EU clinical-investigation application and a central source of device/risk information for investigators. This framework follows MDR Annex XV content expectations and the MDCG 2024-5 guidance structure; it must be populated with the final controlled technical and preclinical evidence before submission.

1. Document control

Title, device name/model, sponsor/manufacturer, IB reference, version/date, confidentiality statement, revision history, authors/reviewers/approvers and list of superseded versions.

2. Device identification and intended purpose

• Investigational device name/model/configuration.
• Intended medical purpose and clinical investigation use.
• Target population and use environment.
• Accessories, consumables, gas sources and compatible OEM components.
• UDI/identifiers where applicable at development stage.

3. Device description and principle of operation

System architecture, ventilation gas path, respiratory cooling principle, sensors, control algorithms, alarms, software, power/gas requirements, user interface, transport configuration and fail-safe behaviour. Diagrams should identify patient-contacting materials and interfaces.

4. Design and manufacturing information relevant to investigators

Current design maturity, configuration freeze, key specifications, sterilisation/cleaning where applicable, shelf life/consumable handling, packaging, storage/transport and known manufacturing controls relevant to safe clinical use.

5. Instructions for use in the investigation

Set-up, pre-use checks, connection to airway/ventilation system, dose/setpoint rules, alarm response, stopping rules, handover, rewarming/transition, emergency removal, cleaning/disposal and prohibited uses. Study-specific quick reference cards should be controlled appendices.

6. Prior non-clinical evidence

Bench heat-transfer performance, gas delivery accuracy, condensation/occlusion, pressure/resistance, FiO₂ performance, electrical/software verification, biocompatibility as applicable, transport/vibration, EMC, usability and large-animal airway/physiology evidence. Each study is summarised with design, configuration, endpoints, result, limitation and relevance to human use.

7. Prior clinical/human evidence

AIRCHILL-specific human work is separated from external therapeutic-cooling literature. Published and unpublished AIRCHILL exposure is described transparently with participant numbers, device configuration, exposure, outcomes and limitations. External studies support scientific rationale and protocol decisions but are not presented as AIRCHILL efficacy evidence.

8. Risk analysis and anticipated adverse device effects

Cross-reference the current ISO 14971 risk-management file. Summarise foreseeable hazards: ventilation compromise, excessive cooling, inappropriate humidity, condensation/ice, airway effects, hypoxaemia/hypercapnia, gas/FiO₂ error, alarm failure, haemodynamic/arrhythmia effects, electrical/power failure, transport/use error and delayed standard treatment. For stroke explicitly include potential reperfusion delay; for cardiac arrest include post-ROSC instability.

9. Risk controls

Operating envelope, alarms, hardware/software limits, circuit design, training, pre-use checks, physiological monitoring, exclusion criteria, stop/hold criteria, independent DSMB and emergency procedures.

10. Benefit-risk rationale for the investigation

State the scientific rationale, uncertainty, existing evidence, why non-clinical testing alone cannot answer the clinical question, expected knowledge gain and why the staged study design minimises exposure while generating necessary safety/performance/efficacy evidence.

11. Investigator responsibilities

Training, delegation, protocol compliance, consent, source documentation, device accountability, safety reporting, deficiency handling, confidentiality, monitoring access and preservation of blinding.

12. Reference safety information

Maintain a controlled table of anticipated adverse device effects with description, severity range and evidence basis. This table drives expectedness assessment and must be updated when new safety information becomes available.

13. Appendices

• Device drawings/system diagram.
• Current investigational IFU.
• Training checklist.
• Risk summary.
• Non-clinical study table.
• Prior clinical investigation table.
• Reference safety information.
• Device accountability instructions.

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