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Regulatory Decision Summary - Defigard Touch 7 - Health Canada

Regulatory Decision Summary for Defigard Touch 7

Device class:

Class IV

Type of application:

New device licence application

Application number:

273449

What was the application for at the time of approval?

This medical device application is for a new Class IV licence. The Defigard Touch 7 is a lightweight, mains - and battery - powered defibrillator featuring an ECG monitor, SpO2/SpCO/SpMet, etCO2, Temperature, and NIBP measurements, and is designed for clinical use.

The Defigard Touch 7 is a defibrillator used for the treatment of ventricular fibrillation (VF) and ventricular tachycardia (VT). Depending on the configuration, the monitoring function of the Defigard Touch 7 delivers the several important parameters (ECG, SpO2, SpCO, SpMet, CO2) and allows continuous monitoring of the patient from the beginning to the end of an intervention. The device is intended for single patient use only. The device is designed to meet the specific needs of ground and air rescue services as well as in-house and inter-hospital transportation. The devices can be used for adults, children and neonates with the corresponding accessories.

What information did Health Canada review?

Safety was supported by a Declaration of Conformity to applicable recognized standards, biocompatibility testing, bench testing including compliance with medical electrical equipment standards, including electrocardiographs per IEC 60601-2-25, non-invasive sphygmomanometers per IEC 80601-2-30, temperature measurement per ISO 80601-2-56, pulse oximeter per ISO 80601-2-61, respiratory gas monitors per ISO 80601-2-55, cardiac defibrillators per IEC 60601-2-4, invasive blood pressure monitoring per IEC 60601-2-34, electromagnetic compatibility testing, and software verification and validation. The manufacturer has demonstrated effectiveness by literature and usability studies and by leveraging the close similarity to their licensed FRED PA-1 and FRED Easy devices. Given the established nature of this technology, clinical data were not required for review.

Decision issued
Approved; issued licence in accordance with Section 36(1) of the Medical Devices Regulations.
Date of decision
2018-09-28
Additional information

Manufacturer:

Schiller Medical

Licence number issued:

101794

Date filed:

2017-09-22