Canadian license application form-regulatory affairs

You are an intern working for Lion Technology for the summer. Your project for
RGA6226 is to submit to your supervisor (me) a Canadian license application form along
with some key elements of a Canadian license submission that will be used to send a
submission to Health Canada. These are items found typically in module 1 of a STED
application format.
You will need to submit the proper Canadian license application form. In addition to the
application form please prepare and submit to me the following components of a
Canadian application that you will need to create based on the data provided below:
Biocompatibility statement
Design Philosophy
Marketing History summary
Canadian Standards summary
Declarations of Conformity form to Health Canada recognized standards
Safety and Effectiveness Summary Table
This is the data you have been provided. Please document very clearly any assumptions
you need to make. The project is meant to be an individual project done independently.

Product name: AITOCSAVON Monitor
Manufactured by: Lion Technology, Inc., 99 Canada Drive, Big City, Michigan, 99999,
USA; phone: 555-111-5555 fax: 555-111-5557 Contact: Mary Hawkins
(Mary.Hawkins@Liontechnology.net)
You are the regulatory correspondent for the submission. Use your real name but a
fictitious address and phone #, e-mail.
The billing contact is Brian Smith.
The AITOCSAVON Monitor consists of the following items:
 AITOCSAVON Display Cat. No: AD1000
 AITOCSAVON Keyboard Cat. No: AK2000
 AITOCSAVON Frame (this is a device where the modules are inserted and
contains the main processing unit) Cat. No: AF3000
 AITOCSAVON EEG Measurement module Cat. No: AEEG4000
 AITOCSAVON Oxygen Measurement module Cat. No: AO24100
 AITOCSAVON ECG Measurement module Cat. No: AECG4200
 AITOCSAVON software version 2.0 Cat. No: SW4000
The AITOCSAVON monitor is indicated for physiological patient monitoring.
The monitor is used to monitor a variety of parameters including ECG and Oxygen and
the electroencephalogram (EEG) signal from the brain in adult patients.
RGA6226 Project Spring 2015 – Updated May 27, 2015
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The device is for use in a hospital and clinics under the supervision of physician.
The monitor uses standard EEG scalp surface electrodes and lead sets (Note: these are the
electrodes placed on the head and the wires that connect them to the EEG Measurement
module ) that have been previously licensed separately (EEG leads Class II Canadian
license: 88888, EEG electrodes Class II Canadian License 88889).
In addition, the AITOCSAVON monitor uses ECG electrodes and lead sets (Note: these
are the electrodes placed on the chest and the wires that connect them to the ECG
measurement module) that have been previously licensed separately (ECG leads Class II
Canadian license: 93334, ECG electrodes Class II Canadian License 93333).
The AITOCSAVON monitor uses an O2 sensor (Note: this is the sensor placed in the
patients breathing tube and connects to the OXYGEN measurement module) previously
licensed separately (O2 Sensor Class II Canadian license: 93348).
The following documentation is available for the device:
AITOCSAVON Sales Brochure
AITOCSAVON USER MANUAL (French/English)
AITOCSAVON Device plate label
AITOCSAVON Mechanical and Environmental test report
AITOCSAVON EMC (electromagnetic compatibility) test report
AITOCSAVON ISO 13485:2003 CMDCAS CERTIFICATE
AITOCSAVON Risk analysis (Note: This analysis shows several cases where erroneous
parameter readings could result in immediate danger to the patient)
AITOCSAVON Electrical Safety Test report
AITOCSAVON Software Description
AITOCSAVON Software Specification
AITOCSAVON Software Test Summary Report
AITOCSAVON EEG Performance report
AITOCSAVON Device Description and Technical Specification
AITOCSAVON Clinical trial report
RGA6226 Project Spring 2015 – Updated May 27, 2015
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The AITOCSAVON monitor is fully compliant to the following standards:
 IEC 60601-1:2005-Ed.3.0
o Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance IEC 60601-1:2005-Ed.3.0 /Cor.1:2006
 IEC 60601-1-2:2007-Ed.3.0
o Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic
compatibility – Requirements and testing
 IEC 60601-2-26:2012-Ed.3.0
o Medical electrical equipment – Part 2-26: Particular requirements for the
basic safety and essential performance of electroencephalographs – Edition
3.0
 IEC 60601-2-27:2011-Ed.3.0
o Medical Electrical Equipment – Part 2-27: Particular Requirements For
The Basic Safety And Essential Performance Of Electrocardiographic
Monitoring Equipment – Edition 3.0 IEC 60601-2-27:2011-Ed.3.0/Cor.1:2012
 IEC 62304:2006-Ed.1.0
o Medical device software – software life cycle processes
 ISO 14971:2007
o Medical devices – Application of risk management to medical devices
The specifications for the AITOCSAVON are:
POWER: 110V @ 50-60Hz
DISPLAY: 19 in. color display
KEYBOARD: Hospital grade
OPERATIONAL TEMPERATURE RANGE: -15 to 115 deg F
Humidity Range: 10-90%
EEG Frequency range: 5-15 Hz
EEG leads displayed at once: up to 12
O2 measurement range 0-22%
The AITOCSAVON display and AITOCSAVON Oxygen Measurement module contains
BPA and the AITOCSAVON EEG measurement Module contains PVC with DEHP in a
quantity less than 0.1% w/w. The AITOCSAVON Frame contains PVC with DEHP in a
quantity of 0.5% w/w. The rest of the components do not contain BPA or DEHP. The
device does not contain a drug and it is not an IVD and it has not been reviewed by
RGA6226 Project Spring 2015 – Updated May 27, 2015
Page 4
Health Canada previously as part of a clinical investigation or special access. There are
no sterile or patient contact components of the AITOCSAVON monitor components
listed above.
The predicate device for AITOCSAVON is the Widget2008, which is licensed separately
in Canada (Canadian License no. 98464). The specifications are the same as the new
AITOCSAVON except the Widget2008 has:
a frequency range of 4-23 Hz
operates in a temperature range of 5 to 115 degrees F
O2 range 9-21%
Humidity Range: 15-90%
The AITOCSAVON can be interfaced to the following devices manufactured by Lion
Technology Inc.:
LionTailNetwork Canadian License 99999
LionTailMonitor Canadian License 99991
The AITOCSAVON system although new for the Canadian market has been sold for
more than a 3 years in the USA (K088706), South Africa (License No. 12ADR456),
Australia (ARTG inclusion no. 23456), Sweden, France and United Kingdom (DOC
signed August 18, 2010. There were 900 units sold to date (40% sold to USA, 5% to
South Africa, 15% to the United Kingdom and 15% to France and 15% to Sweden and
10% to Australia.)
There has been one recall of the AITOCSAVON monitor AITOCSAVON software
version 1.0 Cat. No: SW1000 since sales have started. It has been replaced by
AITOCSAVON software version 2.0 Cat. No: SW4000. There were 3 safety complaints
concerning a software malfunction causing false high O2 readings when using
AITOCSAVON software version 1.0 Cat. No: SW1000. There have been no safety
complaints using AITOCSAVON software version 2.0 Cat. No: SW4000.

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