CE marking for the Q-whet micro current wound stimulator

Device novelty

Applying electrical currents for wound healing is not new, al lot
of studies have been published proving the efficacy of the therapy .
The most promising current type is the micro current because of its
similarity with the natural healing process. Several companies have
such devices already in the market to treat sub-acute and chronic
wounds. Their devices are often bulky and heavy and are complex to
operate. These devices also need a power outlet, so the patient
loses mobility as long as the treatment is given (several hours a
day is necessary). The current is applied by using standard hydrogel
electrodes around or outside the wound. Because the human body is
not a perfect conductor it*s not guaranteed that the current
actually will go through the desired wound area and have therefore
less efficiency.

Wound care specialists searched therefore ways to to get the current
inside the wound. In
many cases by using very moist dressings and use the conductive
hydrogel electrode on top
of these moisturized dressings. But this is a time consuming
process and time is something a
care taker doesn*t have when visiting patients. The preparation and
extra handling of these
wound dressings also creates an higher risk of infection.

QWHET gives a solution to all this: it*s small, portable, battery
operated there is no need forconfiguring and it uses a unique
developed sterile wound electrode that can be placed inside the
wound. The QWHET stimulator differs from these devices in its
approach because it has the
following properties:
* It uses a unique developed sterile wound electrode that can be
placed inside the wound (where it*s the most effective).
* It is portable and battery operated therefore no connection to
the mains supply
which results in a greater mobility for the patient.
* It uses only micro currents because its well-researched and
-documented
* It*s small (can be worn concealed * no stigma)
* It has no control buttons, does not need to be configured. This
reduces the
necessary installation time and hazardous situations while applying
the device.

Configurations
The device is delivered in two configurations
* for treatment inside the wound
* for treatment next to the wound on intact skin
Once the device is applied on the patient and the electrodes are
connected, the device starts
generating an ultra-small electrical current. This current mimics the
healing current of the human body(current of injury). Studies show
that a micro current below 1000*A increase the ATP adenosine
triphosphate substantially.


The device consists out of 3 major parts
* Stimulator
* Pad electrode
* Wound electrode

Stimulator:

The stimulator is for single patient use, the electrodes are for
single use only. The device is battery operated (coin cell). The
device cannot be opened so the battery cannot be replaced. The
device should be applied by a registered wound care expert the
patient does not apply the device.
There are 2 micro current output channels. On the micro current
output channels A and B, 2 types of electrodes can be used;
* the WOUND electrode
* The SKIN electrode

The Stimulator can detect if the SKIN electrode or the WOUND
electrode is connected. The device communicates with the user by
means of a very simple user interface; 3 LED*s and 1 buzzer. Via
the LEDs and the buzzer, the user gets information about:
*the status of the battery,
*if the electrodes are making contact,
*if the therapy is active or ended.

De PAD electrode

This PAD electrode is the common electrical electrode; it*s a
standard hydrogel electrode. On the (non-conductive) top side of the
electrode there is an adhesive area non-conductive side where the
device can be placed on after the protective layer is removed. When
the device is placed on the adhesive side of the PAD electrode and
the connector is inserted in the device , it switches in standby
mode.

USED MATERIAL SKIN AND PAD ELECTRODE
The SKIN and PAD electrodes are standard available hydrogel
electrodes. They hydrogel layer of the electrodes is in contact with
the patients intact skin.

USED MATERIAL WOUND ELECTRODE
The WOUND electrodes is developed in house by QCARE. the production
is outsourced by a certified subcontractor. The monofilament yarn is
coated with a thin (*m) layer of aluminum to make the textile
electrical conductive.


SKIN and PAD Electrode have been tested on Cytotoxicity, Primary
Dermal Irritation, Delayed Contact Hypersensitivity as suggested by
FDA and ISO 10993-1 see *RG-63B Hydrogel Final Biocompatibility
Report*

Objective:

The objective of the study is to test the hypothesis that the QWHET micro
current wound stimulation device has minimal side effects. The study will be
designed as a double blind, prospective study.The results will be used to
obtain a CE marking.

(Future: After obtaining the CE marking, an additional study will be
implemented to test clinical efficacy on wound healing)

The study will be designed as a double blind and prospective study. For this
study we will need 30 patients who will use the QWHET system for a period of 28
days. Before the study, the patient has to sign a informed consent form.

The 30 patients will be divided in 2 groups of 15 patients, group 1 and 2.
Group 1 will receive the QWHET with the skin electrode and group 2 the wound
pad.

Both groups will receive wound treatment every 5 days when the device will be
changed for a new one. The investigator does not know if it is an active or a
non-active device. The devices will be internally modified by the manufacturer
to be an active or non-active device. Only after the study the assignment of
the devices will be revealed for data processing.

At each visit for the change of the device, a questionnaire will be filled out
by the wound consultant or investigator and a separate one by the patient. Also
at the end of the study a questionnaire will be filled out.

Summary of the risk analysis

Most of te risks are related to the fact that a contaminated wound
electrode can cause an infection to the patient. Chronic, delayed
or complex wounds are wounds that do not heal at all or they do
not heal within a normal woundheal period of 4 to 6 weeks. In
most cases this is caused by an infection of the wound. In our
risk analysis, we estimated this risk as serious to severe. When
the electrode and stimulator is appropriately applied, the risk
towards the patient and the operator is low because we use
registered woundcare experts who are trained in standard woundcare
protocols and who know how to handle sterile products and to apply.
The patient does not apply the product. The intensity of the
current that is generated out of the coin battery is so low that
no hazardous situation can arise. The applied micro current is
between 200 *A and 800*A and for the patient not noticable.

For muscle stimulators that cause contractions work in the mA range
(starting at 15mA ), it is suggested that a current density of no
more than 0.5mA/cm² is applicable at the negative(cathode) electrode
and 1.0mA/cm² at the positive(anodal) electrode. Above this value
tissue damage, and especially skin burn, may occur (only with direct
current types).

The wound electrode has a current more than 130 times lower and
therefore not dangerous for the patient.

Results of the risk assessment
As a result of the risk analysis we decided that the biggest risk
lays in the use and production of the wound electrode. The
following measures have been taken. The device will be sold to wound
care organizations (ex.: Q Care medical services BV The Netherlands).
These organizations have wound care specialist who know exactly how
to take care of wounds and wound healing. They use already sterile
wound care dressings so they know how to handle them. So placing
the electrode in the wound in such a way that no contamination can
occur is standard practice for them. Because this action bears the
highest risk we gave special attention to this in the user
manual. The operators are registered wound care specialists, they
have an educational level that lets us conclude that they can
interpret the given safety info in the manual and on the labeling
of the device. Because the device is so simple to operate, only
the electrodes need to be connected to the device (comparable to
charging a cell phone), we don*t see any elevated risks here.

Production of the electrode

Our subcontractor has an ISO13485 QMS and has already experience in
producing wound care products in clean room (Class ISO7). They all
have the necessary experience, they develop and produce wound care
products for the biggest companies active on the wound care market.
These companies audit the organization on a regular basis. Selecting
such a partner assures us that the risk of contamination in
production is minimized. Q Care will audit the critical suppliers on
a regular basis and all critical suppliers have signed our quality
agreements.

Anticipated risks, contra-indications, warnings

Based on the QWHET Risk Analysis and the experience of our wound
care specialists. The following contra indications have been defined
for patient as for the practitioner. Wound care specialists will have
to consider the patients* conditions to decide whether or not to
use QWHET. They will also have to make the decision if QWHET
should be used outside the wound with the normal hydrogel electrodes
or inside the wound with the QWHET wound electrode.

During the treatment periode of maximum 30 days the wound electrode
will be replaced each time the standard wound dressings are replaced
(typically every 3 to 5 days depending on the judgement of the
wound care specialist). The WOUND electrode is single use and the
wound care specialist will also need to observe and report any
abnormalities during the treatment as usual and give approriate
information to the patient as well. QWHET should be kept out of
the reach of children.

QWHET should not be used
*Where there is a carcinoma or melanoma in the wound or adjacent
skin
*On wounds with necrotic tissue (use after debridement)
*Where there is untreated osteomyelitis of a wound.(might cause early
closure of
the soft tissue prior to resolution of the osteomyelitis, leading to
potential abscess formation)
*On cardiac pacemaker and metal implant patients.
*Until etiology is established.
*During pregnancy, delivery and lactation
*Combined with other electronic monitoring or stimulation equipment
(such as ECG).
*If patients start to experience skin irritation or hypersensitivity.
*On cancer patients and lower motor neuron damage individuals.
*On patients allergic to aluminium.
*On patients younger than 18 year.
*During medical visual examinations (MRI/ECG/EEG....)
*Combined with other electrical based high energy examination or
therapy techniques.

QWHET electrodes should not be placed
*across the carotid sinus (neck region), in such a way that current
flows through the
head

Conclusion
Looking at the measures and the actions taken during the development
and production of the device and executing the risk analysis like
described in QWHET Risk Analysis v01_20170622. The management of Q
Care Medical Services has concluded that the overall residual risk
posed by QWHET is acceptable.

Product verification and validation

Biocompatibility
As a result of the conducted risk analysis and the intended use,
it is necessary to perform biocompatibility tests to proof the
patients safety when using the SKIN, PAD and WOUND electrodes. All
referenced documents can be found in the Technical Dossier.

Only the electrodes come in contact with the patients skin, the PAD
and SKIN electrode are placed on intact skin, the wound electrode
in contact with breached skin.

The conductive hydrogel layer of the SKIN and the PAD electrode comes
in contact with intact skin. These electrode types are well known
and distributed on the European market by Peppin Mfg. They are used
for ECG, EEG, EMG recording or for muscle stimulation in
physiotherapy revalidation. Peppin creates an OEM version for QCARE
where non crucial parameters are customized for QCARE (size,
printing, connector, ..) the crucial component, the hydrogel layer,
in contact with the human body are standard and already in use in
their CE certified products.

Biocompatibility of the hydrogel layer is tested

SKIN and PAD Electrode have been tested on Cytotoxicity, Primary
Dermal Irritation, Delayed Contact Hypersensitivity as suggested by
FDA and ISO 10993-1 Hydrogel Final Biocompatibility Report*

WOUND electrodes

Since the circular (wound contact area) part of the wound electrode
is placed on top or inside the chronic wound, the wound textile
comes in contact with breached skin or the wound bed. This
textile is wound care material from the company SEFAR. They have a
textile mesh called COMPRESS MESH-FIX that is placed on the wound
bed to prevent other used wound dressings to grow into the wound.
This product is manufactured in cleanroom The textile shape is cut
out according the specifications of QCARE, to make the textile
electrical conductive the material is covered with extremely thin
aluminum layer.


Sensitisation and irritation used standards ISO 10993-5, ISO 10993-10,
OECD TG 422C, OECD No. 4

Conclusion

Based upon consideration of the overall results of this reports Q
Care Medical services concludes that the used Qwhet WOUND, SKIN
and PAD electrodes meet the requirements and are safe to use on
patients. Reaction from the market related to the use of the
electrodes will be followed up closely via the post market
surveillance.


Sterilisation
The wound electrodes will be sterilised by the company Rose gmbh.
The electrodes used in this clinical evaluation will be ETO
sterilised during a sublethal test.


Electrical / mechanical safety
Because the device is classified as an active device, it was tested
against; electrical safety mechanical safety and electrical
compatibility. The following standards have (see below) been tested.

Medical devices
- Medical electrical equipment EN 60601
- Electromagnetic disturbances - EN 55011:2009
- Radiated Emission EN 61000
- Radiated Immunity EN 61000

The following reports show that the device
passed all tests
- Ref: 17C00309RPT01 DARE Product Safety Test Report
- Ref: 17C00029RPT01 DARE Examination Report
- Ref.: EMC-208-2013 BLUE GUIDE EMC LAB Test Report 20131003
- Ref.: EMC-041-2017 BLUE GUIDE EMC LAB Test Report 20140424


Literature references:

[1] ISO 14155:2011 Clinical investigation of medical devices for
human subjects * Good
clinical practice.

[2] Richtlijn 93/42/EEG van 14 juni 1993 betreffende medische
hulpmiddelen, gewijzigd bij Richtlijn 2007/47/EG van het Europees
Parlement en de Raad van 5 september 2007.

[3] Richtlijn 90/385/EEG van 20 juni 1990 betreffende de onderlinge
aanpassing van de wetgevingen van de lidstaten inzake actieve
implanteerbare medische hulpmiddelen, gewijzigd bij Richtlijn 2007/47/EG
van het Europees Parlement en de Raad van 5 september
2007.

[4] GHTF/SG1/N011:2008 Summary technical documentation for demonstrating
conformity
to the essential principles of safety and performance of medical
devices (STED).

[5] NEN EN ISO 13485:2003 Medische hulpmiddelen *
Kwaliteitsmanagementsystemen *
Bijzondere eisen voor regulering doeleinden.

[6] NEN EN ISO 14971:2009 Medische hulpmiddelen * Toepassing van
risicomanagement voor medische hulpmiddelen (corrected and reprinted).

[7] NEN EN ISO 11135-series over Sterilisatie van producten voor de
gezondheidszorg * Ethyleenoxide.

[8] NEN EN ISO 17665-series over Sterilisatie van producten voor de
gezondheidszorg *
Stoom.
[9] GHTF/SG5/N2R8:2007 Clinical evaluation.

[10] European Commission, Medical Devices: Guidelines on medical
devices * Clinical
evaluation: A guide for manufacturers and notified bodies, MEDDEV
2.7.1 rev 3 (December
2009).