Sophysa Sophy Mini Monopressure valve (SM1) and kits

PRODUCT SPECIFICATIONS

Sophy Mini Monopression valve product specification and specification related verification and
validation activities

No. Clinical claim Technical claims Product Specifications Verification/validation

activities
1 Different nominal 3 pressure levels Pressure-flow Pressure-flow testing –
pressures available to available characteristics described GE016
best fit the patient’s in the IFU:
condition - low: 50 mmH2O, Report 2016148
- medium: 110 mmH2O,
- high: 170 mmH2O
2 Read the valve model The valve is radiopaque Radiopaque in Radiopacity verification
by radiography after to allow X-ray accordance with
implantation identification of the model ISO7197, §4.2
and pressure Test reports

2016297

Test was performed on an

SM8, which is identical in
shape and size to SM1 but
includes magnets thus
constituting a worst-case.

3.1 The device is The device is provided in Sterilization process Sterilization validation
compatible for a sterile state validated following EN
implantation ISO 11135 RV.0604

EO residues evaluation
following EN ISO 10993-7

3.2 The device is The product is found Biocompatibility

biocompatible biocompatible following demonstration described in
EN ISO 10993-1 BQR105

3.3 Device manufactured in a Manufacturing in a Manufacturing flow chart

cleanroom cleanroom compliant with MQP002
ISO 14698
Manufacturing in cleanroom

3.4 The size and form of the Visual control should be Tested routinely during
valve should be free of irregular surfaces manufacturing process
atraumatic and dimensional control following control range
should conform to product GC138
drawing
Test reports

2016136
 Sophysa Sophy Mini Monopressure valve (SM1) and kits

No. Clinical claim Technical claims Product Specifications Verification/validation

activities
3.5 The mechanical The connections must Test report
properties ensure that the withstand an axial force of
shunting is resistant to 10N for one minute. 2002025
traction in implantation 2000049 (section 332, 333)

Tests done on SM8, which

incorporates the same
connector as SM1. Results
are applicable to SM1.

4.1 The device is compatible Long-term stability After 14 and 28 days of Pressure/flow and anti-reflux
for long-term opening/closing cycles at tests following EN ISO 7197.
implantation 37,5°C, the pressure and
anti-reflux function remain
within tolerances. Test report 2016212

4.2 Mechanical properties Fatigue test of the Test reports

ensure resistance of the valve/catheter assembly
shunt to tensile forces 2004085
after implantation

4.3 Five-years shelf-life The performances remain Shelf-life testing

within their specifications
after aging test. Test reports

2016281

2016302

2016283

2016300

5 Direct CSF access The physical properties of To determine the Test report 2016201
through the reservoir, for the materials ensure that maximum quantity of
models with pre- the dome of the reservoir puncture that can be
connected reservoirs is resistant to punctures applied to the dome
without leakage: the
leakage of the reservoir
should be less than 0,1 ml
mL/h after 1 min of
perforations made with a
24G Huber needle

6 Regulatory requirements Compliance to Compliance with EN ISO Testing required by EN ISO

international standards 7197 & ASTM F647 7197 & ASTM F647:

See 1, 2, 3.4, 3.5, 4.1, 4.2,

4.3.

Test reports

2016137

2016138

2016214
 Sophysa Sophy Mini Monopressure valve (SM1) and kits

No. Clinical claim Technical claims Product Specifications Verification/validation

activities
6.1 Microbial contamination Compliance with EN ISO Bioburden report
11737
RV.0013

Cleanroom manufacturing

Sterilization validation report

RV.0604

6.2 The packaging must Device packaged in Packaging validation report

maintain the sterile barrier compliance with EN ISO
11607 RV.0650

6.3 The labelling is in Compliance with EN ISO The labelling is in compliance

compliance with various 7197, EN ISO 15223 with various international
international standards standards

6.4 Labelling allows EAN format barcodes Labelling

traceability affixed on labeling and
traceability records Barcodes compliant with GS1
maintained during system
manufacturing process

6.5 Endotoxin contamination Endotoxin level <0.25IU Endotoxin validation report

per device
RV.0035

The document is extracted from document PVP017.008