technical file summary pyxis-c_120521phn

5/21/2018 Technical File Summary PYXIS-c_120521phn

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Technical File

GeschftsfhrerManaging Directors

Registergericht / Registry Court

Amtsgericht LneburgBankverbindungBanking Account

Steuer-Nr. / Tax-No

50/200/09195

ZertifiziertCertified

Martina Schmitt

Manfred Glcher

Register Nr. / Registration No.

HRB 110723

Volksbank Nordheide eGBLZ 24060300

Konto 4203925800

USt-ID / VAT-No

DE 181 958 536

ISO 9001,ISO 13485 and

MDD 93/42/EEC

IBAN: DE50 240 603 00 420 392 580 0 BIC-/SWIFT-Code: GENODEF1NBU

PYXIS-cPTCA Balloon Catheter

Product PYXIS-c PTCA Balloon Catheter

Manufacturer QualiMed Innovative Medizinprodukte GmbH

Boschstrae 16

D-21423 Winsen

Contact : Martina SchmittDirector

Manfred Glcher - Director

Phone : +49 4171 65780

Fax : +49 4171 657811EMail :[email protected]

Website : www.qualimed.de

Certificates ManufacturerCertificate according to EN ISO 9001

Certificate according to EN ISO 13485

Certificate MDD Annex II excluding section (4)

Product:Certificate MDD Annex II.4

Codes covered

by this technical filePC1510 PC2510 PC3025 PC4012

PC1511 PC2511 PC3030 PC4015

PC1512 PC2512 PC3035 PC4016

PC1515 PC2515 PC3040 PC4020

PC1516 PC2516 PC3210 PC4025

PC1520 PC2520 PC3211 PC4030

PC2010 PC2525 PC3212 PC4035

PC2011 PC2530 PC3215 PC4040

PC2012 PC2535 PC3216 PC4511

PC2015 PC2540 PC3220 PC4512

PC2016 PC2710 PC3225 PC4516

PC2020 PC2711 PC3230 PC4520

PC2025 PC2712 PC3235 PC4525

PC2030 PC2715 PC3240 PC4530PC2035 PC2716 PC3510 PC4535PC2040 PC2720 PC3511 PC4540

PC2210 PC2725 PC3512 PC5011PC2211 PC2730 PC3515 PC5012PC2212 PC2735 PC3516 PC5016PC2215 PC2740 PC3520 PC5020

PC2216 PC3010 PC3525 PC5025PC2220 PC3011 PC3530 PC5030PC2225 PC3012 PC3535 PC5035

PC2230 PC3015 PC3540 PC5040PC2235 PC3016 PC4010PC2240 PC3020 PC4011

Technical File Summary PYXIS-c_120521phn Page 1 of 5


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Technical File




Steuer-Nr. / Tax-No

50/200/09195


Martina Schmitt

Manfred Glcher


HRB 110723


Konto 4203925800

USt-ID / VAT-No

DE 181 958 536


MDD 93/42/EEC


Image

Coating Area

Compliance Chart

Pressure

(bar)

1.50mm 2.00mm 2.25mm 2.50mm 2.75mm 3.00mm 3.25mm 3.50mm 4.00mm 4.50mm 5.00mm

4 1.40 1.80 2.10 2.30 2.55 2.75 3.00 3.15 3.70 4.25 4.70

5 1.42 1.84 2.13 2.34 2.59 2.80 3.05 3.22 3.76 4.30 4.76

6 1.44 1.88 2.16 2.38 2.63 2.85 3.10 3.29 3.82 4.35 4.82

7 1.46 1.92 2.19 2.42 2.67 2.90 3.15 3.36 3.88 4.40 4.88

8 1.48 1.96 2.22 2.46 2.71 2.95 3.20 3.43 3.94 4.45 4.949 1.50 2.00 2.25 2.50 2.75 3.00 3.25 3.50 4.00 4.50 5.00

10 1.52 2.04 2.28 2.54 2.79 3.05 3.30 3.57 4.06 4.55 5.06

11 1.54 2.08 2.31 2.58 2.83 3.10 3.35 3.64 4.12 4.60 5.12

12 1.56 2.12 2.34 2.62 2.87 3.15 3.40 3.71 4.18 4.65 5.18

13 1.58 2.16 2.37 2.66 2.91 3.20 3.45 3.78 4.24 4.70 5.24

14 1.60 2.20 2.40 2.70 2.95 3.25 3.50 3.85 4.30 4.75 5.30

15 1.62 2.24 2.43 2.74 2.99 3.30 3.55 3.92 4.36 4.80 -

16 1.64 2.28 2.46 2.78 3.03 3.35 3.60 3.99 4.42 4.85 -

17 1.66 2.32 2.49 2.82 3.07 3.40 3.65 4.06 - - -

18 1.68 2.36 2.52 2.86 3.11 3.45 3.70 4.13 - - -

Nominal

pressure

9 9 9 9 9 9 9 9 9 9 9

RBP 18 18 18 18 18 18 18 18 16 16 14



3/5

Technical File




Steuer-Nr. / Tax-No

50/200/09195


Martina Schmitt

Manfred Glcher


HRB 110723


Konto 4203925800

USt-ID / VAT-No

DE 181 958 536


MDD 93/42/EEC


Parts

Material Part colorPTCA Catheter

Balloon Tip PEBAX 7033 FDA Black Black in contact with human bodyCatheter coat Hydrophilic coating (composition):

DSM- SDS Primer:

Comfort Coat P41002

andDSM- SDS Top coat:

Comfort CoatTM

Topcoat TC43003

Matt, transparent

Balloon Grilamid L25 Transparent, Natural

Inner tubing

Three layer tubing, Material from outer to

inner layer:

Pebax 7233 / Plexar PX380 /PE-LM6007

Reflex Blue C Color #00080730 NYC

Blue in contact with human body

Hypotube

Tubing PTFE (Xylan) coated stainless

steel 1.4306 (304L)Tapered wire section: uncoated stainless

steel 1.4306 (304L), Color: metallic

XYLAN 8110/G2599 GREY BLACK

Black / Metallic in contact with human body

Shaft marker Stainless steel WKN 1.4306 (304L) Metallic, Natural

X-ray balloon markers 90%Pt, 10% Ir Metallic Natural

Outer Catheter shaft distal part Pebax 7233 SA01 Transparent

Hub Polycarbonate (PC), Lexan HPS 7 Transparent

Kink protection cover Pebax 98%, Blue colorant 2% Blue

Protective wire Stainless Steel WKN 1.4301 Metallic, Natural

Balloon protection cap(protection of the folded balloon only,

to be removed

before use)

PTFE, Polytetrafluoroethylene Various Not in contact with human body



4/5

Technical File




Steuer-Nr. / Tax-No

50/200/09195


Martina Schmitt

Manfred Glcher


HRB 110723


Konto 4203925800

USt-ID / VAT-No

DE 181 958 536


MDD 93/42/EEC


General Specifications

PTCA Catheter

Design Rapid exchange catheter with hydrophilic coating

ManufacturingManufacturing: Clean room ISO class 7

Coating according to QPS hydrophilic CoatingDistal section Two coaxial lumen

Nominal pressure 2.00 to 5.00 mm: 9 bar

Rated burst pressure

1.50 to 3.50 mm: 18 bar

4.00 to 4.50 mm: 16 bar 5.00 mm: 14 bar

Balloon characteristic Semi compliant

Compliance tolerance Tolerance 10%

Balloon folding 1.50 to 2.25 mm: 2-3 folds

2.50 to 5.00 mm: 3 folds

Direction of balloon folding, seen from the tip To left (anti-clockwise)

X - ray balloon markers 2 markers located on the inner tubingunder balloon section

Recommended guide wire 0.014 ( 0.36mm)

Recommended guiding catheter [F/mm]

Minimum inner lumen [mm]

5F /1.67mm

1.42mm

Maximum deflation time 1.50 to 5.00 mm: max. 20 seconds

Refold up to RBP 1.50 to 2.25 mm: 2-3 folds 2.50 to 5.00 mm: 2-3 folds

Catheter length

Usable catheter Length (Tip-kink protection): 1415 15 mm

Length of hypo tube (kink protection distal end of hypotube):1070 15 mmTotal catheter length: 1490 15 mm

Length distal part (Tip-Port) 237 15 mm

Length passage (Port-Hypo tube) 105 15 mm

Length of transition 170 15 mm (pusher wire)

Shaft marker 1 (Tipprox. shaft marker) 985 15 mm

Shaft marker 2 (Tip - dist. shaft marker) 880 15 mm

UBL - Usable Balloon LengthFrom 10 to 40 mm

Tolerance 0.5 mm

LTT - Length Tapered Tip 3.5 0.5 mm

Configuration of shoulder Nominal angle 42

Minimum guide wire lumen 0.39 mm, sliding without rubbing at 18 bars inflation pressure

Proximal shaft diameter Max. 2.1F/ 0.70mm

Distal shaft diameter Max 2.6 F (0.86 0.025 mm)

Tapered tip Entry profile >0.45


5/5

Technical File




Steuer-Nr. / Tax-No

50/200/09195


Martina Schmitt

Manfred Glcher


HRB 110723


Konto 4203925800

USt-ID / VAT-No

DE 181 958 536


MDD 93/42/EEC


Packaging

The balloon catheter is protected with a PTFE protection cap with inner lumen protective stainless steel wire. The catheter is

placed in a protective tubing spiral dispenser of PE. The product is then sealed in a Perfecseal pouch.These sterile packaging materials fulfill the requirements of non-toxic reaction with the enclosed products, as well as compati-

bility with the ethylene oxide sterilization process.

A single sterile unit is placed together with the IFU in a cardboard box with an Open Here sealing label.

Sterilization EO (according to DIN EN ISO 11135-1)

Bioburden Max 220 CFU/catheter

Biocompatibility (e.g.

Hemocompatibility,

Cytotoxicity)

Conformity with DIN EN ISO 10993 (applicable parts)

Usage For single use only

EO indicator EO indicator label

Shelf life 2- years for sterile products

Storage Conditions Keep in a cool, dry and dark place

Data source:QPS _L1_ PC_09_120314


technical file summary pyxis-c_120521phn

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