Relisys Medical Devices Limited Doc. No: 015-0101-4.

PRE CLINICAL STUDY PLAN FOR

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POST DILATATION CATHETERS

Table of Contents

1. Introduction 2

2. Scope 2

3. Product Description 3

4. Biological evaluation of Post Dilatation catheters 5

5. Categorization of Post Dilatation catheters 7

6. Biological evaluation tests for Post Dilatation catheters 8

7. Bench Tests for Post Dilatation Catheter 9

8. Summary 10

9. Revision History 11
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1. Introduction:

The pre clinical studies or non clinical trials are laboratory test of a new medical device. The
tests conducted in vitro are include biocompatibility studies, Bench tests etc…

The Biocompatibility Study of Medical Devices is the protection of humans from potential
biological risks arising from the use of medical devices. An EN ISO 10993-1:2009(E) is
intended to be a guidance document for the biological evaluation of medical devices within a
risk management process, as part of overall evaluation and development of medical devices.

An EN ISO 10993-1 addresses the determination of the effects of medical devices on

tissues, mostly in a general way, rather than in a specific device - type simulation. For a
complete biological safety evaluation, it classifies medical devices according to the nature
and duration of their anticipated contact with human tissues when in use and indicates, in
matrices, the biological data sets that are through to be relevant in the consideration of each
device category.

The role of EN ISO 10993-1 is to serve as a frame work in which to plan a biological
evaluation which, as scientific knowledge advances our understanding of the basic
mechanisms of tissue responses, minimizes the number and exposure of test animals by
giving preference to chemical constituent testing and in-vitro models, in situations where
these methods yield equally relevant information to that obtained from in vivo models.

EN ISO 10993-1 is intended for use by professionals, appropriately qualified training and
experience, who can interpret its requirements and judge the outcome of the evaluation for
medical devices, taking into consideration all the factors relevant to the device, its intended
use and the current knowledge of the medical device provided by review of the scientific
literature and previous clinical experience. The biological data sets recommended in the
evaluation of medical devices, according to their category of body contact and duration of
clinical exposure. This standard contains guidance for the application of risk management
process to medical devices which encompasses biological evaluation.

2. Scope:
The main scope of pre clinical studies is to determine the ultimate product safety &
performance as per the intended use claimed by manufacturer.
The pre-clinical study is to develop adequate data to decide that it is reasonably safe to
proceed with the human trials.
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The scope of Biocompatibility study is to assess the contact between components of a

medical device and the body to prove a safe medical device as per the standard EN ISO
10993-1:2009 (E) and OECD principles on Good Laboratory Practices.

The Biological evaluation of medical devices is performed to determine the potential toxicity
resulting from contact of the device with the body. Testing shall be performed on the sterile
final product only. The test sample shall be chosen to maximize the exposure of the test
system to the components of a device that is known to have potential for a biological
response.

3. Product description:

The Post Dilatation catheter is a standard balloon dilatation catheter with a balloon near the
distal tip. One lumen is used for initiation of the balloon with contrast medium; the other
lumen permits the use of a guide wire to facilitate advancement of the catheter to and
through the lesion to be dilated. The product is offered on rapid exchange delivery platform.
The distal end of the catheter has a conventional nylon blend balloon and the balloon has
radiopaque markers to aid in positioning the balloon in the lesion, and is designed to provide
an expandable segment of known diameter and length at a specific pressure. The proximal
end of the catheter is a SS hypotube jacketed with nylon to give smooth pushability.

The product components physical description, contact with body and materialsdata is
following below.

Physical
S/N Components Contact Material VENDOR
description
PEBAX
Blood 3533 SA
A small tubular
circulation - 01 MED + FOSTER WEST
1. SOFT TIP polymer
Patient, 30% CORPORATION
component
Hand User. BaSO4
WHITE
VESTAMID
ML CARE
BALLOON A Nylon polymer Blood
2. 21 / EMS CHEMIE
TUBE component circulation
GRILAMID
L 25
RISAN PA
A Nylon polymer Blood 11 G FOSTER WEST
3. OUTERLUMEN
component circulation BESVO A CORPORATION
MED

A Multilayer tubular Blood VENTION

4. INNERLUMEN PEBAX
polymer circulation MEDICALS
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Small Metallic Contrast JHONSON

5. MARKERBAND Pt-Ir
tubes Medium MATTHEY
Blood
PTCA A Stainless steel SS 304
6. circulation & CREGGANNA
HYPOTUBE Metallic Shaft PVL
user hand
GRILAMID EMS CHEMIE,
TR 90 FOSTER WEST
Blood
a threaded polymer NATURAL CORPORATION
7. HUB circulation &
component or
user hand
LUSTRAN
ABS 348

Figure 1: Image of the catheter packed in Tyvek pouch and when exposed outside from the
pack

Product details:

Product Name Post Dilatation Catheter

Brand Name VEDA+R NC, JADE NC, ZIRCON NC, RUBY NC, PEARL NC,
GARNET NC, SCARLET NC
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Catheter Sizes
Diameter (mm)/ 2.50 2.75 3.00 3.50 4.00
Length (mm)
8 ✓ ✓ ✓ ✓ ✓
10 ✓ ✓ ✓ ✓ ✓
12 ✓ ✓ ✓ ✓ ✓
13 ✓ ✓ ✓ ✓ ✓
15 ✓ ✓ ✓ ✓ ✓
18 ✓ ✓ ✓ ✓ ✓
20 ✓ ✓ ✓ ✓ ✓
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4. Biological Evaluation of Post Dilatation Catheter:

The biological evaluation of any material or medical device intended for use in humans shall
from part of a structured biological evaluation programme within a risk management process
in accordance with EN ISO 14971:2012. The biological evaluation shall be PLANNED,
carried out, and documented by knowledgeable and experienced professionals.

The following shall be considered for their relevance to the overall biological evaluation of
the device:

▪ The material (s) of manufacturer.

▪ Intended additives, process contaminants, and residues.
▪ Leachable substances.
▪ Degradation products.
▪ Other components and their interactions in the final products.
▪ Physical characteristics of the final product, including but not limited to porosity,
particle size, shape, and surface morphology.

The choice of tests and the data required in a biological evaluation, and their interpretation,
shall consider the chemical composition of the materials, including the conditions of
exposure as well as the nature, degree, frequency, and nature of exposure of the medical
device or its constituents to the body, enabling the categorization of devices to facilitate the
selection of appropriate tests.

Selection of any in vitro or in vivo tests shall be based on end user applications. All tests
shall be conducted according to recognized and valid laboratory, for example Good
Laboratory Practices (GLP) or EN ISO 17025 certified, where applicable and the data shall
be evaluated by competent, informed professionals.
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Summary of the systematic approach to a biological evaluation of medical device as part of risk management process

Biological evaluation
complete
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5. Categorization of Post Dilatation catheter:

Post Dilatation catheters shall be categorized according to the nature and duration of body
contact as described in EN ISO 10993-1.

Nature of body contact: External communicating devices with in circulating blood.

Duration of Contact: Limited exposure, Contact is up to 24 h.

6. Biological evaluation tests for Post Dilatation Catheter:

As per ISO 10993-1:2009 Evaluation of tests for consideration in the following table.

*Highlighted portion of the tests in the above table shall be strictly conducted as per the standard requirements
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The Evaluation of tests for Post Dilatation Catheters are as follows:

[Link] Tests Name Reference Standard

1 Cytotoxicity EN ISO 10993-5:2009

2 Sensitization EN ISO 10993-10:2010

3 Irritation or Intracutaneous reactivity EN ISO 10993-10:2010

4 Systemic toxicity (acute) EN ISO 10993-11:2006

5 Material Mediated Pyrogenicity ISO 10993-11:2017

6 Haemocompatibility EN ISO 10993-4:2002/amd.1:2006

The required biocompatibility tests for Haemocompatibility are as follows:

Hemolysis
Thrombosis

7. Bench Tests for Post Dilatation Catheter:

Safety & performance of Post Dilatation catheter shall be verified by performing bench
tests as per the Product standard such as EN ISO 10555-4 & ISO 594-2 requirements.
Adequacy of the pre clinical tests / bench tests shall be verified in-house or out sourcing
laboratories to ensure the intended purpose, safety & performance of the device.
The test results shall be summarized & can be substantiated for the clinical data to
comply for the safety and efficacy as per regulatory & clinical requirements.
The following are the bench tests shall be performed for all the shapes & sizes as
described in product description to make sure the device preclinical requirements.

S.N Instrument/
Inspection item Specification
o Reference
1 Crossing Profile 0.80 - 1.30 mm LMS
2.50mm – 2.50 ± 0.12mm LMS/PT-1000/
2 Balloon diameter at 8 atm
4.00mm – 4.00 ± 0.12mm Indeflator
2.50mm – 2.65 ± 0.12mm LMS/PT-1000/
3 Balloon diameter at 16 atm
4.00mm – 4.20 ± 0.12mm Indeflator
4 Balloon Inflation Time ≤ 10 sec In deflator
5 Balloon Deflation time ≤ 15 sec In deflator
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Maximum Guide Wire Stylet/ Mandrel/

6 0.014”/ 0.356 mm
Outer Diameter Guide wire
Minimum Guide Catheter
7 0.056”/ 1.42 mm Guiding Catheter
Inner Diameter
No leaks / burst when balloon is In deflator/PT
8 Leak Test
inflated to its RBP 3070
Compatible with 6% male luer
9 Hub compatibility 6% male Luer lock
lock
10 Balloon Fatigue 18 atm/20 cycles LMS/ PT-1000
LMS/
11 Balloon Burst Pressure ≥ 24 atm
PT-1000
12 Burst Type Longitudinal Visual
7.2 N - No neck down at In- House
13 Pull Test
proximal weld is accepted Fabricated
Peak Tensile Force
14
Balloon distal neck - soft tip
3N
welding
Balloon proximal neck - outer
5N Universal Testing
lumen welding
Machine
Hub - Hypotube 5N
Hot gas welding 5N
Conversion bond welding 5N
Absence of microbial growth EN ISO 10555-
15 Corrosion resistance
after 48 hrs 1:2013
16 Radio detectability Corrosion resistant Fluoroscopy
17 Pushability < 1.5 % PTC - 20 N
18 Trackability ± 0.6 N PTC - 20 N
19 Crossability Should cross the lesion PTC - 20 N

8. Summary:
All raw materials and components are same for the manufacturing of Post Dilatation
catheters including all sizes mentioned in the product description.
The Biocompatibility studies for Post Dilatation Catheters must follow EN ISO 10993-
1:2009(E).
The Pre clinical bench tests for Post Dilatation Catheter shall be followed as per EN
ISO 10555-4 & ISO 594-2 and the regulatory requirements as per MEDDEV 2.7.1
rev.4 to ensure the safety & efficacy of the device.
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The summary report shall include the following details:

a) Name and address of testing facility

b) Name of the person(s) who conducted the test
c) Dates of start and end of the test
d) Description of the sample
e) Cell line, justification of the choice and cell source(s)
f) Name of company and batch of medium, serum and antibiotics, when added
g) Assay method and rationale
h) Extraction procedure
i) Negative, positive, and other controls
j) Cell response and other observations
k) Any other relevant data necessary for the assessment of results

The tests shall be conducted according to recognized current/valid best

laboratory/quality practices, for example Good Laboratory Practices (GLP) or ISO 17025,
where applicable and the data shall be evaluated by competent, informed professionals.

The test facility details including required laboratory accreditations shall be attached in
the summary report.

9. Revision History:

S No Date Rev No Reason for change Approved By

1 17/02/2017 00 Initial Release Head QA
2 22/06/2020 01 Included Material Mediated Pyrogenicity Sr. Manager –
Test for Evaluation of Post Dilatation QA & QC
Catheter

Approval:

Prepared By Reviewed By Approved By

22/06/2020 22/06/2020 22/06/2020

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Table of Contents

1. Scope 2

2. Risk Management for Biocompatibility Evaluations 3

3. Biocompatibility Flow Chart 3

3.1 Biocompatibility Flow Chart Evaluation 4

3.2. Categorization according to EN ISO 10993-1:2009 5

3.3. Test-Specific Considerations 5

3.4. Selection and test methods 6

3.5 Testing Results 9

4. Selection and details for Bench Tests / Mechanical Tests 10

5. Conclusion 12

6. Revision History 13
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1. Scope:

The Pre clinical study of Post Dilatation catheter has been carried out to determine its safety
& performance towards the intended use of the device claimed as per Relisys Medical
Devices Limited.

The scope of this document and accompanying attachments is limited to the

biological evaluation of sterile Post Dilatation Catheters that come into direct contact with the
human body and the bench tests conducted in-house & out sourced laboratories. This
document specifically covers the use of EN ISO 10555-4:2013, EN ISO 10993-1: 2009 &
MEDDEV 2.7.1/rev.04 requirements, but also is relevant to other biocompatibility standards
(e.g., other parts of the ISO 10993)

This document discusses the following topics:

1) Use of risk assessments for biocompatibility evaluations for Post Dilatation

Catheters.
2) general biocompatibility testing considerations, including test article preparation;
3) specific considerations for the following testing:

a. Cytotoxicity

b. Skin Sensitization

c. Irritation or Intracutaneous reactivity

d. Systemic toxicity (acute)

e. Material Medicated Pyrogenicity

f. Haemocompatibility

4) Assessments
5) Biocompatibility Evaluation Flow Chart, which illustrates how to proceed with a
biocompatibility evaluation;
6) Biocompatibility Test Report, which includes biocompatibility test reports of Materials
used for Post Dilatation catheter.
7) Bench test results as referred in Product standard, Regulatory & clinical
requirements.
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2. Risk Management for Biocompatibility:

Risks has been considered and assessed for the biocompatibility hazards (Doc
No: RMF-DNC Clause: 5.1.2) due to the material used. All though Raw materials used for
Post Dilatation Catheters are medical grade, change in material properties during
manufacturing process has been considered which call for biocompatibility risks like

Biocompatibility Hazards

• Non-biocompatible
• Allergic to the material
• Incompatible of contrast media

Considering all the above risks Post Dilatation Catheter was performed with biocompatible
tests at GLP certified laboratories to ensure that product is safe to use.

3. Biocompatibility Evaluation Flow Chart

The flow chart below provides pathway to Biocompatibility tests for Post Dilatation catheter.

1.) Flow of biocompatibility

2.) Material considerations
3.) Tests to be conducted
4.) Applicable standards
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3.1. Flow chart of biological evaluation (Annex of ISO 10993-1:2009)

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3.2. Categorization according to EN ISO 10993-1:2009

Post Dilatation Catheter

Category: External communication device References

Clause 5.2 Categorization by nature of

Body contact Circulating blood
body contact and Clause

5.3 Categorization by duration of

Duration of contact Limited exposure: ≤ 24 hours
contact

3.3. Test-Specific Considerations:

POST DILATATION CATHETER

[Link]
Tests Standards

Cytotoxicity EN ISO 10993 - 5: 2009

1

Sensitization EN ISO 10993 - 10: 2010

2

Irritation or Intracutaneous reactivity EN ISO 10993 - 10: 2010

3

Systemic toxicity (acute) EN ISO 10993 - 11: 2006

4

Material Medicated Pyrogenicity ISO 10993-11:2017

5

Haemocompatibility EN ISO 10993 - 4: 2002/Amd1: 2006

6
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3.4. Selection and test details:

Test Item: Post Dilatation Catheter

S. Test Name Study Title Test Method Reference Test Result Reference
No Standards Document Number
1 Cytotoxicity In Vitro Cytotoxicity Biological Evaluation of Observed Grade ‘0’ VLL/0215/G/B008/R
Assessment of “Veda+R Medical devices – EN ISO which indicates material
Dilatation catheter (Veda+R 10993 Part 5: tests for In Non-toxic. Hence there
NC)- Non Compliant” Vitro Cytotoxicity, 2009 is no chemical reaction.
Extraction method on
L929Cells
2 Skin Sensitization a) Skin Sensitization Study Biological Evaluation of COA results shows that VLL/1015/G/B057/R
(GPMT) of Normal Saline Medical devices – EN ISO the sample is Non-Skin
Extract of ‘Veda+R-NC Post 10993 Part 10: tests for sensitizer with the test
Dilatation Catheter’ in Irritation and skin animal
Guinea Pigs. sensitization, 2010.
b) Skin Sensitization Study COA results shows that
(GPMT) of Sesame Oil Biological Evaluation of the sample is Non-Skin
Extract of ‘Veda+R-NC Post Medical devices – EN ISO sensitizer with the test VLL/1015/G/B058R
Dilatation Catheter’ in 10993 Part 12: tests for animal
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Guinea Pigs Sample preparation and

Reference Materials, 2012

Irritation or Intracutaneous Reactivity Biological Evaluation of All the test results are VLL/0215/G/B006/R
3
Intracutaneous test of ‘Veda+R Dilatation Medical devices – EN ISO observed to be at level
reactivity Catheter (Veda+R/NC) Non 10993 Part 10: tests for ‘0’ which indicated the
Compliant’ in New Zealand Irritation and skin sample is Non-Irritant
White Rabbits sensitization, 2010. with the test animal.
and

Biological Evaluation of
Medical devices – EN ISO
10993 Part 12: tests for
Sample preparation and
Reference Materials, 2012
Systemic toxicity Acute Systemic Toxicity Test Biological Evaluation of All the test results are VLL/0215/G/B003/R
4
(acute) of ‘Veda+R Dilatation Medical devices – ISO 10993 observed to be at level
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Catheter (Veda+R/NC) Non Part 11: tests for systemic ‘0’ which indicates that
Compliant’ in Swiss Albino toxicity, 2006. the sample did not
Mice and introduce any Toxicity
into the testing animal.
Biological Evaluation of
Medical devices – ISO 10993
Part 12: tests for Sample
preparation and Reference
Materials, 2012
Material Medicated Test for Material Mediated Biological Evaluation of
5 Based upon the results 315/015
Pyrogenicity in New Zealand Medical Devices - Part 11,
Pyrogenicity
White Rabbits Tests for Systemic Toxicity, obtained in this study
ISO 10993-11:2017(E).
and in line with ISO
Biological Tests - USP 42
<151>Pyrogen Test, 2019. 10993-11:2017 (E) and
USP 42 <151> Pyrogen
Test, 2019; it was
concluded that the given
test item Post Dilatation
Catheter (JADE NC)
(Lot No.: 021036011),
supplied by Relisys
Medical Devices
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Limited, is non-
pyrogenic to New
Zealand White Rabbits.

6 Haemocompatibility a) In Vitro Hemolysis

Assessment of ‘Veda+R Biological Evaluation of All the test results are VLL/0914/G/B010/R
Dilatation Catheter Medical devices – EN ISO observed Avg% of
(Veda+R/NC) – Non 10993 Part 4: Selection of haemolytic index as
Compliant” in Human Whole tests for interactions with ‘0.000’ which indicates
Blood blood, 2006. that the sample Non-
Hemolytic in the testing
Thrombosis: animal.
b) In Vitro Thrombogenicity ARL/2279/2016
testing of “Veda+R – NC
(Post Dilatation Catheter)”
Biocompatibility tests were conducted by GLP certified VIMTA Labs limited, Hyderabad, Accuprec Research Labs Pvt. Ltd., Gujarat, GLR
Laboratories Pvt Ltd., Chennai.

3.5. Testing Results:

Test item Biological effect Method Criteria Result Pass/Fail
Cytotoxicity EN ISO 10993 - 5: 2009 No evidence Yes Pass
Post Dilatation Sensitization EN ISO 10993 - 10: 2010 No reaction Yes Pass
Catheter Irritation or Intracutaneous
EN ISO 10993 - 10: 2010 No reactivity Yes Pass
reactivity
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Systemic toxicity (acute) EN ISO 10993 - 11: 2006 No evidence Yes Pass
Biological Evaluation of Medical
Material Medicated Devices - Part 11, Tests for Systemic
Toxicity, ISO 10993-11:2017(E). Non-Pyrogenic Yes Pass
Pyrogenicity
Biological Tests - USP 42 <151>
Pyrogen Test, 2019.
Haemocompatibility EN ISO 10993 - 4: 2002/Amd.1:2006 Hemocompatible Yes Pass

4. Selection and details for Bench Tests / Mechanical Tests:

Instrument/ Reference
[Link] Inspection item Specification Test Results
Reference Document No.
1 Crossing Profile 0.80 - 1.30 mm LMS Complies 015-0101-06.2
2.50mm – 2.50 ± Complies (Verification &
0.12mm LMS/PT-1000/ Validation)
2 Balloon diameter at 8 atm
4.00mm – 4.00 ± Indeflator
0.12mm
2.50mm – 2.65 ± Complies
0.12mm LMS/PT-1000/
3 Balloon diameter at 16 atm
4.00mm – 4.20 ± Indeflator
0.12mm
4 Balloon Inflation Time ≤ 10 sec In deflator Complies
5 Balloon Deflation time ≤ 15 sec In deflator Complies
Stylet/ Mandrel/ Complies
6 Maximum Guide Wire Outer Diameter 0.014”/ 0.356 mm
Guide wire
7 Minimum Guide Catheter Inner Diameter 0.056”/ 1.42 mm Guiding Catheter Complies
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No leaks / burst when Complies

8 Leak Test balloon is inflated to its In deflator/PT 3070
RBP
Compatible with 6% Complies
9 Hub compatibility 6% male Luer lock
male luer lock
10 Balloon Fatigue 18 atm/20 cycles LMS/ PT-1000 Complies
LMS/ Complies
11 Balloon Burst Pressure ≥ 24 atm
PT-1000
12 Burst Type Longitudinal Visual Complies
7.2 N - No neck down Complies 015-0101-06.2
In- House
13 Pull Test at proximal weld is
Fabricated (Verification &
accepted
Validation)
Peak Tensile Force
14
Balloon distal neck - soft tip welding 3N Complies
Balloon proximal neck - outer lumen welding 5 N Complies
Universal Testing
Hub - Hypotube 5N Complies
Machine
Hot gas welding 5N Complies
Conversion bond welding 5N Complies
EN ISO 10555- Complies
15 Corrosion resistance Corrosion resistant
1:2013
Should be radio Complies
16 Radio detectability Fluoroscopy
detectable
17 Pushability < 1.5 % PTC - 20 N Complies
18 Trackability ± 0.6 N PTC - 20 N Complies
19 Crossability Should cross the lesion PTC - 20 N Complies
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5. Conclusion:

Post Dilatation catheter is intended to use for cardiovascular procedures. Post dilatation catheter is intended for balloon dilatation of a stent
after implantation. Balloon dilatation of stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving
myocardial perfusion. Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-
segment elevation myocardial infarction. Materials used for all the sizes are same in the Declaration of Conformity document. The names
present in Biocompatibility study reports are Veda+R/NC, Veda+R Dilatation catheter-Non-Compliant balloon are referring to the same.
The Biocompatible tests conducted as per EN ISO 10993-1:2009 selection criteria of biocompatibility tests, carried out at GLP Certified
Vimta Labs, Hyderabad, Accuprec Research Labs Pvt. Ltd., Gujarat and GLR Laboratories Pvt Ltd., Chennai. Post Dilatation catheter was
found to be biocompatible based on results of Cytotoxicity, Haemocompatibility, Intracutaneous Reactivity test, Acute Systemic Toxicity,
Material Mediated Pyrogenicity Skin Sensitization. Hence, Post Dilatation Catheters are safe to use in humans for its intended purpose.
The Bench tests are conducted at Relisys Medical Devices as per the Product standard EN ISO 10555-1:2013 & EN ISO 10555-4:2013
requirements. Radio-detectability test has been conducted in Care Hospitals, Hyderabad. All the test results are observed & found that
product met with the predetermined specifications. Hence it is concluded that the Product Post Dilatation catheter is safe to use in humans
for its determined intended use in coronary angiographic procedures.

Reports Enclosed
1: Cytotoxicity test report
2: Sensitization test report
3: Irritation or Intracutaneous reactivity test report
4: Systemic toxicity (acute) test report
5: Material Mediated Pyrogenicity test report
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6: Haemocompatibility test report (Hemolysis and Thrombosis tests)

7: Verification & Validation Summary Report (010-0101-06.2)

6. Revision History

S No Date Rev No Reason for change Approved By

1 06/09/2017 00 Initial Release Head QA

2. 06/08/2020 01 Updated with Material Mediated Pyrogenicity Test results Sr. Manager – QA & QC

Approval:

Prepared By Reviewed By Approved By

06/08/2020 06/08/2020 06/08/2020