Document qaGnEbx0j6LGV8D7qB5QraQDR
Lab Isla L 1538
NOTICE
SBRTC-2015-1052-7
I. It will be invalid for the report without a connective seal. 2. It will be invalid for the report without the signature of study director. 3. It will be invalid for the manual revision of the report. 4. It can't be copied partly on the report without agreement, nor can be as the
recorder of the order receiving and advertisement registration. 5. Please raise the objection to the Center within 15 days after the receipt of the
report, otherwise it will be considered to accept the testing result. 6. It is only responsible for the samples received.
SHANGHAI BIOMATERIALS RESEARCH & TEST CENTER
Add: 201, Building 2, Islp 427 Jumen Road, Shanghai, China
Zip Code: 200023
TEL: 0086-21-63034903
FAX: 0
-- --3
Web site: www.sbrtc.com
E-mail:
D163.com
Page 2 of 9
Lab NQ L 1538
SBRTC-2015-1052-7
TABLE OF CONTENTS
SUMMARY
4
INTRODUCTION
5
MATERIALS
5
METHODS
6-7
RESULTS
7-8
CONCLUSION
9
RECORD STORGE
9
PHOTOGRAPH OF THE TEST ARTICLE
9
SHANGHAI BIOMATERIALS RESEARCH & TEST CENTER
Add: 201, Building 2, No 427 Jumen Road, Shanghai, China
Zip Code: 200023
TEL: 0086-21-63034903
FAX: 0(
3
Web site: www.sbrtc.com
E-mail:
_,163.com
Page 3 of 9
Lab N2 L 1538
SBRTC-2015-1052-7
SUMMARY
The test article, Non-absorbable Surgical Suture (model:PTFE) was extracted in Minimum Essential Medium and DMSO. A chromosomal aberration study was conducted to determine whether the extracts would cause genotoxicity in Chinese Hamster Lung cells in the presence and absence of S9 metabolic activation. This study was conducted to satisfy, in part, the genotoxicity requirement of the International Organization for Standardization ISO 10993-3:2014: Biological Evaluation of Medical Devices, Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity; ISO 10993-12:2012: Biological evaluation of medical devices, Part 12: Sample preparation and reference materials.
A monolayer of Chinese Hamster Lung (CHL) cells was exposed to the test article extracts in triplicate cultures and in the presence and absence of S9 metabolic activation. Parallel testing was also conducted with negative and positive controls. Culture medium was used as the negative control. Mitomycin C (MMC) served as the positive control in the absence of S9 and cyclophosphamide (CP) served as the positive control in the presence of S9.
Under the conditions of this assay, the extracts of test article were not considered genotoxic to Chinese Hamster Lung cells in the presence and absence of S9 metabolic activation. The negative and positive controls performed as expected.
Study and Supervisory Personnel: JI Lina LU Hua
Study Director:
SUN Jiao, Ph.D.
Ale-v 2 . d o lk
Date Completed
SHANGHAI BIOMATERIALS RESEARCH & TEST CENTER
Add: 201, Building 2, Ng 427 Jumen Road, Shanghai, China
Zip Code: 200023
TEL: 0086-21-63034903
FAX: 0(
43
Web site: www.sbrtc.com
E-mail:
'@163.com
Page 4 of 9
Lab Na L 1538
SBRTC-2015-1052-7
INTRODUCTION
A chromosomal aberration study was conducted to determine whether the Minimum Essential Medium and DMSO extracts of Non-absorbable Surgical Suture (model:PTFE) would cause clastogenic changes in Chinese Hamster Lung (CHL) cells. The test was performed in the presence and absence of S9 metabolic activation. The chromosomal aberration genotoxicity test employs CHL cells to detect chromosome structural changes. The detection of the aberrations was accomplished by observing chromosomes in metaphase which had been strained with Giemsa. The test article received on Jun.16, 2015. The test began on Sep.14, 2015, and cell counts concluded on Oct.28, 2015.
This study was completed in the Lab of Shanghai Biomaterials Research & Test Center (SBRTC). SBRTC was conducted in accordance with the provisions of the ISO/IEC 17025-2005.
MATERIALS
The test article provided by the sponsor was identified and handled as follows:
Test Article:
Non-absorbable Surgical Suture(model:PTFE)
< Specification: Z21302-60(USP2-0/EP2.5) >
Identification No:
150642
Storage Conditions:
Room temperature
Extraction Vehicle:
Minimum Essential Medium < Lot N21(1652143> DMSO< Lot N2.20141118>
Test Article Extract:
Based the ISO, 6cm2/ml [Surface area of the test article to volume of extraction vehicle],367.3cm2 test article was covered with 61.2m1 Minimum Essential Medium and 56.5cm2 test article was covered with 9.4m1 DMSO respectively under sterile conditions for preparing the test article extracts at 37C for 72h . The test extracts were then serially diluted with the same vehicle and resulted in the following concentrations: Test A: 25% diluent of the test extraction Test B: 50% diluent of the test extraction Test C: 100% test extraction according to the requirement
Negative Control: Positive Control::
The extraction vehicle without any materials was similarly prepared at 37C for 72h.
Mitomycin C (MMC) was prepared in the absence of S9. Cyclophosphamide (CP) was prepared in the presence of S9.
Condition of Extracts: All the extracts of the test articles and controls were clear.
SHANGHAI BIOMATERIALS RESEARCH & TEST CENTER
Add: 201, Building 2, Ng 427 Jumen Road, Shanghai, China
Zip Code: 200023
TEL: 0086-21-63034903
FAX: 0
r3
Web site: www.sbrtc.com
E-mail:
D163.com
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