Document Eqd98ajnk72O8wKmwRqn8ngDx

Lab Na L 1538 NOTICE SBRTC-2015-1052-1 1. 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. Page 2 of 8 SHANGHAI BIOMATERIALS RESEARCH & TEST CENTER Add: 201, Building 2, No 427 Jumen Road, Shanghai, China Zip Code: 200023 TEL: 0086-21-63034903 FAX: 0 13 Web site: www.sbrtc.com E-mail: @,163.com Lab NQ L 1538 TABLE OF CONTENTS SUMMARY INTRODUCTION MATERIALS METHODS DEVIATIONS RESULTS CONCLUSION RECORD STORAGE PHOTOGRAPH OF THE TEST ARTICLE SBRTC-2015-1052-1 4 5 5-6 6 7 .7 7 7 .8 Page 3 of 8 SHANGHAI BIOMATERIALS RESEARCH & TEST CENTER Add: 201, Building 2, NQ 427 Jumen Road, Shanghai, China Zip Code: 200023 TEL: 0086-21-63034903 FAX: 0 Web site: www.sbrtc.com E-mail:111111111 3163.com Lab Na L 1538 SBRTC-2015-1052-1 INTRODUCTION The study was performed in order to determine whether leachables extracted from the test article would cause cytotoxicity. This test was conducted based on the requirements of ISO 10993-5:2009: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. The test article was received on Jun. 16, 2015. The cells were first exposed to the extract on Oct. 13, 2015, and the final observations were concluded on Oct. 14, 2015. This study, initiated by protocol signature on Aug. 11, 2015, was completed in the Lab of Shanghai Biomaterials Research & Test Center (SBRTC) and 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 Sterilization Status: Sterilized Storage Temperature: -25--,+55r (declaration from the sponsor) Extraction Vehicle: gibco's Minimum Essential Medium (Lot1652143) supplemented with 10% fetal bovine serum (Lot1399413) and 1% L-glutamine (F20150127) Test Extract Preparation: Based on the ISO ratio of 6cm2/ml [Surface area of the test sample to volume of extraction vehicle], 85.5cm2 of the test samples were covered 14.2m1 of extraction vehicle under aseptic condition for preparing the test extract at 37C for 24 hours. The extract was used immediately after extraction. Blank Preparation: The extraction vehicle not containing the test sample, retained in a vessel identical to that which holds the test article and subjected to conditions identical to those to which the test sample is subjected during its extraction. Negative Control Preparation : High-density polyethylene film (140923), which was current SBRTC negative control (having been demonstrated to be noncytotoxicity) coming from Hatano Research Institute Food and Drug Safety Center, The ratio of 3cm2: lml [surface area of the test sample to volume of extraction vehicle] was used and extracted at 37C for 24 hours. Page 5 of 8 SHANGHAI BIOMATERIALS RESEARCH & TEST CENTER Add: 201, Building 2, 1\12 427 Jumen Road, Shanghai, China Zip Code: 200023 TEL: 0086-21-63034903 FAX: OC 3 Web site: www.sbrtc.com E-mail: 163.com Lab Na L 1538 SBRTC-2015-1052-1 DEVIATIONS There were no deviations from the ISO 10993-5:2009 and SBRTC-PROTOCOL-1-259. RESULTS The mean values of optical density of each group were shown as blow: Group The optical density (570nm --650 nm) 100% of the negative control 100% of the test extract 75% of the test extract 50% of the test extract 25% of the test extract 100% of the positive control The blank (row 2) The blank (row 11) 0.8050.037 0.646 0.036 0.6940.013 0.7200.015 0.756 0.034 0.030 0.004 0.800 0.030 0.7980.027 Note: n=6 Viab. % 101 81 87 90 95 4 / / The mean value of optical density of the blank was 0.799 0.027. Both the left (row 2) and the right (row 11) mean of the blanks were less than 15% from the mean of all blanks. Results and conclusions apply only to the test article tested. No further evaluation of these results was made by Shanghai Biomaterials Research & Test Center. CONCLUSION Under the condition of this study, the viability of 100% extract of the test article was 81 %. It can be considered that the test article extracts had not a cytotoxic potential. RECORD STORAGE All raw data pertaining to this study and a copy of the final report are to be stored in the designated archive files at Shanghai Biomaterials Research & Test Center. Page 7 of 8 SHANGHAI BIOMATERIALS RESEARCH & TEST CENTER Add: 201, Building 2, NQ 427 Jumen Road, Shanghai, China Zip Code: 200023 TEL: 0086-21-63034903 FAX: Web site: www.sbrtc.com E-mail0: 11=.3 163.com