Document VGmEEMNOp6mp4nB4BznvgMaNp

Lab NQ L 1538 NOTICE SBRTC-2015-1052-3 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 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 Lab NQ L 1538 TABLE OF CONTENTS SUMMARY INTRODUCTION MATERIALS METHODS DEVIATIONS RESULTS CONCLUSION RECORD STORAGE PHOTOGRAPH OF THE TEST ARTICLE APPENDIX SBRTC-2015-1052-3 4 5 5 7 7 8 8 8 9 Page 3 of 9 SHANGHAI BIOMATERIALS RESEARCH & TEST CENTER Add: 201, Building 2, NQ 427 Jumen Road, Shanghai, China Zip Code: 200023 TEL: 0086-21-63034903 FAX:0 3 Web site: www.sbrtc.com 163.com Lab Ns L 1538 SBRTC-2015-1052-3 INTRODUCTION The test article identified below was extracted to determine whether the test extract would cause local dermal irritant effects following injection into rabbit skin. This test was conducted based on the requirements of ISO 10993-10:2010: Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization. The test article was received on Jun. 16, 2015. Treatment began on Oct. 16, 2015, and the final observations were concluded on Oct. 22, 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 Temperature Tolerance: -25--+55C (declaration from the sponsor) Vehicles: 0.9% Sodium Chloride Injection (SC)<K15062018> Cotton seed oil (CSO)< MKBS9702V> Test Article Preparation: Based on the ISO ratio of 6cm2/ml [Surface area of the test sample to volume of extraction vehicle], 91.3cm2 of the test sample were covered 15.2 ml of extraction vehicle under sterile conditions for preparing the SC or CSO test extract at 37 C for 72 hours respectively. The extracts were used within 1 hour after extraction. Reagent Control: The extraction vehicles without test article were similarly prepared to serve as the test article. Condition of extracts: All the extract of the test and controls were clear. METHODS Test System: Species: Strain: Source: Sex: Body weight range: Rabbit New Zealand White SHANGHAI SONGLIAN LAB ANIMAL-FIELD Male 2.3 kg-2.4 kg Page 5 of 9 SHANGHAI BIOMATERIALS RESEARCH & TEST CENTER Add: 201, Building 2, NQ 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 Ng L 1538 SBRTC-2015-1052-3 The tissue reaction for erythema and oedema was graded according to the classification system given below for each injection site and at each time interval observed, and recorded the results: Reaction Numerical grading Erythema and eschar formation No erythema 0 Very slight erythema (barely perceptible) 1 Well-defined erythema 2 Moderate erythema 3 Severe erythema (beet-redness) to eschar formation preventing grading of 4 erythema Oedema formation No oedema 0 Very slight oedema (barely perceptible) 1 Well-defined oedema (edges of area well-define by definite raising) 2 Moderate oedema (raised approximately lmm) 3 Severe oedema (raised more than 1mm and extending beyond exposure area) 4 After the 72h grading, all erythema plus oedema grades 24h, 48h and 72h were totalled separately for each test extract or reagent control for each individual animal. The score of a test extract or reagent control on each individual animal were calculated and divided the totals by 15 (3 scoring time points X 5 test or reagent injection sires). The over mean score for each test sample and each corresponding reagent were determined, the scores for the three animals were added and divide by three. The final test extract score was obtained by subtracting the score of the reagent from the test extract score. The requirements of the test are met if the final test extract score is 1.0 or less. DEVIATIONS There were no deviations from the ISO 10993-10:2010 and SBRTC-PROTOCOL-4-109. RESULTS All animals appeared clinically normal throughout the study. SC injection sites appeared normal immediately following injection; a little of CSO extract solution was expelled following injection. All the grades of SC and CSO extract of the test article of each rabbit were 0. Individual results of dermal scoring appear in Appendix. Results and conclusions apply only to the test article tested. No further evaluation of these results is made by Shanghai Biomaterials Research & Test Center. Page 7 of 9 SHANGHAI BIOMATERIALS RESEARCH & TEST CENTER Add: 201, Building 2, 1\k, 427 Jumen Road, Shanghai, China Zip Code: 200023 TEL: 0086-21-63034903 FAX: 0 "-- 3 Web site: www.sbrtc.com E-mail: _P,163.com Lab N:2 L 1538 SBRTC-2015-1052-3 CONCLUSION Under the conditions of this study. there was no evidence of significant irritation from the SC and CSO extracts of the test article injected intracutaneously into rabbits. The extract of the test article met the test requirement. RECORD STORAGE All raw data perta .ning 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. PHOTOGRAPH OF THE TEST ARTICLE Non-absorbable Surgical Suture (model: PTFE) No. 150642 Page 8 of 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 1-3 Web site: www.sbrtc.com E-mail: W163. com