Document MG66yMKO8KGrzmxjMm68gwbRk

Lab Na L 1538 TABLE OF CONTENTS SBRTC-2015-1052-5 SUMMARY 4 INTRODUCTION 5 MATERIALS 5 METHODS 6-7 DEVIATIONS 7 RESULTS 7 CONCLUS ION 8 RECORD STORAGE 8 PHOTOGRAPH OF THE TEST ARTICLE 8 Page 3 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: 001111.1 Web site: www.sbrtc.com E-mail: 163.com Lab Nn L 1538 SBRTC-2015-1052-5 INTRODUCTION The test article was conducted to determine whether leachables from the test extract would cause hemolysis in vitro. This test was conducted based on the requirements of ISO 10993-4: 2002+Amd 1: 2006: Biological Evaluation of Medical Devices, Part 4: Selection of tests for interactions with blood. The test article was received on Jun. 16, 2015. Treatment began on Oct. 16, 2015, and the final result was concluded on Oct. 19, 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--,+55 C (declaration from the sponsor) Vehicles: 0.9% Sodium chloride Injection (SC)< K15062018> Test Article Preparation: Based on the ISO ratio of 6cm2/ml [Surface area of the test sample to volume of extraction vehicle], 62.7cm2 of the test sample were covered 10.45m1 of extraction vehicle under sterile conditions for preparing the SC test extract at 37C for 72 hours respectively in each phase. The extracts were used within 1 hour after extraction. Negative Control: The extraction vehicles without test article were similarly prepared to serve as the test article. Positive Control: Distilled water <150907> without test article were similarly prepared to serve as the test article. Condition of extracts: The SC extract of the test was clear. Page 5 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: 00 Web site: www,sbrtc.com E-mail: _,163.com Lab Ns L 1538 SBRTC-2015-1052-5 METHODS Test System: Species: Strain: Source: Sex: Body weight range: Age: Number of animals: Rabbit New Zealand White SHANGHAI SONGLIAN LAB ANIMAL-FIELD Male 2.5 kg Adult One Animal Management: Husbandry: Food: Housing: Environmental: Personnel: Selection: Conditions conformed to "Laboratory animal-Requirements of environment and housing facilities"; "ISO 10993-2:2006: Biological evaluation of medical devices Part 2: Animal welfare requirements". Diet was provided from SHANGHAI SLAC LABORATORY ANIMAL CO. LTD. Healthy animals were acclimatized to the laboratory conditions for 7 days before the treatment, and then they were individually housed in stainless steel suspended cages identified by a card indicating the Identification N2 of the test article and first treatment date. The room temperature and humidity were monitored daily. The room temperature was 24C. The room humidity was 56 %. Associates involved were appropriately qualified and trained. Only healthy animals were selected. The dilution of the fresh anticoagulant rabbit blood preparation: 10mL of fresh rabbit blood with 0.5mL of 20g/L potassium oxalate reagent was prepared for a fresh anticoagulant rabbit blood; then 4mL of fresh anticoagulant rabbit blood with 5mL 0.9% SC was prepared for the dilution of the fresh anticoagulant rabbit blood. Experimental Procedure: Three replicates were prepared per the test extract and controls respectively. Each of three tubes was added l0mL test extract as the test group. Each of three tubes was added 10m1 SC as the negative control group; each of three tubes was added 10m1 distilled water as the positive control group. All the tubes were put into a water-bath at 37V for 30min. Page 6 of 8 SHANGHAI BIOMATERIALS RESEARCH & TEST CENTER Add: 201, Building 2, Na 427 Jumen Road, Shanghai, China Zip Code: 200023 TEL: 0086-21-63034903 FAX: 0086-21-63011643 Web site: www.sbrtc.com E-mail: MIEM163.com