Document nN9xandkKvm5kDdgzOwk09Kgz

Lab Na L 1538 NOTICE SBRTC-2015-1052-9 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: 00 Web site: www.sbrtc.com E-mail: )163.com Lab Na L 1538 SBRTC-2015-1052-9 INTRODUCTION The purpose of this study was to determine whether the extract of the test article induced a pyrogenic response following intravenous injection in rabbits. In vivo biological reactivity was evaluated following a single injection of the extract. This test was conducted based on the requirements of ISO 10993-11:2006 Part 11: Tests for systemic toxicity. The test article was received on Jun. 16, 2015. Treatment began on Oct. 12, 2015, and the final observations were concluded on Oct. 16, 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--+55V (declaration from the sponsor) Vehicles: 0.9% Sterile nonpyrogenic 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], 639.1m2 of the test sample were covered 106.4m1 of extraction vehicle under sterile conditions for preparing the test extract at 37C for 72 hours respectively in each phase. The extracts were used within 1 hour after extraction. The fresh extracts was warmed in a 38C water bath prior to injection. Instrument Preparation: Render the syringes, needles, and glassware free from pyrogens by heating at 180C for 2h. Condition of extracts: The extract of the test was clear. Page 5 of 8 SHANGHAI BIOMATERIALS RESEARCH & TEST CENTER Add: 201, Building 2, Ng 427 Jumen Road, Shanghai, China Zip Code: 200023 TEL: 0086-21-63034903 FAX: 00 Web site: www.sbrtc.com E-mail: j163.com Lab Ns L 1538 SBRTC-2015-1052-9 METHODS Test System: Species: Strain: Source: Sex: Body weight range: Age: Number of animals: Rabbit New Zealand White SHANGHAI SONGLIAN LAB ANIMAL-FIELD Male 2.4 kg-2.6 kg Adult Three 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 No of the test article and first treatment date. The room temperature and humidity were monitored daily. The room temperature was 22C. The room humidity was 59 %. Associates involved were appropriately qualified and trained. Only healthy animals were selected. Prior to using, the animals in this test were conditioned for 5d by a sham test that includes all of the steps as directed under procedure except injection. Experimental Procedure: Not more than 30min prior to injection, the temperature of each animal was measured by ZRY-2D Pyrogen Tester. This temperature was recorded as the control temperature for the study. Each rabbit was received a single intravenous injection of the extract via the marginal ear vein at 10mUkg of body weight. Rectal temperatures were measured and recorded at 30min intervals between 1 and 3h after injection. The maximum temperature rise (as compared to baseline) for each rabbit was determined. Page 6 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: 00Z Web site: www.sbrtc.com E-mail: )163.com Lab Ng L 1538 SBRTC-2015-1052-9 PHOTOGRAPH OF THE TEST ARTICLE Page 8 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