Document RpJ76oEmko6wvg1ko7znw4nZk
Lab Ns L 1538
TABLE OF CONTENTS
SUMMARY INTRODUCTION MATERIALS METHODS DEVIATIONS RESULTS CONCLUSION RECORD STORAGE PHOTOGRAPH OF THE TEST ARTICLE APPENDIX
SBRTC-2016-0335-1
3 4 4 5 8 8 10 .10 11 12
Page 3 of 13
SHANGHAI BIOMATERIALS RESEARCH & TEST CENTER
Add: 201, Building 2, No 427 Jumen Road, Shanghai, China
Zip Code: 200023
TEL: 0086-21-63034903
FAX: 0
Web site: www.sbrtc.com
E-mail:111.111163.com
Lab N2 L 1538
SBRTC-2016-0335-I
INTRODUCTION
The purpose of this study was to evaluate the potential for a local irritant response to material
Milerect contact with muscle tissue. This test was conducted based on the requirements of 2007: Biological Evaluation of Medical Devices, Part 6: Tests for Local Effects after Implantation. The test article was received on Jun. 16, 2015. The animals were implanted on Oct. 20, 2015 and the final observations were concluded on Mar. 17, 2016
This study, initiated by protocol signature on Aug. 20, 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 sample 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:
150643
Sterilization Status:
STERILE
Storage Conditions:
Room temperature
Test Article Preparation:
According to the requirement of sponsor, the samples with 0.303mm in wire diameter were supplied by the sponsor. The test samples were prepared into 10mm in length for testing.
Negative control:
According to the requirement of sponsor, High density polyethylene rod coming from Hatano Research Institute Food and Drug Safety Center was utilized as the negative control, and prepared into 1mm in width and 10mm in length for testing.
METHODS
Test System:
Species:
Rabbit
Strain:
New Zealand White
Source:
SHANGHAI SONGLIAN LAB ANIMAL-FEILD
Sex:
7 male, 7 female
Number of Animals:
14
Body Weight Range:
2.1 kg to 2.6 kg before implantation.
Animal J\12
1
2
3
4
5
6
Weight (kg) 2.1
2.2
2.6
2.3
2.2
2.4
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SHANGHAI BIOMATERIALS RESEARCH & TEST CENTER
Add: 201, Building 2, I\Ia 427 Jumen Road, Shanghai, China
Zip Code: 200023
TEL: 0086-21-63034903
FAX: 0086-21-63011643
Web site: www.sbrtc.com
E-mail: biomatercenter@l63.com
Lab Na L 1538
SBRTC-2016-0335-1
Age: Test Periods:
Animal .N2
7
8
9
10
11
12
Weight (kg) 2.1
2.6
2.4
2.3
2.2
2.2
Animal Ns 13
14
15
16
17
18
Weight (kg) 2.4
2.5
/
/
/
/
Adult
lw, 4w and 12w after implantation
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 Pu Lu Teng Biological Technology 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 range was from 20C to 23C. The room humidity range was from 51 % to 61 %.
Associates involved were appropriately qualified and trained.
Healthy, previously unused animals were selected.
Experimental Procedure: The fur was clipped from the area over paravertebral muscles with appropriate antiseptic and then injected with 3.0% pentobarbital sodium (1.0m1/kg) to achieve whole anesthesia by an ear intravenous injection. After the anesthetic had taken effect, the back was wiped with 0.1% benzal konium bromide tincture and draped. An incision large enough to accommodate the needle was made through the skin over the dorsolumbar region of the vertebral column. A stylet was placed in the needle and the needle withdrawn, leaving the sample in the paravertebral muscle. 2.5-5 cm from the midline and parallel to spinal column, four test samples were implanted and each implanted site was approximately 2.5 cm apart. In the opposite muscle, four negative controls were similarly implanted. Rabbits were returned to the respective cages following the procedure. All the animals were observed daily for general health. At lw, 4w and 12w, the rabbits were euthanasia and the representative tissue implant sites (test and control) from each animal were excised, the area of the tissue surrounding the center portion of each implant strip was examined macroscopically.
Page 6 of 13
SHANGHAI BIOMATERIALS RESEARCH & TEST CENTER
Add: 201, Building 2, Ng 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 Ns L 1538
SBRTC-2016-0335-1
Table 3 Scoring System at 1 week after implantation
Animal Number: Inflammation:
Polymorphonuclear Lymphocytes Plasma Cells Macrophages Giant Cells Necrosis
SUB TOTAL (X2) Neovascularisation
Fibrosis Fatty Infiltrate SUB-TOTAL
TOTAL GROUP TOTAL AVERAGE IRRITANT SCORE Traumatic Necrosis Foreign Debris
Test Sample
I
2
3
Control Sample
1
2
3
0
0
0
1
1
1
0
0
0
1
0
0
0
0
0
0
0
0
4
2
2
2
2
1
2
2
1
0
0
0
4
4
2
8
6
4
18
1
0
2 1
1
1
0
0
0
0
0
0
1
1
1
0
0
0
6
4
8
2
2
3
2
2
3
0
0
0
4
4
6
10
8
14
32
TEST - CONTROL = 18/3 - 32/3 = -4.7 (regarded as 0)
/
/
/
/ I /
/ I/
/
/
/
/ / / / / / Li / / /
Table 4 Scoring System at 4 week after implantation
Animal Number: Inflammation:
Polymorphonuclear Lymphocytes Plasma Cells Macrophages Giant Cells Necrosis
SUB TOTAL (X2) Neovascularisation
Fibrosis Fatty Infiltrate SUB-TOTAL
TOTAL GROUP TOTAL AVERAGE IRRITANT SCORE Traumatic Necrosis Foreign Debris
Test Sample
4
5
6
Control Sample
4
5
6
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
1
1
1
1
1
0
0
0
2
2
2
2
2
2
6
0
0
0
1
1
0
0
0
0
0
1
0
0
0
0
0
0
0
2
4
0
1
1
1
l
1
1
0
0
0
2
2
2
4
6
2
12
TEST - CONTROL = 6/3 - 12/3 = -2.0 (regarded as 0)
/
/
/
/ /
/
/
/
/
/
/
/
/ I/
/
/
/
/
/
Page 9 of 13
SHANGHAI BIOMATERIALS RESEARCH & TEST CENTER
Add: 201, Building 2, Na 427 Jumen Road, Shanghai, China
Zip Code: 200023
TEL: 0086-21-63034903
FAX: 0(
I3
Web site: www.sbrtc.com
E-mail:
16 3.com
Lab Na L 1538
SBRTC-2016-0335-1
Table 5 Scoring System at 12 week after implantation
Animal Number: Inflammation:
Polymorphonuclear Lymphocytes Plasma Cells Macrophages Giant Cells Necrosis
SUB TOTAL (X2) Neovascularisation
Fibrosis Fatty Infiltrate SUB-TOTAL
TOTAL GROUP TOTAL AVERAGE IRRITANT SCORE Traumatic Necrosis Foreign Debris
Test Sample
7
8
9
Control Sample
7
8
9
0
0
0
0
0
0
0
0
0
I
0
0
0
0
0
0
0
0
2
0
0
1
1
1
1
1
1
0
0
0
2
2
2
4
2
2
8
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0
2
0
0
1
1
1
1
1
1
0
1
0
2
3
2
4
3
2
9
TEST - CONTROL = 8/3 - 9/3 = -0.3 (regarded as 0)
/
/
/
/ /
/
/
/
/
/
/
/
/
/ /
/
/
/
/
/
According to the irritant ranking, 12 weeks muscle implantation test of the test sample was regarded as non-irritant.
Results and conclusions apply only to the test article tested. No further evaluation of these results is made by Shanghai Biomaterials Research & Test Center.
CONCLUSION
Under the conditions of this study, macroscopically, there was no visible abnormal reaction for test samples at any implant site of all observation periods. Microscopically, the average irritant scores were 0, 0 and 0 at 1 week, 4 week and 12 weeks respectively. According to the average irritant score at 12 weeks, the test article was considered a non-irritant as compared to the negative control.
RECORD STORAGE
All raw data, paraffin blocks and tissue slides pertaining to this study and a copy of the final report are to be retained in designated SBRTC archive files.
Page 10 of 13
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