Clinical Evaluation Report
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Clinical Evaluation Report
1 Overview Surgical instruments are essential tools for orthopedic surgery. All products for orthopedic implants need to be properly installed and reliably fixed to the patient's body with the appropriate surgical instruments, the safety removing of implantable devices also need appropriate surgical instruments. The production of surgical instruments with a variety of materials, such as: stainless steel, titanium, aluminum and non-metallic materials. Human exposure to traumatic surgical instruments, required hardness, toughness is moderate, leaving debris and difficult to oxidative corrosion, and have some biocompatibility. The M310 440B 05Cr17Ni14Cu4Nb and 304 are the main materials of the instruments which exposure to the trauma for a little long time . All the products manufactured in our company are labeled KH. The author of the clinical evaluation report is: He Shifeng who obtained Orthopedics major from Shaanxi Chinese Medicine University. Currently he is the international business manager of KH, who was employed in Xian 630 hospital and Johnson & Johnson Medical (China) Limited. 2 Product description and intended application 2.1 Material The company produces many types of surgical tools, materials, including metal stainless steel, titanium, aluminum and non-metallic materials, selection of the chemical composition of stainless steel materials are in line with ISO7153-1 "the first part of surgical instruments Metal: Stainless Steel, " Materials Standards Requirements. For a long time exposure to the trauma of the surgical instruments of human material (M310, 440B, 05Cr17Ni14Cu4Nb and 304) biocompatibility tests to be done to meet the ISO 10993-1 on cytotoxicity, sensitization and stimulation of the three requirements. 2.2 Intended Application Products to orthopedic implants implanted or removed easily and reliably. 2.3 Classification of products According to MDD Directive Annex IX rules, instruments are belong to category I. 2.4 Product Type The many types of surgical instruments company, is by the use of different parts into three categories: fracture fixation system of surgical instruments, surgical instruments and spinal Page
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Clinical Evaluation Report
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intramedullary nail fixation of surgical instruments. A surgical operation instrument is a collection of surgical instruments required for the different packages according to type of surgical instruments surgical instruments for more than one refinement package. Intramedullary nail operation instrument for fractures of long tubular body, the make use of intramedullary nail fixation. Nail equipment package is divided into different parts according to the operation: (1) NeoGen interlocking intramedullary nail equipment package; (2) shares nail installation equipment package; (3) installation of supracondylar intramedullary nail equipment package; ( 4) The installation of tibial intramedullary nailing equipment package; (5) of the humerus intramedullary nail equipment package; (6) NeoGen spiral blade proximal femoral nail system equipment package. Spine system equipment package for the correction of spinal deformity, spinal trauma fixed reset, pulling the spine and other spinal surgical reduction. By using different parts can be divided into: (1) Cobra posterior cervical system equipment package; (2) Reno pedicle screw instrument set; (3) spine plate (cervical system) within the fixed equipment package Ceres; (4) spine plate (cervical system) within the fixed equipment package Cerfix; (5) spine plate (Thoracolumbar System) within the fixed equipment package Solidfix; (6) spinal fixation device package (L2); (7) spinal fixation device package (L8) ; (8) Polynices bending equipment package; (9) spinal fixation device package (PolyNices); (10) spinal fixation device package type (PolyNices); (11) spinal fixation system (anterior approach); (12 ) vertebrae fixation device equipment package (cervical) Cercage; (13) vertebrae fixation device equipment package (titanium cage) Diamesh; (14) vertebrae fixation device equipment package (lumbar spine) Bridge; (15) vertebrae fusion fixtures, equipment package (lumbar spine) Lumcage. Package internal fixation devices used in human long bones, clavicle, scapula and other fractures, internal fixation with doing. As part of the bones of the human body shape, different sizes, it required surgery for a bone fixation are not the same, to meet the needs of operation, easy to choose a doctor, Internal fixation device package is divided into the following types: (1) Synplate-large bone equipment package, (2) Synplate-small bone equipment package, (3) Monoloc-large bone equipment package, (4) Monoloc-small bone equipment package, (5) fracture fixation equipment package (MonoLoc-2.7mm locking devices), (6) metal micro-plate equipment package (Synplate micro), (7) metal micro-plate equipment package (facial plate), (8) Goose nail instrument set, (9) DHS/DCS- equipment package, (10) hollow nail equipment package (4.0 mm system), (11) hollow nail equipment package equipment package (4.5 mm system), (12) hollow screw device Package equipment package (7.3 mm system), (13) pelvis equipment package, (14) Liss special equipment packages. The above list of equipment packages and package the device uses see "comprehensive description of tool products." 2.5 Performance Testing 2.5.1 Mechanical properties The company's tool for the inspection agency has not yet been tested, but the products have Page
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Clinical Evaluation Report
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been listed at home and abroad over a decade, has never received customer complaints about product quality and adverse events, and each batch has the company's factory inspection report The report found that the product of hardness, sharpness and other mechanical properties are to meet the registration standards. 2.5.2 Biocompatibility tests We have do the biocompatibility tests for the instruments which manufactured by M310 440B 05Cr17Ni14Cu4Nb and 304. Testing Center of Radiological Medical Research Institute, Soochow University is applied to do the cytotoxicity test, delayed contact sensitization study in the guinea pig and skin irritation test for the products by the quality department. The results are as follows: Cytotoxicity test The test article, SS Instrument(M310) were evaluated for cytotoxicity test in
accordance with ISO10993-51999 Tests for in vitro cytotoxicity. The purpose of this study was to determine the potential cytotoxicity of the testing article to L-929 cell. The result of SS instrument(M310): The testing sample solution is mixed with growing-well L-929 cell, and then incubated for 2 and 4 days. Observe the morphology and the cell well sticking on the culture bottle wall. The RGR(Relative growth Rate) are 92% and 103% respectively by calculation on the basis of cell concentrations of different groups (the negative and positive controls ). The test article, SS Instrument(440B05Cr17Ni14Cu4Nb and 304) were evaluated for cytotoxicity test in accordance with ISO10993-52009 Tests for in vitro cytotoxicity. The purpose of this study was to determine the potential cytotoxicity of the testing article to L-929 cell. The result of SS Instrument(440B05Cr17Ni14Cu4Nb and 304): The testing sample solution was mixed with growing-well L-929 cell, and then incubated for 24h at 37 in 5%CO2. Intracytoplasmic granulation and cell lysis were observed, MTT method was used to determine the potential cytotoxicity ratio of the 100% extract of the test sample were 87.1%, the 50% extract of the test sample were 89.5%, the negative control were 89.9%, the positive control cytotoxicity ratio were 1.3%. This meant that the test was valid and the sample article had no toxicity to L-929 cell. Delayed contact sensitization study in the guinea pig A guinea pig maximization test (ISO 10993-10:2002) of M310 instruments and a guinea
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pig maximization test (ISO 10993-10:2010) of 440B 05Cr17Ni14Cu4Nb and 304 instruments were conducted to evaluate the potential for delayed dermal contact sensitization. Method and result of SS Instrument(M310440B05Cr17Ni14Cu4Nb and 304:The method of Magnusson and Kligman (1970) was adapted for alcohol in a 0.9% sodium chloride USP solution test article extract. The extract of the test article was intradermally injected and occusively patched to ten guinea pigs in an attempt to induce sensitization. Following a recovery period, the original ten test and five previously untreated control animals received a challenge patch of the test article extract and the control vehicle. In addition the test article was applied the same animals. All sites were scored at 24 and 48 hours after patch removal. Under the conditions of this study, the test article extract and the test article showed no signification evidence of causing delayed dermal contact sensitization in the guinea pig. Skin irritation test The test article, SS Instrument(M310) was evaluated for Intracutaeous irritation in accordance with the ISO 10993-10:2002 Tests for irritation and delayed-type hypersensitivity. The 440B 05Cr17Ni14Cu4Nb and 304 instruments were evaluated for Intracutaeous irritation in accordance with the ISO 10993-10:2010 Tests for irritation and delayed-type hypersensitivity. This study was to determine the potential skin irritation after the injection of sample solution into the animal back. Method and result of SS Instrument(M310 440B 05Cr17Ni14Cu4Nb and 304): Observe and write down the skin responds on injection sites in 24, 48 and 72 hours respectively after injection. The skin responses include erythema and oedema. Grade the tissue reaction for erythema and oedema according to the classification system. According to what observed, the response of skin on testing side dose not exceed that on the control side. The primary irritation index for the test article was calculated to be 0. The test result shows that leached solution of sample dose not induce irritation to rabbit skin. ConclusionThrough the biocompatibility tests, there are no potential cytotoxicity, sensitization and skin irritation to our products. So we considered that the machining process of the product is reasonable, the post-process is effective and all of the processes are feasible which can not cause biological damage. 2.6 SterilityNon-sterile package. Page
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Clinical Evaluation Report 2.7 RadioactivityNon-radioactive. 3Expected treatment and/or indications and requirements 3.1Indications
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These instruments are widely used in the indication of the four types of implants of our company. Internal fixation instruments can be applied to indications using bone plates and bone screws. Intramedullary nailing instrument can be applied to indications using spine internal fixation system. 3.2Contraindications 1) Acute general or local infection; 2) Severe osteoporosis; 3) Mental disease or impossible to cooperate; 4) Allergic to metal. 3.3 Attentions 1) Disinfect before use; 2) Clean after use to prevent rusting; 3) The packed instrument set should be kept indoors with humidity under 80%, no corrosive gases and with good ventilation. 3.4 Our company offers 35 kinds of instrument sets. See the composition, application, indications, intraindications and instruction of use on the manuals of each set. 4Evaluation background 4.1 Background and history In early 1850s, Robert Danis first started the study on fracture treatment by operation. In order to support their theory, they recorded and collected all the cases in detail and evaluated, analyzed and summarized the results. The treatment method was continuously improved and developed. In early 1958, AO summarized four principles to improve the performance of fracture treatment. With the applications for over 40 years, the new concept on fracture heal and the development of operation treatment is widely accepted worldwide. Our company has been following the four AO principles since established in 1995 and we control the whole process from design to manufacturing of implants, and make sure the products meet the safety requirement. Since founding in 1995, our company has developed well. The sale of the products is Page
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1000 per year. In the supervision and inspection of every year, the quality of our products is good, and obtained the qualified enterprises of product quality.. 4.2 The considered items, features, special function by special design, basic safety requirement and evaluation requirement are all identified in medical instrument risk management document. See details from Risk Management Report. 5Market feedback Instrumentation products of our company have been clinically used in hundreds of hospitals in China for many years and there is no medical accident caused by quality problem of instrument reported. The expected safety and effectiveness of the product is achieved. The customer satisfaction is more than 95% according to investigation results. 6Clinical Evaluation This product has been used in clinical operations for over ten years both domestic and overseas. However, no clinical trials are conducted either in China or in EU or North America according to local standards. There is only one clinical paper on similar product found on medical magazines and forums. Therefore, the clinical evaluation is based on clinical feedback of our product and a clinical paper on equivalent medical instrument. 6.1 Clinical applications after launch This product has no supporting clinical papers from domestics or overseas, but has been applied in clinical use for more than ten years. It is widely used in internal fixation, intramedullary nailing, and spine internal fixation operations using implants from our company (see instrument set list from clinical evaluation report of the four types of products). Although postoperative complications were reported for several times in implant papers, such as implant loosening, breakage, and coming off; pain and infection on wound, and epidermis etc., but the reasons are in many aspects. As analysis in the papers, some were caused by the malpractice of surgeons, e.g. damage of blood vessels and nerve, hematoma etc., some were caused by special factors of individual patient, e.g. history of tumble, obesity, overload, perform heavy manual or consistent activity under pressure, but not caused by the design or quality problem of the instruments. We analyze and evaluate these risks and manage the identified risks properly. We also state the inevitable risks in instruction of use of our products to minimize the complications and risks. Page
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Clinical Evaluation Report 6.2 Clinical paper of equivalent medical instrument
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Clinical Application of GSS Instrument in Scoliosis Correction Operation Prepared byZhang Junhua Key words scoliosis Edited bystuda20 surgical operation
correction device
GSS is a general spine system. The instrument set is composed of various of models of U type pedicle screws, pedicle hooks, rods, screw caps and crosslink etc. Select a few U type pedicle screws to fit at scoliosis area on continuous or noncontinuous spinal columns. Fix the screws with rod and correct the deformation by distraction, compression or rotation. 16 patients were treated, 7 male and 9 female. Their ages vary from 4-19 and the average age is 15.3. Type of scoliosis: 11 idiopathic and 5 congenital. Pre-op scoliosis Cobbs angle: 4568 for idiopathic with the average of 57; 5295 for congenital with the average of 68. All the 16 patients were operated with GSS instrument correction and graft fusion, and 12 of them were done dorsum razor resection. Results: The average Cobbs angle of the 16 patients before operation were 63 . One-stage correction operation was adopted on all the patients. The average post-op Cobbs angle for idiopathic patients is 29.4, with correction rate of 59.1%. The average post-op Cobbs angle for congenital patients is 33.3, with correction rate of 52.3%. No post-op complication was found. 14 patients were followed up for 6 months minimum and 4 years maximum, with an average of
1.5 years. There was no obvious loss of correction angle found and the graft fusion worked well. With GSS instrument, most mild or moderate scoliosis with reasonable flexibility can be fixed by rotation correction method. As the procured rod rotates at the end of pedicle screws, the coronal deformation changes to saggital kyphosis or lordosis. Therefore, the optimum indications are scoliosis patients with flat back or lumbar kyphosis. For idiopathic King I type patient, fit the precurved rod to the pedicle screws, rotate the rod from convex side of to concave side at thoracic deformation while from concave side to convex side at lumbar. With the elastic change of the rod and the creep of spinal, the thoracic coronal scoliosis is changed to saggital lordosis. Conclusion: The GSS instrument, designed on the principle of CD corrector, has the function of distraction, compression and rotating correction. The instrument can be applied to scoliosis patients at different ages, with big correction force, no occupation of vertebral canal, which is very effective treatment to spinal scoliosis.
The instruments for posterior spine systems of our company, such as Reno, L2 & L8
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system, are similar with GSS instrument in composition, design and function of use etc. The performance is even better than GSS instrument. As shown from the above paper, the instruments for posterior spine system are very effective for the treatment of spinal scoliosis. 7Conclusion Designed in pursuant to international standard, tested in compliance with international inspection standard and proved by clinical reports of launched implants and clinical papers of equivalent instrument, our instrument products have ideal effect of use. The expected applications and performance our company claimed are proved by clinical evidence and the required safety and effectiveness of medical instrument are also achieved. The application risk and operation risk of medical instrument do exist. We manage the risks weve already identified to minimize the risks. The remaining risk is evaluated as acceptable. The benefits that patients get from the internal fixation operations are obvious in despite of the risks. Therefore, we come to the conclusion that the relating risks of the application risks of medical instrument are acceptable compared with the benefits patients can achieve. 8Attchments 1Cytotoxicity test(M310) Testing Center of Radiological Medical Research Institute, Soochow University 2 Delayed contact sensitization study in the guinea pig(M310) Testing Center of Radiological Medical Research Institute, Soochow University 3Skin irritation test(M310) Testing Center of Radiological Medical Research Institute, Soochow University 4 Cytotoxicity test(440B 05Cr17Ni14Cu4Nb and 304) Testing Center of Radiological Medical Research Institute, Soochow University 5Delayed contact sensitization study in the guinea pig(440B05Cr17Ni14Cu4Nb and 304) Testing Center of Radiological Medical Research Institute, Soochow University 6Skin irritation test(440B05Cr17Ni14Cu4Nb and 304) Testing Center of Radiological Medical Research Institute, Soochow University
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