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YY/T 1553-2017 English PDF

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YY/T 1553-2017: Cardiovascular implants - Cardiac occluder
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Basic data

Standard ID YY/T 1553-2017 (YY/T1553-2017)
Description (Translated English) Cardiovascular implants - Cardiac occluder
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C45
Classification of International Standard 11.040.40
Word Count Estimation 40,465
Date of Issue 2017-09-25
Date of Implementation 2018-10-01
Regulation (derived from) China Food & Drug Administration Announcement 2017 No. 118
Issuing agency(ies) State Food and Drug Administration

YY/T 1553-2017: Cardiovascular implants - Cardiac occluder

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Cardiovascular implants-Cardiac occluder ICS 11.040.40 C45 People's Republic of China Pharmaceutical Industry Standard Cardiovascular implant heart occluder Published on.2017-09-25 2018-10-01 implementation State Food and Drug Administration issued

Content

Foreword III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 General requirements 2 5 expected performance 3 6 Design attributes 3 7 material 4 8 Design Evaluation 4 9 Post-marketing supervision 11 10 Manufacturing 11 11 Sterilization 11 12 Packing 11 Appendix A (informative) Laboratory analysis test 14 Appendix B (informative) Preclinical in vivo evaluation 30 Appendix C (informative appendix) Clinical Evaluation 33 Reference 37

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This standard was proposed by the State Food and Drug Administration. This standard is administered by the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices, Cardiovascular Implants Subcommittee (SAC/ TC110/SC2). This standard was drafted. Tianjin Medical Device Quality Supervision and Inspection Center, Xianjian Technology (Shenzhen) Co., Ltd., Shanghai Shape Memory Gold Materials Co., Ltd., Dongguan Kewei Medical Devices Co., Ltd., St. Jude Medical Supplies (Shanghai) Co., Ltd. The main drafters of this standard. Jiao Yongzhe, Qi Hui, Zhang Zhenghui, Fan Platinum, Zhang Deyuan, Shi Xiaoli, Yang Yongsen, Zhuang Yaping, Li Yong, Wu Changsheng, Xing Fang, Zhang Qian. Cardiovascular implant heart occluder

1 Scope

The scope of application of this standard includes transcatheter implanted cardiac occluder for the treatment of lesions such as heart defects, mainly including atrial septal defect Loss occluder, ventricular septal defect occluder, patent ductus arteriosus occluder and patent foramen ovale occluder. This standard specifies the requirements for cardiac occluder based on the current medical knowledge level. Regarding safety, this standard is in advance Requirements for performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging, and information provided by the manufacturer. This standard applies to delivery systems that are part of the release of cardiac occluder. This standard does not cover bioabsorbable and degradation of polymer products and coatings, as well as other time compliance. This standard does not include procedures and instruments used for the implantation of cardiac occluder systems, such as J-type guide wires and measuring balloons. This standard does not include instruments for left atrial appendage closure. Except for sterilization, this standard does not include requirements for animal tissue product evaluation. YY/T 0640-2016 specifies the general requirements for the performance of passive surgical implants. This standard can be regarded as YY/T 0640-2016. Supplement.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 14233.1 Medical infusion, blood transfusion, and injecting machines - Test methods - Part 1 GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management GB 18279 Medical Device Ethylene Oxide Sterilization Confirmation and Conventional Control GB 18280 Health care products sterilization confirmation and routine control requirements radiation sterilization GB/T 19633 final sterilization medical device packaging GB/T.19974 Characteristics of Sterilization Factors for Healthcare Products and Setting, Confirmation and General Control of Medical Device Sterilization Process General requirements YY/T 0316-2008 Medical Device Risk Management for Medical Devices YY/T 0640-2016 General requirements for passive surgical implants ISO 17665-1 Sterilization of health care products - Sterilization - Part 1 . Development, validation and routines Control requirements (Sterilization of health care products-Moistheat-Part 1. Requirements for the develop- Ment,validationandroutinecontrolofasterilizationprocessformedicaldevices)

3 Terms and definitions

The following terms and definitions as defined in YY/T 0640-2016 apply to this document. 3.1 Cardiac occluder system cardiacoccludersystem Includes heart occluder and delivery system. 3.2 Conveying system deliverysystem A system or device for delivering a heart occluder to a desired target location and releasing. Usually by loader, dilator, sheath, delivery Components such as cables. Note. The delivery system will be removed after the heart occluder is deployed. 3.3 Heart occluder cardiacoccluder Placed in a heart defect, abnormal passage or special opening, and block the position to achieve passive surgery to prevent abnormal blood flow The implant mainly includes an atrial septal defect occluder, a ventricular septal defect occluder, an patent ductus arteriosus occluder and a patent foramen ovale occluder. 3.3.1 Atrial septum occluder atrialseptaloccluder A cardiac occluder for treating a diaphragm defect in a room. Note. Although the patent foramen ovale is a type of atrial septal defect, the patent foramen ovale occlusion device does not belong to the atrial septal defect occluder. 3.3.2 Ventricular septal defect occluder ventricularseptaloccluder A cardiac occluder for the treatment of ventricular septal defects. 3.3.3 Patent ductus arteriosus occluder patentartusarteriosusoccluder A cardiac occluder for treating a continuous closure of an arterial catheter. 3.3.4 Open foramen ovale occluder patentforamenovaleocclude A cardiac occluder for blocking the opening of a patent foramen ovale. 3.4 Sheath/dilator sheath/dilator A kit, typically comprising a sheath and a dilator, for establishing a pathway for delivery of a cardiac occluder. 3.5 Loader loader For accommodating the cardiac occluder, when connected to the sheath, the cardiac occluder can be pushed into the sheath. 3.6 Conveyor cable deliverycable A device that is connected to the heart occluder and pushes the heart occluder along the sheath to the intended site of implantation, disconnects and exits after release. 3.7 Barrier membrane A film-like material that acts as a choke in a heart occluder. Note. Some cardiac occluder designs may not contain a baffle.

4 General requirements

4.1 Classification The type of cardiac occluder should be described (see 3.3), the constituent materials, and any surface modification materials. 4.2 Dimensions (in millimeters) Manufacturers should consider the applicable content in the following sizes. a) the diameter of each disk surface; b) the diameter of the waist; c) the height of the waist; d) Other feature structure dimensions. Note 1. It is recommended to use a schematic to mark the dimensions. Note 2. Evaluation can be considered after performing the simulated loading and releasing process. 4.3 Expected clinical use One or more of the following expected clinical applications should be described. a) a septal defect; b) ventricular septal defect; c) patent ductus arteriosus; d) the patent foramen ovale; e) Openings to other heart structures.

5 expected performance

The requirements of Chapter 4 of YY/T 0640-2016 apply to this standard.

6 design properties

6.1 General The requirements of Chapter 5 of YY/T 0640-2016 apply to this standard. In addition, the following should be considered. a) oxidation potential, possibility of crevice corrosion, passivation of related components; b) friction corrosion, galvanic corrosion and pitting corrosion; c) About the contact surface of the cardiac occluder with the human body. 1) relative movement of the heart occluder to the tissue; 2) The force exerted by the heart occluder on the surrounding tissue. d) expected hyperplasia, penetration, perforation, tilting and displacement; e) Guide components and delivery systems. 6.2 cardiac occluder At the same time as design properties that meet the expected performance of the cardiac occluder, at least the following should be considered. a) the ability of the cardiac occluder to be consistent, accurate and safe to release; b) cardiac occluder retractable performance; c) the ability of the cardiac occluder to be effectively secured at the intended location; d) the ability of the cardiac occluder to maintain adequate integrity; e) the ability of the cardiac occluder to plug in to its intended use; f) the size of the cardiac occluder is consistent with its design and should be designed to ensure compatibility at the intended site of implantation; g) compatibility of cardiac occluders in magnetic resonance imaging (MRI) environments; h) The cardiac occluder meets the requirements of other relevant parts of GB/T 16886.1 and GB/T 16886 series; i) Visibility of the cardiac occluder under fluoroscopy or other imaging techniques. 6.3 Conveying system At the same time, at least the following aspects should be considered while meeting the design attributes of the expected performance of the conveyor system. a) the ability of the conveyor system to ensure consistent, accurate and safe access to the intended location; b) the ability of the delivery system to consistently, accurately and safely load the cardiac occluder and push the cardiac occluder to the desired position; c) the ability of the delivery system to ensure consistent, accurate and safe release of the cardiac occluder; d) ergonomic design requirements for the conveyor system; e) the ability of the conveyor system to ensure consistent and safe withdrawal; f) The conveying system meets the requirements of other corresponding parts of GB/T 16886.1 and GB/T 16886; g) the ability of the delivery system to minimize blood loss (hemostasis); h) Visibility of the delivery system under fluoroscopy or other imaging techniques. 6.4 cardiac occluder system To consistently meet the expected performance of the cardiac occluder system, design attributes should consider at least the following. a) the size fit of the sheath/dilator kit and the cardiac occluder; b) the push performance of the cardiac occluder in the sheath/dilator kit; c) the withdrawal performance of the cardiac occluder in the sheath/dilator kit; d) the strength of the connection between the delivery cable in the delivery system and the cardiac occluder; e) the smoothness of the sheath/dilator kit and the cardiac occluder; f) the venting performance of the cardiac occluder system when the heart occluder is in the sheath/dilator kit; g) the leak-proof performance of the cardiac occluder system when the heart occluder is used in conjunction with the sheath/dilator kit; h) the cardiac occluder system is airtight when the heart occluder is used in conjunction with the sheath/dilator kit; i) the ability of the delivery system to safely deliver the cardiac occluder to the intended release position and to be accurately and safely released; j) The ability of the sheath/dilator kit to safely withdraw after the cardiac occluder is released.

7 materials

7.1 General The requirements of Chapter 6 of YY/T 0640-2016 apply to this standard. 7.2 Metal materials Manufacturers should evaluate the metal materials used to make the cardiac occluder. Note 1. The requirements for stainless steel materials are specified in GB 4234. Note 2. The requirements for nickel-titanium shape memory alloy materials are specified in GB 24627. Note 3. The test method for the phase transition temperature of nickel-titanium shape memory alloy is specified in YY/T 0641. 7.3 Barrier film material If the heart occluder structure contains a baffle, the manufacturer should conduct a qualitative study of the baffle material. Barrier film thickness and porosity Manufacturers should evaluate the thickness and porosity of the barrier film as it affects transport flexibility and immediate plugging. Note. The porosity of the baffle material can be tested by the method in YY 0500.

8 Design evaluation

8.1 General The requirements of Chapter 7 of YY/T 0640-2016 apply to this standard. Risk analysis should be carried out and should be in accordance with YY/T 0316-2008 The requirements of Chapters 4, 5, 6, and 7 are carried out. Reasons for not testing should be given for untested product characteristics. Note. Not all tests are applicable to all cardiac occluder system designs. This standard cannot take into account all future emerging technologies. Cardiac occluder systems using emerging technologies require a base in accordance with this standard This requirement is assessed and may need to be characterized using tests outside the scope of this standard. In choosing the right test method The failure mode of the cardiac occluder system and the effect of failure on the performance of the implant should be considered. When any changes are made to the raw materials, structure, shape, application or processing of the product, these changes should be analyzed for the failure mode of the product. The potential impact of its performance. Proper testing should be carried out when necessary. When evaluating certain design attributes, you should consider using a contrasting device for performance comparison. Appropriate testing should be repeated to determine the shelf life of the product. The choice of test should indicate rationality. Note 1. Appendix A provides methods for laboratory analytical testing. Note 2. Appendix B provides preclinical in vivo evaluation methods. Note 3. Appendix C provides a clinical evaluation method. 8.2 Heart occluder 8.2.1 General Table 1 lists the performance, potential failure modes, effects of failures on the device, and potential harmful effects that should be considered in relation to the cardiac occluder. Bed impact. Note 1. The potential failure mode refers to difficulties or equipment failures that may be encountered and may affect the patient or the device (potential failure effects). Note 2. The potential failure effect refers to the possible impact of the failure mode on the device or patient. Table 1 Heart occluder Performance potential failure mode Potential failure impact (instrument) Potential failure impact (clinical) Structural integrity -corrosion -fracture - Heart occluder broken wire - Embolization (including cardiac occluder plugs) Plug) - Hemolysis Fixed validity - Radial force is too large - not fixed - cardiac occluder shift - Heart occluder shedding - Embolization (including cardiac occluder plugs) Plug) - severe residual shunt Cardiac occluder and tissue effect - Heart occluder applies to tissue Excessive force - Geometry interferes with heart structure - Highlight sharp - Heart occluder broken wire - intracardiac tissue damage - perforation/effusion/stuffing, etc. -erosion - Hemolysis Safety particle grade - interaction with the catheter - no - embolization Corrosion - Instrument Corrosion - Broken Wire - Embolization (including cardiac occluder embolization) - tissue damage - perforation/effusion/stuffing, etc. Blocking - incomplete blocking - insufficiency - severe residual shunt -embolism - arrhythmia Table 1 (continued) Performance potential failure mode Potential failure impact (instrument) Potential failure impact (clinical) Magnetic resonance imaging (MRI) compatibility - cardiac occluder magnetic displacement force Or magnetically induced torque is too large - RF temperature rise is too high - image artifacts - cardiac occluder shift - tissue damage - perforation/effusion/stuffing, etc. Fatigue performance - fatigue failure - broken wire - stability loss - foreign body embolism - Embolization (including cardiac occluder plugs) Plug) - tissue damage - perforation/effusion/stuffing, etc. - severe residual shunt Visibility - poor visibility - Passing failure - delivery failure - release failed - retracement failure - Heart occluder is damaged - The contrast is not clear - intracardiac tissue damage - perforation/effusion/stuffing, etc. -embolism 8.2.2 Appearance inspection The cardiac occluder should conform to the manufacturer's design specifications for surface defects and contamination. 8.2.3 Particle contamination The product should be produced under conditions of minimal particulate contamination. Manufacturers should evaluate the particle level of the product. 8.2.4 Size verification Determine the consistency of the corresponding size of the cardiac occluder with its design specifications. 8.2.5 Corrosion Evaluate the corrosion sensitivity of cardiac occluders in actual or simulated environments. Corrosion mechanisms may include pitting, frictional corrosion, crevice corrosion And galvanic corrosion. Potentially harmful clinical effects from corrosion products should be considered. Based on device design or product instruction manual (IFU) It is required to evaluate galvanic corrosion when different metal phases are in contact. Corrosion assessment includes, but is not limited to, evaluation of test results, evaluation of literature And an assessment of the previous clinical manifestations of the material. Guidelines for corrosion assessment are described in many materials (eg literature, textbooks, standards) Quasi-, regulatory guidance documents). Note. GB/T 24196, ASTMB117, ASTMF746, YY/T 0695, ASTMG5, ASTMG15, ASTMG61, ASTMG71 and ASTMG102 introduces additional guidance. 8.2.6 Tensile strength of cardiac occluder The connection strength between the connection points of the cardiac occluder and/or related components is determined. 8.2.7 Stability The force required to detach the cardiac occluder from the simulated lesion location was determined. 8.2.8 Pore or turbulence To assess the effects of pores on blood flow and blood, manufacturers can evaluate the pores of the baffle or product at the appropriate location, or The turbulence was evaluated. Note. The manufacturer can select the appropriate test method to evaluate the pore or turbulence of the product based on the design properties of the product. 8.2.9 Magnetic Resonance Imaging (MRI) Compatibility To evaluate the safety and compatibility of implants in an MRI environment, the risks should be considered but not limited to the following risks. a) magnetically induced displacement and magnetically induced torque; b) radio frequency heating; c) Image quality degradation (artifact). Note 1. YY/T 0987.2, YY/T 0987.5, YY/T 0987.4 and YY/T 0987.3 describe magnetic displacement force, magneto-induced torque, radio frequency heating and pseudo Additional guidance on the film. Note 2. Some artifacts may cause artifacts that may impair MRI imaging and limit the use of MRI in patients implanted with the device. 8.2.10 Visibility The visibility of the cardiac occluder under the imaging technique specified in the instruction manual was evaluated. 8.2.11 Durability 8.2.11.1 General The following items should be considered when evaluating durability. --- Potential failure modes such as cracks, breaks, wear or suture breaks; --- Radial and axial loads, as well as other in vivo loads. These items should be considered in conjunction with anatomical differences and morphological changes. 8.2.11.2 Stress/strain analysis The stress/strain characteristics of the implant under the most severe physiological load conditions, such as finite element analysis (FEA), are evaluated using suitable tools. 8.2.11.3 Fatigue performance The ability of the implant to maintain dimensional and structural integrity over the long term is evaluated. This includes all parts of the implant and their connection and contact with each other Regional integrity. The implant fatigue test should include an in vitro test equivalent to a ten-year fatigue cycle (at least 380 million cycles). If the implant is expected If the life span is less than ten years, the fatigue test time can be appropriately shortened and the rationality can be explained. The rationality of the choice of test conditions should be stated. The test conditions should include, but are not limited to, the number of samples, the size of the implant, and the frequency of testing. The test frequency should be set to meet the implant deformation under test conditions not less than the implant stress or strain water at physiological heart rate. level. The fatigue test should be performed at physiological temperature (eg, 37 ° C ± 2 ° C). A test for assessing the long-term integrity of a cardiac occluder under conditions of periodic one-sided pressure is provided in A.5.1.6. Law, but not limited to this method. Manufacturers can also assess the fatigue performance of cardiac occluders based on the expected clinical performance and failure mode of the product. Test methods and give reasonable reasons. 8.2.12 Chemical properties 8.2.12.1 General Cardiac occluder containing medical polymer materials should be evaluated for its chemical properties. 8.2.12.2 Preparation of extract For the preparation method of the extract, refer to GB/T 14233.1. For example, take samples, add water to each sample in a ratio of 10mL, at 37 ° C ± The sample was separated from the liquid at 1 ° C for 72 h, and cooled to room temperature as a test solution. The same volume of water was placed in a glass container, and a blank control solution was prepared in the same manner. The manufacturer can also use a custom method for the preparation of the extract. 8.2.12.3 Requirements The manufacturer shall specify the chemical performance requirements of the cardiac occluder. 8.3 Conveying system 8.3.1 General Table 2 lists the performance, potential failure modes, effects of failures on the device, and potentially harmful clinical conditions that should be considered. influences. Table 2 Conveying system Performance potential failure mode Potential failure impact (instrument) Potential failure impact (clinical) Conveying system through performance - cannot be pushed to the target location - Mismatch between components of the conveyor system - Passing failure -Accessory failure - Dilator damage - Sheath damage -embolism - tissue damage at the approach site - intracardiac tissue damage - perforation/effusion/stuffing, etc. Dilator retracement performance - connection point separation - Dilator damage - foreign body embolism - retracement failure - Embolization (including cardiac occluder plugs) Plug) - intracardiac tissue damage - perforation/effusion/stuffing, etc. Hemostasis - poor hemostasis - no - intraoperative hemorrhage Visibility - poor visibility - Passing failure - delivery failure - release failed - retracement failure - Heart occluder is damaged - The contrast is not clear - intracardiac tissue damage - perforation/effusion/stuffing, etc. -embolism 8.3.2 Appearance inspection When examined with normal or corrected visual acuity at a 2.5-fold expansion, the outer surface of the effective length of the sheath should be free of impurities. Note 1. In order to minimize the damage to the blood vessels during use, the outer surface of the effective length of the sheath, including the head end, should be free of processing defects and surface defects. Note 2. If the guiding device is coated with a lubricant, when normal or corrected visual acuity is checked, the outer surface of the effective length of the sheath should not be seen to converge on the lubricant. 8.3.3 Size 8.3.3.1 Size verification Determine the consistency of the corresponding dimensions and design specifications. 8.3.3.2 Sheath tip and dilator gap In order to minimize damage to the blood vessels during use, the manufacturer should perform a gap between the tip of the sheath and the dilator. Evaluation. 8.3.4 Tensile strength The relevant components are determined to include the joint point of the system and/or the tensile strength of the fixed joint. 8.3.5 Torsional bond strength If applicable, determine the torque/rotation required to break the joints and/or materials of the various components of the sheath/dilator kit. 8.3.6 Bending/Discounting The ability to evaluate the minimum bend radius or angle that the delivery system can accommodate. 8.3.7 Hemostatic This clause covers the ability of the system to minimize blood loss. Consideration should be given to, but not limited to, the following. a) the dimensions do not match; b) improper sealing; c...

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