{"id":424606,"date":"2024-10-20T06:52:33","date_gmt":"2024-10-20T06:52:33","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-5840-3-2022\/"},"modified":"2024-10-26T12:55:52","modified_gmt":"2024-10-26T12:55:52","slug":"aami-5840-3-2022","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-5840-3-2022\/","title":{"rendered":"AAMI 5840 3 2022"},"content":{"rendered":"

This document establishes an approach for verifying\/validating the design and manufacture of a surgical heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests can include those to assess the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of their materials and components. The tests can also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute. This document includes considerations for implantation of a transcatheter heart valve substitute inside pre-existing prosthetic device configurations.<\/p>\n

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1<\/td>\nANSI\/AAMI\/ISO 5840-3:2022; Cardiovascular implants\u2014Cardiac valve prostheses\u2014Part 3: Heart valve substitutes implanted by transcatheter techniques <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Standard <\/td>\n<\/tr>\n
5<\/td>\nCopyright information
Contents Page <\/td>\n<\/tr>\n
9<\/td>\nCommittee representation <\/td>\n<\/tr>\n
10<\/td>\nBackground of ANSI\/AAMI adoption of ISO 5840-3:2021 <\/td>\n<\/tr>\n
11<\/td>\nForeword <\/td>\n<\/tr>\n
12<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
16<\/td>\n4 Abbreviations <\/td>\n<\/tr>\n
17<\/td>\n5 Fundamental requirements
6 Device description
6.1 General
6.2 Intended use <\/td>\n<\/tr>\n
18<\/td>\n6.3 Design inputs
6.3.1 Operational specifications
6.3.2 Performance specifications
6.3.2.1 General
6.3.2.2 Transcatheter heart valve system
6.3.2.3 Implantable device <\/td>\n<\/tr>\n
19<\/td>\n6.3.2.4 Delivery system
6.3.3 Implant procedure
6.3.4 Packaging, labelling and sterilization
6.4 Design outputs
6.5 Design transfer (manufacturing verification\/validation)
6.6 Risk management
7 Design verification and validation
7.1 General requirements <\/td>\n<\/tr>\n
20<\/td>\n7.2 In vitro assessment
7.2.1 General
7.2.2 Test conditions, sample selection and reporting requirements
7.2.3 Material property assessment
7.2.3.1 General
7.2.3.2 Biological safety
7.2.3.3 Material and mechanical property testing
7.2.4 Hydrodynamic performance assessment <\/td>\n<\/tr>\n
21<\/td>\nTable 1\u2014Minimum in vitro hydrodynamic device performance requirements, aortic
Table 2\u2014Minimum in vitro hydrodynamic device performance requirements, mitral <\/td>\n<\/tr>\n
22<\/td>\n7.2.5 Structural performance assessment
7.2.5.1 General
7.2.5.2 Implant durability assessment
7.2.5.3 Device structural component fatigue assessment
7.2.5.4 Component corrosion assessment
7.2.6 Design- or procedure-specific testing
7.2.6.1 General
7.2.6.2 Device migration resistance
7.2.6.3 Implant foreshortening (length to diameter) <\/td>\n<\/tr>\n
23<\/td>\n7.2.6.4 Crush resistance
7.2.6.5 Recoil
7.2.6.6 Radial resistive force (RRF)
7.2.6.7 Chronic outward force
7.2.6.8 Delivery system design evaluation requirements
7.2.6.9 Visibility
7.2.7 Device MRI compatibility <\/td>\n<\/tr>\n
24<\/td>\n7.2.8 Simulated use
7.2.9 Human factors and usability assessment
7.2.10 Implant thrombogenic and haemolytic potential assessment
7.3 Preclinical in vivo evaluation
7.3.1 General
7.3.2 Overall requirements <\/td>\n<\/tr>\n
26<\/td>\n7.3.3 Methods <\/td>\n<\/tr>\n
27<\/td>\n7.3.4 Test report
7.4 Clinical investigations
7.4.1 General <\/td>\n<\/tr>\n
28<\/td>\n7.4.2 Study considerations <\/td>\n<\/tr>\n
30<\/td>\n7.4.3 Study endpoints
7.4.4 Ethical considerations
7.4.5 Pivotal studies: Distribution of subjects and investigators <\/td>\n<\/tr>\n
32<\/td>\n7.4.6 Statistical considerations including sample size and duration <\/td>\n<\/tr>\n
33<\/td>\nTable 3\u2014Patient-years required to exclude a linearized event rate that is double the expected rate with 80 % power
7.4.7 Patient selection criteria <\/td>\n<\/tr>\n
34<\/td>\n7.4.8 Valve thrombosis prevention
7.4.9 Clinical data requirements
7.4.9.1 General
7.4.9.2 Baseline <\/td>\n<\/tr>\n
35<\/td>\n7.4.9.3 Peri-procedure data <\/td>\n<\/tr>\n
36<\/td>\n7.4.9.4 Follow-up data <\/td>\n<\/tr>\n
37<\/td>\n7.4.9.5 Clinical investigation analysis and reporting
7.4.9.6 Post-market clinical follow-up <\/td>\n<\/tr>\n
39<\/td>\nAnnex A (informative) Description of the transcatheter heart valve system
A.1 General
A.2 Description of the transcatheter heart valve substitute
A.3 Description of delivery system <\/td>\n<\/tr>\n
40<\/td>\nA.4 Chemical treatments, surface modifications or coatings
A.5 Component description
A.6 Implant procedure <\/td>\n<\/tr>\n
41<\/td>\nAnnex B (informative) Transcatheter heart valve substitute hazard analysis example
B.1 Hazards, foreseeable sequence of events, hazardous situations, and associated harms
Table B.1\u2014Example transcatheter heart valve substitute hazards, foreseeable sequence of events, hazardous situations, and associated harms <\/td>\n<\/tr>\n
43<\/td>\nAnnex C (informative) Guidelines for verification of hydrodynamic performance \u2014 Pulsatile flow testing
C.1 General
C.2 Pulsatile-flow testing
C.2.1 General
C.2.2 Measuring equipment accuracy
C.2.3 Test apparatus requirements <\/td>\n<\/tr>\n
44<\/td>\nTable C.1\u2014Performance characterization of pulse duplicator testing using mechanical valves
C.2.4 Test fixture parameters \u2014 Minimum performance testing (for transcatheter aortic valves only) <\/td>\n<\/tr>\n
45<\/td>\nTable C.2\u2014Aortic fixture parameters <\/td>\n<\/tr>\n
47<\/td>\nC.2.5 Test fixture parameters \u2014 Minimum performance testing (for transcatheter mitral valves only) <\/td>\n<\/tr>\n
48<\/td>\nTable C.3\u2014Mitral fixture parameters <\/td>\n<\/tr>\n
49<\/td>\nC.2.6 Test parameters \u2014 Multi-range hydrodynamic characterization testing (all transcatheter valves)
Table C.4\u2014Regurgitant volume test conditions
C.2.7 Test procedure
C.2.8 Test report <\/td>\n<\/tr>\n
51<\/td>\nAnnex D (normative) Requirements for delivery system design and evaluation
D.1 General
D.2 Implant interactions with delivery system
D.3 Loading of the device into\/onto the delivery system <\/td>\n<\/tr>\n
52<\/td>\nD.4 Ability to access and deploy <\/td>\n<\/tr>\n
53<\/td>\nAnnex E (informative) Examples of design specific testing
E.1 Stent creep
E.2 Environmental degradation
E.3 Static pressure; \u201cburst\u201d test
E.4 Calcification
E.5 Particulate generation
E.6 Effects of device post-dilatation
E.7 Expansion uniformity
E.8 Bailout option evaluation
E.9 Intentional cracking of a pre-existing prosthesis <\/td>\n<\/tr>\n
54<\/td>\nAnnex F (informative) Preclinical in vivo evaluation
F.1 General
Table F.1\u2014Examples of evaluations
F.2 Disposition of evaluations
F.2.1 General
F.2.2 Haemodynamic performance <\/td>\n<\/tr>\n
55<\/td>\nF.2.3 Ease of use
F.2.4 Device migration or embolization
F.2.5 Interference with or damage to adjacent anatomical structures
F.2.6 Haemolysis
F.2.7 Thrombo-embolic events
F.2.8 Calcification\/mineralization
F.2.9 Pannus formation\/tissue ingrowth
F.2.10 Structural valve deterioration and non-structural dysfunction
F.2.11 Assessment of valve and non-valve related pathology <\/td>\n<\/tr>\n
56<\/td>\nAnnex G (normative) Adverse event classification during clinical investigation
G.1 General
G.2 Evaluation
G.3 Data collection requirements
G.4 Adverse events
G.5 Adverse device effects
G.6 Device deficiencies <\/td>\n<\/tr>\n
57<\/td>\nG.7 Classification of causal relationships
G.8 Classification of adverse events
G.8.1 General <\/td>\n<\/tr>\n
58<\/td>\nG.8.2 Examples of adverse events <\/td>\n<\/tr>\n
60<\/td>\nG.9 Comparison to surgical valve replacement
G.10 Follow up of SAEs <\/td>\n<\/tr>\n
61<\/td>\nG.11 Device-related mortality <\/td>\n<\/tr>\n
62<\/td>\nAnnex H (informative) Multimodality imaging of TAVI and TMVI pre, peri and post-implantation assessments \u2014 Examples
H.1 General
H.2 Multimodality imaging capabilities <\/td>\n<\/tr>\n
63<\/td>\nTable H.1\u2014Multimodality imaging capabilities: TAVI <\/td>\n<\/tr>\n
64<\/td>\nTable H.2\u2014Multimodality imaging capabilities: TMVI
H.3 Echocardiographic (TTE and TEE) data acquisition <\/td>\n<\/tr>\n
65<\/td>\nH.4 Computed tomography data acquisition and reconstruction
H.5 TAVI & TMVR imaging <\/td>\n<\/tr>\n
66<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 5840-3:2022, Cardiovascular implants\u2014Cardiac valve prostheses\u2014Part 3: Heart valve substitutes implanted by transcatheter techniques<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2022<\/td>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":424614,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-424606","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/424606","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/424614"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=424606"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=424606"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=424606"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}