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AAMI 5840 3 2022

AAMI 5840 3 2022

$153.60

ANSI/AAMI/ISO 5840-3:2022, Cardiovascular implants—Cardiac valve prostheses—Part 3: Heart valve substitutes implanted by transcatheter techniques

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AAMI 2022
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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.

PDF Catalog

PDF Pages PDF Title
1 ANSI/AAMI/ISO 5840-3:2022; Cardiovascular implants—Cardiac valve prostheses—Part 3: Heart valve substitutes implanted by transcatheter techniques
3 Title page
4 AAMI Standard
5 Copyright information
Contents Page
9 Committee representation
10 Background of ANSI/AAMI adoption of ISO 5840-3:2021
11 Foreword
12 Introduction
13 1 Scope
2 Normative references
3 Terms and definitions
16 4 Abbreviations
17 5 Fundamental requirements
6 Device description
6.1 General
6.2 Intended use
18 6.3 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
19 6.3.2.4 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
20 7.2 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
21 Table 1—Minimum in vitro hydrodynamic device performance requirements, aortic
Table 2—Minimum in vitro hydrodynamic device performance requirements, mitral
22 7.2.5 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)
23 7.2.6.4 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
24 7.2.8 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
26 7.3.3 Methods
27 7.3.4 Test report
7.4 Clinical investigations
7.4.1 General
28 7.4.2 Study considerations
30 7.4.3 Study endpoints
7.4.4 Ethical considerations
7.4.5 Pivotal studies: Distribution of subjects and investigators
32 7.4.6 Statistical considerations including sample size and duration
33 Table 3—Patient-years required to exclude a linearized event rate that is double the expected rate with 80 % power
7.4.7 Patient selection criteria
34 7.4.8 Valve thrombosis prevention
7.4.9 Clinical data requirements
7.4.9.1 General
7.4.9.2 Baseline
35 7.4.9.3 Peri-procedure data
36 7.4.9.4 Follow-up data
37 7.4.9.5 Clinical investigation analysis and reporting
7.4.9.6 Post-market clinical follow-up
39 Annex 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
40 A.4 Chemical treatments, surface modifications or coatings
A.5 Component description
A.6 Implant procedure
41 Annex B (informative) Transcatheter heart valve substitute hazard analysis example
B.1 Hazards, foreseeable sequence of events, hazardous situations, and associated harms
Table B.1—Example transcatheter heart valve substitute hazards, foreseeable sequence of events, hazardous situations, and associated harms
43 Annex C (informative) Guidelines for verification of hydrodynamic performance — 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
44 Table C.1—Performance characterization of pulse duplicator testing using mechanical valves
C.2.4 Test fixture parameters — Minimum performance testing (for transcatheter aortic valves only)
45 Table C.2—Aortic fixture parameters
47 C.2.5 Test fixture parameters — Minimum performance testing (for transcatheter mitral valves only)
48 Table C.3—Mitral fixture parameters
49 C.2.6 Test parameters — Multi-range hydrodynamic characterization testing (all transcatheter valves)
Table C.4—Regurgitant volume test conditions
C.2.7 Test procedure
C.2.8 Test report
51 Annex 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
52 D.4 Ability to access and deploy
53 Annex E (informative) Examples of design specific testing
E.1 Stent creep
E.2 Environmental degradation
E.3 Static pressure; “burst” 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
54 Annex F (informative) Preclinical in vivo evaluation
F.1 General
Table F.1—Examples of evaluations
F.2 Disposition of evaluations
F.2.1 General
F.2.2 Haemodynamic performance
55 F.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
56 Annex 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
57 G.7 Classification of causal relationships
G.8 Classification of adverse events
G.8.1 General
58 G.8.2 Examples of adverse events
60 G.9 Comparison to surgical valve replacement
G.10 Follow up of SAEs
61 G.11 Device-related mortality
62 Annex H (informative) Multimodality imaging of TAVI and TMVI pre, peri and post-implantation assessments — Examples
H.1 General
H.2 Multimodality imaging capabilities
63 Table H.1—Multimodality imaging capabilities: TAVI
64 Table H.2—Multimodality imaging capabilities: TMVI
H.3 Echocardiographic (TTE and TEE) data acquisition
65 H.4 Computed tomography data acquisition and reconstruction
H.5 TAVI & TMVR imaging
66 Bibliography

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