II.
LibraryProcess overview
Reference · livelib-process:biomedical-engineering--510k-submission
510k-submission overview
510(k) Premarket Submission Preparation - Prepare comprehensive 510(k) premarket notification submissions demonstrating substantial equivalence to predicate devices for FDA clearance.
Attributes
displayName
510k-submission
description
510(k) Premarket Submission Preparation - Prepare comprehensive 510(k) premarket notification
submissions demonstrating substantial equivalence to predicate devices for FDA clearance.
libraryPath
library/specializations/domains/science/biomedical-engineering/510k-submission.js
specialization
biomedical-engineering
references
- - FDA 21 CFR 807.87 510(k) Content Requirements - FDA Guidance on Format for Traditional and Abbreviated 510(k)s - FDA eCopy Program: https://www.fda.gov/medical-devices/premarket-submissions/ecopy-program
example
const result = await orchestrate('specializations/domains/science/biomedical-engineering/510k-submission', {
deviceName: 'Digital Blood Pressure Monitor',
deviceClass: 'Class II',
productCode: 'DXN',
predicateDevices: [{ name: 'Existing BP Monitor', k_number: 'K123456' }]
});
usesAgents
- general-purpose
Outgoing edges
lib_applies_to_domain1
- domain:biomedical-engineering·DomainBiomedical Engineering
lib_belongs_to_specialization1
- specialization:biomedical-engineering·SpecializationBiomedical Engineering
lib_implements_workflow2
- workflow:experiment-design·WorkflowExperiment Design
- workflow:peer-review-cycle·WorkflowPeer Review Cycle
lib_involves_role2
- role:biomedical-engineer·RoleBiomedical Engineer
- role:research-engineer·RoleResearch Engineer
lib_requires_skill_area3
- skill-area:data-analysis·SkillAreaData Analysis
- skill-area:sensor-fusion·SkillAreaSensor Fusion
- skill-area:statistical-analysis·SkillAreaStatistical Analysis
Incoming edges
None.