{
  "id": "lib-process:biomedical-engineering--510k-submission",
  "_kind": "LibraryProcess",
  "_file": "generated-library/processes.yaml",
  "_cluster": "generated-library",
  "attributes": {
    "displayName": "specializations/domains/science/biomedical-engineering/510k-submission",
    "description": "510(k) Premarket Submission Preparation - Prepare comprehensive 510(k) premarket notification\nsubmissions 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', {\n  deviceName: 'Digital Blood Pressure Monitor',\n  deviceClass: 'Class II',\n  productCode: 'DXN',\n  predicateDevices: [{ name: 'Existing BP Monitor', k_number: 'K123456' }]\n});",
    "usesAgents": [
      "general-purpose"
    ]
  },
  "outgoingEdges": [
    {
      "from": "lib-process:biomedical-engineering--510k-submission",
      "to": "skill-area:data-analysis",
      "kind": "lib_requires_skill_area",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-process:biomedical-engineering--510k-submission",
      "to": "skill-area:sensor-fusion",
      "kind": "lib_requires_skill_area",
      "attributes": {
        "weight": 0.7
      }
    },
    {
      "from": "lib-process:biomedical-engineering--510k-submission",
      "to": "skill-area:statistical-analysis",
      "kind": "lib_requires_skill_area",
      "attributes": {
        "weight": 0.5
      }
    },
    {
      "from": "lib-process:biomedical-engineering--510k-submission",
      "to": "domain:biomedical-engineering",
      "kind": "lib_applies_to_domain",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-process:biomedical-engineering--510k-submission",
      "to": "role:biomedical-engineer",
      "kind": "lib_involves_role",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-process:biomedical-engineering--510k-submission",
      "to": "role:research-engineer",
      "kind": "lib_involves_role",
      "attributes": {
        "weight": 0.7
      }
    },
    {
      "from": "lib-process:biomedical-engineering--510k-submission",
      "to": "workflow:experiment-design",
      "kind": "lib_implements_workflow",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-process:biomedical-engineering--510k-submission",
      "to": "workflow:peer-review-cycle",
      "kind": "lib_implements_workflow",
      "attributes": {
        "weight": 0.7
      }
    },
    {
      "from": "lib-process:biomedical-engineering--510k-submission",
      "to": "specialization:biomedical-engineering",
      "kind": "lib_belongs_to_specialization",
      "attributes": {
        "weight": 0.9
      }
    }
  ],
  "incomingEdges": []
}