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類別: CLASSIFICATION
等同器材
在510(k)提交中用於與新器材進行比較以建立實質等效性的已合法上市器材。等同器材必須具有相同的預期用途和相似的技術特徵。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
A predicate is the legally marketed device used to argue substantial equivalence in a US 510(k). Without a suitable predicate, consider De Novo.
PROCESS / STEPS
- Search cleared devices by product code and intended use.
- Compare indications, technology, and performance needs in an SE matrix.
- Document why differences do not raise new safety/effectiveness questions.
- Support residual gaps with testing or limited clinical data if needed.
EXAMPLES
- Using a cleared infusion pump as predicate for a modified pump with the same intended use.
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SOURCES
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