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Section 7 — Substantial Equivalence
Substantial Equivalence Summary
The CardioFlex Catheter System is substantially equivalent to the predicate device K211045 (Steerable Ablation Catheter) in terms of intended use, technological characteristics, and performance parameters. K211045 21 CFR 870.3610
Both devices are single-use, irrigated radiofrequency ablation catheters intended for the treatment of cardiac arrhythmias in adult patients. The subject device introduces a novel ceramic tip design that does not raise new safety questions. K203312
AI suggestion

“Your predicate used polyamide construction. Add a sentence comparing tip materials and citing ISO 10993-1 biocompatibility equivalence.”

AcceptRewriteIgnore
Citation sources · 3 linked
K211045
Steerable Ablation Catheter · Cleared 2021
21 CFR 870.3610
Cardiac Ablation · Classification reg
ISO 10993-1:2018
Biocompatibility evaluation
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Section compliance
Device DescriptionReady
Substantial EquivalenceReady
Performance Testing1 gap
BiocompatibilityNot started
Suggestion
Performance Testing is missing a citation for the flex cycle test. Add ASTM F2999-16 — all 5 predicates cite it.
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510(k)
Submission Cover Letter
~15 min
510(k)
Indications for Use Statement
~20 min
510(k)
Substantial Equivalence Narrative
~45 min
Labeling
Instructions for Use (IFU)
~2 hrs
Design Controls
Design History File Outline
~1 hr
V&V
Verification Protocol
~1.5 hrs
Risk
Risk Management Plan (ISO 14971)
~2 hrs
Q-Sub
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~45 min
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