510(k) Submission for ECG Interpretation Software (SaMD)

PROBLEM STATEMENT

A client approached D2R Global Consulting with their ECG analysis and interpretation software, a Class II SaMD, seeking 510(k) clearance from the FDA. The software required a detailed regulatory pathway, including comprehensive documentation, clinical data, and comparisons with predicate devices, to ensure compliance and facilitate a smooth submission process.

Our Approach

  • Device Classification and Predicate Identification:D2R confirmed the software’s classification as a Class II medical device and identified suitable predicate devices to demonstrate substantial equivalence, aligning the submission with FDA expectations.
  • Comprehensive Documentation Preparation:D2R meticulously prepared the required documentation, including,
    • Device Description: Detailed functionality and technical specifications of the ECG software.
    • Clinical Data: Compilation of performance validation and clinical evaluation data to substantiate claims.
    • Substantial Equivalence: A comparative analysis with predicate devices to establish safety and efficacy.
  • Regulatory Pathway Support:
  • D2R guided the client through the 510(k) submission process, ensuring adherence to FDA’s Quality System Regulations (QSR). We provided pre-submission reviews, addressing FDA queries proactively to avoid delays.
  • Post-Submission Assistance:D2R worked closely with the client and FDA during the review process, responding to inquiries and ensuring that all additional information was submitted promptly.

Outcome

The company successfully obtained DSIR certification, officially recognizing their pioneering work in regenerative medicine and therapy. This certification not only enabled them to claim tax incentives for their R&D activities but also enhanced their credibility and positioning as an innovative leader in the field.