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The PVK-720ST Endocavitary Transducer will be used with the SSA-380A diagnostic ultrasound system, which was cleared for cardiac; fetal, small organ and peripheral vascular applications in K933743 and abdominal organ imaging in K943303.

PVK-720ST Endocavitary Transducer

This 510(k) summary for the PVK-720ST Endocavitary Transducer does not contain information about acceptance criteria or a study proving device performance against such criteria.

The document primarily focuses on establishing substantial equivalence to previously cleared devices (SSA-380A and PVE-582V) based on:

• Intended Use: Used with the SSA-380A diagnostic ultrasound system for existing cleared applications.
• Technological Characteristics: Similar general technology, software verification/validation procedures, patient contact materials, and acoustic output intensities to previously cleared transducers and systems.
• Safety: A review of complaint files for similar transducers indicates potential failure is not expected to result in patient injury.

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC/standalone studies is not present in this document. This 510(k) relies on the substantial equivalence pathway, which often leverages existing data and regulatory clearances rather than requiring new, comprehensive performance studies as might be seen for novel devices or those undergoing PMA (Pre-Market Approval).

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