Swift Ray 1

The Swift Ray 1 is a portable digital imaging device that helps clinicians assess and document wounds at the point of care. It combines high-resolution digital imaging, fluorescence imaging (to detect bacterial presence), and thermal imaging using long-wave infrared technology to capture visual, fluorescent, and thermal data from wounds.

The Swift Ray 1 is substantially equivalent to the MolecuLight i:X predicate device in intended use, target anatomical sites, patient population, emission wavelengths, working distances, and display features. It adds thermal imaging capabilities that do not raise additional safety or effectiveness concerns. For thermal imaging, it is equivalent to the WoundVision Scout predicate.

ISO 13485 clauses 7.3 (Design controls), 8.3 (Nonconforming product), and 8.5 (Corrective and preventative action) are cited. The document references FDA guidance on cybersecurity in medical devices and software verification and validation but does not cite specific consensus standards like ASTM or IEC.

In vitro bench testing across 24 clinically relevant pathogens (72 strains, 216 images) showed no statistically significant differences in fluorescence intensity compared to the predicate. Clinical accuracy studies on 53 chronic wounds demonstrated that combined clinical signs/symptoms plus fluorescence imaging improved diagnostic accuracy from 54.7% to 79.2% (p=0.004), with positive predictive value of 92.6%, confirming meaningful identification of wounds with bacterial loads >10^4 CFU/gram, matching the predicate device's performance.