SnapshotGLO (KB100)
Kent Imaging Inc.SnapshotGLO is a handheld, point-of-care imaging device that helps clinicians visualize and document skin wounds using autofluorescence technology. It captures images of wounds under excitation light to highlight areas with bacterial presence, enhancing wound assessment alongside clinical signs and symptoms. It is intended as an adjunct tool to aid in wound diagnosis and monitoring but does not itself diagnose or treat wounds.
Intended Use
The SnapshotGLO is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to view and digitally record images of a wound, measure and digitally record the size of a wound, and view and digitally record images of fluorescence emitted from a wound when exposed to an excitation light. The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads >10^4 CFU per gram. The SnapshotGLO device should not be used to rule out the presence of bacteria in a wound. This device does not diagnose or treat skin wounds.
Technology
SnapshotGLO uses autofluorescence imaging technology by exciting wound tissue with 395 nm LEDs, causing native bacterial compounds to emit visible fluorescence (400-700 nm). The device captures both fluorescence images highlighting bacterial presence and white light 'RGB' images for clinical viewing. It is a handheld, non-contact optical imaging device with a 7-inch touchscreen display, using a single RGB camera. The device enables wound dimension measurement and digital recording of images and fluorescence data for clinician review.
Performance
Nonclinical bench tests demonstrated that SnapshotGLO detects red fluorescence from porphyrin-producing bacteria and bacterial biofilms comparably to the predicate MolecuLightDX device, also confirming accurate wound dimension measurements. Clinical data from a retrospective study with 40 patients showed SnapshotGLO had improved accuracy (75-82.5%) and over 88% positive percent agreement when used with clinical signs and symptoms compared to MolecuLightDX (52.5-65%) verified against culture results. These tests support the substantial equivalence and effectiveness of SnapshotGLO.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/5/2024
6 months - 2
FDA Approval
3/26/2025
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