SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0
SPECTRALMD, INC.The SpectralMD DeepView Wound Imaging System 2.0 is a medical imaging device that uses non-contact photoplethysmography (PPG) technology to capture color images showing blood perfusion in tissues. It helps clinicians assess blood flow in a variety of clinical settings, including wound healing, plastic surgery, and vascular surgery, by providing detailed images of microcirculation in healthy or injured skin.
Intended Use
The SpectralMD™ DeepView™ Wound Imaging System 2.0 is an optical imaging device intended for studies of blood flow in the microcirculation. It is suitable for plastic surgery, diabetes, dermatology, vascular surgery, wound healing, neurology, physiology, neurosurgery, and anesthetics. It measures perfusion of healthy and injured skin including burn wounds, skin flaps, chronic wounds, decubitus ulcers, and diabetic ulcers.
Technology
The device utilizes non-contact photoplethysmography (PPG) with LED broadband illumination (400-900 nm) to detect pulsatile blood flow and produce 2D color images of relative blood perfusion. It includes a camera head with LED optics, articulating arm, touchscreen display, and a mobile cart housing hardware and software, with ergonomic and software improvements compared to predicate devices.
Performance
Testing demonstrated the device can detect pulsatile blood flow and AC modulation consistent with tissue-volume changes from blood flow. It showed equivalence to the primary predicate device in detecting pulsatile flow frequency and flow under simulated physiological conditions. Electrical safety, electromagnetic compatibility, and usability testing met relevant standards. No clinical data were required to support equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/28/2016
8 months - 2
FDA Approval
8/17/2017
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