SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0

The SpectralMD DeepView Wound Imaging System 2.0 is an optical device utilizing non-contact photoplethysmography to assess microcirculatory blood flow, providing real-time, 2-D color images of relative tissue perfusion for various clinical applications. It functions by measuring changes in the optical properties of tissue in response to hemodynamic variations when illuminated by LED light, enabling the evaluation of perfusion in healthy and injured skin.

The SpectralMD DeepView Wound Imaging System 2.0 is an optical imaging device designed for non-contact assessment of blood flow within the microcirculation. It operates using photoplethysmography (PPG), where LED-emitted light interacts with subcutaneous vascular tissues; the system measures the resultant changes in optical properties due to varying hemodynamic conditions. Its software then performs real-time digital analysis of this light interaction to produce 2-D color images on a touch-screen display, illustrating relative blood perfusion. The system comprises a Camera Head with LED optics (utilizing an 850 nm wavelength for PPG and 400-900 nm for color reference imaging), an Articulating Arm for camera positioning, a Touch-Screen Display, and a Mobile Cart housing the hardware, software, and an uninterruptible power supply. It is intended for use in diverse clinical applications including plastic surgery, diabetes care, dermatology, vascular surgery, wound healing, neurology, physiology, neurosurgery, and anesthetics, specifically for measuring perfusion in healthy and injured skin, such as burn wounds, skin flaps, chronic wounds, decubitus ulcers, and diabetic ulcers. Performance testing of the DeepView System 2.0 confirmed its ability to detect the pulsatile component of fluid flow. This included identifying the 2% alternating current (AC) modulation characteristic of tissue-volume changes from blood flow in human tissue, detecting these AC modulations across various frequencies corresponding to the human heart rate, and discerning fluid flow beneath optically dense media, simulating physiological conditions. These evaluations, along with successful electrical safety, electromagnetic compatibility, and usability testing, validate its operational capabilities. The device incorporates specific software modules for different wound types (e.g., Burn Wounds, Diabetic/Ischemic Wounds) and offers enhancements like broadband illumination for improved color reference images and better ergonomic design.

AI Regulatory Concerns

Powered by

Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. How does the DeepView System 2.0 account for variations in skin pigmentation and tissue thickness when measuring blood perfusion, and what is its validated depth of penetration for accurate PPG signal acquisition?; What specific quantitative perfusion parameters, beyond relative color mapping, does the system provide, and how do these correlate with clinical outcomes in diverse wound types such as diabetic ulcers versus burn wounds?; Can the broadband illumination (400-900 nm) be utilized for spectral analysis to derive additional physiological information, such as tissue oxygenation or specific chromophore concentrations, beyond providing a color reference image?; What is the test-retest reliability and inter-observer variability of the DeepView System 2.0 in clinical settings, particularly concerning camera positioning and image interpretation across different operators?; How does the system differentiate blood flow changes due to inflammation versus those indicative of neovascularization or improved perfusion during the wound healing process?