Medical Devices; General and Plastic Surgery Devices; Classification of the Light Based Energy Source Device for Topical Application. Final order.

The Food and Drug Administration (FDA or we) is classifying the light based energy source device for topical application into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the light based energy source device for topical application's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Eficácia da fototerapia associada à sulfadiazina de prata no tratamento de úlceras venosas crônicas / Efficacy of the phototherapy associated with silver sulphadiazine in the treatment of chronic venous ulcers

Introdução: Várias são as propostas terapêuticas para úlceras de perna venosas crônicas (UVCs), como curativos, ultrassom, aparelhos fotobioestimuladores (laser/LED) e outros. Objetivo: Analisar a eficácia da fototerapia (LED 660/890 nm) com curativo diário de sulfadiazina de prata 1 por cento creme (SDZ) para úlceras venosas crônicas. Métodos: Estudo randomizado, duplo-cego, com aparelho fototerápico com 2 sondas: 1 (LED 660 nm/5mW) e 2 (1 LED 660 nm e 32 LED 890 nm/500 mW). Selecionaram-se 20 pacientes (n = 32 úlceras) do Ambulatório de Úlceras CSE–FMRP–USP, constituindo-se grupos: G1-sonda 1+SDZ; G2-sonda 2+SDZ e G3-SDZ, seguidos por 90 dias. Aplicaram-se sobre as úlceras, as sondas pontualmente (3,0 J/cm2, 30 seg/5cm2, 2x/semana) e posterior curativo SDZ. Quinzenalmente, foram fotografadas e avaliadas pelo software Image Jâ, mensurando-se as áreas [total, de esfacelo (E); e de tecido de granulação (G)], calculando-se índices de cicatrização das úlceras [ICU = (Ai-Af)/Ai)] e relação E/G. Resultados: G2 apresentou redução significante no 30º e 90º dia (p 0,4, G2 alcançou este índice em 75 por cento das úlceras no 30º e 90º dias, enquanto 33 por cento do G1, somente no 60º. Conclusão: A fototerapia (LED’s) associada à SDZ acelerou processo de cicatrização das UVCs (G1/G2), comparada ao creme isoladamente (G3), pelos ICUs e pela relação E/G.

Introduction: Many therapeutic forms were used to treat chronic venous ulcers such as dressing, ultrasound, photobiostimulator (laser/LED) and other. Objective: To analyze effectiveness of photo­therapy (LED 660/890 nm) with 1 percent silver sulfadiazine cream (SDZ) in chronic venous ulcers. Method: Randomized and double-blind study using the phototherapy device with 2 probes: 1 (LED 660 nm/5mW) and 2 (1 LED 660 nm and 32 LED 890 nm, 500 mW). Twenty patients were selected (n = 32 ulcers) from Ulcer Outpatient Clinic of the School Health Center –FMRP–USP, divided into groups: G1-probe1+SDZ, G2-probe2+SDZ and G3-SDZ, during 90 days. The probes were applied on ulcers, punctually (3 J/cm2, 30 sec/5cm2, twice/week) and posterior daily SDZ’s dressing. Fortnightly, the ulcers were photographed and evaluated by Image J® software, measuring the areas [total, sphacellus (S) and granulation tissue(G)], calculating wound healing rate [WHR = (iA-fA)/iA)] and S/G relation. Results: G2 presented significant reduction in the 30th and 90th days (p 0.4, G2 achieved this rate in 75 percent of the ulcers in the 30th and 90th days, while 33 percent of the G1 only in the 60th days. Conclusion: The phototherapy (LED) associated with SDZ accelerated wound healing of the venous ulcers (G1/G2) compared the cream (G3) by WHRs and S/G relation.