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U.S. Department of Health and Human Services

Product Classification

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Device electrical impedance spectrometer
Definition It is indicated for use on cutaneous lesions with one or more clinical or historical characteristics of melanoma, when a dermatologist chooses to obtain additional information when considering biopsy. It should not be used on clinically obvious melanoma. It is to be used as one element of the overall clinical assessment. The output given by the device should be used in combination with clinical and historical signs of melanoma to obtain additional information prior to a decision to biopsy.
Physical State Device is comprised of 1) Control Unit: processes examination data and presents electrical impedance spectra on the display, includes touch screen for user interaction, 2) Probe: holds the electrode used for lesion evaluation, 3)Probe Cable: connects probe to control unit, 3)Examination Electrodes – single patient use, sterile, disposable: The electrode head is covered with micro invasive pins (approximately 150 µm high with 170 µm triangular base), 4) Training Electrodes – single person use, sterile, disposable, 5) Test Impedance Tool, 6) Lesion Coverage Tool, 7) Power cord, 8)Battery, rechargeable (optional), and 9) USB flash drive
Technical Method It utilizes electric impedance to characterize skin tissue in real-time. It consists of a control unit and a disposable electrode.
Target Area Cutaneous lesions
Review Panel General & Plastic Surgery
Product CodeONV
Premarket Review Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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