Electrical Impedance Spectrometer
Basic Information
- Device Name
- Electrical Impedance Spectrometer
- Trade Name
- NEVISENSE
- PMA Number
- P150046
- Device Class
- FDA Class 3
- Product Code
- ONV
- Generic Name
- Electrical Impedance Spectrometer
- Medical Specialty
- Unknown
- Advisory Committee
- General, Plastic Surgery
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- June 28, 2017
- Date Received
- December 7, 2015
- Expedited Review
- N
- Docket Number
- 17M-3982
Advisory Committee Statement
Approval for the Nevisense. This device 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. Nevisense should not be used on clinically obvious melanoma. The Nevisense result is one element of the overall clinical assessment. The output of Nevisense should be used in combination with clinical and historical signs of melanoma to obtain additional information prior to a decision to biopsy. Nevisense is indicated only for use on: primary skin lesions with a diameter between 2 mm and 20 mm; lesions that are accessible by the Nevisense probe; lesions where the skin is intact (i.e., non-ulcerated or non-bleeding lesions); lesions that do not contain a scar or fibrosis consistent with previous trauma; lesions not located in areas of psoriasis, eczema, acute sunburn, or similar skin conditions; lesions not in hair-covered areas; lesions which do not contain foreign matter; lesions not on special anatomic sites (i.e., not for use on acral skin, genitalia, eyes, mucosal areas).
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ONV | Electrical Impedance Spectrometer | FDA class 3 | Unknown |