NEVISENSE

Electrical Impedance Spectrometer

FDA Premarket Approval P150046

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

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).

• Device: NEVISENSE
• Classification Name: Electrical Impedance Spectrometer
• Generic Name: Electrical Impedance Spectrometer
• Applicant: SCIBASE AB
• Date Received: 2015-12-07
• Decision Date: 2017-06-28
• Notice Date: 2017-06-30
• PMA: P150046
• Supplement: S
• Product Code: ONV
• Docket Number: 17M-3982
• Advisory Committee: General & Plastic Surgery
• Expedited Review: No
• Combination Product: No
• Applicant Address: SCIBASE AB kammakargatan 22 stockholm SE-11-1140
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling Labeling Part 2
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P150046		Original Filing
S004	2019-05-31	Normal 180 Day Track
S003	2018-11-21	30-day Notice
S002	2018-07-06	Normal 180 Day Track
S001	2018-05-09	Real-time Process

NIH GUDID Devices

Device ID	PMA	Supp
07350094440217	P150046	000
07350094440200	P150046	000
07350094440194	P150046	000
07350094440101	P150046	000
07350094440095	P150046	000
07350094440088	P150046	000
07350094440071	P150046	000
07350094440279	P150046	002