General and Plastic Surgery · PMA · 2017
NEVISENSE
SCIBASE AB. Approved by FDA on 28 June 2017 under submission P150046, product code ONV (electrical impedance spectrometer). What FDA's record says, in FDA's words.
Device record · P150046
- Device. NEVISENSEDEVICE
- Company. SCIBASE ABCOMPANY
- Decision. 28 June 2017, PMA, aprlDECISION
- Panel. General and Plastic SurgeryPANEL
- Product code. ONV, Electrical Impedance SpectrometerCODE
- Regulation. 21 CFR 878.1820, Class IIREG
- Source. FDA database entry · decision document (33 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA approved it for
The Indications for Use statement, verbatim, from the decision document.
. D. Overall Conclusions The data in this application support the reasonable assurance of safety and effectiveness of this device when used in accordance with the indications for use. Nevisense provides an objective method, used as a complement to the visual examination, to help the dermatologist decide whether to biopsy the lesion. The device demonstrated a satisfactory safety profile, with few adverse events overall and no serious adverse events. The high observed sensitivity and non-randomness of the device for distinguishing melanomas and non-melanoma malignancies from benign lesions observed in the Pivotal Study, and the improved accuracy relative to standard of care observed in the Reader Study, considered with the indications for use and the warnings, together support the conclusion that the benefits of the Nevisense for use by dermatologists as one element of the overall clinical assessment, used in combination with clinical and historical signs of melanoma to obtain additional information prior to a decision to biopsy, outweigh the risks.
The product code's definition, from FDA's classification record. An electrical impedance spectrometer is a prescription device that measures and analyzes electrical impedance properties of a skin lesion. The device is intended for use by a physician trained in the clinical diagnosis and management of skin cancer as an adjunctive device following identification of a suspicious skin lesion. The output given by the device is intended to be used in combination with clinical and historical signs of skin cancer to obtain additional information prior to a decision to biopsy. It is not for use as a standalone diagnostic and is not for use to confirm a clinical diagnosis Please reference https://www.federalregister.gov/documents/2026/03/25/2026-05772/general-and-plastic-surgery-devices-reclassification-of-optical-diagnostic-devices-for-melanoma.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsnone of the tracked terms matched
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1 report filed against devices carrying product code ONV. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
18 November 2019 · Injury · SPECTROMETER · PERKIN ELMER HEALTH SCIENCES CANADA, INC. · report MW5091162
STROKE AS RESULT OF PRODUCT. THE STATE OF (B)(6) CHANGED THE NEWBORN SCREENING PROVIDERS IN 2014, FROM (B)(6) CLINIC TO PERKIN ELMER AND WERE TOLD THEY WERE BUYING COMPARABLE SERVICE. THE PERKIN ELMER SPECTROMETER WAS REPLACED, I WAS TOLD THE EQUIPMENT WAS NOT SENSITIVE ENOUGH TO HAVE PICKED UP MY SON'S CONDITION. THE STATE OF (B)(6) PROVIDED INFO THAT SHOWED (B)(6) WOULD HAVE CAUGHT HIS CONDITION. THE STATE OF (B)(6) POCKETED THE (B)(6) THEY SAVED BY USING PERKIN ELMER AND ADJUSTED THEIR CUT […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code ONV, in General and Plastic Surgery, or approved in 2017. The whole record is at FDA AI-enabled medical devices.
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