NEVOSCOPE

K954943 · Nizar A. Mullani · KZF · Mar 27, 1996 · General Hospital

Device Facts

• Record ID: K954943
• Device Name: NEVOSCOPE
• Applicant: Nizar A. Mullani
• Product Code: KZF · General Hospital
• Decision Date: Mar 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6320
• Device Class: Class 1

Intended Use

Nevoscope is a hand-held, skin examination microscope that is similar in concept to the Episcope (k920103) and the Dermatoscope devices approved by the FDA. It is a non invasive device that is designed to view skin lesions by either surface illumination or transillumination.

Device Story

Hand-held skin examination microscope; utilizes surface illumination via fiber-optic halogen light ring and transillumination for scattered light imaging; features built-in mirror assembly for simultaneous multi-angle/elevation viewing; variable focus zoom lens for magnification; CCD TV camera for image capture and digitization; computer-based database for image storage and patient archival; used by clinicians in clinical settings; provides visual lesion data to assist in dermatological assessment and monitoring; benefits include enhanced visualization of lesion morphology through multiple lighting and viewing modalities.

Clinical Evidence

Device tested in clinical research settings for three years on skin lesion patients; evidence supported by research papers and scientific presentations demonstrating surface illumination and transillumination imaging capabilities.

Technological Characteristics

Hand-held microscope; AC-powered halogen lamp; optical fiber bundle; built-in mirror assembly; variable focus zoom lens; CCD TV camera; computer-based image storage/database; non-invasive.

Indications for Use

Indicated for the examination of skin lesions in patients requiring visual assessment of skin surface features.

Regulatory Classification

Identification

An AC-powered medical examination light is an AC-powered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.

Predicate Devices

• Episcope (K920103)
• Dermatoscope

Submission Summary (Full Text)

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Mullani 28

Nizar A. Mullani
719 Santa Maria
Sugar Land, TX 77478
Tel: [phone]
Fax: [phone]

Contact Person: Nizar A. Mullani
Date of Summary: October 22, 1995

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being
submitted in accordance with the requirements of SMDA 1990 and 21 CFR
807.92

The assigned 510(k) number is: 954943

Nevoscope is a hand-held, skin examination microscope that is similar in
concept to the Episcope (k920103) and the Dermatoscope devices approved by
the FDA. It is a non invasive device that is designed to view skin lesions by
either surface illumination or transillumination. Light is directed onto the skin by
a special light ring that is coupled to an AC powered halogen lamp by an optical
fiber bundle. Built-in mirrors permit viewing a skin lesion from different
elevations and angles simultaneously. A variable focus zoom lens controls the
magnification of the lesion and a CCD TV camera is attached for image viewing
and digitization. Skin lesion images can be stored in the computer for analysis
and archiving.

The Nevoscope can be operated with surface illumination of the skin in a
manner similar to the Episcope and the Dermatoscope. The transillumination
modality offers additional information by lighting the skin lesion from scattered
light within the skin. The mirror assembly, which provides simultaneous views
of the lesion from different angles and elevations, is also a feature of the
Nevoscope not found in either the Episcope or the Dermatoscope. Image
capture by a CCD camera and viewing of the image by a TV monitor is
available as an option in the Dermatoscope while it is a standard feature in the
Nevoscope. The Nevoscope comprises a computer database and patient
archival storage as a standard feature.

The Episcope has been in clinical use since 1992 and has demonstrated
its ability to highlight skin lesion features with surface lighting and oil immersion
techniques. The Nevoscope has been in clinical research setting for the last
three years and has been tested in skin lesion patients. Research papers and
scientific presentations have been made that demonstrate the surface
illumination imaging with the Nevoscope and the additional information
obtained by transillumination. The Nevoscope and the Episcope are
substantially equivalent in their ability to perform surface illumination and

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Mullani 29

magnification of the skin lesion. However, the Nevoscope has additional features such as transillumination and mirror views not found with either the Episcope or the Dermatoscope.

Nizar A. Mullani
4 Mulle
Oct 22, 1995