(149 days)
No
The description focuses on optical and imaging technology, with no mention of AI or ML for analysis. The "analysis" mentioned likely refers to human interpretation of the images.
No
The device is a diagnostic tool used to view and analyze skin lesions, but it does not treat or cure any condition.
No
The device description indicates it is a "skin examination microscope" used to "view skin lesions" and highlight "skin lesion features." While images can be stored for "analysis," the document does not state that the device itself performs a diagnosis or provides diagnostic outputs. Its function appears to be solely for visualization and image capture to aid in examination.
No
The device description explicitly details hardware components such as a hand-held microscope, light ring, halogen lamp, optical fiber bundle, mirrors, zoom lens, and a CCD TV camera. While it mentions image storage and analysis on a computer, the core device is a physical instrument.
Based on the provided information, the Nevoscope is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Nevoscope's function: The description clearly states that the Nevoscope is a "hand-held, skin examination microscope" that views skin lesions directly on the body using surface illumination or transillumination. It is a non-invasive device.
- No mention of samples: There is no indication that the Nevoscope analyzes samples taken from the body. It is used for direct visualization of the skin.
Therefore, the Nevoscope falls under the category of a medical device used for direct examination and imaging, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
surface illumination or transillumination
Anatomical Site
skin
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 880.6320 AC-powered medical examination light.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.
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Nizar A. Mullani 719 Santa Maria Sugar Land. TX 77478 Tel: (713) 494-0340 Fax: (713) 494-0377
Contact Person: Nizar A. Mullani
MAR 2 7 1996
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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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
Oct 22, 1995
Date