| Note: 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. |
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| Device | MELAFIND |
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| Generic Name | Optical diagnostic device for melanoma detection |
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| Applicant | STRATA SKIN SCIENCES, INC.
100 LAKESIDE DR STE 100
Horsham, PA 19044 |
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| PMA Number | P090012 |
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| Date Received | 06/03/2009 |
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| Decision Date | 11/01/2011 |
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| Product Code |
OYD |
| Docket Number | 12M-0074 |
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| Notice Date | 01/24/2012 |
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| Advisory Committee |
General & Plastic Surgery |
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| Clinical Trials | NCT00434057
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| Expedited Review Granted? | Yes |
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| Combination Product | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
APPROVAL FOR THE MELAFIND DEVICE. MELAFIND IS INTENDED FOR USE ON CLINICALLY ATYPICAL CUTANEOUS PIGMENTED LESIONS WITH ONE OR MORE CLINICAL OR HISTORICAL CHARACTERISTICS OF MELANOMA, EXCLUDING THOSE WITH A CLINICAL DIAGNOSIS OF MELANOMA OR LIKELY MELANOMA. MELAFIND IS DESIGNED TO BE USED WHEN A DERMATOLOGIST CHOOSES TO OBTAIN ADDITIONAL INFORMATION FOR A DECISION TO BIOPSY. MELAFIND SHOULD NOT BE USED TO CONFIRM A CLINICAL DIAGNOSIS OF MELANOMA. MELAFIND IS ONLY FOR USE BY PHYSICIANS TRAINED IN THE CLINICAL DIAGNOSIS AND MANAGEMENT OF SKIN CANCER (I.E., DERMATOLOGISTS) WHO HAVE ALSO SUCCESSFULLY COMPLETED A TRAINING PROGRAM IN THE APPROPRIATE USE OF MELAFIND.THE MELAFIND RESULT IS ONE ELEMENT OF THE OVERALL CLINICAL ASSESSMENT. MELAFIND POSITIVE LESIONS (WHICH MAY INCLUDE MALIGNANT MELANOMA, MELANOMA IN SITU, HIGH GRADE DYSPLASTIC NEVI AND ATYPICAL MELANOCYTIC PROLIFERATION/HYPER-PLASIA) SHOULD BE CONSIDERED FOR BIOPSY; THE BIOPSYDECISION OF A MELAFIND NEGATIVE LESION SHOULD BE BASED ON THE REMAINDER OF THE ENTIRE CLINICAL CONTEXT. LESIONS THAT ARE "NON-EVALUABLE" BY MELAFIND SHOULD BE CAREFULLY RE-EVALUATED FOR BIOPSY.MELAFIND IS INDICATED ONLY FOR USE ON LESIONS WITH A DIAMETER BETWEEN 2 MM AND 22 MM, LESIONS THAT ARE ACCESSIBLE BY THE MELAFIND IMAGER, LESIONS THAT ARE SUFFICIENTLY PIGMENTED (I.E. NOT FOR USE ON NON-PIGMENTED OR SKIN-COLORED LESIONS), LESIONS THAT DO NOT CONTAIN A SCAR ORFIBROSIS CONSISTENT WITH PREVIOUS TRAUMA, LESIONS WHERE THE SKIN IS INTACT (LE., NON-ULCERATED OR NON-BLEEDING LESIONS), LESIONS GREATER THAN 1 CM AWAY FROM THE EYE, LESIONS WHICH DO NOT CONTAIN FOREIGN MATTER, AND LESIONS NOT ON SPECIAL ANATOMIC SITES (IE., NOT FOR USE ON ACRAL,PALMAR, PLANTAR, MUCOSAL, OR SUBUNGUAL AREAS). MELAFIND IS NOT DESIGNED TO DETECT PIGMENTED NON-MELANOMA SKIN CANCERS, SO THE DERMATOLOGIST SHOULD RELY ON CLINICAL EXPERIENCE TO DIAGNOSE SUCH LESIONS. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S004 S005 S006 S007 S008 S009 S001 S003 S011 S002 S010
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