Device label: Indications for use, contraindications, warnings and precautions

Indications for use, contraindications, warnings, & precautions.

With regard to the Indications for Use, while the DermaSensor FDA pivotal validation study (DERM-SUCCESS) included 1,579 lesions biopsied by primary care physicians, and a supplemental melanoma validation study (DERM-ASSESS III) was conducted with biopsied lesions in the dermatology setting, note that the device indication for use is non-dermatologist physicians since the FDA's clearance was based on a benefit-risk evaluation limited to physicians who are not experts in the clinical diagnosis and management of skin cancer.

Indications for Use

The DermaSensor device is indicated for use to evaluate skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in patients aged 40 and above to assist in the decision regarding referral of the patient to a dermatologist. The DermaSensor device should be used in conjunction with the totality of clinically relevant information from the clinical assessment, including visual analysis of the lesion, by physicians who are not dermatologists. The device should be used on lesions already assessed as suspicious for skin cancer and not as a screening tool. The device should not be used as the sole diagnostic criterion nor to confirm clinical diagnosis of skin cancer.

Contraindications

There are no known contraindications.

Warnings

  • Do not use for the direct diagnosis of skin cancer.
  • Always wear gloves during use (or examination).
  • Do not use under direct focused light, such as a surgical or examination light or headlamp.
  • Do not point the tip of the Handheld Unit directly at the eye.
  • Do not attempt to disassemble, repair, or modify the DermaSensor device in any way.
  • Do not immerse the DermaSensor device in liquid.
  • Do not put the DermaSensor device in an autoclave or low temperature sterilizer.
  • Do not buff or use an abrasive cream cleanser that may scratch and damage the tip of the Handheld Unit.
  • Do not simultaneously make contact with the patient while touching or holding the Base or power adapter.
  • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30cm (12 inches) to any part of the
  • DermaSensor device, including cables specified by DermaSensor, Inc.; otherwise, degradation of the performance of this equipment could result.
  • DermaSensor performance has not been assessed for the following types of lesions; thus, safety and effectiveness have not been established when:
    • Lesion is not accessible to the DermaSensor device Handheld Unit and tip (e.g., inside ears, under nails).
    • Lesion is on areas of psoriasis, eczema, acne, or similar inflammatory skin conditions that may impede appropriate DermaSensor device tip placement on the lesion.
    • Lesion is greater than 15mm in diameter at the widest point.
    • Lesion has a targeted area less than 2.5mm in diameter where the DermaSensor device tip cannot be placed entirely within the border of the targeted area of the lesion.
    • Lesion has no contiguous area of at least 2.5mm due to ulceration, erosion or liquid discharge (e.g., blood).
    • Lesion is covered by a crust or scale, and lesion surface can not be cleared of crust or scale such that there is a contiguous area of at least 2.5mm of cleared intact skin that is free of any crust, ulceration, erosion or liquid discharge (e.g., blood).
    • Lesion is obstructed by foreign matter that can not be non-invasively removed (e.g., tattoo, splinter).
    • Lesion is not completely cleared of (i.e., free of any remaining residue) dermoscopy oils, makeup, sunscreen, other topical solutions or powders, markings, and staining treatments (e.g., iodine).
    • Lesion is located on acral skin (e.g., sole or palms).
    • Lesion is located within 10mm of the eye.
    • Lesion is on or adjacent to scars, areas previously biopsied, or areas subjected to any past surgical intervention.
    • Lesion is located on mucosal surfaces (e.g. genitals, lips).
    • Lesion is located in an area with acute sunburn.

Precautions

  • Caution: United States Federal law restricts this device to sale by or on the order of a physician.
  • A complete assessment, including
    • the visual evaluation of the lesion,
    • clinical considerations such as the patient’s ultraviolet light exposure history, and
    • the patient and patient’s family’s skin cancer historyshould be considered, per standards of clinical care, in conjunction with DermaSensor results when making a formal clinical determination about a lesion.
  • The performance of the device has not been specifically evaluated in patients with increased risk for skin cancer, e.g., inherited or drug-induced photosensitivity; genetic predisposition to melanoma or BCC; immune compromise; or other medical conditions that increase the risk of skin cancer or its metastasis.
  • The device is intended to assist in clinical decisions related only to the skin malignancies melanoma (including severely atypical nevi), SCC, and BCC. It has been tested on each of these three common skin cancer types but has not been tested on rare skin cancer types; thus, it should not be used for lesions that are suggestive of malignancies other than melanoma, BCC and/or SCC.
  • The device is intended for use on primary lesions only and has not been tested on lesions that are previously biopsied, recurrent, or metastatic; on scars, tattoos, sunburned skin, or within a hairy area (i.e., dense hair on the scalp); or which are located on palms, soles, mucosal surfaces, genitals, ears, within 1 cm of the eye, or under nails.
  • Consistent with the lower prevalence of skin cancer in Fitzpatrick skin phototypes IV-VI, less data is available for sensitivity of the DermaSensor device for melanoma in these patients. The decision to refer patients with suspicious pigmented lesions in this group should be primarily based on clinical concern.
  • Protect the tip of the Handheld Unit by storing the Handheld Unit in the Base when not in use.
  • To maintain optimal device integrity, follow the cleaning and disinfection instructions before and after use.
  • Use of accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
  • Use of this equipment adjacent to or stacked with other equipment should be avoided as it may result in improper operation. If such use is necessary, this equipment, and the other equipment, should be observed to verify that they are operating normally.
  • Only use the included components and accessories provided as part of the DermaSensor medical equipment system.
  • Connection to IT networks including other equipment could result in previously unidentified risks to patients, operators, or third parties. The user should identify, analyze, evaluate, and control these risks.
  • Changes to the IT network (e.g., changes in network configuration, connection of additional items, disconnection of items, update of equipment, upgrade of equipment) could introduce new risks that require additional analysis.
  • To avoid EMC disturbances, floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

IFU 40-0001 v7