Important Safety and Labeling Information – Claire OCT System

Intended Use / Indications for Use

The Claire OCT System is an adjunctive three-dimensional imaging tool which provides volumetric cross-sectional, real-time depth visualization, coupled with an artificial intelligence computer aided detection algorithm which identifies and marks focal areas suspicious for breast cancer and is used concurrently with physician interpretation of the images.

The Claire OCT System is intended for use in conjunction with other standard methods for evaluation of the margins of excised lumpectomy tissue during surgical procedures in patients with a biopsy-confirmed diagnosis of breast cancer.

Limitations of Use

The device is not intended for concurrent use in surgeries with cryo-assisted localization.

Use clinical expertise and judgement for device use with specimen margins that have been destroyed, damaged, or are otherwise not intact prior to imaging.

The device is has not been evaluated for individuals who:

  • Are under the age of 18
  • Are male
  • Have metastatic cancer (Stage IV)
  • Have lobular carcinoma as their primary diagnosis
  • Have had previous ipsilateral breast surgery for benign or malignant disease within 2 years (including implants and breast augmentation)
  • Have multi-centric disease (histologically diagnosed cancer in 2 different quadrants of the breast), unless resected in a single specimen
  • Have bilateral disease (diagnosed cancer in both breasts)
  • Are currently lactating
  • Are currently pregnant

For more information on unapproved/off-label uses, contact medicalaffairs@perimetermed.com.

Contraindications of Use

  • The Claire OCT System should not be used to replace standard tissue histopathology assessment.
  • The Claire OCT System should not be used for diagnosis.
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Federal law restricts this device to sale by or on the order of a physician.

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The Claire OCT System device offers an additional source of information to the user by providing
rapid, automated visualization of near surface microstructure. This information is an adjunct to
visual observation of the surface of an excised tissue sample and other intraoperative margin
assessment techniques.

To request a copy of the Claire User Manual/Instructions for Use, contact marketing@perimetermed.com.