S-Series OCT System Disclosures

Intended Use

The S-Series OCT is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization with image review manipulation software for identifying and annotating regions of interest.

Unapproved Uses

The S-Series OCT has 510(k) clearance under a general indication and has not been evaluated by FDA specifically for use in breast tissue, breast cancer, other types of cancer, margin evaluation, and reducing re-excision rates. The safety and effectiveness of these uses has not been established.  Refer to https://perimetermed.com/clinical/ for information on clinical evidence and scientific exchange related to Perimeter devices. Contraindications, limitations, warnings and precautions, and how to obtain a full copy of the FDA-required instructions for use are also provided on this page.

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

Contraindications

  • S-Series OCT should not be used to replace standard tissue histopathology assessment.
  • S-Series OCT is not a diagnostic device.

Limitations

  • Device use is limited to users trained by Perimeter personnel only.

Warnings and Cautions

Warnings

  • It is unsafe to operate the device before reading this entire manual.
  • System is for use with Perimeter’s single-use Specimen Immobilizer only. Specimen Immobilizers are single use only. Do not re-use or attempt to sterilize the Specimen Immobilizer.
  • This equipment is intended for use by healthcare professionals only.
  • This equipment may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as reorienting or relocating the equipment or shielding the location.
  • This device contains no user-serviceable parts. Do not disassemble, modify, or attempt to repair the device. User injury and equipment damage may result.
  • No modification of this equipment is allowed.
  • Do not place specimen directly on the Imaging Gate. Placing the specimen directly on the Imaging Gate could lead to the specimen becoming trapped within the device, personal injury, or damage to the device. Placing the specimen directly on the Imaging Gate could require immediate assistance from Perimeter’s Service and Maintenance Team.
  • The moving monitor arm introduces potential hand-crushing hazards. Keep hands clear of pinch-points at all times.
  • Use of this equipment adjacent to or stacked with other equipment should be avoided because it could 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.
  • To avoid risk of shock, S-Series OCT must only be connected to a supply main (power outlet) with protective earth (ground).
  • Only a dedicated USB should be used when exporting data from S-Series OCT. The use of a compromised USB key may affect the security of the device.
  • Planned Operating System, Software and Firmware updates shall be communicated by Perimeter to the Hospital IT Administrator. Updates not authorized by Perimeter should not be installed on S-Series OCT as these may affect performance and may compromise or corrupt data acquired by the device.
  • If you suspect a data security breach or a malware attack, please contact your IT Administrator.

Cautions

  • S-Series OCT is not a sterile device. S-Series OCT should be positioned outside the immediate patient environment, no closer than 1.5 meters (4.9 feet) from the patient table. Take necessary precautions per your facility’s infection prevention and control polices if you wish to use S-Series OCT in a sterile area.
  • Do NOT move S-Series OCT while imaging.
  • Do NOT move or bump the system during initialization.
  • S-Series OCT is intended for indoor use only.
  • Handle the Specimen Immobilizer carefully. The Imaging window of the Specimen Tray is made of glass.
  • Do NOT unplug S-Series OCT unless the system is completely powered off.
  • Select a vacuum level that is appropriate for the specimen you intend to image.

Instructions for Use

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