Use Instructions

PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 7 of 101
o A charging cradle for the Handheld Fluorescence Camera, providing a secure, flat surface
for the HFC to rest while charging. Refer to Section 2.2.5 and Section 6.3.5 for full details.
vi. PSC – Protective Storage Cradle
o A reusable stand to securely store and protect the Handheld Fluorescence Camera when
not in use. Refer to 2.2.6 and Section 6.3.6 for full details.
1.1. Intended Use/Indications for use – Eagle V1.2 Imaging System
The Eagle Imaging System is intended for capturing and viewing white light and fluorescence images and
videos produced with conventional white light illumination, and excitation light at 405nm and emission
light at 500-545 nm and 600-660 nm, respectively. The Eagle Imaging System is indicated for use in imaging
a surgical cavity or excised human tissue specimens, including breast tissue specimens obtained during
breast cancer surgery, and can be used in patients that have received fluorescent imaging contrast agents
with the appropriate optical characteristics.
1.2. Intended Use/indication for use – PD G 506 A
PD G 506 A as an optical imaging agent for real-time visualization of malignant tissue during breast
conserving surgery (lumpectomy, partial mastectomy) for breast cancer.
1.3. Clinical Need
Breast conserving surgery (BCS) is performed on patients with breast cancer to resect and completely
remove the primary malignancy while conserving as much of the surrounding normal tissue as possible.
Currently, surgeons rely on a multitude of methods to assess the adequacy of tissue margins intra-
operatively including visual assessment and palpation, specimen radiology, intraoperative ultrasound and
intraoperative histopathology. There is no consensus on intraoperative resection adequacy and definitive
margin assessment requires histopathological assessment, which is not real-time or practical in the intra-
operative setting. Despite intra-operative measures to obtain clean margins in BCS, the need for re-
excision via a subsequent surgery is not uncommon.
Re-excisions increase poor cosmesis, complications, discomfort, stress, adjuvant delay, medical costs and
risk of local recurrence. Re-excisions due to final positive margins also increase the risk of disease local
recurrence and decrease disease-specific survival. Optimizing surgery to improve resection guidance and
positive margin assessment during initial BCS would be highly impactful, leading to a decreased need for
subsequent surgeries.
In a number of clinical trials, ALA a non-fluorescent non-protein amino acid that is converted into the
fluorophore protoporphyrin IX (PpIX) as part of the heme biosynthesis pathway and preferentially
accumulates in malignant tissue has been administered orally for the purpose of fluorescence-based
imaging of a variety of other cancer types such as rectal carcinomas, malignant gliomas, and palpable
breast tumours.
Optimizing surgery with the use of ALA and an appropriate Fluorescence Imaging device to improve
resection guidance and positive margin assessment during initial BCS would be highly impactful, leading
to a decreased need for subsequent surgeries.
1.4. Principles of Operation
The inability to differentiate tissues of interest during surgical procedures represents a challenge for
surgeons. For example, during surgical resection of solid tumors, visualization of cancer in the resected