| Device |
fluorescence imaging for breast cancer detection |
| Definition |
The combination product consists of an optical imaging agent for injection, and a fluorescence imaging device. The product is intended for use in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. The imaging device is used with the imaging drug for fluorescence imaging of the lumpectomy cavity. |
| Physical State |
Medical imaging device coupled with an injectable drug. |
| Technical Method |
The combination product consists of a device constituent that is a fluorescence imaging device and a drug constituent that is an optical imaging agent for injection. The imaging device consists of a Workstation and a Handheld Probe. The Handheld Probe connects to the Workstation’s Light Source via an optical fiber cable. These components are used together to excite the optical imaging agent and capture and display real-time fluorescence images. During surgery, the Handheld Probe is used to scan the lumpectomy cavity for activated drug by delivering 630 ± 5 nm excitation light and measuring the fluorescence emission signal using a camera after filtering through a 662.5 – 737.5 nm ba |
| Target Area |
Breast tissue during lumpectomy procedures. |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | SAW |
|---|
| Premarket Review |
General Surgery Devices
(DHT4A)
General Surgery Devices
(DHT4A)
|
| Submission Type |
PMA
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
