Device |
parathyroid autofluorescence detection device |
Regulation Description |
Autofluorescence detection device for general surgery and dermatological use. |
Definition |
An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis. |
Physical State |
The device has a patient contacting fiber optic probe connected to a console with a coherent excitation light source in the near infrared spectrum. The device is used to capture autofluorescence signals of the target tissues. Imaging contrast agents are not required for autofluorescence detection. |
Technical Method |
The device is a patient contacting device that quantifies the ratio of autofluorescence of parathyroid to thyroid tissue using a coherent excitation light source in the near infrared spectrum. |
Target Area |
Parathyroid glands. |
Regulation Medical Specialty |
General & Plastic Surgery |
Review Panel |
General & Plastic Surgery |
Product Code | QDF |
Premarket Review |
General Surgery Devices
(DHT4A)
General Surgery Devices
(DHT4A)
|
Submission Type |
510(k)
|
Regulation Number |
878.4550
|
Device Class |
2
|
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 |