Device |
endoscopic light-projecting measuring device |
Definition |
An endoscopic light-projecting measuring device projects light on a mucosal surface and uses software to determine the dimensions of observable features of interest. |
Physical State |
The device consists of a measuring device and a processing unit. The measuring device includes a laser source at the proximal end and a probe at the distal end. The processing unit includes a medical grade PC, touchscreen monitor, video grabber, and device specific software. |
Technical Method |
The device is an endoscope accessory that is inserted through the instrument channel. During use, the measuring device projects a line over a structure on a mucosal surface. An endoscopic image of the structure is taken and then the user can select any two points along the projected line in the image. The device-based software calculates the distance between the selected points. |
Target Area |
Mucosal surfaces |
Regulation Medical Specialty |
Gastroenterology/Urology |
Review Panel |
Gastroenterology/Urology |
Product Code | QTH |
Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
|
Submission Type |
510(k)
|
Regulation Number |
876.1530
|
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 |