| 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 |
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
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 |
