| Device |
autonomous extracorporeal blood leak detector/alarm |
| Regulation Description |
Hemodialysis system and accessories. |
| Definition |
To detect the presence of blood leaking from an extracorporeal connection or needle site in hemodialysis patients and alert the user or attending staff. The device detects colormetric, chemical, or light modulation caused by exposure to leaking blood. |
| Physical State |
Small electronic, microprocessor assisted "black box" with a strap that is attached to the patient's arm. The device has visual indicators with accompanying audible alarm |
| Technical Method |
An optical fiber is connected to an infrared source at one end and an infrared receiver at the other end. In the middle of the fiber is a sharp bend that is covered with an absorbent pad. Blood absorbed into the pad will cause the intensity of infrared source to decrease at the receiver end and activate an alarm. |
| Target Area |
Usually the forearm but could be placed anywhere a blood line and needle are attached to the body. |
| Regulation Medical Specialty |
Gastroenterology/Urology |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | ODX |
|---|
| Premarket Review |
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
876.5820
|
|---|
| 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 |
