| Device |
injection data capture device |
| Regulation Description |
Piston syringe. |
| Definition |
An injection data capture device is an electrically-powered/electromechanical accessory that interfaces with reusable or disposable injection devices for the purposes of interpreting, recording and displaying and/or transmitting injection data to a connected application or software. |
| Physical State |
An injection data capture device may consist of an attachable add-on device that a user attaches to the injection device or could be manufactured directly into the injection device. The device may be single or multi-component and includes electromechanical hardware and software to allow for the detection, transmission and/or display of injection data. |
| Technical Method |
Injection data capture devices are operated manually or automatically to detect injections and record injection data. This can include the ability to detect the amount of dose dialed/administered, detect day/time of dose, or other injection data (e.g., detect prime/no-prime events). This data can be displayed on the injection data capture device directly and/or transmitted to a connected software or mobile application via wired or wireless methods. |
| Target Area |
Injection data capture devices do not have a target area but are instead intended to interface with injection devices. |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | QOG |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.5860
|
|---|
| 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 |
