| Device |
cardiac device identifier |
| Definition |
A cardiac device identifier is a noninvasive device that is intended to provide information about implanted cardiac devices. The device detects and matches telemetry based on manufacturer-specific wireless communication signals, including radiofrequency or inductive signals, to identify an implanted cardiac device, including manufacturer, model, or type. The device is not intended to deliver therapeutic stimulation to, modify the programming of, or manipulate the stored data of the implanted device. |
| Physical State |
Handheld, battery-powered, reusable device. The device may include a display screen, user interface controls, and accessories for charging. The device does not include cables or interfaces for data transfer. |
| Technical Method |
The device emits short-range, low-power wireless signals and detects manufacturer-specific responses from the implanted device. The device uses signal matching or pattern recognition to identify the cardiac implanted device manufacturer and displays the result to the user. |
| Target Area |
Chest or other implant site; intended for external, noninvasive use over the anatomical region where the CIED is implanted. |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
|---|
| Product Code | SJJ |
|---|
| Premarket Review |
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
870.3645
|
|---|
| 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 |
|
|
