| Device |
ultrasound guided nerve block assist |
| Definition |
This device provides real-time interpretation and enhanced visualization of live ultrasound images by highlighting anatomical landmarks in preparation for performing regional anesthesia. |
| Physical State |
The software medical device is installed in a PC which connects to a cleared ultrasound device via cable. The ultrasound images are reproduced on the subject device display monitor. |
| Technical Method |
The device physically connects to a cleared ultrasound device, reproduces ultrasound images, locates and highlights anatomical landmarks such as nerve bundles. The landmark identification assist in targeted delivery of regional anesthesia. |
| Target Area |
• Axillary level brachial plexus • Erector spinae plane • Interscalene level brachial plexus • Popliteal level sciatic nerve • Rectus sheath plane • Sub-sartorial femoral triangle/ Adductor canal • Superior trunk of brachial plexus • Supraclavicular level brachial plexus • Suprainguinal fascia iliaca plane |
| Regulation Medical Specialty |
Anesthesiology |
| Review Panel |
Anesthesiology |
|---|
| Product Code | QRG |
|---|
| Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices
(DHT1C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
868.1980
|
|---|
| 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 |
