Last synced on 19 July 2024 at 11:05 pm

Ultrasound Guided Nerve Block Assist

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.1980
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QRG is linked to regulation 21CFR868.1980, which does not seem to exist yet. It may be pending at the moment.

Ultrasound Guided Nerve Block Assist

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.1980
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QRG is linked to regulation 21CFR868.1980, which does not seem to exist yet. It may be pending at the moment.