ScanNav Anatomy Peripheral Nerve Block

K232787 · Intelligent Ultrasound Limited · QRG · Oct 6, 2023 · Anesthesiology

Device Facts

• Record ID: K232787
• Device Name: ScanNav Anatomy Peripheral Nerve Block
• Applicant: Intelligent Ultrasound Limited
• Product Code: QRG · Anesthesiology
• Decision Date: Oct 6, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1980
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

ScanNav Anatomy Peripheral Nerve Block is indicated to assist qualified healthcare professionals to identify and label the below mentioned anatomy in live ultrasound images in preparation for ultrasound guided regional anesthesia prior to needle insertion for patients 18 years of age or older. The highlighting of structures in the following anatomical regions is supported: - 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 - Longitudinal suprainguinal fascia iliaca plane - Femoral block ScanNav Anatomy Peripheral Nerve Block is an accessory to compatible general-purpose diagnostic ultrasound systems.

Device Story

ScanNav Anatomy Peripheral Nerve Block is a software-as-a-medical-device (SaMD) accessory for general-purpose ultrasound systems. It receives real-time ultrasound video input; processes images using deep learning AI to identify and highlight anatomical structures relevant to regional anesthesia; and displays the highlighted structures on a dedicated panel PC. The primary ultrasound machine display remains unaffected. Used in professional healthcare environments by qualified clinicians, the device assists in anatomical identification prior to needle insertion. By providing real-time visual guidance, it aims to improve the accuracy and safety of nerve block procedures for the patient.

Clinical Evidence

Bench testing only. Validation of the femoral nerve block feature was performed using 183 ultrasound scans. Results showed a 1.1% false positive rate (mis-identification of safety-critical structures), 96.7% accuracy (correct highlighting), and 2.2% false negative rate (non-identification). All software verification tests (unit, integration, fault injection, endurance, system-level) passed without anomalies.

Technological Characteristics

SaMD utilizing machine learning-based AI and image processing algorithms. Hardware includes a panel PC (model IUP10W33M), AC/DC power cord, and 2m shielded HDMI cable; optional external battery. Operates as an accessory to general-purpose diagnostic ultrasound systems. Software-based highlighting displayed on a separate panel PC.

Indications for Use

Indicated for qualified healthcare professionals to identify and label anatomy in live ultrasound images for ultrasound-guided regional anesthesia in patients 18 years or older. Supported regions: Axillary/Interscalene/Supraclavicular brachial plexus, Erector spinae plane, Popliteal sciatic nerve, Rectus sheath plane, Sub-sartorial femoral triangle/Adductor canal, Longitudinal suprainguinal fascia iliaca plane, and Femoral block.

Regulatory Classification

Identification

ScanNav Anatomy Peripheral Nerve Block is a software medical device that assists qualified healthcare professionals in the identification and labeling of anatomical structures in live ultrasound images in preparation for ultrasound-guided regional anesthesia (UGRA) prior to needle insertion for patients 18 years of age or older. It provides real-time interpretation and enhanced visualization by highlighting anatomical landmarks. The device is an accessory to compatible general-purpose diagnostic ultrasound systems and supports the following anatomical regions: 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, and Longitudinal suprainguinal fascia iliaca plane.

Special Controls

In combination with the general controls of the FD&C Act, the real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia is subject to the following special controls:

Predicate Devices

• ScanNav Anatomy Peripheral Nerve Block (DEN220024)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

October 6, 2023

Intelligent Ultrasound Limited Bhaskar Chikkanna Head of Regulatory Affairs Floor 6a, Hodge House, 114-116 St Mary Street Cardiff. CF101DY United Kingdom

Re: K232787

Trade/Device Name: ScanNav Anatomy Peripheral Nerve Block Regulation Number: 21 CFR 868.1980 Regulation Name: Real-Time Ultrasound Anatomy Visualization And Labeling Device For Ultrasound Guided Regional Anesthesia Regulatory Class: Class II Product Code: QRG Dated: September 11, 2023 Received: September 11, 2023

Dear Bhaskar Chikkanna:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic.

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See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Bradley Q. Quinn -S

Bradley Quinn Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K232787

Device Name

ScanNav Anatomy Peripheral Nerve Block

#### Indications for Use (Describe)

ScanNav Anatomy Peripheral Nerve Block is indicated to assist qualified healthcare professionals to identify and label the below mentioned anatomy in live ultrasound mages in preparation for ultrasound guided regional anesthesia prior to needle insertion for patients 18 years of age or older.

The highlighting of structures in the following anatomical regions is supported:

- · 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
- · Longitudinal suprainguinal fascia iliaca plane
- Femoral block

ScanNav Anatomy Peripheral Nerve Block is an accessory to compatible general-purpose diagnostic ultrasound systems.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/4/Picture/0 description: The image shows the logo for Intelligent Ultrasound. The logo consists of a blue sphere made up of interconnected dots on the left, and the words "INTELLIGENT ULTRASOUND" in gray on the right. Below the words is the phrase "for smarter scanning" in blue.

# 510(k) Summary K232787

September 27, 2023

# Applicant details:

Applicant Name: Intelligent Ultrasound Limited Applicant Address: Floor 6a, Hodge House, 114-116 St Mary Street, Cardiff, UK Applicant Contact Name: Bhaskar Chikkanna Applicant Contact Number: [phone] Applicant Contact Email: [e-mail]

# Device details:

Device Trade Name: ScanNav Anatomy Peripheral Nerve Block Common Name: Software as a Medical Device Classification: Class II Regulation Number: 21 CFR 868.1980 Product Code: QRG

# Predicate Device details:

Device Trade Name: ScanNav Anatomy Peripheral Nerve Block Predicate #: DEN220024 Product code: QRG

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Image /page/5/Picture/0 description: The image shows the logo for Intelligent Ultrasound. The logo consists of a blue sphere made up of interconnected circles on the left, and the words "INTELLIGENT ULTRASOUND" in gray on the right. Below the words is the phrase "for smarter scanning" in blue. The logo is clean and modern, and the colors are calming and professional.

#### Device description summary:

ScanNav Anatomy Peripheral Nerve Block is a software (SaMD) which assists qualified healthcare professionals to identify and label relevant anatomical structures in preparation for ultrasound guided regional anesthesia prior to needle insertion for patients 18 years of age or older.

The device receives ultrasound images in real-time from a compatible general-purpose ultrasound machine. It processes these images using deep learning artificial intelligence algorithms and highlights relevant anatomical structures. The ultrasound machine display remains unaffected, and the highlighting is only displayed on a general-purpose panel PC provided with the device.

#### Intended use/Indications for use:

ScanNav Anatomy Peripheral Nerve Block is indicated to assist qualified healthcare professionals to identify and label the below mentioned anatomy in live ultrasound images in preparation for utrasound guided regional anesthesia prior to patients 18 years of age or older.

The highlighting of structures in the following anatomical regions is supported:

- 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
- · Longitudinal suprainguinal fascia iliaca plane
- Femoral block

ScanNav Anatomy Peripheral Nerve Block is an accessory to compatible general-purpose diagnostic ultrasound systems.

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Image /page/6/Picture/0 description: The image contains the logo for Intelligent Ultrasound. The logo consists of a blue sphere made up of interconnected circles on the left. To the right of the sphere are the words "INTELLIGENT ULTRASOUND" in gray, with the word "INTELLIGENT" stacked on top of the word "ULTRASOUND". Below the words "INTELLIGENT ULTRASOUND" is the phrase "for smarter scanning" in a light blue script font.

# Substantial Equivalence

| Attributes | Predicate (DEN220024) | Modified device | Comments |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Intended use | ScanNav Anatomy Peripheral Nerve Block is<br>intended to assist in the identification and<br>labelling of anatomical structures in live<br>ultrasound images. | ScanNav Anatomy Peripheral Nerve Block is<br>intended to assist in the identification and<br>labelling of anatomical structures in live<br>ultrasound images. | No change |
| Indications for use | ScanNav Anatomy Peripheral Nerve Block is<br>indicated to assist qualified healthcare<br>professionals to identify and label the below<br>mentioned anatomy in live ultrasound images in<br>preparation for ultrasound guided regional<br>anesthesia prior to needle insertion for patients<br>18 years of age or older.<br>The highlighting of<br>structures in the following anatomical regions is<br>supported:<br>• Axillary level brachial plexus<br>• Erector spinae plane<br>• Interscalene level brachial plexus<br>• Popliteal level sciatic nerve<br>• Rectus sheath plane<br>• Sub-sartorial femoral triangle / Adductor canal<br>• Superior trunk of brachial plexus | ScanNav Anatomy Peripheral Nerve Block is<br>indicated to assist qualified healthcare<br>professionals to identify and label the below<br>mentioned anatomy in live ultrasound images in<br>preparation for ultrasound guided regional<br>anesthesia prior to needle insertion for patients<br>18 years of age or older.<br>The highlighting of<br>structures in the following anatomical regions is<br>supported:<br>• Axillary level brachial plexus<br>• Erector spinae plane<br>• Interscalene level brachial plexus<br>• Popliteal level sciatic nerve<br>• Rectus sheath plane<br>• Sub-sartorial femoral triangle / Adductor canal<br>• Superior trunk of brachial plexus | Addition of Femoral block<br>to the list of supported<br>ultrasound guided<br>regional anesthesia<br>procedures |
| | | | |
| | • Supraclavicular level brachial plexus | • Supraclavicular level brachial plexus | |
| | • Longitudinal suprainguinal fascia iliaca plane | • Longitudinal suprainguinal fascia iliaca plane | |
| | | • Femoral | |
| | ScanNav Anatomy Peripheral Nerve Block is an<br>accessory to compatible general-purpose<br>diagnostic ultrasound systems. | ScanNav Anatomy Peripheral Nerve Block is an<br>accessory to compatible general-purpose<br>diagnostic ultrasound systems. | |
| Intended users | Qualified healthcare professionals | Qualified healthcare professionals | No change |
| Intended use<br>environment | Professional healthcare environment | Professional healthcare environment | No change |
| Technology/Operating<br>principle | Machine learning based artificial intelligence<br>in combination with image processing<br>algorithms | Machine learning based artificial intelligence<br>in combination with image processing<br>algorithms | No change |
| Device hardware (panel<br>PC and cables) | Panel PC model IUP10W33M<br>Ac/Dc power cord<br>2m shielded HDMI cable | Panel PC model IUP10W33M<br>Ac/Dc power cord<br>2m shielded HDMI cable | No change |
| | Optional: external battery unit with power<br>supply | Optional: external battery unit with power<br>supply | |
| Labelling (incl.<br>instructions for use) | Instructions for use v1.0<br><br>Device labelling | Instructions for use v2.0<br><br>Device Labelling | Labelling updated to<br>reflect the changes to the<br>indications for use with<br>new nerve block. |

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Image /page/7/Picture/0 description: The image is a logo for Intelligent Ultrasound. The logo features a blue sphere made up of interconnected circles on the left. To the right of the sphere is the text "INTELLIGENT ULTRASOUND" in gray, with the word "INTELLIGENT" stacked on top of "ULTRASOUND". Below the text is the phrase "for smarter scanning" in a light blue, script-like font.

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Image /page/8/Picture/0 description: The image shows the logo for Intelligent Ultrasound. The logo consists of a blue sphere made up of interconnected dots on the left side. To the right of the sphere, the words "INTELLIGENT ULTRASOUND" are written in gray, with the word "INTELLIGENT" above the word "ULTRASOUND". Below the words, the phrase "for smarter scanning" is written in blue.

# Summary of Clinical/Non-Clinical tests:

The device change subject to this 510(k) has undersy and safety validation tests. The non-clinical test results show that the device has met the predefined acceptance criteria and has passed all tests without any unresolved anomalies. The actray validation tests carried out using the established test protocols hat the addition of femoral neve block has met the established acceptance criteria and the device continues to provide reasonable of safety and effectiveness. No new risks have been identified with this device change. The results are summarized in the table below.

| Verification/Validation<br>Methods | Acceptance Criteria | Summary of<br>results |
|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Femoral Block – Safety and Accuracy validation.<br><br>Established protocol and acceptance criteria same as that<br>used for the predicate device. | FP rate: Mis-identification rate of safety critical anatomical<br>structures in the indicated procedures is less than 5%. | 1.1% (2 out of<br>183 scans) |
| | Accuracy (TP+TN) rate: Correct highlighting of safety critical<br>anatomical structures in the indicated procedures at least<br>80% of the time. | 96.7% (177 out<br>of 183 scans) |
| | FN rate: non-identification rate of safety critical anatomical<br>structures in the indicated procedures is less than 15%. | 2.2% (4 out of<br>183 scans) |
| Software tests<br><br>Established test cases and protocol same as that used for<br>the predicate device. | Unit test<br>Integration test<br>Fault Injection test<br>Endurance test<br>Use case test<br>Software system level test<br>Requirements traceability test | All software tests have<br>been successfully<br>completed without any<br>anomalies |

#### Conclusion:

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Image /page/9/Picture/0 description: The image shows the logo for Intelligent Ultrasound. The logo consists of a blue sphere made up of interconnected circles on the left, and the words "INTELLIGENT ULTRASOUND" in gray on the right. Below the words is the phrase "for smarter scanning" in blue.

The subject device and the predicate device have intended use and the technological different questions of safety and effectiveness.