ScanNav Anatomy Peripheral Nerve Block

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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. {2}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 {3}------------------------------------------------ # 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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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: +442920756534 Applicant Contact Email: bhaskar.chikkanna@intelligentultrasound.com # 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 {5}------------------------------------------------ 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. {6}------------------------------------------------ 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. | {7}------------------------------------------------ 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. {8}------------------------------------------------ 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: {9}------------------------------------------------ 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.