Who is the manufacturer of Venue Go?

GE Medical Systems Ultrasound and Primary Care Diagnostics filed the 510(k) submission for Venue Go (K220800).

What is the FDA product code for Venue Go?

IYN. It is classified under 21 CFR 892.1550 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Venue Go?

510(k) clearance (submission type: Traditional).

Does Venue Go use AI or machine learning?

Yes. Venue Go (K220800) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like Venue Go?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like Venue Go get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

Venue Go

K220800 · GE Medical Systems Ultrasound and Primary Care Diagnostics · IYN · Jun 21, 2022 · Radiology

Device Facts

Record ID	K220800
Device Name	Venue Go
Applicant	GE Medical Systems Ultrasound and Primary Care Diagnostics
Product Code	IYN · Radiology
Decision Date	Jun 21, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	AI/ML, Pediatric

Intended Use

The Venue Go is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Venue Go is intended to be used in a hospital or medical clinic. Venue Go clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatic), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD, B/CWD, B/Color/CWD.

Device Story

Venue Go is a portable, compact diagnostic ultrasound system for hospital/clinic use by trained professionals. It processes ultrasound signals from linear, convex, and phased array transducers to generate real-time images. The system supports B, M, PW/CW/Color/Power Doppler, and harmonic imaging modes. It features an integrated touch-interface, battery/AC power, and wireless DICOM connectivity. Input includes ultrasound probes, ECG traces (for gating), barcode/RFID scanners. Clinical tools include cNerve (nerve tracking), PDI+, Real-Time EF, and automated probe checks. Output is displayed on a high-resolution monitor to assist clinicians in diagnosis, interventional guidance (biopsy/drainage), and patient management. The device benefits patients by providing non-invasive, real-time anatomical visualization and procedural guidance.

Clinical Evidence

No clinical studies were required. Substantial equivalence is supported by non-clinical bench testing, including acoustic output, biocompatibility, electrical/electromagnetic safety, and software verification/validation. Performance of the cNerve algorithm was verified using a dataset of 124 sequences (3776 frames) from 44 individuals, demonstrating performance against ground truth annotations.

Technological Characteristics

Portable ultrasound system with high-res color LCD and multi-touch interface. Uses linear, convex, and phased array transducers. Connectivity: Wireless LAN, DICOM. Safety standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359, ISO 14971. Software includes automated tools for nerve tracking, ejection fraction, and probe diagnostics.

Indications for Use

Indicated for qualified healthcare professionals to perform ultrasound imaging, measurement, and analysis of the human body and fluid in hospital or clinic settings. Applications include abdominal, thoracic/pleural, ophthalmic, fetal/OB, small organ, vascular, neonatal/adult cephalic, pediatric, musculoskeletal, cardiac, transrectal, transvaginal, transesophageal, intraoperative, and interventional guidance.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

Venue Go (K202233)

Reference Devices

Versana Premier (K210438)
Vivid iq (K161706)
LOGIQ P10 (K203114)
HS40 (K210426)
Vivid E95 (K202658)
Optima XR240amx (K182234)

Related Devices

K202233 — Venue Go · GE Medical Systems Ultrasound and Primary Care Diagnostics · Nov 18, 2020
K183362 — Venue GO · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jan 28, 2019
K203137 — Venue Fit · GE Medical Systems Ultrasound and Primary Care Diagnostics · Dec 29, 2020
K220848 — Venue Fit · GE Medical Systems · Jun 27, 2022
K180599 — Venue · GE Medical Systems Ultrasound and Primary Care Diagnostics · May 2, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ June 21, 2022 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & 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" in blue and "ADMINISTRATION" in a smaller font size below. GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC % Lee Bush Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226 Re: K220800 Trade/Device Name: Venue Go Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: May 23, 2022 Received: May 24, 2022 Dear Lee Bush: 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 (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 located 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. 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 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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. 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. For Michael D. O'Hara, Ph.D. Deputy Director DHT 8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. Three water droplet-like shapes surround the circle, adding a decorative element to the design. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) Venne Go Indications for Use (Describe) The Venue Go is a general purpose diagnostic ultuse by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Venue Go is intended to be used in a hospital or medical clinic. Venue Go clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatic), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/ PWD, B/Color/PWD, B/Power/PWD, B/CWD, B/Color/CWD. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per resoonse, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (7/17) PSC Publishing Services (361) 485-6746 {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the text 'K220800' in a clear, sans-serif font. The characters are well-defined and evenly spaced. The 'K' is capitalized, followed by the numbers '220800'. The text is presented against a plain white background. Image /page/3/Picture/7 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. The circle is surrounded by a series of curved lines that resemble water droplets. The logo is simple and recognizable, and it is associated with a well-known and respected company. 510(k) Premarket Notification Submission ## 510(k) Summary | Date: | In accordance with 21 CFR 807.92 the following summary of information is provided: June 17, 2022 | |------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | GE Medical Systems Ultrasound and Primary Care Diagnostics 9900 Innovation Drive Wauwatosa, WI 53226 | | Primary Contact Person: | Lee Bush Regulatory Affairs Director GE Healthcare T: (262) 3099429 | | Secondary Contact Person: | Karin Shimoni Regulatory Affairs Manager GE Healthcare | | Device Trade Name: Common/Usual Name: Classification Names: Product Code: | Venue Go Diagnostic Ultrasound System Class II Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX | | Primary Predicate Device: Classification Names: Product Code: | K202233 Venue Go, Diagnostic Ultrasound System Class II Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX | | Reference Device(s): Classification Names: Product Code: | K210438 Versana Premier, Diagnostic Ultrasound System Class II Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90- IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX | | Reference Device(s): Classification Names: Product Code: | K161706 Vivid iq, Diagnostic Ultrasound System Class II Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90- IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX | | Reference Device(s): Classification Names: Product Code: | K203114 LOGIQ P10, Diagnostic Ultrasound System Class II Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90- IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX | | Reference Device(s): Classification Names: Product Code: | K210426 HS40, Diagnostic Ultrasound System Class II Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90- IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX | | Reference Device(s): Classification Names: Product Code: | K202658 Vivid E95, Diagnostic Ultrasound System Class II Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90- IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX; Diagnostic intravascular catheter, 21 CFR 870.1200, 90- OBJ | | Reference Device(s): Classification Names: Product Code: | K182234 Optima XR240amx, Mobile X-ray system Class II Mobile x-ray system 21 CFR 892.1720 IZL, Solid state x-ray imager 892.1680 MOB | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are four white flourishes around the edge of the circle, one in each quadrant. The logo is simple and recognizable, and it is associated with a well-known and established company. 510(k) Premarket Notification Submission {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. The letters are stylized and have a vintage look. There are also some white swirls around the letters, which give the logo a dynamic and modern feel. Device Description: Venue Go is a general-purpose diagnostic ultrasound system intended for use by qualified healthcare professionals to evaluate the body by ultrasound imaging and fluid flow analysis. > The Venue Go is a compact, portable system with a small footprint. The system can be hand carried using an integrated handle, placed on a horizontal surface, attached to a mobile cart or wall mounted. It has a high resolution color LCD monitor, with a simple, multi-touch user interface that makes the system intuitive. The system can be powered through an electrical wall outlet for long term use or from an internal battery for a short time. The Venue Go utilizes a varietv of linear, convex, and phased array transducers which provide high imaging performance and support standard acquisition modes. Compatible biopsy kits can be used for needle-guidance procedures. The system is capable of displaying the patient's ECG trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal which is used as an input for gating during scanning. The ECG signal can be input directly from the patient or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis. A barcode reader and RFID scanner are available as additional input devices. A roller bag will also be available for the customer to use when transporting the system. Venue Go is capable of wireless communication through a builtin Wireless LAN device. The system meets DICOM requirements to support image storage and archiving (local PACS or products such as Q-Path) and allows for output to printing devices. The user documentation is available electronically. The Venue Go is a general purpose diagnostic ultrasound system Intended Use: for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Venue Go is intended to be used in a hospital or medical clinic. Venue Go clinical applications include: {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. There are three water droplet-like shapes surrounding the circle. The logo is simple and recognizable, representing the company's brand identity. | | abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD, | |----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | B/CWD, B/Color/CWD. | | Technology: | The Venue Go employs the same fundamental scientific technology as its predicate and reference devices. | | Determination of Substantial Equivalence: | Comparison to Predicate Device The Venue Go system is substantially equivalent to the predicate device with regards to imaging capabilities, technological characteristics and safety and effectiveness. All probes used with the proposed Venue Go system are used unchanged from the cleared predicate. They are made of the same materials and their shape is unchanged. | | | The proposed Venue Go and predicate Venue Go (K202233) have identical clinical indications for use. | | | The proposed Venue Go and predicate Venue Go (K202233) have identical imaging modes. | | | The following is an overview of the differences between the proposed Venue Go and the predicate Venue Go: The proposed Venue Go and predicate Venue Go (K202233) systems transducers are similar, except for: Additions of M5Sc-RS which was first cleared on Vivid iq K161706. This probe is used unchanged from the cleared reference device (K161706). It is made of the same materials and its shape is unchanged. The clinical indications of M5Sc-RS are the same on the proposed Venue Go as they are on the reference device Vivid E95 K202658 with M5Sc-D probe. The M5Sc-RS probe is the same as the M5Sc-D except it uses an RS connector | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are three white curved lines around the letters, resembling water droplets or stylized flourishes. The logo is simple and recognizable, representing the company's brand identity. 510(k) Premarket Notification Submission instead of a D connector. The transducer body is identical between the two. - New applications are added to the following transducers: . - o M5Sc-RS transducer: added Ophthalmic application. This application was already cleared with 3Sc-RS in predicate Venue Go (K202233) which is a similar transducer. - 3Sc-RS, E8C-RS, 6S-RS, 12S-RS: added O Nonvascular access to the Interventional guidance application which was already cleared with these probes on reference device Versana Premier (K210438). ## Features/Functionality: - . Scribble: assists the user during system training and teaching by providing a touch-operated pointer and free drawing capabilities. - . Power Doppler Imaging+ (PDI+): is intended for slow blood flows like those found in wrists, ankles, hands, and feet. - Catheter Vessel Ratio: a measurement that supports clinicians in selecting the appropriate sized catheter based on vessel diameter. - . Probe Check: provides an automated probe element check and notifies user of potential probe issue. - . Shoulder Diagram: simplifies documentation and assists the clinician in the follow up for patients with suspected shoulder disorders. Is similar to the Renal Diagram feature previously available on the cleared predicate Venue Go (K202233), except it does not contain an anatomical organ drawing and the question/request that appears to the user is tailored to the shoulder region. - . cNerve: mav help the user to detect and track nerves during the scouting stage of a nerve block procedure, prior to inserting the needle to inject the anesthetic material. Is similar to the NerveTrack tool on cleared reference HS40 system by Samsung (K210426). The cNerve tool on proposed Venue Go system is available for adults only. - . Expanding B-lines tool for pediatrics (excluding neonates). This allows Lung sweep and Lung Diagram to pediatrics (excluding neonates) as well. B-lines tool is {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script in the center. The circle is surrounded by a white border with four white water droplets equally spaced around the circle. The logo is simple and recognizable, and it is associated with a well-known and respected company. 510(k) Premarket Notification Submission available on the cleared predicate Venue Go (K202233) for adults only. - Expanding Real-Time Ejection Fraction (EF) to pediatrics ● (excluding neonates). Real-Time EF tool is available on the cleared predicate Venue Go (K202233) for adults only. - Updates to software related to workflow improvements. ● ## Accessories: - . Adding compatible OEM biopsy guides (for 3Sc-RS, E8C-RS and M5Sc-RS transducers). - Adding RFID scanner that enables easy login/logout using a badge. This capability is similar to RFID option on reference device Optima XR240amx, K182234. #### Summary of Non-Clinical Tests: The proposed Venue Go has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to comply with applicable medical device safety standards. The Venue Go complies with voluntary standards: - AAMI/ANSI ES60601-1, Medical Electrical Equipment -. Part 1: General Requirements for Safety, 2005/ A2:2012 - . IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests, 2020 - IEC 60601-2-37, Medical Electrical Equipment Part 2-● 37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2015 - . IEC 62359, Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2017 - . ISO 14971, Application of risk management to medical devices, 2019 - NEMA PS 3.1 3.20, Digital Imaging and ● Communications in Medicine (DICOM) Set, 2016 {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. Three curved lines, resembling water droplets or stylized flames, surround the circle, adding a dynamic element to the design. The overall impression is one of a classic and recognizable corporate symbol. The following quality assurance measures are applied to the development of the system: - Risk Analysis - Requirements Reviews - Design Reviews ● - Testing on unit level (Module verification) ● - Integration testing (System verification) . - Performance testing (Verification & Validation) - . Safety testing (Verification) Transducer material and other patient contact materials are biocompatible. ## AI Summary of Testing ## cNerve: Summary test statistics and other results including acceptance criteria and information supporting the appropriateness of the characterized performance Dataset: - Test dataset representative of the Nerve block scouting ● procedures which cNerve supports was assessed for accuracy. - Test dataset included 124 sequences, and 3776 frames. Appropriateness of the characterized performance: - Success criteria were based on conformance of the cNerve . detections to ground truth annotations of nerve bundles in individual frames. Since the intended use is nerve tracking during scouting rather than nerve segmentation accuracy, success criteria were derived via a preliminary survey. The target of the survey was to identify thresholds for pixel accuracy in frames and for frame accuracy in sequences that are appropriate for the intended use. - cNerve performance requirements. - Sequence accuracy requirement - for testing overall cNerve performance: At least 70% of the sequences are meaningfully detected, and at least 80% of the meaningfully detected sequences are successfully detected (meeting frame accuracy criteria). The number of individuals images were collected from: {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are water droplet-like shapes surrounding the circle. The logo is simple and recognizable, and it is associated with a well-known company. 510(k) Premarket Notification Submission - A total of 44 individuals contributed to the verification ● dataset. The number of samples, if different from above, and the relationship between the two: - . Each individual contributed up to 2 sequences per view location. Often both laterals (left and right) were scanned. - Test dataset included 124 sequences, and 3776 frames. . Demographic distribution including: - Gender: Male and Female . - Age: 18-82 years - Ethnicity/Country: USA, Japan, Israel ● Information about clinical subgroups and confounders present in the dataset: - The algorithm performance was verified via frame ● accuracy on all demographic subgroups: Gender (M/F), Age (<60 / >=60), BMI (<=25 / >25). - . Similarly, it was tested for all supported nerve block locations and all supported probe types. Information about equipment and protocols used to collect images: - Mix of data from across five different probes in the . appropriate nerve mode, and three different Console variants. Information about how the reference standard was derived from the dataset (i.e. the "truthing" process): - . Ground truth annotations of the verification dataset were obtained as follows: Frames from scouting sequences were annotated by a single clinical expert, where the anatomical area of the nerves was marked in each frame. Description of how independence of test data from training data was ensured: {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are three white curved lines around the letters, resembling water droplets or stylized flourishes. The logo is simple and recognizable, representing the company's brand identity. - The data used for verification is completely distinct from . that used during training process and there is no overlap between the two. ## Summary of Clinical Tests: The subject of this premarket submission, Venue Go, did not require clinical studies to support substantial equivalence. - GE Healthcare considers the Venue Go to be as safe, as effective, Conclusion: and performance is substantially equivalent to the predicate device.