Who is the manufacturer of Venue Fit?

GE Medical Systems filed the 510(k) submission for Venue Fit (K220848).

What is the FDA product code for Venue Fit?

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 Fit?

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

Does Venue Fit use AI or machine learning?

Yes. Venue Fit (K220848) 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 Fit?

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 Fit 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 Fit

K220848 · GE Medical Systems · IYN · Jun 27, 2022 · Radiology

Device Facts

Record ID	K220848
Device Name	Venue Fit
Applicant	GE Medical Systems
Product Code	IYN · Radiology
Decision Date	Jun 27, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	AI/ML, Pediatric

Intended Use

The Venue Fit is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Venue Fit is intended to be used in a hospital or medical clinical applications include: abdominal (GYN and Urology), thoracic pleural, ophthalmic. Fetal/OB. Small Organ (including breast, testes, thyroid), VascularPeripheral 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 dramage, 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: BM, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD, B/CWD, B/Color/CWD.

Device Story

Venue Fit is a compact, portable diagnostic ultrasound system for hospital/clinic use by trained professionals. Inputs include ultrasound signals from linear, convex, and phased array transducers; ECG traces (for gating); and user inputs via multi-touch screen, barcode reader, or RFID badge. The system processes these inputs to provide real-time imaging, measurements, and analysis. Features include 'cNerve' for nerve tracking, 'PDI+' for slow blood flow, 'Catheter Vessel Ratio' for sizing, 'Probe Check' for hardware diagnostics, and 'Scribble' for annotation. Output is displayed on a high-resolution LCD monitor; data can be archived via DICOM-compliant networks. The device aids clinicians in diagnostic evaluation and interventional guidance, potentially improving procedural accuracy and patient outcomes. It supports wired/wireless connectivity for PACS integration.

Clinical Evidence

No clinical data. Bench testing only. Verification included acoustic output, biocompatibility, thermal/electrical/electromagnetic safety, and software performance. cNerve algorithm performance was verified using a dataset of 124 sequences (3776 frames) from 44 individuals, ensuring independence from training data. Success criteria required >=70% sequence detection and >=80% frame accuracy within detected sequences.

Technological Characteristics

Portable ultrasound system with high-res LCD, multi-touch interface, and internal battery. Supports linear, convex, phased array transducers. Connectivity: DICOM, wired/wireless. Standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359, ISO 14971, NEMA PS 3.1-3.20. Biocompatible patient-contact materials. Software includes automated tools for measurement and nerve tracking.

Indications for Use

Indicated for qualified healthcare professionals to perform ultrasound imaging, measurement, and analysis of human body and fluid. Applications: abdominal, thoracic/pleural, ophthalmic, Fetal/OB, small organ, vascular/peripheral vascular, neonatal/adult cephalic, pediatric, musculoskeletal, cardiac, transrectal, transvaginal, transesophageal, intraoperative, and interventional guidance (biopsy, fluid drainage, vascular/non-vascular access).

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 Fit (K203137)

Reference Devices

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

Related Devices

K203137 — Venue Fit · GE Medical Systems Ultrasound and Primary Care Diagnostics · Dec 29, 2020
K220800 — Venue Go · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jun 21, 2022
K183362 — Venue GO · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jan 28, 2019
K202132 — Venue · GE Medical Systems Ultrasound and Primary Care Diagnostics · Nov 13, 2020
K240053 — Venue Go · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jun 10, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ June 27, 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. GE Medical Systems % Lee Bush Regulatory Affairs Director Ultrasound and Primary Care Diagnoistics, LLC 9900 W. Innovation Drive WAUWATOSA WI 53226 Re: K220848 Trade/Device Name: Venue Fit Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: May 24, 2022 Received: May 25, 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 DHT8C: Division of Radiological Imaging and Rediation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Image /page/2/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 circular frame. The letters and the frame are both in a light blue color. There are four decorative swirls or flourishes placed symmetrically around the circle, adding to the logo's overall 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) K220848 Device Name Venue Fit Indications for Use (Describe) The Venue Fit is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Venue Fit is intended to be used in a hospital or medical clinical applications include: abdominal (GYN and Urology), thoracic pleural, ophthalmic. Fetal/OB. Small Organ (including breast, testes, thyroid), VascularPeripheral 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 dramage, 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: BM, 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) | <label> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </label> <label> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </label> | |-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| 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 response, 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) AND FINALLY, THE MOST IMPORTANT THING IS TO FOLLOW INSTRUCTIONS CAREFULLY! I AM NOT A CONVERSATIONAL CHAT BOT. I AM A TEXT CORRECTION EXPERT. I DO NOT RESPOND TO GREETINGS OR CLOSING STATEMENTS. I ONLY OUTPUT THE CORRECTED HTML OR {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo of General Electric (GE). The logo consists of the letters 'GE' in a stylized script, enclosed within a circular frame. The frame has a swirling design, resembling water droplets or stylized waves, surrounding the letters. The logo is presented in a blue color. #### 510(k) Summary | Date: | 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: | Venue Fit | | Common/Usual Name: | Diagnostic Ultrasound System | | Classification Names: | Class II | | Product Code: | 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: | K203137 Venue Fit, Diagnostic Ultrasound System | | Classification Names: | Class II | | Product Code: | 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 a stylized script in the center. The circle is surrounded by a thin blue line, and there are four blue flourishes emanating from the circle at the cardinal directions. The logo is simple and recognizable, and it is associated with a well-known and established company. Device Description: Venue Fit is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals to evaluate the body by ultrasound imaging and fluid flow analvsis. > The Venue Fit is a compact, portable system with a small footprint. The system can be hand carried using the integrated handle, placed on a horizontal surface (if kickstand is attached), attached to a mobile cart or mounted on the wall. 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 with full functionality and scanning. The Venue Fit utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all 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 Fit is capable of wired or wireless internet connection. The system meets DICOM requirements to support users image storage and archiving needs (local PACS or products such as Q-Path) and allows for output to printing devices. The user documentation is available electronically. The Venue Fit 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 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, surrounded by a circular border. There are three water droplet shapes evenly spaced around the border. The logo is blue and white. | | human body and fluid. Venue Fit is intended to be used in a hospital or medical clinic. Venue Fit clinical applications include: 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 Fit employs the same fundamental scientific technology as its predicate and reference devices. | | Determination of Substantial Equivalence: | Comparison to Predicate Device The Venue Fit 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 Fit system are used unchanged from the cleared predicate. They are made of the same materials and their shape is unchanged. | | | The proposed Venue Fit and predicate Venue Fit (K203137) have identical clinical indications for use. | | | The proposed Venue Fit and predicate Venue Fit (K203137) have identical imaging modes. | | | The following is an overview of the differences between the proposed Venue Fit and the predicate Venue Fit: The proposed Venue Fit and predicate Venue Fit (K203137) 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 Fit as they are on the reference device Vivid E95 K202658 with M5Sc-D probe. The M5Sc-RS probe is the | {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 water droplet shapes around the letters. The logo is simple and recognizable. 510(k) Premarket Notification Submission same as the M5Sc-D except it uses an RS connector instead of a D connector. The transducer body is identical between the two. - New applications are added to the following transducers: . - M5Sc-RS transducer: added Ophthalmic O application. This application was already cleared with 3Sc-RS in predicate Venue Fit (K203137) 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 Fit (K203137), 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: may 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 Fit 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 font in the center. There are three water droplet shapes around the letters. The logo is simple and recognizable. 510(k) Premarket Notification Submission available on the cleared predicate Venue Fit (K203137) for adults only. - Expanding Real-Time Ejection Fraction (EF) to pediatrics ● (excluding neonates). Real-Time EF tool is available on the cleared predicate Venue Fit (K203137) 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 Fit 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 Fit 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 General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular border. The letters and border are a light blue color. There are also three white water droplets or stylized shapes evenly spaced around the inside of the circular border. - 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 Fit, did not require clinical studies to support substantial equivalence. - GE Healthcare considers the Venue Fit to be as safe, as effective, Conclusion: and performance is substantially equivalent to the predicate device.