Venue Fit

{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. 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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) | <span> <label> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </label> </span> <span> <label> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </label> </span> | |-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The logo is presented in a blue color. #### 510(k) Summary | Date: | June 17, 2022 | |----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | GE Medical Systems Ultrasound and Primary Care Diagnostics<br>9900 Innovation Drive<br>Wauwatosa, WI 53226 | | Primary Contact Person: | Lee Bush<br>Regulatory Affairs Director<br>GE Healthcare<br>T: (262) 3099429 | | Secondary Contact Person: | Karin Shimoni<br>Regulatory Affairs Manager<br>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,<br>90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570,<br>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,<br>90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570,<br>90-ITX | | Reference Device(s):<br>Classification Names:<br>Product Code: | K210438 Versana Premier, Diagnostic Ultrasound System<br>Class II<br>Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-<br>IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560,<br>90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570,<br>90-ITX | | Reference Device(s):<br>Classification Names:<br>Product Code: | K161706 Vivid iq, Diagnostic Ultrasound System<br>Class II<br>Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-<br>IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560,<br>90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570,<br>90-ITX | | Reference Device(s):<br>Classification Names:<br>Product Code: | K203114 LOGIQ P10, Diagnostic Ultrasound System<br>Class II<br>Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-<br>IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560,<br>90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570,<br>90-ITX | | Reference Device(s):<br>Classification Names:<br>Product Code: | K210426 HS40, Diagnostic Ultrasound System<br>Class II<br>Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-<br>IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560,<br>90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570,<br>90-ITX | | Reference Device(s):<br>Classification Names:<br>Product Code: | K202658 Vivid E95, Diagnostic Ultrasound System<br>Class II<br>Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-<br>IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560,<br>90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570,<br>90-ITX; Diagnostic intravascular catheter, 21 CFR 870.1200, 90-<br>OBJ | | Reference Device(s):<br>Classification Names:<br>Product Code: | K182234 Optima XR240amx, Mobile X-ray system<br>Class II<br>Mobile x-ray system 21 CFR 892.1720 IZL, Solid state x-ray<br>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<br>hospital or medical clinic. Venue Fit clinical applications include:<br>abdominal (GYN and Urology), thoracic/pleural, ophthalmic,<br>Fetal/OB, Small Organ (including breast, testes, thyroid),<br>Vascular/Peripheral vascular, neonatal and adult cephalic,<br>pediatric, musculoskeletal (conventional and superficial), cardiac<br>(adults and pediatric), Transrectal, Transvaginal,<br>Transesophageal, Intraoperative (vascular) and interventional<br>guidance (includes tissue biopsy, fluid drainage, vascular and<br>non-vascular access). Modes of operation include: B, M, PW<br>Doppler, CW Doppler, Color Doppler, Color M Doppler, Power<br>Doppler, Harmonic Imaging, Coded Pulse and Combined modes:<br>B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD,<br>B/CWD, B/Color/CWD. | |----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Technology: | The Venue Fit employs the same fundamental scientific<br>technology as its predicate and reference devices. | | Determination of<br>Substantial Equivalence: | Comparison to Predicate Device<br>The Venue Fit system is substantially equivalent to the predicate<br>device with regards to imaging capabilities, technological<br>characteristics and safety and effectiveness. All probes used with<br>the proposed Venue Fit system are used unchanged from the<br>cleared predicate. They are made of the same materials and their<br>shape is unchanged. | | | The proposed Venue Fit and predicate Venue Fit (K203137) have<br>identical clinical indications for use. | | | The proposed Venue Fit and predicate Venue Fit (K203137) have<br>identical imaging modes. | | | The following is an overview of the differences between the<br>proposed Venue Fit and the predicate Venue Fit:<br>The proposed Venue Fit and predicate Venue Fit (K203137)<br>systems transducers are similar, except for:<br>● Additions of M5Sc-RS which was first cleared on Vivid<br>iq K161706. This probe is used unchanged from the<br>cleared reference device (K161706). It is made of the<br>same materials and its shape is unchanged. The clinical<br>indications of M5Sc-RS are the same on the proposed<br>Venue Fit as they are on the reference device Vivid E95<br>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.