Venue Fit

{0}------------------------------------------------ Image /page/0/Picture/0 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 seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the words "U.S. Food & Drug Administration" and "Administration" written out. GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC % Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226 December 29, 2020 Re: K203137 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: December 16, 2020 Received: December 17, 2020 Dear Tracey Ortiz: 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 and Part 809); 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 medical devices and radiation-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 Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K203137 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 clinic. Venue Fit clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, thyroid), VascularPeripheral 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, 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 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized, cursive font, enclosed within a circular frame. The color of the logo is a light blue. K203137 GE Healthcare 510(k) Premarket Notification Submission ## 510(k) Summary | | In accordance with 21 CFR 807.92 the following summary of information is provided:<br>Date: October 19,2020 | |--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC<br>9900 W. Innovation Drive<br>Wauwatosa, WI 53226 | | Primary Contact Person: | Tracey Ortiz<br>Regulatory Affairs Director<br>GE Healthcare<br>T:(262)470-1003 | | Secondary Contact Person: | Karin Shimoni<br>Regulatory Affairs Leader<br>GE Healthcare | | Device Trade Name:<br>Common/Usual Name:<br>Classification Names:<br>Product Code: | Venue Fit<br>Diagnostic Ultrasound System<br>Class II<br>Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-<br>IYN; Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-<br>ITX; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560,<br>90-IYO | | Primary Predicate Device:<br>Reference Device(s): | Venue Go (K183362)<br>Venue (K180599)<br>Versana Premier (K200138)<br>Vivid iq (K200708)<br>LOGIQ e (K133533)<br>LOGIQ e (K151028)<br>Voluson S8 (K120741)<br>Vivid q (K121062)<br>Venue 50 (K152758)<br>Vscan Extend (K180995)<br>Vivid S70N (K182450) | | Device Description: | Venue Fit is a general-purpose diagnostic ultrasound system<br>intended for use by qualified and trained healthcare professionals<br>to evaluate the body by ultrasound imaging and fluid flow<br>analysis. The Venue Fit is a compact, portable system with a<br>small footprint. The system can be hand carried using the | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a blue circle. The circle has decorative swirls around its perimeter, giving it a classic and recognizable appearance. # GE Healthcare 510(k) Premarket Notification Submission 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. Some transducers are compatible with OEM biopsy kits to support needle-guidance procedures. The system has the capability for 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. The ECG signal can be input directly from the patient leads or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis. Venue Fit is capable of wired or wireless internet connection and a barcode reader is available to be used as an input device. The system meets DICOM requirements to support users image storage and archiving needs (local PACS or products such as O-Path) and allows for output to printing devices. The user documentation is available electronically. An additional accessory available for the customer is a roller bag. 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 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. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. The blue color is consistent throughout the logo, providing a clean and recognizable brand identity. GE Healthcare 510(k) Premarket Notification Submission | 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. | | | The following is an overview of the differences between the<br>proposed Venue Fit and the predicate Venue Go.<br>The proposed Venue Fit and predicate Venue Go (K183362) have similar clinical indications for use. Vascular has been added with peripheral vascular and for intraoperative, this clarifies on vessels and is not a change in imaging. No impact to safe or effectiveness use. Interventional guidance is used instead of Imaging guidance of interventional procedures, as it was in the IFU tables in the predicate Venue Go (K183362). Non-vascular access is added as sub category from the predicate IFU table. Fluid drainage is added. There is no change to the intended use from the predicate and no impact to safe or effective use. The IFU statement adds "trained" to the operator qualification. No impact to safe or effective use. Device use settings and modes of operation are added as required in the 2019 ultrasound guidance. The modes and the use environment are the same as the predicate. | | | Transducers and Modes:<br>The proposed Venue Fit and predicate Venue Go (K183362) have identical imaging modes. The proposed Venue Fit and predicate Venue Go (K183362) systems transducers are similar, except for: Adding of ML6-15-RS which was first cleared on Voluson S8, K120741. The clinical indications of ML6-15-RS are similar on the proposed Venue Fit as they are on the reference device Vivid iq, K200708. Adding 12S-RS, which was first cleared on Vivid q, K121062. The clinical indications of 12S-RS are the same on the proposed Venue Fit as they are on the reference device Vivid iq, K200708. Adding L10-22-RS which was first cleared on LOGIQ e, K133533. The clinical indications of | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. The circle is surrounded by swirling, wave-like elements, also in blue, giving the logo a dynamic and recognizable appearance. # GE Healthcare 510(k) Premarket Notification Submission L10-22-RS are similar on the proposed Venue Fit as they are on the reference device LOGIQ e, K151028. - L4-20t-RS is a new transducer being added to the o proposed Venue Fit system. The L4-20t-RS has similar clinical indications for use as the predicate L4-12t-RS transducer which was first cleared on LOGIQ e K133533. L4-20t-RS is a surface, linear array transducer which operates in a wider range of frequencies compared to the predicate L4-12t-RS. The clinical indications of L4-20t-RS are the same as the L4-12t-RS transducer cleared with predicate device Venue Go, K183362. - New applications are added to transducers: ● - ML6-15-RS transducer: added Ophthalmic, Cardiac O (Pediatric and Adult), Thoracic/Pleural, Interventional guidance (vascular and non-vascular access), cleared with 12L-RS in predicate Venue Go (K183362) which is a similar transducer. - L10-22-RS transducer: added Pediatric, cleared with o L8-18i-RS in predicate Venue Go (K183362) which is a similar transducer. - L8-18i-RS transducer: added Ophthalmic, cleared o with 12L-RS in predicate Venue Go (K183362) which is a similar transducer. - 8C-RS transducer: added Musculoskeletal O (Conventional and Superficial) and Adult cephalic, cleared with reference Venue (K180599). - Adding Coded Pulse mode to Vascular/Peripheral ● Vascular, Vascular Access and Non-vascular on L10-22-RS. Features/Functionality: - Simple Screen is a modification of Full Screen that is on ● predicate Venue Go (K183362). - Follow-up feature is being added with minor modifications to what has been cleared on Versana Premier, K200138. - Venue View is being added and is a different name for ● LOGIQ View that has been cleared on Versana Premier, K200138. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. There are swirling, wave-like designs surrounding the circle, giving it a dynamic and recognizable appearance. The logo is simple, yet iconic, representing the brand's long history and global presence. # GE Healthcare 510(k) Premarket Notification Submission - Lung Sweep allows multiple lung scans to play 0 simultaneously during review. Lung scanning was available also on predicate Venue Go (K183362). - . cNeedle enhances the needle. and projects a trajectorv line. Capabilities are similar to needle recognition that has been cleared on predicate Venue Go. K183362 and Pinpoint GT feature on reference Venue 50, K152758, respectively. - Real-Time Ejection Fraction (EF) is being added and is similar to the Auto EF feature on reference Vivid S70N, K182450. - Renal Diagram is similar to the eFAST Navigation Tool ● cleared on predicate Venue Go, K183362. - Added biopsy guidzones cleared on reference Versana Premier, K200138. - Added additional off-the-shelf SW. o ### Accessories: - Adding compatible OEM ECG triggering leads for pediatrics, similarly to what is on predicate Vivid iq K200708. - Adding compatible OEM biopsy guide accessory ● compatibility for the C1-5-RS, for 12L-RS & L4-12t-RS and for L4-20t-RS transducers. ## HW: - LCD Screen size of 14'' (vs. 15.6'' in predicate Venue ● Go, K183362) - 2 probe ports (vs. 3 in predicate Venue Go, K183362) - 1 battery (vs. 2 in predicate Venue Go, K183362) - Simple cart design (no cradle, no printer mount on cart, no o power distribution module). ### 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: {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. The circle has decorative swirls around its perimeter, giving it a dynamic and recognizable appearance. # GE Healthcare 510(k) Premarket Notification Submission - AAMI/ANSI ES60601-1, Medical Electrical Equipment -0 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, 2014 - IEC 60601-2-37, Medical Electrical Equipment Part 2-● 37: Particular Requirements for the Safetv of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2015 - ISO 10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing- Third Edition, 2009 - IEC 62359, Ultrasonics Field characterization Test ● methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2017 - o ISO 14971, Application of risk management to medical devices, 2019 - o NEMA PS 3.1 - 3.20, Digital Imaging and Communications in Medicine (DICOM) Set, 2016 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) o - . Performance testing (Verification & Validation) - . Safety testing (Verification) Transducer material and other patient contact materials are biocompatible. Summary of Clinical Tests: The subject of this premarket submission, Venue Fit, did not require clinical studies to support substantial equivalence. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. There are decorative swirls around the outside of the circle. GE Healthcare 510(k) Premarket Notification Submission GE Healthcare considers the Venue Fit to be as safe, as effective, Conclusion: and performance is substantially equivalent to the predicate device.