Who is the manufacturer of Vivid S60N, Vivid S70N?

GE Medical Systems Ultrasound and Primary Care Diagnostics filed the 510(k) submission for Vivid S60N, Vivid S70N (K200497).

What is the FDA product code for Vivid S60N, Vivid S70N?

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

What is the regulatory pathway for Vivid S60N, Vivid S70N?

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

Does Vivid S60N, Vivid S70N use AI or machine learning?

Yes. Vivid S60N, Vivid S70N (K200497) 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 Vivid S60N, Vivid S70N?

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 Vivid S60N, Vivid S70N 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.

Vivid S60N, Vivid S70N

Q: What are the predicate devices for Vivid S60N, Vivid S70N?

Vivid S60N, Vivid S70N (K182450).

K200497 · GE Medical Systems Ultrasound and Primary Care Diagnostics · IYN · Jul 16, 2020 · Radiology

Device Facts

Record ID	K200497
Device Name	Vivid S60N, Vivid S70N
Applicant	GE Medical Systems Ultrasound and Primary Care Diagnostics
Product Code	IYN · Radiology
Decision Date	Jul 16, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	AI/ML, Pediatric

Intended Use

Vivid S60N/Vivid S70N is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (including renal, GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transvaginal, Transrectal, Intra-cardiac and Intra-luminal, Interventional Guidance (including Biopsy, Vascular Access), and Intraoperative (vascular). Modes of operation include: 3D/4D Imaging mode, B, M, PW Dopler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

Device Story

Mobile diagnostic ultrasound system; provides digital acquisition, processing, analysis, and display of ultrasound data. Inputs: electronic array transducers (linear, curved, sector/phased, matrix, dual, CW, real-time 3D, ICE). Operation: physician-operated in hospitals/clinics; system includes signal processing, software computing, and network connectivity (LAN/wireless). Features AI-based auto-measurement and spectrum recognition tools to assist clinicians in cardiac assessment (e.g., LV/RV/LA strain, EF). Output: real-time images and automated measurements displayed on LCD monitor. Benefits: facilitates clinical decision-making through semi-automated quantification of cardiac function and remote viewing capabilities via Stream Server.

Clinical Evidence

No clinical data required; substantial equivalence supported by bench testing, including acoustic output, biocompatibility, thermal/electrical/electromagnetic safety, and software verification/validation.

Technological Characteristics

Mobile console with LCD touch panel and monitor. Transducers: linear, curved, sector/phased, matrix, dual, CW, real-time 3D, ICE. Connectivity: LAN/wireless. Standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 14971, NEMA PS 3.1-3.20 (DICOM). Software includes AI-based cardiac analysis tools.

Indications for Use

Indicated for ultrasound imaging, measurement, display, and analysis of human body and fluid in patients requiring cardiac, fetal/obstetric, abdominal, pediatric, small organ, neonatal/adult cephalic, vascular, musculoskeletal, urological, and interventional procedures. Used by or under direction of qualified physicians in hospitals or private offices.

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

Vivid S60N, Vivid S70N (K182450)

Reference Devices

Vivid E95 (K181685)
LOGIQ E9 (K163077)
Vivid S60N, Vivid S70N (K170878)
Vivid 7 (K051449)

Related Devices

K200851 — Vivid T8, Vivid T9 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Sep 9, 2020
K220619 — Vivid S60N, Vivid S70N · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jul 15, 2022
K220882 — Vivid E80, Vivid E90, Vivid E95 · Ge Medical Systems Ultrasound And · Jul 22, 2022
K200743 — Vivid E80/ Vivid E90/ Vivid E95 · Ge Medical Systems Ultrasound And · Jul 23, 2020
K221147 — Vivid T8, Vivid T9 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jul 18, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. GE Medical Systems Ultrasound and Primary Care Diagnostics % Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226 ### Re: K200497 Trade/Device Name: Vivid S60N, Vivid S70N Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: June 16, 2020 Received: June 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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see July 16, 2020 {1}------------------------------------------------ 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) Device Name Vivid S60N, Vivid S70N #### Indications for Use (Describe) Vivid S60N/Vivid S70N is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (including renal, GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transvaginal, Transrectal, Intra-cardiac and Intra-luminal, Interventional Guidance (including Biopsy, Vascular Access), and Intraoperative (vascular). Modes of operation include: 3D/4D Imaging mode, B, M, PW Dopler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. Type of Use (Select one or both, as applicable) | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | |-------------------------------------------------------------------------------------------------------------------------------| | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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' intertwined in a stylized script, enclosed within a blue circle. The circle has decorative white swirls around the perimeter, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, and is widely associated with the multinational conglomerate. GE Healthcare 510(k) Premarket Notification Submission ## 510(k) Summary | | In accordance with 21 CFR 807.92 the following summary of information is provided: | |-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date: Submitter: | February 26, 2020 GE Medical Systems Ultrasound and Primary Care Diagnostics 9900 Innovation Drive Wauwatosa, WI 53226 | | Primary Contact Person: | Tracey Ortiz Regulatory Affairs Director GE Healthcare T:(262)676-6120 | | Secondary Contact Person: | Carmel Lehrer Regulatory Affairs Specialist | | Device Trade Name: Common/Usual Name: Classification Names: | Vivid S60N / Vivid S70N Diagnostic Ultrasound System Class II | | Product Code: | IYN (primary), IYO, ITX (secondary) 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 | | Primary Predicate Device: Reference Device(s): | Vivid S60N, Vivid S70N (K182450) Vivid E95 (K181685) LOGIQ E9 (K163077) Vivid S60N, Vivid S70N (K170878) Vivid 7 (K051449) | | Device Description: | Vivid S60N / Vivid S70N is a Track 3, diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It is a full featured diagnostic ultrasound system that provides digital acquisition, processing, analysis and display capability. | | | The Vivid S60N / Vivid S70N consists of a mobile console with a height-adjustable control panel, color LCD touch panel, LCD display monitor and optional image storage and printing devices. It includes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array or dual array | {4}------------------------------------------------ Image /page/4/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. Three swirling shapes surround the circle, adding a dynamic element to the design. The logo is simple, recognizable, and associated with the multinational conglomerate. ## GE Healthcare 510(k) Premarket Notification Submission format, including dedicated CW transducers and real time 3D transducer. System also can be used with compatible ICE transducers. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for Image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection. Intended Use: Vivid S60N/Vivid S70N is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (including renal, GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transesophageal, Transvaginal, Transrectal, Intra-cardiac and Intra-luminal, Interventional Guidance (including Biopsy, Vascular Access), and Intraoperative (vascular). Modes of operation include: 3D/4D Imaging mode, 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 or CWD, B/Color/PWD or CWD, B/Power/PWD. The Vivid S60N / Vivid S70N employs the same fundamental Technology: scientific technology as its predicate devices. Determination of Comparison to Predicate Devices Substantial Equivalence: The Vivid S60N / Vivid S70N is substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness. The following is an overview of the differences between the proposed Vivid S60N / Vivid S70N and its predicates. Transducers and Modes: {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 circle has decorative swirls around its perimeter, giving it a dynamic and recognizable appearance. GE Healthcare - 510(k) Premarket Notification Submission - Adding ML6-15-D which was previously cleared in ● LOGIQ E9 (K163077). - Expanding the M5Sc-D and 10T-D transducer to the ● Vivid S60N that was previously cleared on Vivid S70N (K182450). - Adding Biplane/Tri-plane imaging to the 6VT-D ● transducer to the Vivid S60N that was previously cleared on Vivid S70N (K182450). Indications for Use: - o There are no additional clinical applications, however the statement wording has been modified to align with the new ultrasound guidance. Features/Functionality additions: - o AI Auto Measure - 2D: AI (Artificial Intelligence) based Cardiac Auto 2D feature that enables semi-automated measurements on a PLAX images using similar process as IMT feature first released on Vivid 7, K051449 and manual workflow on predicate Vivid S60N, Vivid S70N. - AI Auto Measure Spectrum Recognition: AI based ● Spectrum Recognition feature that enables automated recognition of common Doppler spectra and automatically starts the Auto Doppler measurement or opens the appropriate manual measurement folder. - AFI 3.0: based on AFI 2.0 (cleared in Vivid S60N/S70N, ● K182450), adds the ability to analyze the left ventricle on both GEHC raw data images and DICOM images from 3rd party ultrasound scanners. - Auto EF 3.0: based on Auto EF 2.0 (cleared in K182450), ● adds the ability to assess LV function on raw data images acquired with GEHC scanners as well as on DICOM images from other vendors systems. - o AFI RV: based on AFI 2.0 (cleared in K182450) but modified for the right ventricle (RV). It is a parametric tool giving quantitative data for right ventricular longitudinal global strain, free wall strain and segmental strain derived from the apical 4-chamber RV focused view. - AFI LA: based on AFI 2.0 (cleared in K182450) but ● modified for the left atrium. It provides quantitative data {6}------------------------------------------------ Image /page/6/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 inside. There are three white swirls around the letters. The logo is simple and recognizable, and it is associated with a well-known and established company. for left atrial (LA) global strain. The tool also supports measurements of LA volumes and emptying fraction (EF). - Launchpad: allows the display and launch/starting of . third-party software apps that have been installed on the system. Only apps that have been qualified and compatibility verified can be installed on the system. - . HD Color: enhances the perception of 4D color on a 2D monitor by addition of shadowing and specular reflection techniques, providing transparency control. - DICOM PDF Read: The system supports read-only access ● to DICOM PDF reports created on a DICOM server. - 4D Markers enhancement: Feature cleared in Vivid S60N/S70N (K182450), is modified to allow the user to modify individual markers. - Zscore enhancement: Three Z-score sets of values added based on published literature - are being added to those previously cleared in Vivid S60N/S70N (K182450). - Stream Server use was changed from an information only ● purpose to allowing the user to get guidance and/or second opinion by a remote viewer which was cleared in Vivid E95 (K181685). ### Summary of Non-Clinical Tests: Vivid S60N / Vivid S70N were evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and have been found to comply with applicable medical device safety standards. The Vivid S60N / Vivid S70N complies with voluntary standards: - AAMI/ANSI ES60601-1, Medical Electrical Equipment -● Part 1: General Requirements for Safety and Essential Performance, 2005/ A2:2012 - IEC 60601-1-2, Medical Electrical Equipment Part 1-2: ● General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbance - Requirements and Tests, 2014 - IEC 60601-2-37, Medical Electrical Equipment Part 2-● 37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2015 {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 three curved lines that surround the letters, giving the impression of movement or energy. The logo is simple, yet recognizable, and represents the brand identity of General Electric. # GE Healthcare 510(k) Premarket Notification Submission - ISO 10993-1, Biological Evaluation of Medical Devices-0 Part 1: Evaluation and Testing Within A Risk Management Process, 2009 - 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, 2007 - NEMA PS 3.1-3.20, Digital Imaging and ● Communications in Medicine (DICOM) Set. (Radiology), 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) ● - Performance testing (Verification and Validation) ● - Safety testing (Verification) ● Transducer material and other patient contact materials are biocompatible. Summary of Clinical Tests: The subject of this premarket submission, Vivid S60N / Vivid S70N, did not require clinical studies to support substantial equivalence. - GE Healthcare considers the Vivid S60N / Vivid S70N to be as Conclusion: safe, as effective, and performance is substantially equivalent to the predicate device(s).