(175 days)
The Vivid is high-performance compact diagnostic ultrasound system designed for Cardiovascular and Shared Services. It is intended for use by qualified and trained Healthcare professionals for Ultrasound imaging, measurement, display and analysis of the human body and fluid. Vivid iq clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN, Urology), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vasculoskeletal Conventional, Musculoskeletal Superficial, Transcranial, Transrectal, Transvaginal, Transesophageal, Interventional Guidance (including Biopsy), Intraoperative(Vascular), Intracardiac and Intraluminal. Modes of operation include: B, M, PW Doppler, CW Doppler, Color M, Power Doppler, Harmonic Imaging, Real-Time (RT) 3D Mode (4D), Coded Pulse and Combined modes: B/M, B/Color M, B/WD, B/CWD, B/Color/PWD, B/Color/CWD, B/Power/PWD. The device is intended for use in an indoor hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab, in private medical offices, and in limited settings outside of professional Healthcare facilities.
The proposed Vivid iq system is a general-purpose, Track 3, diagnostic ultrasound device, primarily intended for cardiovascular diagnostic use and shared service imaging. It is an ultrasound imaging & analysis system, consisting of a compact console with control panel including a track pad, numeric keyboard. There are options for image storage, USB wireless connectivity, cardiac signal input for cardiac gating and output capabilities to printing devices. Vivid iq utilizes a variety of linear, sector, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes.
The provided text does not contain information regarding the acceptance criteria of and performance of the device "Vivid iq". It also lacks details about a specific study designed to prove the device meets such criteria, as well as information on sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC).
The document is a 510(k) premarket notification for the Vivid iq, which primarily discusses the device's substantial equivalence to existing predicate devices based on technological characteristics and intended use. It lists various features and functions, noting that many are the "same feature as cleared on" other GE Healthcare devices.
However, based on the information provided in the text, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the given text. The document states that the Vivid iq uses the "same fundamental scientific technology as its predicate and reference devices" and lists various feature updates (e.g., AI Auto Measure, AFI 3.0, Auto EF 3.0) that are "same feature as cleared on" other GE Healthcare systems. Implicitly, the acceptance criteria for these features would have been met during the clearance of the previous devices, and the performance of the Vivid iq with these features is presumed to be equivalent. However, explicit numerical acceptance criteria and performance metrics for the Vivid iq itself are not detailed in this submission.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given text. The document states, "The subject of this premarket submission, Vivid iq, did not require clinical studies to support substantial equivalence." This implies that no new clinical test set was used for this specific submission to prove the performance of the listed features.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable/not provided as no new clinical test set was seemingly evaluated for this 510(k) submission. For the features inherited from other devices, the original submissions for those devices would contain this information.
4. Adjudication Method for the Test Set
This information is not applicable/not provided as no new clinical test set was seemingly evaluated for this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not provided in the given text. While some AI-based features are mentioned (e.g., "AI Auto Measure – 2D" and "AI Auto Measure – Spectrum Recognition"), the document does not detail any MRMC study conducted for the Vivid iq or the effect size of AI assistance on human readers. It only states that these are "same feature as cleared on Vivid S70N(K200497)," suggesting that any such studies would have been part of the K200497 submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not provided in the given text. Given that clinical studies were not required for this submission, standalone performance data for the AI algorithms specifically on the Vivid iq system are not detailed here.
7. The Type of Ground Truth Used
This information is not provided in the given text for the Vivid iq itself. For the features inherited from other devices (e.g., AI Auto Measure components), the ground truth type (e.g., expert consensus, manual measurements, pathology) would have been established during the development and clearance of those original devices.
8. The Sample Size for the Training Set
This information is not provided in the given text. For the AI-based features, the training set size would have been part of the K200497 submission.
9. How the Ground Truth for the Training Set was Established
This information is not provided in the given text. For the AI-based features, the method for establishing ground truth for the training set would have been part of the K200497 submission.
In summary, the provided document focuses on confirming "substantial equivalence" based on existing technologies and previously cleared features from other devices, rather than presenting new clinical study data with detailed acceptance criteria, test set specifics, or human-in-the-loop performance metrics for the Vivid iq specifically.
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GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC % Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226
Re: K200708
Trade/Device Name: Vivid iq Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: July 20, 2020 Received: July 21, 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.
September 9, 2020
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
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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
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Indications for Use
510(k) Number K200708
Device Name
Vivid iq
Indications for Use (Describe)
The Vivid is high-performance compact diagnostic ultrasound system designed for Cardiovascular and Shared Services. It is intended for use by qualified and trained Healthcare professionals for Ultrasound imaging, measurement, display and analysis of the human body and fluid. Vivid iq clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN, Urology), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vasculoskeletal Conventional, Musculoskeletal Superficial, Transcranial, Transrectal, Transvaginal, Transesophageal, Interventional Guidance (including Biopsy), Intraoperative(Vascular), Intracardiac and Intraluminal. Modes of operation include: B, M, PW Doppler, CW Doppler, Color M, Power Doppler, Harmonic Imaging, Real-Time (RT) 3D Mode (4D), Coded Pulse and Combined modes: B/M, B/Color M, B/WD, B/CWD, B/Color/PWD, B/Color/CWD, B/Power/PWD. The device is intended for use in an indoor hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab, in private medical offices, and in limited settings outside of professional Healthcare facilities.
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) |
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K200708 GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
| Date: | July 20, 2020 |
|---|---|
| Submitter: | GE Medical Systems Ultrasound and Primary Care Diagnostics9900 Innovation DriveWauwatosa, WI 53226 |
| Primary Contact Person: | Tracey OrtizRegulatory Affairs DirectorGE HealthcareT:(262)676-6120 |
| Secondary Contact Person: | Wang YuanRegulatory AffairsGE Healthcare |
| Device Trade Name: | Vivid iq |
| Common/Usual Name: | Diagnostic Ultrasound System |
| Classification Names: | Class IIIYN (primary), IYO, ITX (secondary) |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550,90- IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR892.1560, 90-IYO; Diagnostic Ultrasound Transducer, 21 CFR892.1570, 90-ITX |
| Predicate Device: | Vivid iq (K181727) |
| Reference Devices: | Vivid T8 (K160078)Vivid E95 (K181685)Versana Balance (K191792)Vivid S70N (K200497) |
| Device Description: | The proposed Vivid iq system is a general-purpose, Track 3,diagnostic ultrasound device, primarily intended forcardiovascular diagnostic use and shared service imaging. It isan ultrasound imaging & analysis system, consisting of acompact console with control panel including a track pad, |
numeric keyboard. There are options for image storage, USB
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GE Healthcare
510(k) Premarket Notification Submission wireless connectivity, cardiac signal input for cardiac gating and output capabilities to printing devices. Vivid iq utilizes a variety of linear, sector, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes.
Intended Use: The Vivid iq is high-performance compact diagnostic ultrasound system designed for Cardiovascular and Shared Services. It is intended for use by qualified and trained Healthcare professionals for Ultrasound imaging, measurement, display and analysis of the human body and fluid. Vivid iq clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN, Urology), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Transcranial, Transrectal, Transvaginal, Transesophageal, Interventional Guidance (including Biopsy), Intraoperative(Vascular), Intracardiac and Intraluminal. Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M, Power Doppler, Harmonic Imaging, Real-Time (RT) 3D Mode (4D), Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, B/CWD, B/Color/PWD, B/Color/CWD, B/Power/PWD. The device is intended for use in an indoor hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab, in private medical offices, and in limited settings outside of professional Healthcare facilities.
- Technology: The Vivid iq employs the same fundamental scientific technology as its predicate and reference devices.
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GE Healthcare 510(k) Premarket Notification Submission
| Determination of | Comparison to Predicate Device |
|---|---|
| Substantial Equivalence: | The Vivid iq system is substantially equivalent to the predicate device with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness. There are no additional clinical applications, however the indications for use wording has been modified to align with the new ultrasound guidance, identify users similar to reference device Versana Balance (K191792), and provide information on the environments the system can be used in.The Vivid iq and predicate Vivid iq (K181727) have the same transducersAdding combine modes B/Color M, B/CWD and B/Color/CWD to 6VT-D transducer already cleared on Vivid E95(K181685).AI Auto Measure – 2D: same feature as cleared on Vivid S70N(K200497). It is AI (Artificial Intelligence) based Cardiac Auto 2D feature that enables automated measurements on a PLAX image.AI Auto Measure – Spectrum Recognition: same feature as cleared on Vivid S70N(K200497). It is 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: same feature as cleared on Vivid S70N(K200497), has the ability to analyze the left ventricle on both GEHC raw data images and DICOM images from 3rd party ultrasound scannersAuto EF 3.0: same feature as cleared on Vivid S70N(K200497), has the ability to assess LV function on raw data images acquired with GEHC scanners as well as on DICOM images from other vendors systems.AFI RV: same feature as cleared on Vivid S70N(K200497). 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: same feature as cleared on Vivid S70N(K200497). It provides quantitative data for left atrial (LA) global strain. The tool also supports |
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GE Healthcare
510(k) Premarket Notification Submission measurements of LA volumes and emptying fraction (EF).
- . HD Color: same feature as cleared on Vivid S70N(K200497). It enhances the perception of 4D color on a 2D monitor by addition of shadowing and specular reflection techniques, providing transparency control.
- . 4D Markers: same feature as cleared on predicate Vivid iq (K181727). It is enhanced to allow the user to modify individual markers.
- Scan Coach: same feature as cleared on Vivid T8 ● (K160078), is designed to display information which helps user acquire the right scan plane.
- Stream Server: same feature as cleared on Vivid E95 ● (K181685), is modified slightly and enables the user to get guidance and/or second opinion by a remote viewer.
- . Launchpad: same feature as cleared on Vivid S70N(K200497), 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.
- Adding additional lung imaging presets ●
- DICOM PDF Read: same feature as cleared on Vivid S70N (200497). The system supports read-only access to DICOM PDF reports created on a DICOM server.
Summary of Non-Clinical Tests:
The proposed Vivid ig 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 Vivid ig complies with voluntary standards:
- o AAMI/ANSI ES 60601-1, Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance -2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012
- IEC 60601-1-2, Medical electrical equipment o Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements
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GE Healthcare
510(k) Premarket Notification Submission and tests - Edition 4.0, 2014
- IEC 60601-2-37, Medical electrical equipment -O Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment -Edition 2.1, 2015
- ISO 10993-1, Biological Evaluation of Medical O Devices- Part 1: Evaluation and Testing- Third Edition, 2009
- Ф IEC 62359. Ultrasonic - Field characterization -Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields - Edition 2.1, 2017
- ISO 14971, Application of risk management o to medical devices, 2007
- NEMA PS 3.1 3.20, Digital Imaging and O 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)
- · Performance testing (Verification & Validation)
- · Safety testing (Verification)
Transducer material and other patient contact materials are biocompatible.
Summary of Clinical Tests:
Conclusion: The subject of this premarket submission, Vivid iq, did not require clinical studies to support substantial equivalence
GE Healthcare considers the Vivid iq to be as safe, as effective, and performance is substantially equivalent to the predicate and reference devices.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
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.(b)
Classification. Class II.