(139 days)
No
The document mentions "Mentions AI, DNN, or ML: Yes", but this is a metadata field provided in the input, not a statement within the actual 510(k) summary text. The summary itself describes a standard diagnostic ultrasound system with various imaging modes and processing capabilities, but it does not mention any features or functions that explicitly utilize AI or ML.
No
The "Intended Use / Indications for Use" section states that the device is for "ultrasound imaging, measurement, display and analysis," which are diagnostic functions, not therapeutic ones.
Yes
The "Device Description" explicitly states, "Vivid S60N / Vivid S70N is a Track 3, diagnostic ultrasound system." The "Intended Use / Indications for Use" also describes its use for "ultrasound imaging, measurement, display and analysis of the human body and fluid," which are all diagnostic functions.
No
The device description explicitly states it is a "full featured diagnostic ultrasound system" consisting 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 also includes "a variety of electronic array transducers" and "electronics for transmit and receive of ultrasound data." These are all hardware components, making it a hardware-based medical device with integrated software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Vivid S60N/Vivid S70N is an ultrasound system. Ultrasound imaging is a non-invasive technique that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
- Intended Use: The intended use describes imaging, measurement, display, and analysis of the human body and fluid using ultrasound. This aligns with diagnostic imaging, not in vitro testing.
Therefore, while it is a diagnostic device, it falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Ultrasound
Anatomical Site
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).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified and trained physician / hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this premarket submission, Vivid S60N / Vivid S70N, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Vivid S60N, Vivid S70N (K182450)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Vivid E95 (K181685), LOGIQ E9 (K163077), Vivid S60N, Vivid S70N (K170878), Vivid 7 (K051449)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
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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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 |
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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:
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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
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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
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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).