(89 days)
Yes
The document explicitly mentions "testing of the AI algorithm" and provides details about the test set and performance metrics (average dice score), which are indicative of AI/ML components.
No.
The device is described as a "diagnostic ultrasound system" and "specialized for use in cardiac imaging" to perform "ultrasound imaging, measurement, display and analysis." Its purpose is to aid in diagnosis, not to provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section states that the device is for "ultrasound imaging, measurement, display and analysis of the human body and fluid," and the "Device Description" section explicitly calls it a "diagnostic ultrasound system."
No
The device description clearly states it is a "full featured diagnostic ultrasound system" consisting of a mobile console, control panel, display monitor, transducers, and other hardware components. While it includes software for processing and analysis, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "ultrasound imaging, measurement, display and analysis of the human body and fluid." This describes a diagnostic imaging system that visualizes internal structures and processes within the body.
- 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. This device does not perform such tests on samples.
- Device Description: The description details an ultrasound system with transducers, a console, and display capabilities. This aligns with the description of an imaging device, not an IVD.
- Clinical Applications: The listed clinical applications are all related to imaging and visualization of different parts of the body.
- Modes of Operation: The modes of operation (B, M, Doppler, etc.) are standard ultrasound imaging modes.
While the device is used for diagnostic purposes, it does so through imaging the body directly, not by analyzing samples taken from the body. Therefore, it falls under the category of a diagnostic imaging device, not an In Vitro Diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
The Vivid T8/Vivid T9 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by qualified and trained Healthcare professionals 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 in private medical offices. The systems support the following clinical applications: Fetal/ Obstetrics, Abdominal (includes GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vasculoskeletal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transesophageal, Transrectal, Transvaginal, Interventional guidance (including Biopsy, Fluid Drainage), Thoracic/Pleural, Intraoperative(Vascular). Modes of operation include: B, M, PW Doppler, CW Doppler, Color M, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/PWD, B/Color/PWD, B/Power/PWD.
Product codes
IYN, IYO, ITX
Device Description
Vivid T9/Vivid T8 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 T9/Vivid T8 consists of a mobile console with 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, and dual array including dedicated CW transducers.
The user-interface includes an operator control panel, a 21.5-inch-wide screen LCD monitor (mounted on an arm for rotation and/or adjustment of height), a 10.1-inch touch panel with multi-touch capabilities and alpha-numeric keyboard.
The smart standby battery is an option to allow the system to not have to be powered down when moving from room to room. Imaging is not allowed when it is not plugged in.
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.
Vivid T8 and Vivid T9 are based on the same SW platform and similar HW design. Each system may have different configurations available. The configurations may differ by available SW-options and transducers provided commercially. Vivid T9 has height-adjustable control panel, while Vivid T8's control panel can't be adjustable. Vivid T9 has monitor flexible arm, while Vivid T8 has a monitor fixed arm and monitor flexible arm as an option.
The product named Vivid T9 represents the system that has the full functionality and is offered with full support for transducers.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal/Obstetrics, Abdominal (includes GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vasculoskeletal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transesophageal, Transrectal, Transvaginal, Thoracic/Pleural, Intraoperative (Vascular)
Indicated Patient Age Range
Fetal, Neonatal, Pediatric, Adult
Intended User / Care Setting
Qualified and trained Healthcare professionals. Intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab, and 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
The number of individual patients' images were collected from: 45 exams from assumed 45 patients (exact number of patients unknown due to anonymization of dataset).
The number of samples, if different from above, and the relationship between the two: 135 images extracted from the 45 exams
Demographic distribution including: Gender: Unknown, due to data anonymization during data collection; Age: Adult, specific age unknown; Ethnicity/Country: Europe, Asia, US
Information about clinical subgroups and confounders present in the dataset: During testing of the AI algorithm, we have included images from different countries, from different scanning views, and a range of different LV Volumes
Information about equipment and protocols used to collect images: Mix of data from across 5 different probes and 4 different Console variants. The data collection protocol was standardized across all data collection sites.
Information about how the reference standard was derived from the dataset (i.e., the "truthing" process): For all datasets, two certified cardiologists performed manual delineation, then reviewed the annotations for each other. A consensus reading was first done whereby the two cardiologists discussed if they agreed on or not. A panel of experienced experts further reviewed annotations that the two cardiologists could not agree on. Hence, the ground truth used are the annotations that the two cardiologists agreed with each other, and the consensus annotations achieved in the review meeting by a panel of experienced experts.
Description of how independence of test data from training data was ensured. To ensure that the testing dataset is not mixed with the training data, we used datasets from different clinical sites for testing as compared to the clinical sites for training.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Tests: Vivid T8/Vivid T9 is evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic, and mechanical safety, and have been found to comply with applicable medical device safety standards. The accuracy of the AI algorithm (average dice score) as tested on datasets from different countries, is 92% or higher, as tested on datasets from different scanning views, is 91% or higher; as tested on dataset from different left ventricle volumes, is 92% or higher.
Summary of Clinical Tests: The subject of this premarket submission, Vivid T8/Vivid T9, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The accuracy of the AI algorithm (average dice score) as tested on datasets from different countries, is 92% or higher, as tested on datasets from different scanning views, is 91% or higher; as tested on dataset from different left ventricle volumes, is 92% or higher.
Predicate Device(s)
Vivid T8/Vivid T9 (K200851)
Reference Device(s)
Vivid iq (K161706), Venue Go (K202233), Versana Premier (K210438)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
July 18, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC % Lee Bush Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226
Re: K221147
Trade/Device Name: Vivid T8, Vivid T9 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: July 1, 2022 Received: July 5, 2022
Dear Lee Bush:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Michael D. O'Hara, Ph.D. Deputy Director DHT 8C: Division of Radiological Imaging and Radiation Therapy Devices OHT 8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular shape. The logo is blue and has a white background.
GE Healthcare 510(k) Premarket Notification Submission
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
221147 Device Name
Vivid T8. Vivid T9
Indications for Use (Describe)
The Vivid T8/Vivid T9 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by qualified and trained Healthcare professionals 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 in private medical offices. The systems support the following clinical applications: Fetal/ Obstetrics, Abdominal (includes GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Ceplalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vasculosketal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transesophageal, Transrectal, Transvaginal, Interventional guidance (including Biopsy, Fluid Drainage), Thoracic/Pleural, Intraoperative(Vascular). Modes of operation include: B, M, PW Doppler, CW Doppler, Color M, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/PWD, B/Color/PWD, 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)
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."
FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (701)-443-6740 EF
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 script, enclosed within a blue circle. The circle has a wavy border, giving it a dynamic appearance. The logo is simple, recognizable, and represents the brand identity of General Electric.
510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Date: July 12, 2022 Submitter: GE Medical Systems Ultrasound and Primary Care Diagnostics 9900 Innovation Drive Wauwatosa, WI 53226
Primary Contact Person: Lee Bush Regulatory Affairs Director GE Healthcare T: (262)309-9429
Secondary Contact Person: Yuan Wang Regulatory Affairs Leader GE Healthcare
Trade Name: Vivid T8/Vivid T9 Device
Common/Usual Name: Diagnostic Ultrasound System
Classification Names: Class II
Product Code(s): 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
Predicate Device: Vivid T8/Vivid T9 (K200851), Diagnostic Ultrasound System Classification Names: Class II Product Code(s): 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
4
Image /page/4/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. Four stylized swirls surround the circle, positioned at roughly equal intervals around the perimeter.
GE Healthcare
| 510(k) Premarket Notification Submission | |
|---|---|
| Reference Device: | Vivid iq (K161706), Diagnostic Ultrasound System |
| Classification Names: | Class II |
| Product Code(s): | 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 | |
| Reference Device: | Venue Go (K202233), Diagnostic Ultrasound System |
| Classification Names: | Class II |
| Product Code(s): | 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 | |
| Reference Device: | Versana Premier (K210438), Diagnostic Ultrasound System |
| Classification Names: | Class II |
| Product Code(s): | 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 |
Device Description:
Vivid T9/Vivid T8 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 T9/Vivid T8 consists of a mobile console with 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, and dual array including dedicated CW transducers.
The user-interface includes an operator control panel, a 21.5-inch-wide screen LCD monitor (mounted on an arm for rotation and/or adjustment of height), a 10.1-inch touch panel with multi-touch capabilities and alpha-numeric keyboard.
The smart standby battery is an option to allow the system to not have to be powered down when moving from room to room. Imaging is not allowed when it is not plugged in.
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.
Vivid T8 and Vivid T9 are based on the same SW platform and similar HW design. Each system may have different configurations available. The configurations may differ by available SW-options and transducers provided commercially. Vivid T9 has height-adjustable control panel, while Vivid T8's control panel can't
5
Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a blue circle. The circle is surrounded by a stylized pattern of swirling lines, also in blue, giving the impression of movement or energy.
510(k) Premarket Notification Submission
be adjustable. Vivid T9 has monitor flexible arm, while Vivid T8 has a monitor fixed arm and monitor flexible arm as an option.
The product named Vivid T9 represents the system that has the full functionality and is offered with full support for transducers.
Intended Use/Indication For Use:
The Vivid T9/Vivid T8 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by qualified and trained Healthcare professionals 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 in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (includes GYN). Pediatric. Small Organ (includes breast, testes, thyroid). Neonatal Cephalic. Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vasculoskeletal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transesophageal, Transrectal, Transvaginal, Interventional guidance (including Biopsy, Fluid Drainage), Thoracic/Pleural, Intraoperative(Vascular). Modes of operation include: B, M, PW Doppler, Color Doppler, Color M, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/PWD, B/Color/PWD, B/Power/PWD.
Technology:
The Vivid T8/Vivid T9 employs the same fundamental scientific technology as its predicate device.
Determination of Substantial Equivalence:
The proposed Vivid T8/Vivid T9 system is substantially equivalent to the predicate device Vivid T8/Vivid T9 and reference devices with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness.
The following is an overview of the differences between the proposed Vivid T8/Vivid T9 and its predicate device.
Indications for use:
The proposed Vivid T8/Vivid T9 and predicate Vivid T9 (K200851) have similar clinical indications for use, except for:
- Added Thoracic/Pleural application, which was cleared on reference device Venue Go (K202233). ●
- Urology (Including prostate) is listed independently instead of within Abdominal as it was in the ● predicate Vivid T8/Vivid T9 (K200851). There is no change in imaging or the product. No impact to safe or effective use.
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 within a blue circle. The circle has a stylized design with wave-like elements around the perimeter, giving it a distinctive and recognizable appearance.
510(k) Premarket Notification Submission
Transducer and modes:
- The proposed Vivid T8/Vivid T9 and predicate Vivid T9 (K200851) have identical ● imaging modes.
- The proposed Vivid T8/Vivid T9 and predicate Vivid T9 (K200851) transducers are similar, except for:
- Addition of M5Sc-RS on Vivid T8 and Vivid T9, which was first cleared on Vivid ig o (K161706). The clinical applications and imaging modes of M5Sc-RS are similar on the proposed Vivid T8/Vivid T9 as they are on the reference device Vivid iq (K161706).
- Addition of L4-20t-RS on Vivid T9, which was first cleared on Venue Go (K202233). The O clinical applications and imaging modes of L4-20t-RS are similar on the proposed Vivid T8/Vivid T9 as they are on the reference device Venue Go (K202233).
- Addition of C1-5-RS on Vivid T8. which was cleared on predicate device Vivid T9 (K200851). O The clinical applications and imaging modes of C1-5-RS are similar on the proposed Vivid T8 as they are on Vivid T9 (K200851).
- The Thoracic/Pleural application is added to the transducers: ●
- 3Sc-RS,6S-RS, 9L-RS, 12L-RS, ML6-15-RS, L8-18i-RS, C1-5-RS, 8C-RS, and L4-20t-RS O based on the clearance of reference device Venue Go (K202233).
- 4C-RS based on the clearance of reference device Versana Premier (K210438). O
- 12S-RS is a similar transducer to 6S-RS cleared with reference device Venue Go (K202233) O
- M5Sc-RS is a similar transducer to 3Sc-RS cleared with reference device Venue Go (K202233) O
Software:
- Added workflow enhancements tools: Pre-Post Compare, Image Spooler ●
- Updates made to: 2D Color Flow, Launchpad ●
- Added Easy Auto EF -based on Auto EF 3.0 (includes AI Auto ROI algorithm) ●
- Added Easy AFI LV -based on AFI 3.0 (includes AI Auto ROI algorithm)
- Added Spline Tool - area, circumference, and volume measurement method
- Added Strain Elastography feature added, cleared in Versana Premier (K210438) ●
- Added Imaging Insights Data Collection Support provides device usage information ●
- Added Probe check (Transducer Element Check) ●
Accessories:
- Added compatible OEM biopsy guide accessory compatibility for the L4-201-RS and M5Sc-RS ● transducer
7
Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The letters are stylized and connected, giving the logo a distinctive and recognizable appearance. The blue color of the circle and letters is consistent, providing a clean and professional look.
510(k) Premarket Notification Submission
Summary of Non-Clinical Tests:
Vivid T8/Vivid T9 is evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic, and mechanical safety, and have been found to comply with applicable medical device safety standards. The Vivid T8/Vivid T9 complies with voluntarv 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, Ed. 2.1, 2015
- ISO 10993-1, Biological Evaluation of Medical Devices- 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, 2019
- 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)
- Safety testing (Verification) .
Transducer materials and other patient contact materials are biocompatible.
AI Summary of Testing: Easy Auto EF and Easy AFI LV
Summary test statistics or other test results including acceptance criteria or other information supporting the appropriateness of the characterized performance
- The accuracy of the AI algorithm (average dice score) as tested on datasets from different . countries, is 92% or higher, as tested on datasets from different scanning views, is 91% or higher; as tested on dataset from different left ventricle volumes, is 92% or higher.
- . The number of individual patients' images were collected from: 45 exams from assumed 45 patients (exact number of patients unknown due to anonymization of dataset).
- The number of samples, if different from above, and the relationship between the two: ● 135 images extracted from the 45 exams
8
Image /page/8/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, wave-like elements around its perimeter, giving it a distinctive and recognizable appearance.
GE Healthcare 510(k) Premarket Notification Submission
Demographic distribution including:
- Gender: Unknown, due to data anonymization during data collection
- Age: Adult, specific age unknown ●
- Ethnicitv/Country: Europe, Asia, US ●
Information about clinical subgroups and confounders present in the dataset:
-
During testing of the AI algorithm, we have included images from different countries, from . different scanning views, and a range of different LV Volumes
Information about equipment and protocols used to collect images: -
Mix of data from across 5 different probes and 4 different Console variants. The data collection ● protocol was standardized across all data collection sites.
Information about how the reference standard was derived from the dataset (i.e., the "truthing" process) -
For all datasets, two certified cardiologists performed manual delineation, then reviewed the ● annotations for each other. A consensus reading was first done whereby the two cardiologists discussed if they agreed on or not. A panel of experienced experts further reviewed annotations that the two cardiologists could not agree on.
-
Hence, the ground truth used are the annotations that the two cardiologists agreed with each other, ● and the consensus annotations achieved in the review meeting by a panel of experienced experts.
Description of how independence of test data from training data was ensured.
- To ensure that the testing dataset is not mixed with the training data, we used datasets from ● different clinical sites for testing as compared to the clinical sites for training.
Summary of Clinical Tests:
The subject of this premarket submission, Vivid T8/Vivid T9, did not require clinical studies to support substantial equivalence.
Conclusion:
GE Healthcare considers the Vivid T8/Vivid T9 to be as safe, as effective, and performance is substantially equivalent to the predicate and reference devices.