(113 days)
Yes
The summary explicitly mentions testing an "AI algorithm" and provides details about the test set and performance metrics (dice score) for this algorithm.
No
The device is intended for diagnostic review and analysis of ultrasound images, patient record management, and reporting, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "EchoPAC Software Only / EchoPAC Plug-in is intended for diagnostic review and analysis of ultrasound images".
Yes
The device description explicitly states "EchoPAC Software Only will be offered as SW only to be installed directly on customer PC hardware". While it processes images from ultrasound systems, the device itself is presented as a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "diagnostic review and analysis of ultrasound images". Ultrasound imaging is an in vivo (within the living body) diagnostic modality, not in vitro (outside the living body, typically involving analysis of biological samples).
- Device Description: The device processes and analyzes ultrasound images acquired from GE ultrasound scanners and DICOM ultrasound images. This reinforces its role in analyzing images from in vivo procedures.
- Input Imaging Modality: The input is explicitly stated as "Ultrasound".
IVD devices are designed to perform tests on biological specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device works with images generated from within the patient's body.
No
The provided input states "Control Plan Authorized (PCCP) and relevant text Not Found," and does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device.
Intended Use / Indications for Use
EchoPAC Software Only / EchoPAC Plug-in is intended for diagnostic review and analysis of ultrasound images, patient record management and reporting, for use by, or on the order of a licensed physician. EchoPAC Software Only / EchoPAC Plug-in allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images.
Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic,3D, and Real time (RT) 3D Mode (4D).
Clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN); Urology (including prostate); Pediatric; Small organs (breast, testes, thyroid); Neonatal and Adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Transrectal (TR); Transvaginal (TV): Intraoperative ( vascular); Intra-Cardiac; Thoracic/Pleural and Intra-Luminal.
Product codes (comma separated list FDA assigned to the subject device)
QIH, LLZ
Device Description
EchoPAC Software Only / EchoPAC Plug-in provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval functionality to ultrasound images that are acquired via the GE Healthcare Vivid family of ultrasound systems, as well as DICOM images from other ultrasound systems. EchoPAC Software Only will be offered as SW only to be installed directly on customer PC hardware and EchoPAC Plug-in is intended to be hosted by a generalized PACS host workstation. EchoPAC Software Only / EchoPAC Plug-in is DICOM compliant, transferring images and data via LAN between systems, hard copy devices, file servers and other workstations.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic, 3D, and Real time (RT) 3D Mode (4D).
Anatomical Site
Fetal/Obstetrics; Abdominal (including renal and GYN); Urology (including prostate); Pediatric; Small organs (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Transrectal (TR); Transvaginal (TV); Intraoperative (vascular); Intra-Cardiac; Thoracic/Pleural and Intra-Luminal.
Indicated Patient Age Range
Neonatal and Adult and pediatric
Intended User / Care Setting
for use by, or on the order of a licensed physician.
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)
- 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.
- 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.
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.
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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, LLC % Lee Bush Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226
Re: K220940
July 22, 2022
Trade/Device Name: EchoPAC Software Only/ EchoPAC Plug-in Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH, LLZ Dated: June 30, 2022 Received: July 1, 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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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,
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of 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
EchoPAC Software Only / EchoPAC Plug-in
Indications for Use (Describe)
EchoPAC Software Only / EchoPAC Plug-in is intended for diagnostic review and analysis of ultrasound images, patient record management and reporting, for use by, or on the order of a licensed physician. EchoPAC Software Only / EchoPAC Plug-in allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images.
Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic,3D, and Real time (RT) 3D Mode (4D).
Clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN); Urology (including prostate); Pediatric; Small organs (breast, testes, thyroid); Neonatal and Adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Transrectal (TR); Transvaginal (TV): Intraoperative ( vascular); Intra-Cardiac; Thoracic/Pleural and Intra-Luminal.
| 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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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 or swirling pattern around the letters, giving it a dynamic and recognizable appearance.
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: | July 21, 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: | Charlotte Jørgensen |
| Sr. Regulatory Affairs Leader GE | |
| Healthcare | |
| Device Trade Name: | EchoPAC Software Only / EchoPAC Plug-in |
| Common/Usual Name: | Workstation Software for ultrasound image review, |
| analysis and reporting | |
| Classification Names: | Class II |
| Product Code(s): | |
| (Primary) | Automated Radiological Image Processing Software, 21 CFR |
| 892.2050, QIH | |
| Product Code(s): | |
| (Secondary) | Picture Archiving and Communications System, 21 CFR 892.2050, LL |
| Predicate Device: | |
| Classification Names: | |
| Product Code(s): | EchoPAC Software Only / EchoPAC Plug-in (K200852), Workstation |
| Software for ultrasound image review, analysis and reporting | |
| Class II | |
| Picture Archiving and Communications System, 21 CFR 892.2050, LL | |
| Reference Device: | |
| Classification Names: | |
| Product Code(s): | LOGIQ E10 (K211488), Diagnostic Ultrasound System |
| Class II | |
| 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 |
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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a circular frame. The color of the logo is a light blue.
GE Healthcare
510(k) Premarket Notification Submission
| Reference Device: | Vivid E95 (K202658), 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 (K202132), 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:
EchoPAC Software Only / EchoPAC Plug-in provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval functionality to ultrasound images that are acquired via the GE Healthcare Vivid family of ultrasound systems, as well as DICOM images from other ultrasound systems. EchoPAC Software Only will be offered as SW only to be installed directly on customer PC hardware and EchoPAC Plug-in is intended to be hosted by a generalized PACS host workstation. EchoPAC Software Only / EchoPAC Plug-in is DICOM compliant, transferring images and data via LAN between systems, hard copy devices, file servers and other workstations.
Intended Use/Indication for Use:
EchoPAC Software Only / EchoPAC Plug-in is intended for diagnostic review and analysis of ultrasound images, patient record management and reporting, for use by, or on the order of a licensed physician. EchoPAC Software Only / EchoPAC Plug-in allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images.
Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic, 3D, and Real time (RT) 3D Mode (4D).
Clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN); Urology (including prostate); Pediatric; Small organs (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Transrectal (TR); Transvaginal (TV); Intraoperative (vascular); Intra-Cardiac; Thoracic/Pleural and Intra-Luminal.
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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. The intertwined letters are enclosed within a circular shape, and the entire logo is in a light blue color.
GE Healthcare 510(k) Premarket Notification Submission
Technology:
The EchoPAC Software Only / EchoPAC Plug-in employs the same fundamental scientific technology as its predicate device.
Determination of Substantial Equivalence:
The proposed EchoPAC Software Only / EchoPAC Plug-in is substantially equivalent to the predicate EchoPAC Software Only / EchoPAC Plug-in and reference devices with regards to intended use, indications for use, imaging capabilities, technological characteristics and safety effectiveness.
The following is an overview of the differences between the proposed EchoPAC Software Only / EchoPAC Plug-in and its predicate device.
Indications for use:
-
Added Thoracic/Pleural application, cleared in reference Venue (K202132) ●
Software: -
Added CT Fusion, cleared in reference Vivid E95 (K202658) ●
-
Added workflow enhancements tools: Dual Crop, Pre-Post Compare and ● SR Interpreter
-
. Updates made to: Flexi-Slice, Launchpad, DICOM Spooler, 4D Auto LVQ and 4D Auto TVQ
-
Added Easy AutoEF -based on AutoEF 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 measurement method ●
-
Added Strain Elastography feature, cleared in LOGIO E10 (K211488)
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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular border. The logo is in a light blue color, and the background is white.
GE Healthcare
510(k) Premarket Notification Submission
Summary of Non-Clinical Tests:
The EchoPAC Software Only / EchoPAC Plug-in complies with voluntary standards:
- 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
- IEC 62304:2006 A1 2015 - Medical device software - Software life cycle process
- IEC 62366-1: 2015 Medical Device-Part 1: Application of Usability ●
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)
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
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.
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Image /page/7/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "ge" in a stylized, cursive font, enclosed within a circular frame. The frame has decorative swirls or flourishes around the perimeter. The logo is presented in a blue color.
GE Healthcare 510(k) Premarket Notification Submission
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, EchoPAC Software Only / EchoPAC Plug-in, did not require clinical studies to support substantial equivalence.
Conclusion:
GE Healthcare considers the EchoPAC Software Only / EchoPAC Plug-in to be as safe, as effective, and performance is substantially equivalent to the predicate and reference devices.