(84 days)
Image display of GE Ultrasound 3D/4D data sets for diagnostic purposes including measurements on displayed image.
Standalone software product with Primary Operating Functions:
• Display and editing of GE Ultrasound 3D/4D data sets
• Measurements on displayed image incl. derived calculations based on medical literature in the following applications: Abdominal, Obstetrics, Gynecology, Cardiology, Transrectal, Vascular, Cephalic, Small Parts, Pediatrics, Musko-Skeletal (MSK)
• Data storage (image, measurement and patient data)
• Data transfer to and from remote systems (e.g. via DICOM®1)
• Adding annotations to acquired image
This document describes the 510(k) premarket notification for GE Medical Systems Ultrasound and Primary Care Diagnostics' 4D View device. The 4D View is a software product intended for image display of GE Ultrasound 3D/4D datasets for diagnostic purposes, including measurements.
The submission claims substantial equivalence to its predicate device, 4D View (K131118), and references Voluson E10 (K172342). As the submission explicitly states, "The subject of this premarket submission, 4D View, did not require clinical studies to support substantial equivalence." Therefore, there is no study described that proves the device meets specific acceptance criteria based on clinical performance.
Based on the provided text, the following information can be extracted regarding the device and its assessment for substantial equivalence.
1. A table of acceptance criteria and the reported device performance:
Since no clinical studies were performed, there are no specific performance-based acceptance criteria or reported device performance metrics in terms of clinical accuracy (e.g., sensitivity, specificity, accuracy). The acceptance criteria for this submission are based on demonstrating substantial equivalence to the predicate device in terms of:
| Acceptance Criteria Category | Equivalence Claimed |
|---|---|
| Intended Use | Same |
| Capabilities | Same |
| Technological Characteristics | Same |
| Safety | Same |
| Effectiveness | Same |
The document states that the proposed 4D View adds workflow improvements and improvements to archive and DICOM functionality, implying performance enhancements in these areas compared to the predicate, but no quantitative metrics are given.
2. Sample size used for the test set and the data provenance:
Not applicable, as no clinical studies with a test set were conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical studies with a test set were conducted.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as no clinical studies with a test set were conducted.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. The 4D View is described as a standalone software product primarily for displaying and measuring GE Ultrasound 3D/4D datasets. There is no mention of "AI" or a human-in-the-loop component that would require an MRMC study to assess reader improvement with AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
While the device is a "standalone software product," the documentation does not describe a performance study for the algorithm without human-in-the-loop. The substantial equivalence is based on the device's functional and technological similarities to the predicate, not on a standalone performance study against a clinical ground truth.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as no clinical studies were conducted that required establishing a clinical ground truth for performance evaluation.
8. The sample size for the training set:
Not applicable, as this device's submission does not describe an AI/machine learning model development process that would involve a training set.
9. How the ground truth for the training set was established:
Not applicable, as this device's submission does not describe an AI/machine learning model development process.
Summary of Non-Clinical Tests Used for Substantial Equivalence:
The primary evidence for substantial equivalence for the 4D View device came from non-clinical tests and a comparison to its predicate device. These included:
- Compliance with voluntary standards:
- ISO 14971:2007 (Risk Management)
- NEMA PS 3.1 -3.20 (DICOM standards)
- IEC 62304:2006 (Medical device software life cycle process)
- Quality assurance measures applied during development:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Performance testing (Verification)
The manufacturer concluded that the proposed 4D View is as safe, as effective, and its performance is substantially equivalent to the predicate devices based on these non-clinical assessments and the functional comparison.
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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 & 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.
December 21, 2018
GE Medical Systems Ultrasound and Primary Care Diagnostics, Tracev Ortiz Regulatory Affairs Director 9900 W Innovation Drive WAUWATOSA, WI 53226
Re: K182750
Trade/Device Name: 4D View Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: September 27, 2018 Received: September 28, 2018
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/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
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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 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Hole 2. Nils
for Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name 4D View
Indications for Use (Describe)
Image display of GE Ultrasound 3D/4D data sets for diagnostic purposes including measurements on displayed image.
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 'g' and 'e' intertwined within a circular frame. The color of the logo is a light blue.
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: | September 27, 2018 |
| Submitter: | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC9900 Innovation DriveWauwatosa, WI 53226 |
| Primary Contact Person: | Tracey OrtizRegulatory Affairs DirectorGE HealthcareT:(262)676-6120 |
| Secondary Contact Person: | Charlotte K. Munthe JørgensenSenior Regulatory Affairs LeaderGE Healthcare Austria GmbH& Co OG |
| Device Trade Name: | 4D View |
| Common/Usual Name: | PACS / Picture archiving and communications system |
| Classification Names: | Class II |
| Product Code: | Picture archiving and communications system, 21 CFR 892.2050,LLZ |
| Primary Predicate Device(s): | 4D View (K131118) |
| Reference Predicate Device(s): | Voluson E10 (K172342) |
| Device Description: | Standalone software product with Primary Operating Functions:• Display and editing of GE Ultrasound 3D/4D data sets• Measurements on displayed image incl. derived calculationsbased on medical literature in the following applications:Abdominal, Obstetrics, Gynecology, Cardiology, Transrectal,Vascular, Cephalic, Small Parts, Pediatrics, Musko-Skeletal (MSK)• Data storage (image, measurement and patient data)• Data transfer to and from remote systems (e.g. via DICOM®1)• Adding annotations to acquired image |
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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular frame. The frame has a swirling, wave-like design, giving it a dynamic and fluid appearance. The color of the logo is a light blue.
GE Healthcare 510(k) Premarket Notification Submission
Intended Use/ Indication Image display of GE Ultrasound 3D/4D data sets for diagnostic for Use: purposes including measurements on displayed image.
Technology:
4D View version 18 employs the same fundamental scientific technology as its predicate device.
Determination of Substantial Equivalence:
Comparison to Predicates
The proposed 4D View is substantially equivalent to the predicate 4D View (K131118) with regards to intended use, capabilities, technological characteristics, safety and effectiveness. The following is an overview between the proposed 4D View and the predicate 4D View (K131118).
- The proposed 4D View and the predicate 4D View ● software are both picture archiving and communication systems.
- The proposed 4D View and the predicate 4D View software have the same clinical applications.
- . Both software systems devices operate on the same platform.
- The proposed 4D View and the predicate 4D View have the same image processing techniques.
- . The software devices process the same type of images.
- . The proposed 4D View and the predicate 4D View software device have similar capabilities in terms of performing measurements, capturing digital images, reviewing and reporting studies.
- . The proposed 4D View and the predicate 4D View software operate with the same main interfaces of connectivity and archiving.
- The proposed 4D View adds workflow improvements to ● already cleared measurement functionality.
- The proposed 4D View adds improvements to the already ● cleared archive and DICOM functionality.
The reference predicate, Voluson E10 and 4D View are also similar in that they display ultrasound medical images and utilize DICOM.
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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo, which is a stylized monogram of the letters 'G' and 'E' intertwined. The monogram is enclosed within a circular frame. The logo is colored in a shade of blue, and the background is white.
510(k) Premarket Notification Submission
Summary of Non-Clinical Tests:
The 4D View and its applications comply with voluntary standards:
-
- ISO 14971:2007 Medical devices Application of risk management to medical devices
-
- NEMA PS 3.1 -3.20 Digital Imaging and Communications in Medicine (DICOM) set
-
- IEC 62304:2006 Medical device software Software life cycle process
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)
Summary of Clinical Tests:
The subject of this premarket submission, 4D View, did not require clinical studies to support substantial equivalence.
- GE Healthcare considers the proposed 4D View to be as safe, as Conclusion: effective, and performance is substantially equivalent to the predicate devices.
§ 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).