(84 days)
No
The summary describes standard image display, editing, measurement, storage, and transfer functions for ultrasound data, with no mention of AI or ML technologies. The "image processing techniques" mentioned are likely traditional methods, and the lack of information on training/test sets and performance metrics further suggests the absence of AI/ML.
No.
The device is used for displaying and editing diagnostic image data and performing measurements, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "Image display of GE Ultrasound 3D/4D data sets for diagnostic purposes". Additionally, the "Device Description" mentions "Measurements on displayed image incl. derived calculations based on medical literature," which are essential components of diagnostic processes.
Yes
The device is explicitly described as a "Standalone software product" and its functions are purely software-based (display, editing, measurements, storage, transfer, annotations). It processes existing ultrasound data and does not include any hardware components.
Based on the provided information, 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 primary function of this device is the display and editing of GE Ultrasound 3D/4D data sets and performing measurements on displayed images. Ultrasound is an imaging modality 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 is "Image display of GE Ultrasound 3D/4D data sets for diagnostic purposes including measurements on displayed image." This clearly describes an imaging-based diagnostic tool, not an in vitro test.
Therefore, this device falls under the category of medical imaging software, not an IVD.
N/A
Intended Use / Indications for Use
Image display of GE Ultrasound 3D/4D data sets for diagnostic purposes including measurements on displayed image.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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 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
Mentions image processing
The proposed 4D View and the predicate 4D View have the same image processing techniques.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
GE Ultrasound 3D/4D data sets
Anatomical Site
Abdominal, Obstetrics, Gynecology, Cardiology, Transrectal, Vascular, Cephalic, Small Parts, Pediatrics, Musko-Skeletal (MSK)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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, 4D View, 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 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
1
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, LLC |
| 9900 Innovation Drive | |
| Wauwatosa, WI 53226 | |
| Primary Contact Person: | Tracey Ortiz |
| Regulatory Affairs Director | |
| GE Healthcare | |
| T:(262)676-6120 | |
| Secondary Contact Person: | Charlotte K. Munthe Jørgensen |
| Senior Regulatory Affairs Leader | |
| GE 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 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 |
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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.