(53 days)
No
The document describes an image viewer and explicitly states that it uses the same image processing techniques as the predicate device, with no mention of AI, ML, or related terms.
No.
The device is used for image display of medical images for diagnostic and non-diagnostic review purposes, which is not a therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "diagnostic and non-diagnostic review purposes."
No
The device description explicitly states it is an "image display" and "viewer," implying it is software running on a hardware platform (likely a computer or workstation) to display images. While it processes images, it doesn't explicitly state it is only software and doesn't include the hardware it runs on.
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 Invenia ABUS Viewer is described as a device for the image display of medical images, specifically breast ultrasound and other DICOM images. It receives, transmits, and displays these images for diagnostic and non-diagnostic review.
- No sample analysis: The device does not perform any analysis on biological samples taken from the patient. Its function is solely related to the visualization of medical images.
Therefore, the Invenia ABUS Viewer falls under the category of medical imaging display devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Image display of Automated Breast Ultrasound (ABUS), as well as other multi-modality DICOM medical images for diagnostic and non-diagnostic review purposes. The device will be used by trained healthcare professionals.
Product codes
LLZ
Device Description
The Invenia ABUS Viewer is intended for the image display of breast ultrasound images. The Invenia ABUS Viewer can received, transmit, and display medical images and associated patient medical information from the Invenia ABUS Scan Station as well as from other ultrasound or image acquisition devices.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Automated Breast Ultrasound (ABUS), as well as other multi-modality DICOM medical images
Anatomical Site
breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals.
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, Invenia ABUS Viewer, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K151075 BR-ABVS Viewer 1.0
Reference Device(s)
K150420 Centricity Universal Viewer
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
Image /page/0/Picture/10 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.
GE Healthcare % Mr. Bryan Behn Regulatory Affairs Director 9900 Innovation Drive WAUWATOSA WI 53226
May 4, 2018
Re: K180641
Trade/Device Name: Invenia ABUS Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 8, 2018 Received: March 12, 2018
Dear Bryan Behn:
We have reviewed vour 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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/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,
Michael D. O'Hara For
Robert Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 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' in a stylized, cursive font, enclosed within a circular frame. The frame has decorative swirls or flourishes around the letters, giving it a classic and recognizable appearance.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name Invenia ABUS Viewer
Indications for Use (Describe)
Image Display of Automated Breast Ultrasound (ABUS), as well as other multi-modality DICOM medical images for diagnostic and non-diagnostic review purposes. The device will be used by trained healthcare professionals.
| 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
"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."
3
Image /page/3/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 background of the circle is filled with a solid color, while the letters and the frame are in a contrasting color, creating a visually distinct and recognizable emblem.
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: March 8, 2018 GE Healthcare Submitter: 9900 Innovation Drive Wauwatosa, WI 53226
| Primary Contact Person: | Bryan Behn
Regulatory Affairs Director
GE Healthcare
T:(262)247-5502
F:(414)918-8275 |
|---------------------------|--------------------------------------------------------------------------------------------------|
| Alternate Contact Person: | Elizabeth Gemmel
T: (262)788-3816 |
| Device: | Trade Name: Invenia ABUS Viewer |
| Common/Usual Name: | Invenia ABUS Viewer |
| Classification Names: | Class II |
|---|---|
| Product Code: | Picture archiving and communication system. 21 CFR 892.2050 LLZ |
| Primary Predicate Device: | K151075 BR-ABVS Viewer 1.0 |
| Reference Predicate Device(s): | K150420 Centricity Universal Viewer |
| Device Description: | The Invenia ABUS Viewer is intended for the image display of breast ultrasound images. The Invenia ABUS Viewer can received, transmit, and display medical images and associated patient medical information from the Invenia ABUS Scan Station as well as from other ultrasound or image acquisition devices. |
| Indications for Use: | Image display of Automated Breast Ultrasound (ABUS), as well as other multi-modality DICOM medical images for diagnostic and non-diagnostic review purposes. The device will be used by trained healthcare professionals. |
Invenia ABUS Viewer employs the same fundamental scientificInvenia ABUS Viewer employs the same fundamental scientific technology as its predicate device(s).
4
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, cursive font. The letters are enclosed within a circular border, and there are decorative flourishes or swirls around the letters within the circle.
Technology:
Determination of Comparison to Predicates Substantial Equivalence:
The proposed Invenia ABUS Viewer is a new platform substantially equivalent to the predicate devices. The following is an overview of the similarities between the proposed Invenia ABUS Viewer and the predicate BR-ABVS Viewer 1.0 (K151075). The systems are all intended for picture archiving and communication systems.
- The Invenia ABUS Viewer and predicate BR-ABVS . Viewer 1.0 software have the same clinical applications.
- Both software systems operate/devices on the same ● operating platform.
- Invenia ABUS Viewer and predicate have the same image ● processing techniques.
- The software systems/devices process the same type of ● images.
- The Invenia ABUS Viewer and predicate BR-ABVS ● software systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
- The Invenia and predicate operate with the same main ● interfaces of connectivity and archiving
The reference predicate, Centricity Universal Viewer, and Invenia ABUS Viewer are also similar in that they display medical images from various sources and utilize DICOM.
Summary of Non-Clinical Tests:
The Invenia ABUS Viewer and its applications comply with voluntary standards:
- ISO14971, Application of risk management to medical devices: Second edition 2007
- NEMA PS 3.1 3.20 (2011), Digital Imaging and ● Communications in Medicine (DICOM) Set. (Radiology)
- IEC 62304, Medical device software Software life cycle ● processes
The following quality assurance measures are applied to the development of the system:
- Risk Analysis ●
5
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 letters are enclosed within a circular shape, and there are decorative swirls or flourishes around the outer edge of the circle.
GE Healthcare 510(k) Premarket Notification Submission
- Requirements Reviews ●
- Design Reviews ●
- Testing on unit level (Module verification) ●
- Integration testing (System verification)
- Final Acceptance Testing (Validation) ●
- Performance testing (Verification) ●
- Safety testing (Verification)
Summary of Clinical Tests:
The subject of this premarket submission, Invenia ABUS Viewer, did not require clinical studies to support substantial equivalence.
- GE Healthcare considers the Invenia ABUS Viewer to be as safe, Conclusion: as effective, and performance is substantially equivalent to the predicate device(s).