(106 days)
Not Found
No
The document describes a software solution for remote viewing and control of ultrasound images, focusing on streaming and collaboration features. There is no mention of AI, ML, or any related technologies being used for image analysis, interpretation, or other functions. The performance studies focus on the quality of remote viewing compared to local viewing.
No
The device is described as a software solution for live streaming ultrasound images for diagnostic viewing, remote access, review, consultation, guidance, support, and education; it does not directly treat or prevent a medical condition.
No
Explanation: The device is described as a software solution for "diagnostic image viewing," "remote access, review, consultation, guidance, support and education." It enables healthcare professionals to stream and view ultrasound images and even remotely control the ultrasound equipment. While it facilitates the viewing and consultation of diagnostic images, the device itself does not perform a diagnostic function; rather, it is a tool for sharing and accessing diagnostic images produced by an ultrasound system. The description explicitly states "healthcare professionals can provide clinical diagnostics at a remote location as if directly using the ultrasound equipment," indicating the diagnostic function resides with the professional using the ultrasound equipment, not the SonoSync software.
Yes
The device is described as a "software solution" and its functionality is focused on streaming and remote control of existing ultrasound equipment. While it interacts with hardware (ultrasound systems), the device itself is presented as a software layer enabling these remote capabilities.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "diagnostic image viewing" and "clinical diagnostics at a remote location". This indicates the software is intended to be used in the process of making a diagnosis.
- Device Description: The description reinforces the diagnostic purpose by mentioning "real-time access to diagnostic imaging" and the ability for healthcare professionals to "provide clinical diagnostics at a remote location".
- Input Imaging Modality: The input is Ultrasound, which is a medical imaging modality used for diagnostic purposes.
- Intended User / Care Setting: The intended users are "Qualified healthcare professionals" in a "Clinical environment", which aligns with the use of IVD devices.
- Predicate Device: The listed predicate device, K212777 Collaboration Live, is also likely an IVD or a device with similar diagnostic support functions, further supporting the classification.
While the device is software and facilitates remote access, its core function is to enable the viewing and interpretation of diagnostic images (ultrasound) for the purpose of making a diagnosis. This falls squarely within the definition of an In Vitro Diagnostic device, even though it doesn't directly analyze biological samples. The "In Vitro" aspect in this context refers to the analysis of data derived from the patient (the ultrasound images) outside of the patient's body.
N/A
Intended Use / Indications for Use
SonoSync is a software solution for live streaming images acquired through ultrasound systems to healthcare professionals for diagnostic image viewing, remote access, review, consultation, quidance, support and education in real time.
It is required to follow the technical and operator requirements in the User Manual.
As users of this remote solution, the healthcare professionals take responsibility for ensuring that image quality, display contrast and ambient light conditions meet the generally accepted practices of the ultrasound imaging.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, IYN, IYO
Device Description
SonoSync is a software solution that allows medical professionals to stream ultrasound images live, providing real-time access to diagnostic imaging, remote viewing, reviewing, consulting, guiding, supporting, and educating.
SonoSync supports four main features: remote diagnostic viewing and guiding, remote clinical training and education, collaboration, and remote service support.
With permission from the person operating the ultrasound equipment, a remote user can control the ultrasound equipment using a virtual remote touch panel and remote control panel.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified healthcare professionals / Clinical environment
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Pre-set criteria were utilized in validation tests to assess whether remote viewing and reviewing with SonoSync matched the performance of local ultrasound systems. Specifications for remote displays and required network bandwidth to ensure diagnostic image quality were identified. Labeling materials have been prepared to inform users about the necessary specifications for safely and effectively conducting remote diagnostic reviews and viewing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
0
August 23, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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.
Samsung Medison Co., Ltd. Jee Young Ju Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, Gangwon-do 25108 REPUBLIC OF KOREA
Re: K241302
SonoSync Trade/Device Name: Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ, IYN, IYO Dated: July 12, 2024 Received: July 12, 2024
Dear Jee Young Ju:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to. 21 CFR 820.30. Design controls: 21 CFR 820.90. Nonconforming product: and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-reporting-mdr-how-reportmedical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Marjan Bakhtiari-nejad -S For
Yanna Kang, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
SonoSync
Indications for Use (Describe)
SonoSync is a software solution for live streaming images acquired through ultrasound systems to healthcare professionals for diagnostic image viewing, remote access, review, consultation, quidance, support and education in real time.
It is required to follow the technical and operator requirements in the User Manual.
As users of this remote solution, the healthcare professionals take responsibility for ensuring that image quality, display contrast and ambient light conditions meet the generally accepted practices of the ultrasound imaging.
Type of Use (Select one or both, as applicable)
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."
3
SAMSUNG
Traditional 510(k)
K241302
510(K) Summary:
In accordance with 21 CFR 807.92, the following summary of information is provided:
- Date Prepared May 9, 2024 1.
-
- Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do, Republic of Korea
-
- Primary Contact Person Ju, Jee-Young Regulatory Affairs Specialist Phone: +82.2.2194.0861 Fax: +82. 2.2194.0273 Email: jee.ju(@samsungmedison.com
- Secondary Contact Person 4. Ninad Gujar Vice President Phone: +1.978.564.8632 Fax: +1.978.564.8677 Email: ngujar@neurologica.com
న్. Proposed Device
- Common/Usual Name : System, Image Processing, Radiological. -
- -Proprietary Name : SonoSync
- : Medical image management and processing system. Regulation Name -
- Regulatory Class : Class II -
- Product Code : LLZ(Primary), IYN, IYO -
- Regulation Number : 21 CFR 892.2050(Primary), 892.1550, 892.1560 -
- Predicate Devices 6.
- Collaboration Live (K212777) Primary -
-
- Device Description
SonoSync is a software solution that allows medical professionals to stream ultrasound images live, providing real-time access to diagnostic imaging, remote viewing, reviewing, consulting, guiding, supporting, and educating.
SonoSync supports four main features: remote diagnostic viewing and guiding, remote clinical training and education, collaboration, and remote service support.
With permission from the person operating the ultrasound equipment, a remote user can control the ultrasound equipment using a virtual remote touch panel and remote control panel.
Furthermore, under the technical, operational, and environmental conditions described in
4
Image /page/4/Picture/0 description: The image shows the word "SAMSUNG" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is plain white, which makes the blue letters stand out.
the manual, healthcare professionals can provide clinical diagnostics at a remote location as if directly using the ultrasound equipment.
-
- Indication for Use
SonoSync is a software solution for live streaming images acquired through ultrasound systems to healthcare professionals for diagnostic image viewing, remote access, review, consultation, guidance, support and education in real time.
- Indication for Use
It is required to follow the technical and operator requirements in the User Manual.
As users of this remote solution, the healthcare professionals take responsibility for ensuring that image quality, display contrast and ambient light conditions meet the generally accepted practices of the ultrasound imaging.
| Attribute | SonoSync
(Subject Device) | Collaboration Live
K212777
(Predicate Device) | Compa
rison |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Regulation Name | Medical image management
and processing system | Medical image management and
processing system | Identical |
| Product
Code(s) | Primary: LLZ
Secondary: IYN, IYO | Primary: LLZ
Secondary: IYN, IYO | Identical |
| Indications
for Use | SonoSync is a software solution for
live streaming images acquired
through ultrasound systems to
healthcare professionals for
diagnostic image viewing, remote
access, review, consultation,
guidance, support and education in
real time.
It is required to follow the technical
and operator requirements in the
User Manual.
As users of this remote solution, the
healthcare professionals take
responsibility for ensuring that
image quality, display contrast and
ambient light conditions meet the
generally accepted practices of the
ultrasound imaging. | Collaboration Live is indicated for
remote console access of the
Philips ultrasound system for
diagnostic image viewing and
review, consultation, guidance,
support, and education in real
time. Access must be granted by
the healthcare professionals
operating the ultrasound system.
Compliance with the technical
and operator requirements
specified in the User Manual is
required.
It is the responsibility of the
healthcare professionals at the
remote client to ensure image
quality , display contrast, and
ambient light conditions are
consistent with the generally
accepted standards of the clinical
application. | Identical |
- Comparison of Technological Characteristics with the Predicate Device 9.
5
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| Features | - Streaming
- Text Chat
- Voice Chat
- Video Chat
- Image Sharing
- Remote Control
- Marking
- Remote Image Quality
- Invitation | - Image viewing and review
- Text Chat
- Voice Calling
- Video Calling
- Remote Asset Sharing
- Remote Control
- Network Indicator
- Remote Image Quality
- Remote User Measurement | Identical |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Remote
System
Hardware | Commercially available off-the-
shelf computer hardware | Commercially available off-the-
shelf computer hardware | Identical |
| Supported
Imaging
Modalities | Ultrasound | Ultrasound | Identical |
| Intended
Users | Qualified healthcare professionals | Qualified healthcare professionals | Identical |
| Remote-client
Use
Environment | Clinical environment with ambient
light condition consistent with the
generally accepted standards of the
clinical application. | Clinical environment with ambient
light condition consistent with the
generally accepted standards of the
clinical application. | Identical |
| Remote
Diagnostic Use | Image visualized for
diagnostic review and viewing
on Chrome compliant Browser | Image visualized for diagnostic
review and viewing on remote-
client
Reacts | Identical |
10. Summary of Non-Clinical Testing
Pre-set criteria were utilized in validation tests to assess whether remote viewing and reviewing with SonoSync matched the performance of local ultrasound systems. Specifications for remote displays and required network bandwidth to ensure diagnostic image quality were identified. Labeling materials have been prepared to inform users about the necessary specifications for safely and effectively conducting remote diagnostic reviews and viewing.
11. Conclusion
Since the predicate device and the subject device have a similar intended use and key technological features, the non-clinical data support the safety of the device and demonstrate that the SonoSync should perform as intended in the specified use conditions. Therefore, SAMSUNG MEDISON CO., LTD. considers the subject device to be as safe, as effective, and performance is substantially equivalent to the primary predicate device that is currently marketed for the same indication for use.