(30 days)
Not Found
No
The document describes a standard PACS system with image management and viewing capabilities. There is no mention of AI, ML, or any features that would typically utilize these technologies for image analysis, diagnosis, or workflow optimization beyond basic PACS functions.
No
This device is a PACS (Picture Archiving and Communication System) intended for image management and viewing, not for treating or preventing disease. While it supports medical personnel in diagnosis, it does not directly perform therapeutic actions on patients.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "diagnostic viewing" as one of the functions of Nucleus.io, and the "Device Description" mentions "High-speed, zero-footprint diagnostic review of medical images."
Yes
The device description explicitly states that Nucleus.io is a "software-based image management solution and PACS" and is comprised of "software modules." While it integrates with "standard off-the-shelf hardware/software," the core medical device functionality described is purely software-based for image management, viewing, and distribution. The performance studies also focus on "Software verification and validation testing."
Based on the provided information, Nucleus.io is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that Nucleus.io is a software-based image management solution and PACS for managing medical images. It is used by radiologists, other medical personnel, and patients for viewing, storing, distributing, and manipulating medical images. This is related to medical imaging and workflow, not in vitro diagnostic testing.
- Device Description: The description details the functions of a PACS system, such as image acceptance, transfer, viewing, storage, and management. These are all related to handling and displaying medical images obtained from imaging modalities.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The input is medical images from various imaging modalities, not biological samples.
Therefore, Nucleus.io falls under the category of a medical image management and viewing system, which is distinct from an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Nucleus.io is a software-based image management solution and PACS to be used by radiologists, other medical personnel and patients. Nucleus.io is comprised of software modules that provide image receipt. diagnostic viewing, storage, distribution, enhancement, sharing, manipulation, and networking of medical 2D/3D images at distributed locations. All modules of Nucleus.io are web-based and can operate on off-the-shelf hardware, as needed. Nucleus.io consists of the following primary components: Nucleys.io Viewer (dX) with image streaming technology for use by medical professionals for diagnostic and clinical image review-Nucleus.io Image Exchange (iX) for image acceptance, transfer, and sharing with hospitals/clinics as well as between facilities , Nucleus.io Infinite Store (iS) for secure cloud-based image storage and management through HPAA compliant encryption-Nucleus.io PACS for radiology workflow and worklist features when used in conjunction with Nucleus.io dX and, optionally , Nucleus.io PaaS, which provides a vendorneutral Class I platform that can be incorporated as a component of other devices.
Nucleus io interfaces with health information systems (HIS) using industry-standard image exchange protocols-such as DICOM, HL7, and HTML-through web-based networked gateways and local and wide area networks. Nucleus.io is compatible with modalities including Computed Tomography (CT), Magnetic Resonance Imaging (MR), Ultrasound (US), Computed Radiography (DX), Digital Radiography (DX), Nuclear Medicine (NM), Positron Emission Tomography (PET), and X-Ray Angiography (XA). When appropriate, Nucleus.io provides and installs software and, optionally, off-the-shelf server hardware at client facilities to facilitate secure, web-based connections for image transmission to and from hospital central servers via the Internet. Additionally, industry standard HTTPS, VPNs, and other encryption methodologies are utilized to allow for optimal, secure, rapid streaming of image compression and encryption adhere to standard industry protocols. Nucleus.io can be used as a full-featured PACS or as an independent viewer in clinical settings.
Although the web and thin client technologies allow the software to be run on a variety of hardware platforms, for diagnostic purposes the user must make sure that the display hardware used for reading the images complies with state of- the-art diagnostic requirements and currently valid laws.
Only DICOM for presentation images can be used on an FDA approved monitor for primary image diagnosis.
Only uncompressed or non-lossy compressed images must be used for primary image diagnosis in mammography. Not for diagnostic use on mobile devices.
Product codes
LLZ
Device Description
Nucleus.io is a PACS which, when integrated with standard off-the-shelf hardware/software, acts similarly to its predicate device and other industry standard PACS systems.
The Nucleus System has the following primary features and functions:
- Zero-footprint HTML5 medical image acceptance (upload) and transfer of medical . images between facilities.
- . Easy, real-time access to images for all participants in the healthcare process, including radiologists, imaging
- technicians, workflow coordinators, physicians, nurses, and other patient care facilitators.
- High-speed, zero-footprint diagnostic review of medical images using industry-standard ● tools for manipulation, annotation, measurement, and comparison.
- . Simultaneous information review with multiple parties, including radiologists and coordinators.
- . Sharing of medical images between healthcare providers, facilities, and patients.
- . Encrypted transmission of medical images through secured wired and wireless networks.
- . Encrypted storage of medical images.
- Orqanization and matching of multiple medical images based on patient name, medical . record number, facility, etc.
- . Quality assurance review of studies by coordinators and preparation of information for study interpretation by radiologists.
- Notification of care coordinators that studies need to be transferred to client systems. ●
- . HIPAA-compliant data management and LDAP security integration with external systems
- Management of users, roles, permissions, and organization accounts
- Configuration of image acceptance (upload) and transfer settings ●
The Nucleus.io System consists of the following primary components:
Nucleus.io Image Exchange (iX)™
- Exam acceptance (upload), transfer, sharing, and management .
Nucleus.io Viewer (dX)™
- Zero-footprint streaming viewer suitable for diagnostic image review of all modalities .
Nucleus.io Infinite Store (iS)™ (formerly Image Store)
- Image storage and archiving .
Nucleus.io PACS™
- Radiology workflow and worklist features .
Nucleus PaaS
- Vendor-neutral Class I platform that can be incorporated as a component of other ● devices
Note: When Nucleus is used as a PaaS, the resulting device carries its own intended use, and must be filed as a separate medical device which uses Nucleus as a component, as appropriate. PaaS is mentioned here only to assist in understanding the features present in Nucleus IMS.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT), Magnetic Resonance Imaging (MR), Ultrasound (US), Computed Radiography (CR), Digital Radiography (DX), Nuclear Medicine (NM), Positron Emission Tomography (PET), X-Ray Angiography (XA)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiologists, other medical personnel and patients.
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)
Software verification and validation testing was conducted. The software for this device was classified as a Moderate Level of Concern software medical device due to the low potential for injury. No pre-mitigation items are life-threatening, and all have been mitigated to "minor" or lower. Verification and Validation Protocols and Test Reports were created to ensure adequate testing and evaluate acceptability of results. All technological characteristics and performance requirements identified in the Predicate Device Comparison were tested successfully. Risk Management and Verification and Validation activities confirm that Nucleus.io meets its specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "U.S. FOOD & DRUG" in a larger font size above the word "ADMINISTRATION" in a smaller font size.
December 4, 2020
Nucleus Health, LLC % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114
Re: K203249
Trade/Device Name: Nucleus.io Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: November 3, 2020 Received: November 4, 2020
Dear Prithul Bom:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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,
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203249
Device Name Nucleus.io
Indications for Use (Describe)
Nucleus.io is a software-based image management solution and PACS to be used by radiologists, other medical personnel and patients. Nucleus.io is comprised of software modules that provide image receipt. diagnostic viewing, storage, distribution, enhancement, sharing, manipulation, and networking of medical 2D/3D images at distributed locations. All modules of Nucleus.io are web-based and can operate on off-the-shelf hardware, as needed. Nucleus.io consists of the following primary components: Nucleys.io Viewer (dX) with image streaming technology for use by medical professionals for diagnostic and clinical image review-Nucleus.io Image Exchange (iX) for image acceptance, transfer, and sharing with hospitals/clinics as well as between facilities , Nucleus.io Infinite Store (iS) for secure cloud-based image storage and management through HPAA compliant encryption-Nucleus.io PACS for radiology workflow and worklist features when used in conjunction with Nucleus.io dX and, optionally , Nucleus.io PaaS, which provides a vendorneutral Class I platform that can be incorporated as a component of other devices.
Nucleus io interfaces with health information systems (HIS) using industry-standard image exchange protocols-such as DICOM, HL7, and HTML-through web-based networked gateways and local and wide area networks. Nucleus.io is compatible with modalities including Computed Tomography (CT), Magnetic Resonance Imaging (MR), Ultrasound (US), Computed Radiography (DX), Digital Radiography (DX), Nuclear Medicine (NM), Positron Emission Tomography (PET), and X-Ray Angiography (XA). When appropriate, Nucleus.io provides and installs software and, optionally, off-the-shelf server hardware at client facilities to facilitate secure, web-based connections for image transmission to and from hospital central servers via the Internet. Additionally, industry standard HTTPS, VPNs, and other encryption methodologies are utilized to allow for optimal, secure, rapid streaming of image compression and encryption adhere to standard industry protocols. Nucleus.io can be used as a full-featured PACS or as an independent viewer in clinical settings.
Although the web and thin client technologies allow the software to be run on a variety of hardware platforms, for diagnostic purposes the user must make sure that the display hardware used for reading the images complies with state of- the-art diagnostic requirements and currently valid laws.
Only DICOM for presentation images can be used on an FDA approved monitor for primary image diagnosis.
Only uncompressed or non-lossy compressed images must be used for primary image diagnosis in mammography. Not for diagnostic use on mobile devices.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Department of Health and Human Services Food and Druq 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 0MB number."
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1 Introduction and Administrative Information
This 510(k) Summary provides a high-level summary of the contents of the Nucleus.io Premarket Notification (510(k)), including a comparison of Nucleus.io to existing legally marketed medical devices.
This Premarket Notification (510(k)) Summary contains no confidential or trade secret information. For additional information, please contact the Establishment's contact listed below.
This summary was prepared on July 09, 2020.
Submitter 1.1
| Submitter | NucleusHealth, LLC |
|---|---|
| Submitter Address | 13280 Evening Creek Dr. S |
| San Diego CA, 92128 | |
| Submitter Phone | (858) 251-3400 |
| Submitter Website | www.nucleushealth.io |
| Establishment Number | 3008008144 |
| Establishment Contact | Zachary Wright |
| Contact Title | Manager, Regulatory Affairs and Quality |
| Contact Phone | (858) 251-3400 |
| Contact Fax | (858) 546-3900 |
| Contact Email | zwright@nucleushealth.io |
1.2 Device Identification
| Proprietary Name(s): | Nucleus.io |
|---|---|
| Classification Name: | Picture Archiving & Communications System (PACS) |
| Common / Usual Name: | Medical Image Processing Software |
1.3 Device Classification
Nucleus.io is product code LLZ, which is a Class II medical device per 21 CFR 892.2050.
Similarly, classification of Nucleus.io per IEC 62304 Edition 1.0 2015-06 was assigned by assessing the highest risk classification first:
- Death or serious injury is not possible. Thus, the device is not Class C.
4
- . Non-serious injury is possible. Thus, the device is Class B.
- . As some injury or damage to health is possible, the device is not Class A.
1.4 Related Previous Submissions
Previously cleared as "Nucleus Imagement System" in the United States as a Class II medical device under 510(K) K171130.
Predicate Device Identification 1.5
| Proprietary Name(s): | Visage PACS/CS |
|---|---|
| 510(k) File: | K082269 |
| Classification Name: | Picture Archiving & Communications System (PACS) |
No reference devices were used in this submission.
2 Device Description and Intended Use
2.1 Device Description
Nucleus.io is a PACS which, when integrated with standard off-the-shelf hardware/software, acts similarly to its predicate device and other industry standard PACS systems.
The Nucleus System has the following primary features and functions:
- Zero-footprint HTML5 medical image acceptance (upload) and transfer of medical . images between facilities.
- . Easy, real-time access to images for all participants in the healthcare process, including radiologists, imaging
- technicians, workflow coordinators, physicians, nurses, and other patient care facilitators.
- High-speed, zero-footprint diagnostic review of medical images using industry-standard ● tools for manipulation, annotation, measurement, and comparison.
- . Simultaneous information review with multiple parties, including radiologists and coordinators.
- . Sharing of medical images between healthcare providers, facilities, and patients.
- . Encrypted transmission of medical images through secured wired and wireless networks.
- . Encrypted storage of medical images.
- Orqanization and matching of multiple medical images based on patient name, medical . record number, facility, etc.
- . Quality assurance review of studies by coordinators and preparation of information for study interpretation by radiologists.
- Notification of care coordinators that studies need to be transferred to client systems. ●
- . HIPAA-compliant data management and LDAP security integration with external systems
- Management of users, roles, permissions, and organization accounts
- Configuration of image acceptance (upload) and transfer settings ●
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The Nucleus.io System consists of the following primary components:
Nucleus.io Image Exchange (iX)™
- Exam acceptance (upload), transfer, sharing, and management .
Nucleus.io Viewer (dX)™
- Zero-footprint streaming viewer suitable for diagnostic image review of all modalities .
Nucleus.io Infinite Store (iS)™ (formerly Image Store)
- Image storage and archiving .
Nucleus.io PACS™
- Radiology workflow and worklist features .
Nucleus PaaS
- Vendor-neutral Class I platform that can be incorporated as a component of other ● devices
Note: When Nucleus is used as a PaaS, the resulting device carries its own intended use, and must be filed as a separate medical device which uses Nucleus as a component, as appropriate. PaaS is mentioned here only to assist in understanding the features present in Nucleus IMS.
The graphic below provides a high-level architectural view of how the product interacts with external users and systems:
Image /page/5/Figure/15 description: The image shows a diagram of the Nucleus.io application suite. The suite includes applications for users, such as patients, physicians, and operators, as well as applications for health systems, such as PACS, modality, and RIS/EMR. The Nucleus.io application suite is connected to Microsoft Azure via HTTPS and API. The diagram also shows third-party apps that are connected to the Nucleus.io application suite.
Figure 1. Marketing Description, Nucleus.io architecture
6
The following images provide visual examples of features used in the most common user workflows. Many additional features are available, and are fully described in the User Manuals, discussed in the Proposed Labeling (Section D of the submission).
The interface depicted in Figure 2, below, is displayed when the user logs in. This interface provides access to the most common features used by hospital staff and Radiologists.
| nucleus.io | Change Healthcare | SU | System User | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ACTIONS | PATIENT | EXAM DATE | MOD | DESCRIPTION | IMAGES | RECEIVED | SOURCE | PUSH TO PACS | ||||||
| Clear | Advanced > | MRN: NDX-DEMO-15 DOB: 02-02- | 09:38 AM | |||||||||||
| 1 | 11-25-2014 | |||||||||||||
| OB: 02-02- 09:45 AM | CT | CT CHEST W CONTRAST | 563 | 08-18-2020 | ||||||||||
| 12:35 PM | Uploader | Never Pushed | ||||||||||||
| 2 | Exam Info | HIPAA Log | Push History | Shares Out | Download | Delete | ||||||||
| 3 | MRN | PATIENT NAME | DATE OF BIRTH | GENDER | ACC. # | EXAM DESCRIPTION | ||||||||
| NDX-DEMO-15 | Hanging, Harriet | 02-02-1985 | Female | 000092218 | CT CHEST W CONTRAST | |||||||||
| EXAM DATE | EXAM TIME | MOD | ||||||||||||
| 11-25-2014 | 09:45 AM | CT | ||||||||||||
| More Info > | Edit | |||||||||||||
| 4 | Healy, Joe | |||||||||||||
| MRN: 7487619 DOB: 03-23-1952 | 10-31-2017 | |||||||||||||
| 12:07 AM | XA | XA Brain | 7 | 08-18-2020 | ||||||||||
| 12:35 PM | Uploader | Never Pushed | ||||||||||||
| 5 | ||||||||||||||
Figure 2. Nucleus.io Primary User Interface
| ltem | Description |
|---|---|
| By selecting the ellipsis icon () on an exam line item, an authorized user can | |
| share the exam to another Organization, to the patient, to another professional, or | |
| directly to an email address. | |
| 2 | Detailed exam information can be viewed by selecting the arrow icon (>) on an |
| exam line item. | |
| 3 | From this expanded view, an authorized user can edit, download or delete the |
| exam. Exam history, including all access to Personal Health Information (PHI) is | |
| also available. | |
| ব | By selecting the eye icon ( ® ), an authorized user can view the exam. See Figure |
| 4 for the interface displayed when viewing exams. | |
| 5 | By selecting the button in the Push to PACS column, an authorized user can send |
| the exam to a configured external PACS system. The icon displays the current | |
| push status for the exam (e.g., Never Pushed, In Progress, Complete). |
Figure 3 depicts the clinical exam viewer available from the main user interface. This viewer meets the needs of most system users. The "Dx" viewer, also available within Nucleus.io, has additional image manipulation and diagnostic features, but shares a similar interface.
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Image /page/7/Figure/2 description: The image shows a medical imaging software interface, likely for viewing CT scans. The interface displays a series of thumbnails on the left, labeled with information such as "Hanging, Harriet NDX-DEMO-15" and "CT CHEST W CONTRAST". A larger image of a full body scan is displayed in the center, with a scale on the right indicating a location of 342.0 and a thickness of 2.0.
Figure 3. Nucleus.io Clinical Viewer User Interface
| Item | Description |
|---|---|
| 1 | Icons in the tool bar at the top of the screen allow the user to work with the images |
| on screen. This includes features such as changing contrast, rotating, zoom, | |
| measuring, and playback. The user may also configure the layout of the viewer to | |
| determine settings such as how many series/images can be displayed at once. | |
| 2 | The windows at the left show the exam series available, as specified when the |
| exam was performed and compiled into a DICOM-compatible format. | |
| 3 | The main window shows the selected image series (per Item 2) and may be |
| configured to show more than one image at a time. | |
| 4 | The scroll bar serves multiple functions, including the ability to scroll and a "loading" |
| bar to show download (or "streaming" progress of the displays series. In this | |
| example, the blue portion of the scroll bar indicates images which have loaded, and | |
| the darker portion of the scroll bar indicates images which are still loading. |
Intended Use/Indications for Use 2.2
Nucleus.io is a software-based image management solution and PACS to be used by radiologists, other medical personnel and patients. Nucleus.io is comprised of software modules that provide image receipt, diagnostic viewing, storage, distribution, enhancement, sharing, manipulation, and networking of medical 2D/3D images at distributed locations.
All modules of Nucleus.io are web-based and can operate on off-the-shelf hardware, as needed. Nucleus.io consists of the following primary components: Nucleus.io Viewer (dX) with image streaming technology for use by medical professionals for diagnostic and clinical image review—Nucleus.io Image Exchange (iX) for image acceptance, transfer, and sharing with hospitals/clinics as well as between facilities, Nucleus.io Infinite Store (iS) for secure cloud
8
based image storage and management through HIPAA compliant encryption—Nucleus.io PACS for radiology workflow and worklist features when used in conjunction with Nucleus.io dX and, optionally, Nucleus.io iS-and Nucleus.io PaaS, which provides a vendor-neutral Class I platform that can be incorporated as a component of other devices.
Nucleus.io interfaces with health information systems (HIS) using industry-standard image transfer and data exchange protocols-such as DICOM, HL7, and HTML-through web-based networked gateways and local and wide area networks. Nucleus.io is compatible with modalities including Computed Tomography (CT), Magnetic Resonance Imaging (MR), Ultrasound (US), Computed Radiography (CR), Digital Radiography (DX), Nuclear Medicine (NM), Positron Emission Tomography (PET), and X-Ray Angiography (XA). When appropriate Nucleus.io provides and installs software and, optionally, off-the-shelf server hardware at client facilities to facilitate secure, web-based connections for image transmission to and from hospital central servers via the Internet. Additionally, industry standard HTTPS, VPNs, and other encryption methodologies are utilized to allow for optimal, secure, rapid streaming of images. Lossless image compression and encryption adhere to standard industry protocols. Nucleus.jo can be used as a full-featured PACS or as an independent viewer in clinical settings.
Although the web and thin client technologies allow the software to be run on a variety of hardware platforms, for diagnostic purposes the user must make sure that the display hardware used for reading the images complies with state of- the-art diagnostic requirements and currently valid laws.
Only DICOM for presentation images can be used on an FDA approved monitor for mammography for primary image diagnosis.
Only uncompressed or non-lossy compressed images must be used for primary image diagnosis in mammography.
Not for diagnostic use on mobile devices.
3 Predicate Device Comparison
3.1 Context for Predicate Device Selection
Nucleus.io was previously cleared under 510(k) K171130 as Nucleus Image Management System, contraindicated for diagnosis of mammography. This submission seeks to remove that contraindication now that features are available to support this indication. Within the K171130 submission, StatPACS (K092134) was identified as a predicate device. StatPACS is a client-server-based PACS which is contraindicated for diagnosis of mammography.
Within the StatPACS (K092134) submission, Visage PACS/CS (K082269) was identified as a predicate device. Visage PACS/CS is also a client-server-based PACS but includes an indication for diagnosis of mammography. A key difference between StatPACS and Visage PACS/CS is that Visage PACS/CS is indicated for diagnosing mammography. Note: This difference was not noted in K092134 as the StatPACS indications for use did not include diagnosis of mammography.
In conclusion, the predicate device selected for this submission is Visage PACS/CS (K082269) as the technological differences have previously been shown to not introduce additional safety
9
or effectiveness concerns; and because the features provided for diagnosis of mammography are similar to those provided in Nucleus.io.
Device Comparison 3.2
The features in Nucleus.io related to diagnosis of mammography were developed based on the principle features and operations within its predicate device. Visage PACS/CS (K082269). There are two primary differences between the products:
-
- Nucleus.io is modular, allowing the user to gain access to either minimal features needed in smaller/niche environments, or scale to a full PACS,
-
- Nucleus.io uses cloud architecture to replace traditional server hosting, and web browser technology to replace thick client applications, in order to increase the availability of the system for medical professionals in remote locations and to access to health records for patients.
Both Visage PACS/CS and Nucleus.io run on off-the-shelf PC hardware utilizing industrystandard operating systems and interfaces to all hospital modalities.
Both products support non-compressed, lossless compressed, and lossy compressed image/data transmission. The default mode of operation is non-compressed, lossless compression. Changes to the standards which may affect the compression coding will be evaluated to worth and merit and if adopted, validated and verified to show compliance to the standard. This method fully preserves image data integrity but allows reduced transmission times and reduced storage requirements.
As PACS (Picture Archiving and Communications Systems) are multi-site/location systems, both Visage PACS/CS and Nucleus.io support various industry standard connectivity including, but not limited to LAN/WAN/VPN/Wireless technology, which enables data/images to be transmitted with speed and accuracy. Nucleus.io has adopted image transfer using streaming technology, which enables the medical professional to obtain the images in a fast, safe and efficient manner as compared to the traditional file download features used in Visage PACS/CS.
3.2.1 Indications for Use Comparison
The intended uses/indications for use of the devices, shown below, include comparable purposes. Differences include:
- . Patients are specifically mentioned as users in the Nucleus.io documentation, as patients may access their records for non-diagnostic purposes similar to the common practice of a physician providing the patient a CD-ROM.
- . Non-exhaustive lists of modalities compatible with the devices are provided; and different modalities were selected to include in the list by each company. However, all modalities listed for each can be found in the DICOM Conformance Statements for each device; these differences are limited to the wording used and specific items to be included in the non-exhaustive list. Both DICOM Conformance statements are provided in Section C of this submission. In particular, the following Classes confirm their equivalence with respect to the Intended Uses:
- 1.2.840.10008.5.1.4.1.1.3.1 O
- 1.2.840.10008.5.1.4.1.1.6.1 O
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- 1.2.840.10008.5.1.4.1.1.1 O
- O 1.2.840.10008.5.1.4.1.1.20
- O 1.2.840.10008.5.1.4.1.1.128
- O 1.2.840.10008.5.1.4.1.1.12.1
- Two warnings are included at the bottom of the Visage PACS/CS intended use which . are not explicitly mentioned in the Nucleus.io intended use. Nucleus.io has implemented these warnings differently in documentation, including these within the User Manuals.
| Subject Device | Comparable Device |
|---|---|
| Nucleus.io (NA – Proposed Device) | Visage PACS/CS (K082269) |
| Nucleus.io is a software-based image management solution and PACS to be used by radiologists, other medical personnel, and patients. Nucleus.io is comprised of software modules that provide image receipt, diagnostic viewing, storage, distribution, enhancement, sharing, manipulation, and networking of medical 2D/3D images at distributed locations. All modules of Nucleus.io are web-based and can operate on off-the shelf hardware, as needed. The Nucleus.io IMS consists of the following primary components: Nucleus.io Viewer (dX) with image streaming technology for use by medical professionals for diagnostic and clinical image review—Nucleus.io Image Exchange (iX) for image acceptance, transfer, and sharing with hospitals/clinics as well as between facilities—Nucleus.io Infinite Store (iS) for secure cloud based image storage and management through HIPAA compliant encryption—Nucleus.io PACS for radiology workflow and worklist features when used in conjunction with Nucleus.io dX and, optionally, Nucleus.io iS—and Nucleus.io PaaS, which provides a vendor-neutral Class I platform that can be incorporated as a component of other devices. | Visage PACS/CS is a system for distributing, viewing, processing, and archiving medical images within and outside health care environments. |
The Visage PACS/CS server receives images data in DICOM format via the hospital network. This provides universal connections to archives, modalities, and workstations. The supported modalities are listed in the DICOM Conformance Statement.
Besides general image interpretation and processing tools, Visage PACS/CS provides specific tool sets for several clinical applications, including:
- CT/MR angiography, e.g., for vascular analysis and stent planning
- Cardiac analysis, including calcium scoring and functional assessment of cardiac CT data
- Neuroradiology, including CT and MR brain perfusion analysis |
| Nucleus.io interfaces with health information systems (HIS) using industry standard image transfer and data exchange protocols—such as DICOM, HL7, and HTML—through web-based networked gateways and local and wide area networks. Nucleus.io is compatible with modalities including, but not limited to: Computed Tomography (CT), Magnetic Resonance Imaging (MR), Ultrasound (US), Computed Radiography (CR), Digital Radiography (DX), Nuclear Medicine (NM), Positron Emission Tomography (PT), and X-Ray Angiography (XA). When appropriate, | Visage PACS/CS is to be used only by trained and instructed health care professionals. It can support physicians and/or their medical staff in providing their own diagnosis for medical cases. The final decision regarding diagnoses, however, resides with the doctors and/or their medical staff in their own area of responsibility.
Although the web and thin client technologies allow the software to be run on a variety of hardware platforms, for diagnostic purposes the user must make sure that the display hardware used for reading the images complies with state-of-the-art diagnostic requirements and currently valid laws. |
| Subject Device | Comparable Device |
| Nucleus.io provides and installs software and,
optionally, off-the-shelf server hardware at client
facilities to facilitate secure, web-based
connections for image transmission to and from
hospital central servers via the Internet.
Additionally, industry standard HTTPS, VPNs, and
other methodologies are utilized to allow for
optimal, secure, rapid streaming of images.
Lossless image compression and encryption
adhere to standard industry protocols. Nucleus.io
can be used as a full-featured PACS or as an
independent viewer in clinical settings. | Only DICOM for presentation images can be
used on an FDA approved monitor for
mammography for primary image diagnosis.
Only uncompressed or non-lossy compressed
images must be used for primary image
diagnosis in mammography. |
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3.2.2 Tabular Comparison of Features
The table below provides a side-by-side comparison of key features.
| Feature/Function | Subject Device | Comparable Device |
|---|---|---|
| Product Name | Nucleus.io | Visage PACS/CS |
| 510(k) Number | N/A - Proposed | |
| Device | K082269 | |
| Primary Predicate | ||
| Device | ||
| Manufacturer | Nucleus Health, LLC | Visage Imaging, Inc. |
| Web Site | www.nucleushealth.i | |
| o | www.visageimaging.com | |
| Overview of devices | PACS/clinical | |
| viewing/image | ||
| sharing/storage/long | ||
| term archiving | PACS/clinical | |
| viewing/image | ||
| sharing/storage/long | ||
| term archiving | ||
| User Types | Hospital | |
| Administrative Staff, | ||
| Technicians, | ||
| Radiologists, | ||
| Patients | Hospital Administrative | |
| Staff, Technicians, | ||
| Radiologists, Patients | ||
| Supports DICOM image transfer | Yes | Yes |
| Software based | Yes (moderate | |
| concern) | Yes (moderate concern) | |
| LAN/WAN support | Yes | Yes |
| Feature/Function | Subject Device | Comparable Device |
| HTML/Web based image transfer | Yes | Yes |
| Client Hardware | Zero-footprint | |
| (browser) minimum | Thin Client minimum | |
| Image streaming | Yes | No |
| Secure image sharing to outside locations | Yes | Yes |
| Dual monitor support | Yes | Yes |
| Diagnostic/Clinical viewing | Yes | Yes |
| Off the shelf hardware | Yes | Yes |
| JPEG/industry standard lossy/lossless | ||
| compression | Yes | Yes |
| Zoom/panning features | Yes | Yes |
| Image flip/rotate capability | Yes | Yes |
| Text annotation | Yes | Yes |
| Statistical reporting | Yes | Yes |
| ROI | Yes | Yes |
| Window level by region | Yes | Yes |
| HIS/RIS connectivity | Yes | Yes |
| Off-site viewing (including teleradiology) | Yes | Yes |
| Fax support | Yes | Yes |
| Scalable platform | Yes | Yes |
| HIPAA compliant (encryption) | Yes | Yes |
| HL-7 integration | Yes | Yes |
| LDAP security integration | Yes | Yes |
| Archiving to cloud based or network servers | Yes | Yes |
| Feature/Function | Subject Device | Comparable Device |
| General admin features (assign, relate studies, | ||
| etc.) | Yes | Yes |
| Secure log in | Yes | Yes |
| Support for Mammography | Yes | Yes |
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··· nucleushealth"
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Features specifically implemented for viewing mammography studies are shown below.
| Feature/Function | Subject Device | Comparable Device |
|---|---|---|
| Product Name | Nucleus.io | Visage PACS/CS |
| Quadrant Navigation | Yes | Yes |
| Next/Previous Prior Exam | Yes | Yes |
| Change between 2D, Projection, and 3D (Tomo) | ||
| Display | Yes | Yes |
4 Performance Data
4.1 Risk Management
The Nucleus.io Hazard and Risk Management Plan, Analysis, and Report was performed to determine and evaluate all potential health and safety hazards associated with use of the platform. All foreseeable system hazards, effects, and causes have been evaluated to determine necessary and appropriate risk mitigation and validation, risk mitigation traceability, and design review, have been performed to ensure effective implementation of the stated risk mitigations.
4.2 Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was classified as a Moderate Level of Concern software medical device, due to the low potential for injury possible in the event of software/hardware failure, both directly and indirectly. Per the Hazard and Risk Management Plan, Analysis, and Report, no pre-mitigation items are life-threatening, and all have been mitigated to "minor" (results in temporary injury or impairment not requiring professional medical intervention) or lower.
Verification and Validation Protocols have been executed to ensure adequate testing of all defined product design requirements and specifications. Verification and Validation Test Reports have been created to evaluate the acceptability of test results and product module / product release preparedness. All applicable design and development and verification and
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validation activities and records have been completed to ensure safety and effectiveness of the final Nucleus.io platform
All technological characteristics and performance requirements identified in the Predicate Device Comparison have been tested to ensure success of the design implementation. There are no new or different issues of safety or effectiveness introduced by the stated design change. Risk Management and Verification and Validation activities confirm that Nucleus.io meets its specifications.
5 Conclusions
The comparison above in tabular format enables one to see how Nucleus.io compares in intent and usage to its predicate device, Visage PACS/CS. Specifically, all features identified for diagnosing mammography by Visage PACS/CS are also available within Nucleus.io. Therefore, Nucleus.io raises no new issues of safety or effectiveness from its predicate device.