The Nucleus Image Management System (Nucleus IMS) is a software based PACS, to be used by radiologists and other medical personnel. The Nucleus IMS 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 the Nucleus IMS are web-based and can operate on off-the-shelf hardware, as needed. The Nucleus IMS consists of the following primary components: Nucleus Viewer with image streaming technology for use by medical professionals for diagnostic and clinical image review-Nucleus Image Exchange (iX) for image acceptance, transfer, and sharing with hospitals/clinics as well as between facilities-and Nucleus Image Store for secure cloud based image storage and management through HIPAA compliant encryption. Nucleus iX integrates with the Nucleus Viewer and Nucleus Image Store. Nucleus.io, a web based class I PaaS device, provides the basis for the system and for vendor neutral applications.

The Nucleus IMS 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. The Nucleus IMS 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 (PT), and X-Ray Angiography (XA). When appropriate, the Nucleus IMS provides and installs software and, optionally, server hardware at client 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. The Nucleus IMS can be used as a full featured PACS or as an independent viewer in clinical settings.

Nucleus Image Management System is not intended for display of mammography imaging for diagnosis.

Device Description

Nucleus Image Management System is not intended for display of mammography imaging for diagnosis.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) submission for the Nucleus Image Management System:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Diagnostic Image Quality Equivalence	Diagnostic image quality of the Nucleus Viewer matched the image quality of the predicate device (StatPacs K092134).
Feature and Functional Performance (Nucleus Viewer)	Detailed feature and functional performance tests for diagnostic reviews were performed, and results were accepted.
Image Exchange Features and Functions Equivalence	Image exchange features and functions of the Nucleus Image Exchange were reviewed, and validation test results were accepted, demonstrating substantial equivalence to the predicate device.
Meeting all Product Requirements (from PRS)	All verification tests traced to requirements in the Product Requirements Specification (PRS) were completed, and results met established acceptance criteria.
Safety, Usability, and Security Requirements	Verification & validation testing confirmed the device meets performance, safety, usability, and security requirements.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document mentions "several full image data sets" were used for the Nucleus Viewer validation. It does not specify an exact number of cases or images.
Data Provenance: Not explicitly stated. The study appears to be a retrospective technical and performance validation comparing the new device against a predicate, rather than a clinical study with patient outcome data. The country of origin of the data is not specified, but given the company location and FDA submission, it's likely U.S.-based.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts:
- For the Nucleus Viewer validation (diagnostic quality and features): "a licensed Radiologist." (One expert mentioned.)
- For the Nucleus Image Exchange validation (image exchange features): "a NucleusHealth Customer Service Supervisor." (One expert mentioned.)
Qualifications:
- Radiologist: "licensed Radiologist." No specific years of experience are mentioned, but implicitly, a licensed radiologist is qualified to assess diagnostic image quality.
- Customer Service Supervisor: Their qualification for validating image exchange features is based on their role in NucleusHealth, implying familiarity with system operations.

4. Adjudication Method for the Test Set

The document implies a none or single-reader adjudication method, as it states validations were performed by a single "licensed Radiologist" for the viewer and a "NucleusHealth Customer Service Supervisor" for the image exchange. There is no mention of multiple readers or consensus processes for resolving discrepancies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC study was done. The submission explicitly states, "No clinical trials were performed in the development of the device." The study focused on technical performance, feature validation, and substantial equivalence to a predicate device, not on human reader improvement with AI assistance. The device is a PACS system and viewer, not an AI diagnostic algorithm.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable in the typical sense of AI algorithms. The Nucleus Image Management System is a PACS (Picture Archiving and Communications System) and medical image viewer. Its "performance" refers to how well it functions as an image management and viewing system, not as an AI algorithm that provides diagnostic readings independently. The validations focused on system functionality, image quality for diagnostic review (by a human), and data exchange.

7. The Type of Ground Truth Used

The ground truth was established by expert assessment/consensus against the predicate device's performance.
- For diagnostic image quality: The licensed radiologist assessed the image quality of the Nucleus Viewer and compared it to "the image quality of the predicate device."
- For features and functions: The experts validated that the features and functions performed as expected and were substantially equivalent to the predicate.
It was not pathology, surgical outcomes, or a large-scale clinical outcomes data.

8. The Sample Size for the Training Set

Not applicable/Not specified. This is a PACS and viewer system, not an AI/machine learning model that undergoes a "training set" process in the typical sense for learning medical image features. Its development followed general software development and quality management procedures (ISO 13485, ISO 14971, FDA QSR).

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted above, there's no mention of a "training set" as understood in machine learning. The "ground truth" for the device's development (its requirements and expected behavior) would have been established through a Product Requirements Specification (PRS) and validated against through the verification and validation process.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 4, 2017

NucleusHealth, LLC % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street. NW BUFFALO MN 55313

Re: K171130

Trade/Device Name: Nucleus Image Management System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 13, 2017 Received: April 17, 2017

Dear Mr. Job:

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. 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 (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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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

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Indications for Use

510(k) Number (if known) K171130

Device Name Nucleus Image Management System

Indications for Use (Describe)

The Nucleus Image Management System (Nucleus IMS) is a software based PACS, to be used by radiologists and other medical personnel. The Nucleus IMS 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 the Nucleus IMS are web-based and can off-the-shelf hardware, as needed. The Nucleus IMS consists of the following primary components: Nucleus Viewer with image streaming technology for use by medical professionals for diagnostic and clinical image review-Nucleus Image Exchange (iX) for image acceptance, transfer, and sharing with hospitals/clinics as well as between facilities-and Nucleus Image Store for secure cloud based image storage and management through HIPAA compliant encryption. Nucleus iX integrates with the Nucleus Viewer and Nucleus Image Store. Nucleus.io, a web based class I PaaS device, provides the basis for the system and for vendor neutral applications.

Nucleus Image Management System is not intended for display of mammography imaging for diagnosis.

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/1 description: The image shows the logo for Nucleus Health, with the word "nucleus" in blue and the word "health" in gray. To the left of the word "nucleus" is a graphic of a plus sign made of dots. The address "13280 Evening Creek Dr. So. Ste. 110 San Diego, CA" is to the right of the logo.

13280 Evening Creek Dr. So. Ste. 110 San Diego, CA

510k Summary Nucleus Image Management System 3.0

This summary of 510k Safety and Effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

I. Submitter Information:

Date Prepared:	April 28, 2017
Submitter/Mfg:	Nucleushealth, LLC13280 Evening Creek Dr., San Diego, CA 92128858-546-3800Nucleushealth.io
Company Contact:	Linda J. Moore, Director of Regulatory Affairs408-504-0565 Imoore@nucleushealth.io.
II. Device:
Device Name:	Nucleus Image Management System
Common/usual name:	Medical Imaging Processing/Teleradiology System
Classification Name:	System, Image Processing/Radiological/Picture Archiving and CommunicationSystem (PACS)
Regulation Number:	21 CFR 892.2050
Product Code:	LLZ
Regulatory Class:	Class II
Device Panel:	Radiology
Predicate device(s):	StatRad, LLC StatPacs K092134

III Device Description/Intended use:

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·· nucleushealth

1. Device Description

The Nucleus Image Management System is a PACS which, when integrated with standard off-the-shelf hardware, 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.
. Organization 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 System consists of the following primary components:

Nucleus iX (Image Exchange)™ . Exam acceptance (upload), transfer, sharing, and management
. Nucleus Viewer Zero-footprint streaming viewer suitable for diagnostic image review of all modalities except breast mammography
Nucleus Image Store . Image storage and archiving

2. Intended/Indications for Use:

Nucleus Image Management System 510k

13280 Evening Creek Dr. So. Ste. 110 San Diego, CA

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TM

: nucleushealth

13280 Evening Creek Dr. So. Ste. 110 San Diego, CA

The Nucleus IMS 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. The Nucleus IMS 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, the Nucleus IMS provides and installs software and, optionally, server hardware at client 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. The Nucleus IMS can be used as a full featured PACS or as an independent viewer in clinical settings.

Nucleus Image Management System is not intended for display of mammography imaging for diagnosis.

IV. Technical Characteristics:

This is a medical imaging software device that is used with off the shelf computer hardware in a picture archiving and communications system user environment. The device does not contact the patient, nor does it control any life sustaining devices, and/or have any biocompatibility concerns. The technical characteristics are similar in design, technical requirements and intended use to its predicate device. Storage of medical images is done in a secured cloud environment as all images are transferred and stored in an encrypted state.

V. Substantial Equivalence Summary:

The Nucleus Image Management System is substantially equivalent to its predicate device, StatPacs (K092134) in design, technical requirements, and intended use as a diagnostic radiological workstation, and/or PACS, image management and storage systems. The predicate device comparison clearly demonstrates that the Nucleus Imagement System is substantially equivalent in all areas such as functionality, user/software features, off the shelf hardware components and connectivity.

Differences are minimal and include a Viewer which may be de-featured for clinical viewing, image streaming methodology which allows for faster and more effective image transfer using industry standard protocols.

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··· nucleushealth

13280 Evening Creek Dr. So. Ste. 110 San Diego, CA

VI. Performance Data:

Verification & validation testing confirmed the device meets performance, safety, usability and security requirements. No clinical trials were performed in the development of the device.

There are no applicable FDA mandated performance standards for this device beyond the requirements of the FDA QSR therefore NucleusHealth followed their in house Product Development Procedure during the development of the software and to set the requirements of the verification and validation testing. This process and the test methodology were used during the testing of the predicate device StatPacs K092134.

These procedures, also conform to the following standards:

ISO 13485:2003 Medical Devices - Quality Management Systems
트 ISO 14971:2007 Application of Risk Management to Medical Devices

Verification

The Verification tests for Nucleus IMS were traced to all requirements defined in the Product Requirements Specification (PRS) and identified risk control measures ensuring complete test coverage. Product testing was performed and all tests were completed. Results met the established acceptance criteria.

Validation

Following verification, validation testing was performed. The Nucleus Viewer validation was performed by a licensed Radiologist. The Nucleus Image Exchange validation was performed by a NucleusHealth Customer Service Supervisor.

The Nucleus Viewer validation included diagnostic quality review of several full image data sets as well as detailed feature and functional performance tests used during diagnostic reviews. The validation test results were accepted and the diagnostic image quality matched the image quality of the predicate device.

The Nucleus Image Exchange validation reviewed the image exchange features and functions. The validation test results were accepted and demonstrated substantial equivalence to the predicate device.

Summary

The verification and validation tests which were performed successfully, demonstrated that the device is as safe and effective and performs as well or better than the predicate device StatPacs K092134.

VII. Conclusion:

The device has indications for use that are consistent with those of the legally marketed predicate device. Any differences between this device and its predicate were included in the verification and validation testing. shown to be safe and effective, and do not alter the intended use. Based on the information provided in this premarket notification submission, the Nucleus Image Management System is substantially equivalent to its predicate device, StatPacs, (K092134) and raises no new issues of safety or effectiveness from its predicate device.

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13280 Evening Creek Dr. So. Ste. 110 San Diego, CA

Regulation Number and Section

§ 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).