Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The summary explicitly states that the device includes a "deep learning-based Automatic ventricular segmentation Algorithm" and refers to it as an "AI algorithm".

Therapeutic

No
The device is a software solution intended for viewing, manipulating, and analyzing medical images. It provides post-processing tools and analytical functions for various types of MR images, aiding in interpretation and evaluation, rather than directly providing therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the software supports "interpretation and evaluation of examinations" and lists specific applications like "evaluating the molecule constitution and spatial distribution of cell metabolism," "evaluating dynamic processes and images," and "evaluating MR vascular images," all of which point to its use in making a diagnosis or aiding in the diagnostic process.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states that uOmnispace.MR is a "post-processing software" and is "software based". The intended use and device description focus solely on software functionalities for viewing, manipulating, and analyzing medical images. While it processes data from MR hardware, the device itself is presented as a software solution.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
Device Function: The uOmnispace.MR software is described as a post-processing tool for viewing, manipulating, and analyzing medical images (specifically MR images). It works with data acquired from the patient (the MR scans), not from specimens taken from the patient.
Intended Use: The intended use focuses on the interpretation and evaluation of examinations (MR scans) and the analysis of the image data itself. While this information can be used to aid in diagnosis and treatment, the device's function is centered on image processing, not the analysis of biological specimens.
Lack of Specimen Handling: There is no mention of the device handling or analyzing biological specimens.

Therefore, the uOmnispace.MR software falls under the category of medical image processing and analysis software, which is distinct from In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.

Overview

Intended Use / Indications for Use

uOmnispace.MR is a software solution intended to be used for viewing, manipulating and analyzing medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications:

The uOmnispace.MR Stitching is intended to create full-format images from overlapping MR volume data sets acquired at multiple stages.

The uOmnispace.MR Dynamic application is intended to provide a general postprocessing tool for time course studies.

The uOmnispace.MR MRS (MR Spectroscopy) is intended to evaluate the molecule constitution and spatial distribution of cell metabolism. It provides a set of tools to view, process, and analyze the complex MRS data. This application supports the analysis for both SVS (Single Voxel Spectroscopy) and CSI (Chemical Shift Imaging) data.

The uOmnispace.MR MAPs application is intended to provide a number of arithmetic and statistical functions for evaluating dynamic processes and images. These functions are applied to the grayscale values of medical images.

The uOmnispace.MR Breast Evaluation application provides the user a tool to calculate parameter maps from contrast-enhanced time-course images.

The uOmnispace.MR Brain Perfusion application is intended to allow the visualization of temporal variations in the dynamic susceptibility time series of MR datasets.

· MR uOmnispace.MR Vessel Analysis is intended to provide a tool for viewing, manipulating, and evaluating MR vascular images.

The uOmnispace.MR DCE analysis is intended to view, manipulate, and evaluate dynamic contrast-enhanced MRI images.

The uOmnispace.MR United Neuro is intended to view, manipulate MR neurological images.

■ The uOmnispace.MR Cardiac Function is intended to view, evaluate functional analysis of cardiac MR images.

The uOmnispace.MR Flow Analysis is intended to view, evaluate flow analysis of flow MR images.

Product codes

QIH

Device Description

The uOmnispace.MR is a post-processing software based on the uOmnispace platform (cleared in K230039) for viewing, manipulating, evaluating and analyzing MR images, can run alone or with other advanced commercially cleared applications.

This proposed device contains the following applications:

uOmnispace.MR Stitching
uOmnispace.MR Dynamic
uOmnispace.MR MRS
uOmnispace.MR MAPs
uOmnispace.MR Breast Evaluation
. uOmnispace.MR Brain Perfusion
uOmnispace.MR Vessel Analysis
uOmnispace.MR DCE Analysis
uOmnispace.MR United Neuro
uOmnispace.MR Cardiac Analysis
uOmnispace.MR Flow Analysis

Mentions image processing

Yes

Mentions AI, DNN, or ML

Yes

Input Imaging Modality

MR

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare institutions.

Description of the training set, sample size, data source, and annotation protocol

As for the training ground truth, it was manually drawn on short axis slices in diastole and systole by two cardiologists with more than 10 years of experience each.

In details, manual tracing of the cardiac was performed by an experienced user. The validation of these contours was done by two independent expert (more than 10 years) in this domain. If there is a disagreement, a consensus between the experts was done.

Description of the test set, sample size, data source, and annotation protocol

Testing Data Information
114 samples from 114 different patients
Gender: Male: 35, Female:20, Unknown: 59
Age: [14, 25]: 5, (25, 40]: 12, (40, 60]: 22, (60, 79]: 13, Unknown: 62
Ethnicity: Europe: 50, Asia: 53, USA: 11
Manufacturer: UIH: 58, GE: 2, Philips: 2, Siemens: 52
Magnetic Field: 1.5T: 23, 3.0T: 41, Unknown: 50

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance Verification
Performance tests were conducted to assess the algorithms of the uOmnispace.MR. These tests have been performed to assess the algorithms of the Subject Device. The results of all conducted testing were found acceptable and do not raise any new issues of safety or effectiveness. All testing data demonstrates that the Subject Device is as safe and effective when compared to the Predicate Device that is currently marketed for the same intended use.

The performance functionality of new parameters or algorithms for uOmnispace.MR has been tested and validated, including SER (signal enhancement ratio) parameter in MR Breast Evaluation, T1rho parameter in MR MAPs, as well as semi-automatic contour segmentation for Contour Segmentation function, mean pressure gradient and peak pressure gradient parameters for Parameters Calculation function in MR Flow Analysis.

In this submission. LV&RV Contour Segmentation is an AI algorithm. which is cleared in K192601.

To validate the uOmnispace.MR software from a clinical perspective, the deep learning-based Automatic ventricular segmentation Algorithm for the LV&RV Contour Segmentation feature in MR Cardiac Function contained in the product underwent a scientific evaluation. The results of clinical data-based software validation for the proposed device demonstrated high consistency in comparison to the predicate device.

Automatic ventricular segmentation Algorithm
The performance testing for deep learning-based Automatic ventricular segmentation Algorithm was performed on 114 subjects (data shown in the Table 1 below) during the product development.

Acceptance Criteria
The validation type and acceptance criteria is shown in the Table 1 below:
Dice: To evaluate the proposed device of automatic ventricular segmentation, we compared the results with those of the cardiac function application of predicate device. The Sørensen-Dice coefficient is used to evaluate consistency. If dice>0.95, it is considered consistent between the two devices.

Performance Testing Summary
The dice between the proposed and predicate device is 1.00 and shows the high consistency between the two devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Dice: The dice between the proposed and predicate device is 1.00.

Predicate Device(s)

K192601

Reference Device(s)

K220332, K141480, K230152, K113456

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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Image /page/0/Picture/0 description: The image shows 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 logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

Shanghai United Imaging Healthcare Co., Ltd. Gao Xin Official Correspondent No. 2258 Chengbei Road. Jiading District Shanghai. 201807 China

Re: K233186

Trade/Device Name: uOmnispace.MR Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: March 7, 2024 Received: March 7, 2024

Dear Gao Xin:

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).

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

April 17th, 2024

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Your device is also subject to, among other requirements, the Quality System (QS) 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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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-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,

Ningzhi Li-S

for

Daniel M. Krainak, 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

Submission Number (if known)

K233186

Device Name

uOmnispace.MR

Indications for Use (Describe)