Predicate Devices

Reference Devices

K103480, K033326, K090546, K113442, K150843, K120331, K133643, K162025

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard image processing and analysis tools without mentioning AI or ML.

Therapeutic

No
The device is described as a software solution for viewing, manipulating, and analyzing medical images and data, primarily for diagnostic and evaluative purposes, not for providing therapy.

Diagnostic

Yes

The device supports "interpretation and evaluation of examinations" and various applications "intended to support fast-tracking routine diagnostic oncology," or provide "a tool for the user to perform the segmentation and volumetric evaluation of suspicious lesions" and "quantitative parameters, structure information to evaluate the lung and airway," as well as "quantitative and characterizing information about nodules." It also explicitly mentions "analysis of vascular stenosis, plaque and heart function" and calculation of parameters "in order to analyze functional blood flow information." These functions directly aid in diagnosing medical conditions by processing and analyzing medical images.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states "uWS-CT is a comprehensive software solution". While it processes medical images from CT scanners, it does not include any hardware components itself.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The uWS-CT software is described as a solution for viewing, manipulating, communicating, and storing medical images (specifically CT scans). It provides tools for analyzing these images, performing measurements, and generating reports based on the visual information.
Lack of Biological Sample Analysis: The device does not process or analyze biological samples from the patient. Its input is image data, not biological material.
Intended Use: The intended use clearly states its purpose is for interpreting and evaluating examinations (which are image-based), and providing tools for analyzing features within those images.

While the software provides valuable diagnostic information to a physician, it does so by processing and analyzing medical images, not by performing tests on biological samples. Therefore, it falls under the category of medical imaging software, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

uWS-CT is a software solution intended to be used for viewing, manipulation, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications:

The CT Oncology application is intended to support fast-tracking routine diagnostic oncology, staging, and follow-up, by providing a tool for the user to perform the segmentation of suspicious lesions in lung or liver. The CT Colon Analysis application is intended to provide the user a tool to enable easy visualization and efficient evaluation of CT volume data sets of the colon.

The CT Dental application is intended to provide the user a tool to reconstruct panoramic and paraxial views of jaw. The CT Lung Nodule application is intended to provide the user a tool for the review and analysis of thoracic CT images, providing quantitative and characterizing information about nodules in the lung in a single study, or over the time course of several thoracic studies.

The CT Vessel Analysis application is intended to provide a tool for viewing, manipulating CT vascular images.

The Inner view application is intended to perform a virtual camera view through hollow structures (cavities), such as vessels.

The CT Lung Density Analysis application is intended to segment pulmonary, lobes, and airway, providing the user quantitative parameters, structure information to evaluate the lung and airway.

The CT Brain Perfusion application is intended to calculate the parameters such as: CBV, CBF, etc. in order to analyze functional blood flow information about a region of interest (ROI) in the brain.

The CT Heart application is intended to segment heart and extract coronary artery. It also provides analysis of vascular stenosis, plaque and heart function.

The CT Calcium Scoring application is intended to identify calcifications and calculate the calcium score.

The CT Dynamic Analysis application is intended to provide visualization of the CT datasets over time with the 3D/4D display modes.

The CT Bone Structure Analysis application is intended to provide visualization and labels for the ribs and spine, and support batch function for intervertebral disk.

The CT Liver Evaluation application is intended to provide processing and visualization for liver segmentation and vessel extraction. It also provides a tool for the user to perform liver separation and residual liver segments evaluation.

Product codes

LLZ

Device Description

uWS-CT is a comprehensive software solution designed to process, review and analyze CT studies. It can transfer images in DICOM 3.0 format over a medical imaging network or import images from external storage devices such as CD/DVDs or flash drives. These images can be functional data, as well as anatomical datasets. It can be at one or more time-points or include one or more time-frames. Multiple display formats including MIP and volume rendering and multiple statistical analysis including mean, maximum and minimum over a user-defined region is supported. A trained, licensed physician can interpret these displayed images as well as the statistics as per standard practice.

This proposed device contains the following modifications/improvements in comparison to the predicate device uWS-CT:

Modified Indications for Use Statement;
Modified CT Lung Density Analysis, CT Heart and CT Calcium Scoring application;
Added some advanced applications:
. CT Brain Perfusion
CT Dynamic Analysis
. CT Bone Structure Analysis
CT Liver Evaluation

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT

Anatomical Site

Lung, Liver, Colon, Jaw, Thorax, Vascular, Brain, Heart, Ribs, Spine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Trained, licensed physician can interpret these displayed images as well as the statistics as per standard practice within healthcare institutions.

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 provided to demonstrate safety and efficacy of the proposed device. This includes a hazard analysis, and the potential hazards have been classified as a moderate level of concern (LOC). Those documentations include:

Software description
Hazard Analysis
Software requirements specification (SRS)
Software Architecture Description
Software Development Environment Description
Software Verification and Validation
Cyber security Documents

Performance Evaluation Reports were conducted for the following applications:

CT Lung Density Analysis
CT Brain Perfusion
CT Heart
CT Calcium Scoring
CT Dynamic Analysis
CT Bone Structure
CT Liver Evaluation

The uWS-CT was found to have a safety and effectiveness profile that is similar to the predicate device and reference devices.

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

Not Found

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.

K173001

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.

K103480, K033326, K090546, K113442, K150843, K120331, K133643, K162025

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

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

0

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 24, 2019

Shanghai United Imaging Healthcare Co., Ltd. % Xin Gao Regulatory Affairs Specialist NO. 2258 Chengbei Road Shanghai, Shanghai 201807 CHINA

Re: K183170

Trade/Device Name: uWS-CT Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: May 28, 2019 Received: May 29, 2019

Dear Xin Gao:

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 vou, 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

1

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 (QS) 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 medical devices and radiation-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) K183170

Device Name uWS-CT

Indications for Use (Describe)