(17 days)
Not Found
No
The description focuses on standard image processing techniques like segmentation, centerline extraction, and 3D visualization, without mentioning AI/ML terms or capabilities.
No
The device is described as a soft-copy reading workstation for reviewing CT images and supporting Virtual Colonoscopy (VC) function to aid in diagnosis. It does not provide any treatment or therapy.
Yes
The device is described as allowing "easy acquisition, transmission and review of the medical images" and states that "Images may be interpreted by a trained physician to obtain information that may be useful in the determination of a diagnosis," directly indicating its role in the diagnostic process.
Yes
The device description explicitly states "NeuColonCARE software product is a soft-copy reading workstation" and details only software functions for image processing and analysis, without mentioning any accompanying hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis.
- This device is a software workstation used for the clinical review of in vivo (within the body) CT images. It processes and visualizes images acquired directly from the patient's body.
The description clearly states its purpose is for reviewing and analyzing CT abdominal images, which are obtained from the patient directly, not from a specimen in a lab.
N/A
Intended Use / Indications for Use
The NeuColonCARE is a soft-copy reading workstation intended for clinical review of CT abdominal (gastrointestinal) images which allows easy acquisition, transmission and review of the medical images and supports VC (Virtual Colonoscopy) function. Images may be interpreted by a trained physician to obtain information that may be useful in the determination of a diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
NeuColonCARE software product is a soft-copy reading workstation used to clinically evaluate the CT abdominal (gastrointestinal) images. It is a self-contained software package, providing the functions of patient information management, image viewer (2D view, standard MPR views and 3D visualization view), and the analysis and processing of the gastrointestinal system, especially the colon. It allows the user to conduct air segmentation based on a customized threshold value, extract the centerline automatically and interactively, view the colon lumen structure in the manner of virtual colonoscopy or virtual dissection along the centerline, view the ROI, and finally acquire useful clinical information by marking and measuring the ROI (3D distance and CT value).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
abdominal (gastrointestinal) / colon
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician / Not Found
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)
Not Found
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Neusoft
r.
で
Summary of Safety and Effectiveness
JAN 2 8 2011
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h)
General Information:
| Trade Name: | NeuColonCARE |
|---|---|
| Version Number: | 1.0 |
| Common Name: | Soft-Copy Medical Image Reading Workstation |
| CFR Section: | 21 CFR Part 892.2050 |
| Classification Name: | Picture Archiving and Communication System (PACS). |
| Product Code: | LLZ |
| Device Class: | Class II |
| Applicable Standard: | DICOM 3.0 |
| Manufacturer and | |
| Distributor: | Neusoft Medical Systems Co., Ltd. |
| No. 16, Shiji Road, Hunnan Industial Area, | |
| Shenyang,Liaoning, China | |
| Post Code : 110179 | |
| Submitter: | Contact': Tian Yuehui |
Title : Manager of Quality Management Department Tel : 86-24-83660646 Fax : 86-24-83780480 E-Mail :tianyh@neusoft.com
Summary prepared : Nov.24,2010
1
Safety and Effectiveness Information
Intended Uses:
The NeuColonCARE is a soft-copy reading workstation intended for clinical review of CT abdominal (gastrointestinal) images which allows easy acquisition, transmission and review of the medical images and supports VC (Virtual Colonoscopy) function. Images may be interpreted by a trained physician to obtain information that may be useful in the determination of a diagnosis.
Device Description:
NeuColonCARE software product is a soft-copy reading workstation used to clinically evaluate the CT abdominal (gastrointestinal) images. It is a self-contained software package, providing the functions of patient information management, image viewer (2D view, standard MPR views and 3D visualization view), and the analysis and processing of the gastrointestinal system, especially the colon. It allows the user to conduct air segmentation based on a customized threshold value, extract the centerline automatically and interactively, view the colon lumen structure in the manner of virtual colonoscopy or virtual dissection along the centerline, view the ROI, and finally acquire useful clinical information by marking and measuring the ROI (3D distance and CT value).
Technological characteristics:
The NeuColonCARE software product is executed on a general PC and employs the same or similar fundamental technology as its predicate devices.
Summary of Non-Clinical Tests:
The device has been evaluated for conformance to its design specifications and applicable industry standards for software development. A summary of the software design description, risk management, level of concern and verification&validation testing information can be found in the attached submission. It is further verified for system compatibility with the devices with which it communicates, including conformance to DICOM 3.0 standard.
Predicate Device:
K070831 : Voxar 3D Entreprise with ColonMetrix K032096 : Philips ViewForum 2003
Statement of Substantial Equivalence:
2
The Neusoft NeuColonCARE is comparable and substantially equivalent to the Voxar 3D Entreprise with ColonMetrix (K070831) and the Philips ViewForum 2003 (K032096).
The NeuColonCARE and the Philips ViewForum 2003 share similar technological specifications. Both of them support DICOM protocol for communication of images with other medical imaging devices. Furthermore, they both provide various tools for physicians to view images.
The NeuColonCARE has the similar technological characteristics with the Voxar 3D Entreprise with ColonMetrix. Both of them provide functions such as standard MPR, Virtual Endoscopy, Virtual Dissection and they both provide the function of ROI bookmark and measurement, as well as quantitative analysis of the ROI.
According to the comparison based on the requirements of 21.CFR 807.87, we state that these devices are substantially equivalent.
Conclusion:
The NeuColonCARE software product employs the same or similar fundamental technology as its predicate devices and dose not introduce any new potential safety risks. So, Neusoft Medical Systems considers the NeuColonCARE software product to be as safe, as effective, and performance is substantially equivalent to the predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Neusoft Medical Systems Co., Ltd. % Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories, Inc. 2600 N.W. Lake Road CAMAS WA 98607-8542
JAN 2 8 2011
Re: K110077
Trade/Device Name: NeuColonCARE Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 21, 2010 Received: January 11, 2011
Dear Mr. Mouser:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours.
Mary Postel.
Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Neusoft
510(k)
Indications for Use Form
510(k) Number (if known) :
Device Name: NeuColonCARE
Indications for use:
The NeuColonCARE is a soft-copy reading workstation intended for clinical review of CT abdominal (gastrointestinal) images which allows easy acquisition, transmission and review of the medical images and supports VC (Virtual Colonoscopy) function. Images may be interpreted by a trained physician to obtain information that may be useful in the determination of a diagnosis.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Deices (OIVD)
ely D'Ahm
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K110077
Page 1 of 1