(437 days)
Not Found
No
The summary describes standard image processing and parameter calculation techniques for CT perfusion analysis, without mentioning AI, ML, or related concepts. The performance study compares the device's output to a predicate device using traditional statistical methods.
No
The device is an image processing and analysis software designed to assist in the diagnosis and assessment of brain CT perfusion scans, not to treat a condition.
Yes
Explanation:
The "Intended Use / Indications for Use" section states that the software is used for "image viewing, processing, analysis and communication of computed tomography (CT) perfusion scans of the brain," and that "Results of image processing... may be viewed on existing radiological imaging viewers." The "Device Description" also mentions that "The results of image analysis produced by RealNow should be viewed through appropriate diagnostic viewers when used in clinical decision making." These statements indicate that the device produces information intended to aid in diagnosis or clinical decision-making.
Yes
The device is described as an "image processing software package" that runs on standard computer platforms and processes data from DICOM compliant imaging devices. There is no mention of any hardware components being part of the device itself.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- RealNow's Function: RealNow is an image processing software that analyzes in vivo (within the living body) CT perfusion scans of the brain. It processes images acquired directly from a patient using a CT scanner.
- Specimen Type: RealNow does not analyze specimens derived from the human body (like blood, urine, or tissue samples) in a laboratory setting. It works with imaging data.
- Purpose: While the information provided by RealNow (perfusion parameters) is used to inform clinical decision-making regarding a physiological or pathological state (brain perfusion and potential stroke), the method of obtaining this information is through image analysis of in vivo data, not through the examination of in vitro specimens.
Therefore, RealNow falls under the category of a medical device that processes and analyzes medical images, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
RealNow is an image processing software package to be used by trained professionals including physicians. The software runs on a standard "off-the-shelt" computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, analysis and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM compliant imaging devices.
RealNow provides viewing, analysis and communication capabilities for functional and dynamic imaging datasets that are acquired with CT Perfusion imaging protocols.
Analysis includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Results of image processing which include CT perfusion parameter maps generated in the standard DICOM format and may be viewed on existing radiological imaging viewers.
Product codes
LLZ
Device Description
RealNow image analysis includes calculation of the following perfusion related parameters:
- Cerebral Blood Flow (CBF)
- Cerebral Blood Volume (CBV)
- Mean Transit Time (MTT)
- Residue function time-to-peak (TMax)
- Arterial Input Function (AIF)
The primary users of RealNow are medical imaging professionals who analyze dynamic CT perfusion studies. The results of image analysis produced by RealNow should be viewed through appropriate diagnostic viewers when used in clinical decision making.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT)
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals including physicians.
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
CTP images (Real-World Evidence) are paired uploaded to RealNow and RAPID for perfusion analysis. The parametric maps from the subject device's output have been directly compared to the Rapid outputs in the additional study. The RealNow resulting CBF maps were compared on a pixel by pixel basis to the "ground truth" RAPID CBF maps. Intraclass Correlation Coefficient of the all the pixel values per scan was calculated to assess correlation, of the CBF estimates to the reference values. Volumetry from our device's out to RAPID on the same patient data have been statistically analyzed using MedCalc, and Bland-Altman analysis statistics been performed.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Non-Clinical Test (software verification and validation testing)
Sample Size: Not explicitly stated, but refers to "all the pixel values per scan" and "the same patient data" for volumetry.
Key Results:
For each scan, parametric map is considered acceptable when the ICC is greater than 0.75, which ICC was calculated per scan from all the voxels within the brain tissue. All Proportion of Acceptable (CBF Parameter Maps, CBV Parameter Maps, MTT Parameter Maps, Tmax Parameter Maps, ) more than the 90% (p=0.0009, p=0.0009, p=0.0196.).The assessment revealed bias is not significant for Rapid_Volume (CBF 0.75
Proportion of Acceptable CBF Parameter Maps > 90% (p=0.0009)
Proportion of Acceptable CBV Parameter Maps > 90% (p=0.0009)
Proportion of Acceptable MTT Parameter Maps > 90% (p=0.0196)
Bias not significant for Rapid_Volume (CBF
§ 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and 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.
YIWEI Medical Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O.box 120-119 Shanghai. 200120 CHINA
Re: K213891
February 24, 2023
Trade/Device Name: RealNow Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: January 29, 2023 Received: January 30, 2023
Dear Diana Hong:
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 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.
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT 8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213891
Device Name RealNow
Indications for Use (Describe)
RealNow is an image processing software package to be used by trained professionals including physicians. The software runs on a standard "off-the-shelt" computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, analysis and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM compliant imaging devices.
RealNow provides viewing, analysis and communication capabilities for functional and dynamic imaging datasets that are acquired with CT Perfusion imaging protocols.
Analysis includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Results of image processing which include CT perfusion parameter maps generated in the standard DICOM format and may be viewed on existing radiological imaging viewers.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug 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 OMB number."
3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K213891
-
- Date of Preparation: 2/23/2023
-
- Sponsor Identification
YIWEI Medical Technology Co., Ltd
Room 1001, MaiKelong Building, No. 6, Gaoxin South 6th Road, Dist.Gaoxin, Yuehai Street, Dist.Nanshan, Shenzhen, 518057, China.
Establishment Registration Number: Not registered yet.
Contact Person: Eric Ke Position: Management Representative Tel: +86-0755-82333762 Email: rick.ke@drbrain.com.cn
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850 Fax: 360-925-3199 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: RealNow Common Name: Picture Archiving Communications System
Regulatory Information
Classification Name: Picture archiving and communications system Classification: II; Product Code: LLZ; Regulation Number: 21CFR 892.2050 Review Panel: Radiology;
Indication for Use:
RealNow is an image processing software package to be used by trained professionals, such as physicians. The software runs on a standard "off-the-shelf" computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, analysis and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM compliant imaging devices.
RealNow provides viewing, analysis and communication capabilities for functional and dynamic imaging datasets that are acquired with CT Perfusion imaging protocols.
Analysis includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Results of image processing which include CT perfusion parameter maps generated in the standard DICOM format and may be viewed on existing radiological imaging viewers.
Device Description
RealNow image analysis includes calculation of the following perfusion related parameters:
- Cerebral Blood Flow (CBF)
- Cerebral Blood Volume (CBV)
- Mean Transit Time (MTT)
- · Residue function time-to-peak (TMax)
- · Arterial Input Function (AIF)
The primary users of RealNow are medical imaging professionals who analyze dynamic CT perfusion studies. The results of image analysis produced by RealNow should be viewed through appropriate diagnostic viewers when used in clinical decision making.
- Identification of Predicate Device న.
5
510(k) Number: K121447 Product Name: RAPID Manufacturer: iSchemaView, Inc.
Non-Clinical Test Conclusion 6.
The software verification and validation testing was conducted on the proposed device
CTP images (Real-World Evidence) are paired uploaded to RealNow and RAPID for perfusion analysis. The parametric maps from the subject device's output have been directly compared to the Rapid outputs in the additional study. The RealNow resulting CBF maps were compared on a pixel by pixel basis to the "ground truth" RAPID CBF maps. Intraclass Correlation Coefficient of the all the pixel values per scan was calculated to assess correlation, of the CBF estimates to the reference values. Volumetry from our device's out to RAPID on the same patient data have been statistically analyzed using MedCalc, and Bland-Altman analysis statistics been performed.
For each scan, parametric map is considered acceptable when the ICC is greater than 0.75, which ICC was calculated per scan from all the voxels within the brain tissue. All Proportion of Acceptable (CBF Parameter Maps, CBV Parameter Maps, MTT Parameter Maps, Tmax Parameter Maps, ) more than the 90% (p=0.0009, p=0.0009, p=0.0196.).The assessment revealed bias is not significant for Rapid_Volume (CBF