(227 days)
Not Found
No
The summary describes standard image processing and parameter calculation based on tracer kinetic theory, without mentioning AI or ML techniques. The performance testing relies on simulated datasets with known ground truth, which is typical for validating deterministic algorithms, not necessarily ML models.
No
This device is image processing software for diagnostic purposes (analysis of CT perfusion scans), not a therapeutic device.
Yes
Explanation: The device, PerfusionGo Plus, performs image processing and analysis of CT perfusion scans to calculate parameters related to tissue flow and blood volume (e.g., CBF, CBV, MTT, Tmax). These calculated parameters are intended to be viewed on diagnostic viewers for clinical decision-making by medical imaging professionals, directly aiding in the diagnostic process.
Yes
The device is explicitly described as a "standalone software package" that runs on a standard "off-the-shelf" computer and processes DICOM data from existing imaging devices. There is no mention of proprietary hardware included with the device.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- PerfusionGo Plus Function: PerfusionGo Plus processes and analyzes imaging data (CT perfusion scans of the brain) acquired from a patient. It does not examine biological specimens (blood, tissue, etc.) in vitro.
- Intended Use: The intended use is to perform image processing, analysis, and communication of CT perfusion scans of the brain to provide information about tissue flow and blood volume. This is based on interpreting images, not analyzing biological samples.
While the software provides information about a physiological state (perfusion), the method of obtaining that information is through image analysis, not in vitro examination of specimens.
N/A
Intended Use / Indications for Use
PerfusionGo Plus is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" computer, and can be used to perform image processing, analysis, and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM-compliant imaging devices.
PerfusionGo Plus provides both analysis and communication capabilities for 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 from a raw CTP scan are exported in the standard DICOM format and may be viewed on existing radiological imaging viewers.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
PerfusionGo Plus is a standalone software package that is comprised of several modules including Login Module, Image List Module, Image Processing Module and Management Configuration Module. PerfusionGo Plus allows a DICOM-compliant device to send files directly from the image modality, through a node on a local network, or from a PACS server. The device is designed to automatically receive, identify, extract, and analyze a CTP study of the head embedded in DICOM image data. The software outputs parametric maps related to tissue blood flow (perfusion) and tissue blood volume that are written back to the source DICOM. Following such analysis, the results of analysis can be exported manually. The software allows for repeated use and continuous processing of data and can be deployed on a supportive infrastructure that meets the minimum system requirements.
PerfusionGo Plus image analysis includes calculation of the following perfusion related parameters:
- . Cerebral Blood Flow (CBF)
- Cerebral Blood Volume (CBV) ●
- Mean Transit Time (MTT) .
- . Time-to-peak (TTP)
- Residue function time-to-peak (Tmax) .
- . Time-density curve (TDC)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed tomography (CT)
Anatomical Site
brain (specifically, head/brain for CTP study)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, including but not limited to physicians and medical technicians.
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
Yukun performed software verification and validation testing of the device and additional performance testing on a commercially available simulated datasets (digital phantom) generated by simulating tracer kinetic theory, and includes a wide range of clinically relevant values of perfusion parameters as ground truth. Correlations between the output of the PerfusionGo Plus and the ground truth values were calculated.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Yukun performed software verification and validation testing of the device and additional performance testing on a commercially available simulated datasets (digital phantom) generated by simulating tracer kinetic theory, and includes a wide range of clinically relevant values of perfusion parameters as ground truth. The results of performance testing showed that the PerfusionGo Plus achieved the preestablished performance goals for each perfusion parameters: CBF, CBV, MTT and Tmax. Thus, the performance testing demonstrated that the PerfusionGo Plus provides accurate computation of perfusion parameters. Combined with software verification and validation, the performance evaluation demonstrates that the PerfusionGo Plus satisfies all design requirements and specifications.
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
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" in a larger font and the word "Administration" in a smaller font.
Yukun (Beijing) Technology Co., Ltd. Qi Wang Regulatory Affairs Manager Room 313, 315, Building 3, No.11 Chuangxin Road, Science Park, Changping District Beijing, 102200 China
Re: K221627
Trade/Device Name: PerfusionGo Plus Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: December 15, 2022 Received: December 15, 2022
January 19, 2023
Dear Qi Wang:
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 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.
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: 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)
Device Name PerfusionGo Plus
Indications for Use (Describe)
PerfusionGo Plus is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" computer, and can be used to perform image processing, analysis, and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM-compliant imaging devices.
PerfusionGo Plus provides both analysis and communication capabilities for 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 from a raw CTP scan are exported in the standard DICOM format and may be viewed on existing radiological imaging viewers.
| Type of Use (Select one or both , as applicable) |
|---|
| ---------------------------------------------------------------- |
X 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/0 description: The image shows a logo with a stylized letter 'M'. The 'M' is formed by three connected diamond shapes, each in a different shade of purple and blue. To the right of the 'M' is a small, solid circle, also in a shade of blue. The logo has a modern and abstract design.
510(k) Summary
1. Submitter
K221627
510(k) Submitter
Submitter/Company Name: Yukun (Beijing) Technology Co., Ltd. Address: Room 313, 315, Building 3, No.11 Chuangxin Road, Science Park, Changping District, Beijing, 102200, China.
Correspondent
Primary Correspondent: Qi Wang. Title: Regulatory Affairs Manager. Telephone: +86-10-89735152. Email: wangqi@shukun.net.
Date Prepared: 12/15/2022
-
- Device
Device Type
Trade Name: PerfusionGo Plus. Common Name: PACS - Picture Archiving and Communications System.
Classification
Classification Regulation: 21 CFR 892.2050; Class: Class II; Panel: Radiology; Product Code: LLZ;
-
- Predicate Device
510 (k) number: K180161; Trade name: Viz CTP; 510(k) submitter/holder: Viz.ai, Inc.
- Predicate Device
-
- Device Description
PerfusionGo Plus is a standalone software package that is comprised of several modules
- Device Description
4
including Login Module, Image List Module, Image Processing Module and Management Configuration Module. PerfusionGo Plus allows a DICOM-compliant device to send files directly from the image modality, through a node on a local network, or from a PACS server. The device is designed to automatically receive, identify, extract, and analyze a CTP study of the head embedded in DICOM image data. The software outputs parametric maps related to tissue blood flow (perfusion) and tissue blood volume that are written back to the source DICOM. Following such analysis, the results of analysis can be exported manually. The software allows for repeated use and continuous processing of data and can be deployed on a supportive infrastructure that meets the minimum system requirements.
PerfusionGo Plus image analysis includes calculation of the following perfusion related parameters:
- . Cerebral Blood Flow (CBF)
- Cerebral Blood Volume (CBV) ●
- Mean Transit Time (MTT) .
- . Time-to-peak (TTP)
- Residue function time-to-peak (Tmax) .
- . Time-density curve (TDC)
The primary users of PerfusionGo Plus are medical imaging professionals who analyze dynamic CT perfusion studies. The results of image analysis produced by PerfusionGo Plus should be viewed through appropriate diagnostic viewers when used in clinical decision making.
-
- Indications for Use
PerfusionGo Plus is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" computer, and can be used to perform image processing. analysis, and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM-compliant imaging devices.
- Indications for Use
PerfusionGo Plus provides both analysis and communication capabilities for 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 from a raw CTP scan are exported in the standard DICOM format and may be viewed on existing radiological imaging viewers.
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Image /page/5/Picture/1 description: The image shows a logo with a stylized letter 'M' formed by three overlapping shapes in different colors. The left shape is a gradient of purple and blue, the middle shape is a gradient of blue and teal, and the right shape is a solid teal circle. The logo has a modern and abstract design.
| Item | Proposed device | Predicate device (K180161) | Analysis |
|---|---|---|---|
| Product Code | LLZ | LLZ | Same |
| Regulation | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Intended | |||
| Use/Indications | |||
| for Use | PerfusionGo Plus is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" computer, and can be used to perform image processing, analysis, and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM-compliant imaging devices. |
PerfusionGo Plus provides both analysis and communication capabilities for 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 from a raw CTP scan are exported in the standard DICOM format and may be | Viz CTP is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" computer or a virtual platform, such as VMware, and can be used to perform image processing, analysis, and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM-compliant imaging devices.
Viz CTP provides both analysis and communication capabilities for 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 from a raw CTP scan are exported in the standard DICOM format and may be viewed on existing radiological | Same |
Comparison of Technological Characteristic with the Predicate Device 6.
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Image /page/6/Picture/0 description: The image shows a logo with a stylized letter 'M'. The logo is composed of several geometric shapes in shades of blue, purple, and teal, creating a gradient effect. The shapes are arranged to form the letter 'M', with a small circle to the right of the letter.
| | viewed on existing radiological
imaging viewers. | imaging viewers. | | | | |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--|--|--|
| PACS Functionality | | | | | | |
| Basic PACS
Functions | Yes | Yes | Same | | | |
| Computer | Standard "Off-the-Shelf" PC | Standard "Off-the-Shelf" PC | Same | | | |
| Platform | Workstation or Server | Workstation or VMWare | Different 1 | | | |
| DICOM
Compliance | Yes | Yes | Same | | | |
| Functional
Overview | PerfusionGo Plus is a software
package that provides for the
visualization and study of
changes of tissue perfusion in
digital images captured by CT.
PerfusionGo Plus allows
viewing and quantification. | Viz CTP is a software package
that provides for the
visualization and study of
changes of tissue perfusion in
digital images captured by CT.
Viz CTP allows viewing and
quantification. | Same | | | |
| Data
Acquisition | Acquires medical image data
from DICOM compliant
imaging devices and modalities. | Acquires medical image data
from DICOM compliant
imaging devices and modalities. | Same | | | |
| Data/Image
Types | Computed Tomography (CT) | Computed Tomography (CT) | Same | | | |
| Acquisition and Modalities Features | | | | | | |
| CT | CT Perfusion (CTP) | CT Perfusion (CTP) | Same | | | |
| Computed Parameter Maps | | | | | | |
| Perfusion CT | Cerebral Blood Flow (CBF) | Cerebral Blood Flow (CBF) | Same | | | |
| | Cerebral Blood Volume (CBV) | Cerebral Blood Volume (CBV) | | | | |
| | Mean Transit Time (MTT) | Mean Transit Time (MTT) | | | | |
| | Tissue residue function time to
peak (Tmax) | Tissue residue function time to
peak (Tmax) | | | | |
| Measurements/Tools | | | | | | |
| CT Tools | Time-density Curve (TDC) | Arterial Input Function (AIF) | Different 2 | | | |
| | Brain mask | Brain mask | Same | | | |
| | Export perfusion files to PACS
and DICOM file systems | Export perfusion files to PACS
and DICOM file systems | Same | | | |
| | Acquire, transmit, process, and
store medical images | Acquire, transmit, process, and
store medical images | Same | | | |
Substantial Equivalence Discussion for Different 1:
The platform of the proposed device is different from that of the predicate device. However,
7
the difference is in hardware only. The configuration requirements have been provided in instructions of use and the verification and validation tests have been performed on the proposed device and the test results met the acceptance criteria. Therefore, the difference will not affect the safety and effectiveness of the proposed device.
Substantial Equivalence Discussion for Different 2:
The CT tools of the proposed device is different from that of the predicate device. The proposed device displays Time density Curve (TDC), including Arterial input function (AIF) and Venous output function (VOF), although the predicate device displays Arterial input function (AIF) only. However, the verification and validation tests have been performed on the proposed device and the test results met the acceptance criteria. Therefore, the difference will not affect the safety and effectiveness of the proposed device.
- Performance Data 7.
PerfusionGo Plus complies with DICOM (Digital Imaging and Communications in Medicine), developed by the American College of Radiology and the National Electrical Manufacturers Association. NEM PS 3.1-3.20 (2016).
Yukun performed software verification and validation testing of the device and additional performance testing on a commercially available simulated datasets (digital phantom) generated by simulating tracer kinetic theory, and includes a wide range of clinically relevant values of perfusion parameters as ground truth. Correlations between the output of the PerfusionGo Plus and the ground truth values were calculated.
The results of performance testing showed that the PerfusionGo Plus achieved the preestablished performance goals for each perfusion parameters: CBF, CBV, MTT and Tmax.
Thus, the performance testing demonstrated that the PerfusionGo Plus provides accurate computation of perfusion parameters. Combined with software verification and validation, the performance evaluation demonstrates that the PerfusionGo Plus satisfies all design requirements and specifications.
Conclusion 8.
The proposed device is as safe and effective as the predicate device (K180161). The proposed device has the same intended use as its predicate device with respect to CTP functionalities. In addition, the minor technological differences between the proposed
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Image /page/8/Picture/0 description: The image shows a logo with two stylized letter 'M's. The 'M's are formed by connected lines, with the left 'M' being slightly larger than the right one. The color palette consists of shades of purple, blue, and teal, creating a gradient effect across the logo. A small teal circle is positioned to the right of the second 'M'.
device and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the proposed device is as safe and effective as the predicate for performing CTP analysis. Thus, the PerfusionGo Plus is substantially equivalent.