PerfusionGo Plus

K221627 · Yukun (Beijing) Technology Co., Ltd. · LLZ · Jan 19, 2023 · Radiology

Device Facts

• Record ID: K221627
• Device Name: PerfusionGo Plus
• Applicant: Yukun (Beijing) Technology Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Jan 19, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

PerfusionGo Plus is a standalone software package for processing dynamic CT perfusion (CTP) brain scans. It receives DICOM-compliant image data from imaging modalities or PACS servers. The software automatically identifies and extracts CTP studies to calculate perfusion parameters: Cerebral Blood Flow (CBF), Cerebral Blood Volume (CBV), Mean Transit Time (MTT), Time-to-peak (TTP), Residue function time-to-peak (Tmax), and Time-density curve (TDC). It generates parametric maps, which are written back to the source DICOM format for viewing on standard radiological diagnostic viewers. Used by physicians and medical technicians in clinical settings, the device assists in the visualization and quantification of tissue perfusion changes. By providing standardized perfusion maps, it supports healthcare providers in clinical decision-making regarding brain perfusion status.

Clinical Evidence

Bench testing only. Performance was evaluated using commercially available simulated datasets (digital phantoms) generated via tracer kinetic theory, covering a wide range of clinically relevant perfusion values. The device achieved pre-established performance goals for CBF, CBV, MTT, and Tmax. Software verification and validation confirmed the device meets all design requirements.

Technological Characteristics

Standalone software package; runs on standard off-the-shelf PC; DICOM-compliant (NEMA PS 3.1-3.20); processes dynamic CT perfusion datasets; outputs parametric maps (CBF, CBV, MTT, Tmax, TDC).

Indications for Use

Indicated for trained professionals, including physicians and medical technicians, to perform image processing, analysis, and communication of brain CT perfusion scans.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Viz CTP (K180161)

Submission Summary (Full Text)

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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" 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

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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 ([e-mail]) or phone [phone] 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

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## Indications for Use

510(k) Number (if known)

K221627

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 <i>one</i> or <i>both</i> , 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: [phone]. Email: [e-mail].

## Date Prepared: 12/15/2022

- 2. 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;

- 3. Predicate Device
510 (k) number: K180161; Trade name: Viz CTP; 510(k) submitter/holder: Viz.ai, Inc.

- 4. Device Description
PerfusionGo Plus is a standalone software package that is comprised of several modules

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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.

- 5. 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.

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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<br>Use/Indications<br>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.<br><br>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.<br><br>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<br>imaging viewers. | imaging viewers. | | | | |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--|--|--|
| PACS Functionality | | | | | | |
| Basic PACS<br>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<br>Compliance | Yes | Yes | Same | | | |
| Functional<br>Overview | PerfusionGo Plus is a software<br>package that provides for the<br>visualization and study of<br>changes of tissue perfusion in<br>digital images captured by CT.<br>PerfusionGo Plus allows<br>viewing and quantification. | Viz CTP is a software package<br>that provides for the<br>visualization and study of<br>changes of tissue perfusion in<br>digital images captured by CT.<br>Viz CTP allows viewing and<br>quantification. | Same | | | |
| Data<br>Acquisition | Acquires medical image data<br>from DICOM compliant<br>imaging devices and modalities. | Acquires medical image data<br>from DICOM compliant<br>imaging devices and modalities. | Same | | | |
| Data/Image<br>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<br>peak (Tmax) | Tissue residue function time to<br>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<br>and DICOM file systems | Export perfusion files to PACS<br>and DICOM file systems | Same | | | |
| | Acquire, transmit, process, and<br>store medical images | Acquire, transmit, process, and<br>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,

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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.