K Number

Device Name

Neurophet SCALE PET

Manufacturer

NEUROPHET, Inc.

Date Cleared

2022-08-05

(81 days)

Product Code

LLZ

Regulation Number

892.2050

Intended Use

Neurophet SCALE PET is a software for the registration, fusion, display and analysis of medical images from multiple modalities including MRI and PET. The software aids clinician in the assessment and quantification of pathologies from PET Amyloid/FDG scans of the human brain. It enables automatic analysis and visualization of amyloid protein concentration through the calculation of standard uptake volume ratios (SUVR) within target regions of interest and comparison to those within the reference regions. The software is deployed via medical imaging workplaces and is organized as a series of workflows which are specific to use with radio-tracer and disease combinations.

Device Description

Neurophet SCALE PET is a standalone software product that automatically calculates standardized uptake value ratios (SUVR) and provides quantified calculation results for quantitative analysis of FDG and Amyloid PET images. The calculation results are intended to aid clinicians in diagnosing patients' pathologies. Furthermore, the function provided to visualize the results of the analysis of the image is designed to help clinicians perform accurate visual interpretation. Functions and workflow supported by the product are as follows: The user may set specified region as reference region, however, in order to achieve reliable constant count in the reference region, FDA recommends the selection of the pons or cerebellar white matter as reference region for assessment of SUVR in FDG PET imaging. Because this product complies with the standard DICOM medical imaging protocol, it can be used by being linked with picture archive and communications systems (PACS).

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K203142

Reference Devices

K121074

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes automated image processing and quantification but does not mention AI, ML, or any related technologies like deep learning. The performance metrics and validation methods are standard for image processing software, not specifically indicative of AI/ML.

Therapeutic

The device is a software for image analysis and quantification that aids clinicians in diagnosis, but it does not directly treat or alleviate a disease or condition.

Diagnostic

Yes

The device aids clinicians in the assessment and quantification of pathologies and the calculation results are intended to aid clinicians in diagnosing patients' pathologies.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states it is a "standalone software product" and the performance studies focus on software verification/validation and measurement accuracy, not hardware performance.

IVD (In Vitro Diagnostic)

Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states that the software "aids clinician in the assessment and quantification of pathologies from PET Amyloid/FDG scans of the human brain." It also mentions enabling "automatic analysis and visualization of amyloid protein concentration through the calculation of standard uptake volume ratios (SUVR)." These actions are directly related to providing information about a patient's condition based on the analysis of biological samples (the PET scans, which reflect the distribution of a tracer in the brain).
Device Description: The device description reinforces this by stating the software "automatically calculates standardized uptake value ratios (SUVR) and provides quantified calculation results for quantitative analysis of FDG and Amyloid PET images. The calculation results are intended to aid clinicians in diagnosing patients' pathologies." This further emphasizes the diagnostic purpose of the software.
Analysis of Biological Samples: While the input is medical images (MRI and PET), these images are derived from the uptake of a radiotracer within the patient's brain. The software analyzes the distribution and concentration of this tracer, which is a biological indicator of the patient's physiological state related to amyloid and glucose metabolism. This analysis of biological information is a key characteristic of an IVD.

The fact that it processes images and provides quantitative results to aid in diagnosis and assessment of pathologies from biological samples (the PET tracer distribution) aligns with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Neurophet SCALE PET is a software for the registration, display and analysis of medical images from multiple modalities including MRI and PET. The software aids clinician in the assessment and quantification of pathologies from PET Amyloid/FDG scans of the human brain. It enables automatic analysis and visualization of amyloid protein concentration through the calculation of standard uptake volume ratios (SUVR) within target regions of interest and comparison to those within the reference regions.

The software is deployed via medical imaging workplaces and is organized as a series of workflows which are specific to use with radio-tracer and disease combinations.

Product codes

LLZ

Device Description

Functions and workflow supported by the product are as follows: The user may set specified region as reference region, however, in order to achieve reliable constant count in the reference region, FDA recommends the selection of the pons or cerebellar white matter as reference region for assessment of SUVR in FDG PET imaging.

Because this product complies with the standard DICOM medical imaging protocol, it can be used by being linked with picture archive and communications systems (PACS).

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

MRI and PET

Anatomical Site

Human brain

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Clinician / medical imaging workplaces (Hospital)

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)

SW verification/validation and the measurement accuracy test were conducted to establish the performance, functionality and reliability characteristics of the subject devices. The device passed all of the tests based on pre-determined Pass/Fail criteria.

1) Segmentation Accuracy

The performance of the Segmentation function was evaluated by comparing the Dice similarity coefficient (DSC) between Neurophet SCALE PET-produced segmentation and manual segmentation done by experts. For the DSC evaluation, the subject device performed a DSC of 86.39±3.12% on major subcortical brain structures.

2) SUVR Calculation Reliability

The reliability of the SUVR results was evaluated by statistical test using intraclass correlation coefficient between Neurophet SCALE PET-and conventional PET processing tools. For the ICC, the subject device was shown the good reliability (all ROI ICC scores > 0.6).

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

Dice similarity coefficient (DSC): 86.39±3.12% for segmentation accuracy.
Intraclass correlation coefficient (ICC): all ROI ICC scores > 0.6 for SUVR calculation reliability.

Predicate Device(s)

K203142

Reference Device(s)

K121074

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 5, 2022

NEUROPHET, Inc. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave., STE 160 IRVINE CA 92612

Re: K221405

Trade/Device Name: Neurophet SCALE PET Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: May 4, 2022 Received: May 16, 2022

Dear Priscilla Chung:

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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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.

for

Michael D. O'Hara, Ph.D. Deputy Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K221405

Device Name Neurophet SCALE PET

Indications for Use (Describe)

The software is deployed via medical imaging workplaces and is organized as a series of workflows which are specific to use with radio-tracer and disease combinations.

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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510(k) Summary (K221405)

This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

1. Date: 7/20/2022

2. Applicant / Submitter

NEUROPHET, Inc. 12F, 124, Teheran-ro, Gangnam-gu Seoul, Republic of Korea Tel : +82-2-6954-7971 Fax : +82-2-6954-7972

3. U.S. Designated Agent

Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine, CA 92612 Fax: 714.409.3357 Tel: 714.202.5789 Email: juhee.c@LKconsultingGroup.com

4. Trade/Proprietary Name:

Neurophet SCALE PET

5. Common Name:

Medical Image Processing Software

6. Classification:

Medical Image Management and Processing System (21CFR 892.2050, Product code LLZ, Class 2, Radiology)

7. Device Description:

visualize the results of the analysis of the image is designed to help clinicians perform accurate visual interpretation.

Because this product complies with the standard DICOM medical imaging protocol, it can be used by being linked with picture archive and communications systems (PACS).

8. Indication for use:

The software is deployed via medical imaging workplaces and is organized as a series of workflows which are specific to use with radio-tracer and disease combinations.

9. Predicate Device:

Primary Predicate: . Veuron-Brain-pAb (K203142) by HEURON CO., LTD.
. Reference Device: Scenium 2.0 (K121074) by Siemens Medical Solutions USA, Inc

10. Substantial Equivalence:

	Subject Device	Primary predicate Device	Reference Device
Device name	Neurophet SCALE PET	Veuron-Brain-pAb	Scenium 2.0
510(k)	K221405	K203142	K121074
Manufacturer	NEUROPHET, Inc.	HEURON CO., LTD.	Siemens Medical Solutions
USA, Inc
Product Code	LLZ	LLZ	LLZ
Indications for
Use	Neurophet SCALE PET is
a software for the
registration, fusion, display
and analysis of medical
images from multiple
modalities including MRI
and PET. The software aids
clinician in the assessment
and quantification of
pathologies from PET
Amyloid/FDG scans of the
human brain. It enables
automatic analysis and
visualization of amyloid
protein concentration
through the calculation of
standard uptake volume
ratios (SUVR) within target
regions of interest and
comparison to those within
the reference regions. The
software is deployed via
medical imaging
workplaces and is
organized as a series of
workflows which are
specific to use with radio-
tracer and disease
combinations.	The Veuron-Brain-pAb is a
software for the registration,
fusion, display and analysis of
medical images from multiple
modalities including MRI and
PET.
The software aids clinician in
the assessment and
quantification of pathologies
from PET Amyloid scans of
the human brain. It enables
automatic analysis and
visualization of amyloid
protein concentration through
the calculation of standard
uptake volume ratios (SUVR)
within target regions of
interest and comparison to
those within the reference
regions. The software is
deployed via medical imaging
workplaces and is organized as
a series of workflows which
are specific to use with radio-
tracer and disease
combinations.	The Scenium display and
analysis software has been
developed to aid the
Clinician in the assessment
and quantification of
pathologies taken from PET
and SPECT scans.
The software is deploted via
medical imaging workplaces
and is organized as a series of
workflows which are specific
to use with particular drug
and disease combinations.
The software aids in the
assessment of human brain
scans enabling automated
analysis through
quantification of mean pixel
values located within
standard regions of interest. It
facilitates comparison with
existing scans derived from
FDG-PET, amyloid PET, and
SPECT studies and
calculation of uptake ratios
between regions of interest.
Target
Anatomical Sites	Brain	Brain	Brain
Where Used	Hospital	Hospital	Hospital
Design Features	• Import DICOM data
Perform automatic post-
processing
• Provide the user
confirmation
• Export the resulting data
through data network or
USB	• Import DICOM data Perform
automatic post-processing
• Provide the user confirmation
• Export the resulting data only
through USB	• Import DICOM data
Perform automatic post-
processing
• Provide the user
confirmation
• Export the resulting data
only through data network
Physical
characteristics	• Software package
• Operates on off-the-shelf
hardware (multiple
vendors)	• Software package
• Operates on off-the-shelf
hardware (multiple vendors)	No software required
• Operates in a serverless
cloud environment
• User interface through
PACS (multiple vendors)
Operating
System	Windows 10, 64-bit	Windows 10, 64-bit	Windows 7, 64-bit
Standards	• ISO 14971	• ISO 14971	• ISO 14971
	• IEC 62304	• IEC 62304	• IEC 62304
	• IEC 62366	• IEC 62366	• IEC 62366
Software
verification and
validation	Tested in accordance with
verification and validation
processes and planning.
The testing results support
that all the system
requirements have met their
acceptance criteria and are
adequate for its intended
use.	Tested in accordance with
verification and validation
processes and planning. The
testing results support that all
the system requirements have
met their acceptance criteria
and are adequate for its
intended use.	Tested in accordance with
verification and validation
processes and planning. The
testing results support that all
the system requirements have
met their acceptance criteria
and are adequate for its
intended use.
Compatible
Input Data
Format and
Modality	DICOM & NiFTI
PET, MRI	DICOM & NiFTI
PET, MRI	DICOM
PET, SPECT, MRI, CT
Input Patient
Data	Manual through
keyboard/mouse	Manual through
keyboard/mouse	Manual through
keyboard/mouse
Output Patient
Data	Pictures: nii.gz
Report: .csv, pdf	Pictures: PNG
Report: .csv	Pictures: JPEG
Report: DICOM
Study list
functionality	Search, Importing,
Exporting	Search, Importing, Exporting	Search, Importing, Exporting,
Deleting

The subject device (Neurophet SCALE PET) and the predicate device are the image analysis software for PET images scanned the Human Brain.

Both devices have the same intended purpose to support clinicians in the assessment and quantification of pathology through PET scan images.
Both devices automatically calculate the Standardized Uptake Value Ratio (SUVR) value using brain MRI and PET images and provide quantitative analysis results as a report.
Both devices are DICOM compatible and operate on off-the-shelf hardware. Both devices are used by physicians skilled in brain MR imaging.
The compatible input data format and modality are also the same.

Therefore, Neurophet SCALE PET is functionally similar and improved from a previous 510(k) market-cleared Veuron-Brain-pAb software device (K203142).

Following are the differences between Neurophet SCALE PET and the predicate device:

ltem	Neurophet SCALE PET	Veuron-Brain-pAb	Scenium 2.0
Supported
PET image
types	Amyloid PET
FDG PET	Amyloid PET	Amyloid PET
FDG PET
SPECT
Output	Pictures: nii.gz	Pictures: PNG	Pictures: JPEG

Patient Data	Report: .csv, pdf	Report: .csv	Report: DICOM
Design
Features	Export the resulting data
network or user PC	Export the resulting data
only through USB	Export the resulting
data only through
data network

Although both are technically similar, there is a difference in the supported PET image type. The subject device supports Amyloid PET and FDG PET analysis, while the predicate device, Veuron-Brain-pAb(K203142). supports only Amyloid PET analysis. So, we additionally identified a reference device that covered the scope of supported PET image type for the subject device. The reference device, Scenium 2.0(K121074), is an image analysis software that has a similar purpose to the subject device and can support Amyloid PET, FDG PET, SPECT image analysis.

Also, there is a difference in output patient data between the subject device and the predicate device. However, this is only a difference in file format, and the types of output data that users can obtain are the same.

In the data export path, the predicate device can export the data only through a USB. So, we additionally identified a reference device that can export resulting data through data network. Therefore. it is possible to cover this difference by considering both the predicate device and the reference device.

11. Performance Data:

The result of the performance test is as follows.

1) Segmentation Accuracy

2) SUVR Calculation Reliability

12. Conclusion:

The subject device is substantially equivalent in the areas of technical characteristics, general

function, application, and indications for use. The new device does not introduce a fundamentally new scientific technology, and the device has been validated through system level test. Therefore, we conclude that the subject device described in this submission is substantially equivalent to the predicate device.