QP-Brain®

K232231 · Quibim S.L. · QIH · Dec 13, 2023 · Radiology

Device Facts

• Record ID: K232231
• Device Name: QP-Brain®
• Applicant: Quibim S.L.
• Product Code: QIH · Radiology
• Decision Date: Dec 13, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

QP-Brain® is a medical imaging processing application intended for automatic labeling and volumetric quantification of segmentable brain structures and white matter hyperintensities (WMH) from a set of adults and adolescents 18 and older MR images. Volumetric measurements may be compared to reference percentile data. The application is used by clinicians with proper training, as a support tool in assessment of structural MRIs. Patient management decisions should not be based solely on the results of the device.

Device Story

QP-Brain® is an automated medical imaging post-processing software; inputs 3D T1-weighted Gradient Echo structural MRI scans and T2 FLAIR sequences; performs artifact correction, segmentation, atlas-based parcellation, WMH quantification, volume calculation, and report generation; uses AI for WMH identification; outputs segmented brain volumes, color overlays, and quantitative reports; displays results on third-party DICOM workstations/PACS; used by trained clinicians as a support tool for structural MRI assessment; provides longitudinal reporting and normative database comparisons; aids clinical decision-making by providing quantitative data; benefits patients through standardized, objective brain structure analysis.

Clinical Evidence

Bench testing only. Performance evaluated by comparing QP-Brain® outputs to manual expert segmentation (reference standard). Brain volumetry (GM, WM, CSF, ICV) showed high DICE scores (0.955–0.994). WMH analysis across varying sizes (Low to Very High) yielded DICE scores from 0.406 to 0.806 and absolute volume errors from 0.455 mL to 5.668 mL. Pearson's correlation for WMH count was 0.88.

Technological Characteristics

Software-based medical image processing system; compatible with DICOM standard; inputs 3D T1-weighted MRI and T2 FLAIR; automated pipeline includes artifact correction, segmentation, atlas-based parcellation, and volume calculation; operates on off-the-shelf hardware; AI-based segmentation for WMH; no specific material standards applicable as it is a software-only device.

Indications for Use

Indicated for adults and adolescents 18+ requiring automatic labeling and volumetric quantification of brain structures and white matter hyperintensities (WMH) from structural MRIs.

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

• NeuroQuant (K170981)

Reference Devices

• Quantib™ Brain 1.3 (K173939)
• Qyscore Software (K192531)

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). 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.

December 13, 2023

Quibim S.L. % John J. Smith, M.D., J.D. Partner Hogan Lovells US LLP 555 13th St. NW Washington, DC 20005

Re: K232231

Trade/Device Name: QP-Brain® Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH, LLZ Dated: November 15, 2023 Received: November 15, 2023

Dear John Smith:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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,

Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K232231

#### Device Name

#### QP-Brain®

Indications for Use (Describe)

QP-Brain® is a medical imaging processing application intended for automatic labeling and volumetric quantification of segmentable brain structures and white matter hyperintensities (WMH) from a set of adults and adolescents 18 and older MR images. Volumetric measurements may be compared to reference percentile data. The application with proper training, as a support tool in assessment of structural MRIs. Patient management decisions should not be results of the device.

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

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### 510(k) SUMMARY Quibim's QP-Brain®

## Submitter Quibim S.L. Avenida Aragon 30, 13th floor, Office I-J, 46021 Valencia (Spain)

Phone:

- . [phone]
Contact Person:

- Ángel Alberich Bayarri, CEO and Founder of Quibim ([e-mail]) ●
- Josep Hortigüela Zamora, VP of Quality Assurance and Regulatory Affairs . ([e-mail])

Date Prepared: November 15, 2023

## Name of Device: QP-Brain®

Common or Usual Name: Medical image management and processing system Classification Name: 892.2050 Medical image management and processing system Requlatory Class: Class II Product Code: QIH, LLZ

## Predicate Device

- . Manufacturer's name: CorTechs Labs, Inc. 4690 Executive Drive, Suite 250, San Diego, CA 92121
- Device's trade name: NeuroQuant
- . 510(k) number: K170981
- Product code: LLZ

## Reference Devices

Reference Device #1:

- Manufacturer's name: Quantib B.V. Westblaak 106, 3012 KM Rotterdam (Netherlands).
- Device's trade name: Quantib™ Brain 1.3 ●
- 510(k) number: K173939
- Product code: LLZ .

Reference Device #2:

- Manufacturer's name: Qynapse. PariSanté Campus, 2-10 rue d'Oradour-sur-Glane, . 75015 Paris, France
- . Device's trade name: Qyscore Software
- 510(k) number: K192531
- Product code: LLZ

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### Device Description

QP-Brain® is a medical image processing and analyzing software intended for image processing to analyze brain MR imaging studies. These brain MR images, when interpreted by clinicians with proper training, may yield clinically useful information.

QP-Brain® is an automated MR imaging post-processing medical device software that uses 3D T1-weighted (T1w) Gradient Echo structural MRI scans to provide a quantitative imaging analysis and automatic segmentation of brain regions. If T2 FLAIR images are uploaded. QP-Brain® uses this sequence to automatically identify white matter hyperintensities using Artificial Intelligence.

Once the T1 MR or T2 FLAIR has been uploaded, QP-Brain® will check the available sequences for compatibility before automatically launching the analysis.

The output of the medical device consists of specific volumes with seqmentation overlay as well as different reports with quantitative information. The outputs can be returned to and displayed on third-party DICOM workstations and Picture Archive and Communication Systems (PACS).

In case age and gender information is available on the study DICOM tags for brain structure analysis module, all quantified volumes are framed in a normative database to be compared with cognitively normal adults of the same age and gender.

QP-Brain® also allows for longitudinal information reporting if a patient has acquired more than one MRI over time.

### Intended Use / Indications for Use

QP-Brain® is a medical imaging processing application intended for automatic labeling and volumetric quantification of segmentable brain structures and white matter hyperintensities (WMH) from a set of adults and adolescents 18 and older MR images. Volumetric measurements may be compared to reference percentile data. The application is used by clinicians with proper training, as a support tool in assessment of structural MRIs. Patient management decisions should not be based solely on the results of the device.

### Comparison to predicate device

The QP-Brain® and predicate devices differs on the following elements:

- . QP-Brain® and the predicate device NeuroQuant® have very similar indications statements. Both are intended for a medical image processing application intended for automatic labeling and volumetric quantification of segmentable brain structures and white matter hyperintensities (WMH) from a set of MR images. NeuroQuant® uses the word "lesions" meaning White Matter Hyperintensities points to hyperintense area, which is within QP-Brain® scope. This wording difference does not alter the intended use effect of QP-Brain® as a support tool to clinicians in assessment of structural MRIs.

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- QP-Brain® has the same intended use environment and intended user, and the intended patient population (adult patients and adolescent patients aged 18 through 21) is covered by the intended patient population of the predicate device (pediatric and adult patients).
# Summary of Technological Characteristics

At a high level, the subject and predicate devices are based on the following same technological elements:

- Both devices are compatible with DICOM standard. .
- . Both devices have the same input to run the analysis module: 3D T1 MRI scans (for brain structures) and T2 FLAIR M (for White Matter Hyperintensities) acquired with specified protocols.
- · Both devices have the same automated internal pipeline to perform the analysis.
- · Both devices have the same clinical outputs.

The following technological differences exist between the subject and predicate devices:

- The difference in processing architecture (since they are not exactly the ● same algorithm), could affect its safety or effectiveness, but does not raise any different questions of safety or effectiveness, because a set of verification and validation tests (performance testing) demonstrate the safety and effectiveness of QP-Brain®.
A table comparing the key features of the subject and predicate devices is provided below:

| Feature | Proposed device:<br>QP-Brain® (K232231) | Predicate device:<br>NeuroQuant® (K170981) |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| REGULATORY DATA | | |
| Class | II | II |
| Regulation name | Picture Archiving and<br>Communication System | Medical Image management<br>and processing system |
| Regulation number | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Classification Panel | Radiology | Radiology |
| Product Code | QIH, LLZ | LLZ |
| Manufacturer: | Quibim S.L. | CorTechs Labs, Inc. |
| INTENDED USE | | |
| Medical device description | QP-Brain® is a medical<br>imaging processing<br>application intended for<br>automatic labeling and<br>volumetric quantification of | NeuroQuant® is intended<br>for automatic labeling,<br>visualization and volumetric<br>quantification of<br>segmentable brain |
| Feature | Proposed device:<br>QP-Brain® (K232231) | Predicate device:<br>NeuroQuant® (K170981) |
| | segmentable brain<br>structures and white matter<br>hyperintensities (WMH) from<br>a set of adults and<br>adolescents 18 and older<br>MR images. | structures and lesions from<br>a set of MR images.<br>It is intended to automate<br>the manual process of<br>identifying, labeling and<br>quantifying the volume of<br>segmentable brain<br>structures identified on MR<br>images. |
| Medical device intended<br>use environment | Software as a Medical<br>Device, DICOM compatible<br>and operate on off-the-self<br>hardware (multiple vendors). | Software as a Medical<br>Device, DICOM compatible<br>and operate on off-the-self<br>hardware (multiple vendors). |
| Medical device intended<br>user | The application should be<br>used by clinicians with<br>proper training, as a support<br>tool in assessment of<br>structural MRIs.<br>Patient management<br>decisions should not be<br>based solely on the results<br>of the device. | NeuroQuant® is used by<br>medical professionals, such<br>as radiologists, neurologists<br>and neuroradiologists, as<br>well as by clinical<br>researchers, as a support<br>tool in assessment of<br>structural MRIs. |
| Medical device intended<br>patient population | Adult patients and<br>adolescent patients aged 18<br>through 21 with brain MRI<br>study. Available up to 94<br>years. | Adult and pediatric patients<br>with brain MRI study.<br>Available for ages 3 to 100<br>years. |
| Clinical output | Provides volumetric<br>measurements of brain<br>structures.<br>- Includes segmented<br>color overlays and<br>morphometric<br>reports.<br>- Automatically<br>compares results to<br>reference percentile<br>data and to prior<br>scans when<br>available.<br>Supports DICOM format as<br>output of results that can be<br>displayed on DICOM<br>workstations and Picture<br>Archive and<br>Communications Systems. | Provides volumetric<br>measurements of brain<br>structures.<br>- Includes segmented<br>color overlays and<br>morphometric<br>reports.<br>- Automatically<br>compares results to<br>reference percentile<br>data and to prior<br>scans when<br>available.<br>Supports DICOM format as<br>output of results that can be<br>displayed on DICOM<br>workstations and Picture<br>Archive and<br>Communications Systems. |
| Data source | MRI scanner: 3D T1 MRI<br>scans (for brain structures) | MRI scanner: 3D T1 MRI<br>scans (for brain volumetry) |
| Feature | Proposed device:<br>QP-Brain® (K232231) | Predicate device:<br>NeuroQuant® (K170981) |
| | and T2 FLAIR MR (for White<br>Matter Hyperintensities)<br>acquired with specified<br>protocols.<br>QP-Brain® supports DICOM format as input. | and T2 FLAIR MR (for White<br>Matter Hyperintensities)<br>acquired with specified<br>protocols.<br>NeuroQuant® supports DICOM format as input. |
| Processing architecture | Automated internal pipeline<br>that performs:<br>- artifact correction<br>- segmentation<br>- atlas-based<br>parcellation<br>- WMH quantification<br>- volume calculation<br>- report generation | Automated internal pipeline<br>that performs:<br>- artifact correction<br>- segmentation<br>- atlas-based<br>parcellation<br>- lesion quantification<br>- volume calculation<br>- report generation |
| Safety | Automated quality control<br>function: scan protocol<br>verification.<br>Results must be reviewed<br>by a clinician with proper<br>training. | Automated quality control<br>functions:<br>- Tissue contrast<br>check.<br>- Scan protocol<br>verification.<br>- Atlas alignment<br>check.<br>Results must be reviewed<br>by a trained physician |

# Table 1: Comparison of key features of QP-Brain® (Quibim) and the predicate device NeuroQuant® (CorTechs Labs, Inc.)

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### Performance Data

QP-Brain® software was developed according to FDA recognized consensus standards for software development. Software verification and validation was performed following V&V plans and protocols verifying that product specifications were met.

For the performance evaluation, QP-Brain® outputs were compared to manual expert segmentation (reference standard) for Gray Matter (GM), White Matter (WM), Cerebrospinal fluid (CSF) and White Matter Hyperintensities (WMH).

For brain regions segmented from 3D T1 MRI scans, the results between manual segmentation and QP-Brain® segmentation are summarized below:

| Region | DICE Score | Relative Volume Difference |
|--------|-----------------------|----------------------------|
| GM | 0.983 (0.981 – 0.986) | 2.846 (2.523 – 3.008) |
| WM | 0.990 (0.988 – 0.992) | 1.643 (0.923 – 1.684) |
| CSF | 0.955 (0.944 – 0.965) | 7.495 (3.950 – 7.718) |
| ICV | 0.994 (0.994 – 0.995) | 0.496 (0.298 – 0.694) |

### Table 2: Summary of the performance testing for QP-Brain® Brain volumetry analysis module.

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For White Matter Hyperintensities segmented from T2 FLAIR, the results between manual segmentation and QP-Brain® segmentation are summarized below:

## Table 3: Summary of the performance testing for QP-Brain® Brain WMH analysis module.

| Size | DICE Score | Absolute volume error | F1 score |
|---------------|------------|-----------------------|----------|
| Low WMH | 0.506 | 0.675 mL | |
| Medium WMH | 0.636 | 2.544 mL | |
| High WMH | 0.774 | 3.097 mL | 0.692 |
| Very High WMH | 0.885 | 7.833 mL | |

Wilcoxon signed-rank test is used to establish uncertainty intervals. The results are summarized below:

## Table 4: Summary of the performance testing for QP-Brain® Brain WMH analysis module (confidence intervals).

| Size | DICE Score | Absolute volume error | F1 score |
|---------------|--------------------------|------------------------------|-----------------|
| Low WMH | 0.406<br>(0.360 - 0.450) | 0.455 mL<br>(0.317 - 0.682) | |
| Medium WMH | 0.622<br>(0.559 - 0.699) | 2.084 mL<br>(1.190 - 3.704) | 0.701 |
| High WMH | 0.748<br>(0.707 – 0.790) | 2.871 mL<br>(1.311 - 4.763) | (0.666 - 0.739) |
| Very High WMH | 0.806<br>(0.677 - 0.923) | 5.668 mL<br>(2.853 - 15.831) | |

The Pearson's correlation coefficient result for the WMH count is 0.88.

The test results demonstrate that QP-Brain® functioned as intended, is acceptable for clinical use, and is as safe and effective as its predicate device, without introducing new questions of safety and efficacy.

## Conclusions

The QP-Brain® is as safe and effective as the NeuroQuant®. The QP-Brain® has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not alter the intended diagnostic use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the QP-Brain® and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the QP-Brain® is as safe and effective as the NeuroQuant®. Thus, the QP-Brain® is substantially equivalent.