QBRAIN

K050703 · Medis Medical Imaging Systems BV · LLZ · Apr 21, 2005 · Radiology

Device Facts

• Record ID: K050703
• Device Name: QBRAIN
• Applicant: Medis Medical Imaging Systems BV
• Product Code: LLZ · Radiology
• Decision Date: Apr 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The QBrain software has been developed for the objective and reproducible analysis of MR images of the brain. It performs quantities the volumes of intracranial cavities, areas that contain cerebrospinal fluid (CSF), and white matter hyperintensities (lesions). These parameters should only be used by trained medical professionals in clinical trials.

Device Story

QBrain is a standalone software package for post-processing MR brain images; operates in hospitals and core labs by neuro-radiologists and specialists. Input consists of MR brain images; device performs automatic segmentation to identify and quantify volumes of intracranial cavities, CSF, and white matter hyperintensities (lesions). Output provides objective quantitative results; supports diagnostic or therapy response assessment. Healthcare providers review results to accept or reject; aids clinical decision-making in clinical trials. Benefits include objective, reproducible brain structure quantification.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by risk management, hazard analysis, and verification/validation testing.

Technological Characteristics

Standalone software for MR image post-processing. Utilizes automatic segmentation algorithms to quantify brain structures. Operates on standard computing hardware. No specific materials or energy sources; software-only device.

Indications for Use

Indicated for trained medical professionals to perform objective, reproducible quantitative analysis of brain MR images, specifically measuring intracranial cavity volumes, cerebrospinal fluid (CSF) areas, and white matter hyperintensities (lesions) for use in clinical trials.

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

• IQuantify workstation software (K011196)

Submission Summary (Full Text)

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K050703

# 12. SUMMARY OF SAFETY AND EFFECTIVENESS

12. SUMMARY OF SAFETY AND E. F 20.000.01.2019 Part 807.87(h)

| • Submitter<br>Address | : Medis medical imaging systems b.v.<br>: Schuttersveld 9<br>: 2316 XG Leiden, The Netherlands |
|------------------------|------------------------------------------------------------------------------------------------|
| Telephone | : [phone] |
| Fax | : [phone] |
| Contact Person | : J.I. Hollander, Quality Coordinator |
| Prepared | : March 03, 2005 |
| • Device Name | : Automatic quantitative analysis of MR brain images |
| Common Name | : QBrain |
| Device Class. Name | : Class II; PACS software |
| Regulation Number | : 21 CFR 892.2050 (90 LLZ) |
| • Predicate Device(s) | : IQuantify workstation software, K011196 |

· Device Description and indications for Use · Device Description and indications for of other MRI vendors. Mask data, generated by automatic segmentation and/or manual editing, and quantitative results from different users generated by automatic segmentation aftarer manality of results from different users and easy export to standard spreadsheet software.

and easy export to standard spreadsheer onliners.
Neuro-(radio)logists in hospitals and specialists in core labs use the understing, and Neuro-(radio)logists in nospitals and specialists in the provided objective and analytical soliware package in image pot. process or are used in the quantitative Values Support the utagnostic und / or therapy response.

## · Intended use

• Intended use The QErain sonware has been developped for the onalyses on MR brain images of based on automatic segmentation. More specifically, it quantifies the volumes of based on automatic segmentation: more openiture, more openiture (CSF), and white matter hyperintensities (lesions).

nyperimenties (lesions).
These parameters should only be used by trained medical professionals in alinian trials These parameters should only be used by trained weach conclusions in clinical trials.

# • Substantial equivalence Information

· Substantial equivalent to the Predicate Device of Insightful Corporation QBRAIN IS substantially equivalent to the Products annique for the same intended use.

### Conclusion

It is our opinion, QBrain is safe because during the development ond rick, and rick, and rick, and rick, and rick, and rick, and rick, and rick, and rick, and rick, and rick, It is our opinion, QBrain is sale because canning and hazard and risk analyses,
were controlled by a risk management plan, including hazard and risk andyses, were controlled by a fisk management partic partic and literature support this verticalion and validation tests. Endinone if will not have any adverse effects on statement. The solware package QDrain noon will not have any any any and chooses to accept or reject the results.

accept of reject the results.
In current thinking, the level of concern for the standalone software in image post-In current thinkling, the lever of QBrain does not change the intended use of MRI processing is "Minor and the use result in any new potential hazard.

scanners in practice, nor does the use roour in any conclude that the subject device is Based of the information ouplikalent to the predicate device.

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Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The eagle is facing left and appears to be in flight. The logo is black and white.

## Public Health Service

APR 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. J.I. Hollander Quality Coordinator Medis Medical Imaging Systems bv Schuttersveld 9, 2316 XG Leiden THE NETHERLANDS

Re: K050703 Trade/Device Name: QBrain Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications systems Regulatory Class: II Product Code: LLZ Dated: March 3, 2005 Received: March 18, 2005

Dear Mr. Hollander:

Doar Mr 2001
We have reviewed your Section by the time to maket the indications for use stated in We have reviewed your Section 510(K) premainst interested (for the indications for use stated in
above and have determined the device is substantially equival in interests pr above and have determined the devices is substances marketed in interstate commerce prior to
the enclosure) to legally marketed predicated in interstate or to devices that ha the enclosure) to legally marketed predical Device Amendments, or to devices that have been
May 28, 1976, the enactment date of the Medical Device and Cosmetic Act (Act) the May 28, 1976, the enactment date of the Necded Dely, and Cosmetic Act (Act) that reclassified in accordance with the provisions of and of the A. You may, therefore, market the do not require approval of a premarket approval application (The eyeneral controls provisions of the Act
device, subject to the general controls provisions of the Act manufac device, subject to the general controls provisions of devices, good manufacturing practice, labeling, metude requirements iss misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Prematket
) (Special Control (States (Altimal and Prel - Evicting major regul If your device is classified (see above) into crails . Existing major regulations affecting your Approval), it may be subject to such additions, Title 21, Pars 800 to 898. In addition, FDA
device can be found in the Code of Federal Regulation in the Federal Register device can be found in the Code of I edolar regulation of the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that FDA s issualice of a substances with other requirements of the Act or any
FDA has made a determination that your device complies. You must comply with FDA has made a determination inal your device whales what agencies. You must comply with all the Federal statutes and regulations administered by enistration and listing (21 CFR Part 807); labeling
Act's requirements, including, but not limited to registration as as fort Act's requirements, including, but not mined to registed to the the quality systems (QS)
(21 CFR Part 801); good manufacturing practice requirements as set forth in the quali (21 CFR Part 801); good manuacium production in a sectronic product radiation control provisions
regulation (21 CFR Part 820); and if applicable, the electronic product radia (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k)
Children and construction of alience frame faulicatial equivalence of your devic This letter will allow you to begin marketing your also as as as your device of your device to a legally
premarket notification. The FDA indine of substantial equivalence of premarket notification. The FDA finding of substantial equivalence of your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r and the may of the filler following numbers, hased on the regulation numb If you desire specific advice for your device on our labeling regaration (even and on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation while for stime of researce to premarket notification" (21 CFR Also, please note the regulation entitled, Misolaning on your responsibilities under the Act from the 807.97). You may obtain other general information on your responsibility and its toll-free number (800)
Division of Small Manufacturers, International and Consumer Assistanc Division of Small Manafastarana, at its Internet address.
638-2041 or [phone] or at its Internet address 038-2041 of (501) +15 -0/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K050703

Device Name: QBrain

Indications For Use: The QBrain software has been developed for the objective and Indications For USe. The Qurain soltware from In Marc one offically analysis of MR
reproducible analysis of MR images of the brain. It performs quantities the reproducible analysis of Mrs images of the brain. More specifically, it quantifies the brain images based on adtomatic segmentation more opening ;
volumes of intracranial cavities, areas that contain cerebrospinal fluid (CSF), and white matter hyperintensities (lesions).

matter nypermiensities (tesions).
These parameters should only be used by trained conclusions in clinical trials These parameters should only be used by trained model practice and to reach conclusions in clinical trials.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Snowdon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________