QBRAIN

{0}------------------------------------------------ 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 | : +31 71 522 3244 | | Fax | : +31 71 521 5617 | | 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. {1}------------------------------------------------ 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. {2}------------------------------------------------ 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 (301) 443-6597 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 {3}------------------------------------------------ # 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 ________________________________________________________________________________________________________________________________________________________________