ImPACT

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 23, 2017 ImPACT Applications, Inc Michael Zagorski Director of Regulatory Affairs 9665 Granite Ridge Drive Suite 550 San Diego, California 92123 Re: K170209 Trade/Device Name: ImPACT Regulation Number: 21 CFR 882.1471 Regulation Name: Computerized Cognitive Assessment Aid For Concussion Regulatory Class: Class II Product Code: POM Dated: January 23, 2017 Received: January 24, 2017 Dear Mr. Zagorski: 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. 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 {1}------------------------------------------------ Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely. # Michael J. Hoffmann -S Carlos L. Peña. PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K170209 Device Name ImPACT #### Indications for Use (Describe) ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-59. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------| | <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-weight: bold;"> <span style="color: black;"> </span> </span> </span> </span> | | | <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-weight: bold;"> <span style="color: black;"> <input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </span> </span> | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | # CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The logo is surrounded by a blue border. # Section 5 - 510(k) Summary # Submission Date: January 23, 2016 # Submitter Information: | Company: | ImPACT Applications, Inc.<br>9665 Granite Ridge Drive, Suite 550<br>San Diego, CA 92123 | |----------|-----------------------------------------------------------------------------------------| |----------|-----------------------------------------------------------------------------------------| | Contract Person: | Michael Zagorski | |------------------|---------------------------------| | | Director of Regulatory Affairs | | | ImPACT Applications, Inc. | | | Tel: 412-567-8400 ext. 939 | | | Email: mzagorski@impacttest.com | #### Device Information: | Trade Name: | ImPACT®, ImPACT® Workplace | |------------------------|------------------------------------------------------| | Common Name: | Computerized Cognitive Test | | Classification Name: | Computerized cognitive assessment aid for concussion | | Device Classification: | Class II | | Product Code: | POM, 21 CFR 882.1471 | | Panel: | Neurology | | Predicate Device: | ImPACT, DEN150037 | | Reason for submission | Device Modifications | #### Indications for Use: ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. lmPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-59. #### Device Description: ImPACT® (Immediate Post-Concussion Assessment and Cognitive Testing) is a computer-based neurocognitive test battery. {4}------------------------------------------------ ImPACT is a software-based tool that allows healthcare professionals to conduct a series of neurocognitive tests on individuals to gather basic data related to the neurocognitive functioning of the test subject. This computerized cognitive test battery evaluates and provides a healthcare professional with measures of various neurocognitive functions, including the reaction time, memory, attention, spatial processing speed and symptoms of an individual. ImPACT provides healthcare professionals with a set of well-developed and researched neurocognitive tasks that have been medically accepted as state-of-the-art best practices and is intended to be used as part of a multidisciplinary approach to making return to activity decisions. # Comparison to Predicate Device: ImPACT (HTML5 Version) is substantially equivalent to ImPACT (Flash version), manufactured by ImPACT Applications, Inc., and cleared under DEN150037. Both devices have intended use and indications for use as computerized neurocognitive tests to aid in the assessment of concussion. They are also similar in terms of technological characteristics as both are software applications using general purpose computing platform to electronically record objective performance measurements (speed and accuracy) as the test taker responds to stimuli presented on the screen via input devices. Further, all functionality of both devices is identical. The differences between the new device and the predicate are limited to a modification to the software code language used to develop the device. # Device Modifications The software of the predicate device, Adobe Flash Rich Internet Application (RIA) written in Adobe ActionScript programming language, was re-written using HTML5/CSS/JavaScript. The rewrite effort preserved all functions of the original version. The changes are preventive, to improve software maintainability, and adaptability to cope with changes in the software environment. There are no changes to the intended use, indication for use, including users, patient population, environment of use, or the conditions assessed. Further, there are no changes to the design of neurocognitive test battery; all tasks, stimuli, and captured information remain identical to the original version. # Summary of Performance Testing: Software verification and validation activities including code reviews, evaluations, analyses, traceability assessment, and manual testing were performed in accordance with IEC 62304 and other software standards to demonstrate device performance and functionality. All tests met the required acceptance criteria. Risk Management activities conducted in accordance with ISO 14971 assure all risk related to use of a computerized neurocognitive test, including use related risks are appropriately mitigated. Additionally, to validate the effect of the software change on the performance, two laboratory studies (one bench, one in volunteers age 19-22) were conducted to compare the results of the predicate device (Flash code) and the new device for reaction time. The studies showed that the differences in performance are statistically and clinically insignificant. #### Substantial Equivalence: The differences in design described above do not affectiveness of ImPACT for its intended use, functionality or performance, which was demonstrated through performance testing. Therefore, ImPACT (HTML5 version) is substantially equivalent to predicate ImPACT (Flash version).