(30 days)
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No
The summary describes a computer-based neurocognitive test battery that provides objective measures of cognitive function. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on providing standardized tests and data for healthcare professionals to interpret.
No.
The device is a diagnostic tool that aids in the assessment and management of concussion by providing objective measures of neurocognitive functioning; it does not provide any therapy or treatment.
Yes.
The device is intended to "aid in the assessment and management of concussion" and provides "objective measure of neurocognitive functioning as an assessment aid," which aligns with the definition of a diagnostic device used to identify a condition or disease.
Yes
The device description explicitly states "ImPACT is a software-based tool" and the performance studies focus on software verification and validation, with no mention of hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ImPACT's Function: ImPACT is a computer-based neurocognitive test battery. It assesses cognitive functions through interactive tasks and provides data to healthcare professionals. It does not analyze biological samples from the body.
- Intended Use: The intended use clearly states it's a "computer-based neurocognitive test battery to aid in the assessment and management of concussion." This involves evaluating cognitive performance, not analyzing biological markers.
Therefore, ImPACT falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
POM
Device Description
ImPACT (Immediate Post-Concussion Assessment and Cognitive Testing) is a computer-based neurocognitive test battery.
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
12-59
Intended User / Care Setting
healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 882.1471 Computerized cognitive assessment aid for concussion.
(a)
Identification. The computerized cognitive assessment aid for concussion is a prescription device that uses an individual's score(s) on a battery of cognitive tasks to provide an indication of the current level of cognitive function in response to concussion. The computerized cognitive assessment aid for concussion is used only as an assessment aid in the management of concussion to determine cognitive function for patients after a potential concussive event where other diagnostic tools are available and does not identify the presence or absence of concussion. It is not intended as a stand-alone diagnostic device.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's cognitive function, must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Software verification, validation, and hazard analysis must be performed.
(2) Clinical performance data must be provided that demonstrates how the device functions as an interpretation of the current level of cognitive function in an individual that has recently received an injury that causes concern about a possible concussion. The testing must:
(i) Evaluate device output and clinical interpretation.
(ii) Evaluate device test-retest reliability of the device output.
(iii) Evaluate construct validity of the device cognitive assessments.
(iv) Describe the construction of the normative database, which includes the following:
(A) How the clinical workup was completed to establish a “normal” population, including the establishment of inclusion and exclusion criteria.
(B) Statistical methods and model assumptions used.
(3) The labeling must include:
(i) A summary of any clinical testing conducted to demonstrate how the device functions as an interpretation of the current level of cognitive function in a patient that has recently received an injury that causes concern about a possible concussion. The summary of testing must include the following:
(A) Device output and clinical interpretation.
(B) Device test-retest reliability of the device output.
(C) Construct validity of the device cognitive assessments.
(D) A description of the normative database, which includes the following:
(
1 ) How the clinical workup was completed to establish a “normal” population, including the establishment of inclusion and exclusion criteria.(
2 ) How normal values will be reported to the user.(
3 ) Representative screen shots and reports that will be generated to provide the user results and normative data.(
4 ) Statistical methods and model assumptions used.(
5 ) Whether or not the normative database was adjusted due to differences in age and gender.(ii) A warning that the device should only be used by health care professionals who are trained in concussion management.
(iii) A warning that the device does not identify the presence or absence of concussion or other clinical diagnoses.
(iv) A warning that the device is not a stand-alone diagnostic.
(v) Any instructions technicians must convey to patients regarding the administration of the test and collection of cognitive test data.
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Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows a logo for ImPACT. The logo features a blue silhouette of a head with a brain inside. The word "ImPACT" is written in blue letters next to the head. The logo is surrounded by a blue border.
Section 5 - 510(k) Summary
Submission Date: January 23, 2016
Submitter Information:
| Company: | ImPACT Applications, Inc.
9665 Granite Ridge Drive, Suite 550
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).