(165 days)
Not Found
No
The summary describes a computer-based neurocognitive test battery that provides objective measures and uses established neurocognitive tasks. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The focus is on standard statistical analysis of test results.
No.
The device is a diagnostic aid used to assess neurocognitive functioning to aid in the assessment and management of concussion, not to treat it.
Yes
Explanation: The device is intended to aid in the assessment and management of concussion by providing objective measures of neurocognitive functioning, which is a diagnostic purpose.
Yes
The device description explicitly states "lmPACT is a software-based tool" and the performance studies focus on software verification and validation, usability, and clinical performance of the software itself, without mentioning any associated hardware components that are part of the medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests 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 like reaction time, memory, and attention through interactive tasks performed by the individual directly on a computer. It does not analyze biological samples.
- Intended Use: The intended use is to "aid in the assessment and management of concussion" by providing "objective measure of neurocognitive functioning." This is a behavioral and cognitive assessment, not a diagnostic test performed on a biological sample.
Therefore, while ImPACT is a medical device used in healthcare, it falls outside the definition of an In Vitro Diagnostic.
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.
lmPACT 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.
lmPACT 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.
lmPACT for use in supervised and unsupervised settings incorporates several risk controls to mitigate the risk of external factors affecting the validity of the test results. These include:
- Test structure that assesses several different cognitive domains. .
- Subscale scores, composite scores based on factor analysis, and supporting measures (e.g., Invalidity Indicator, Cognitive Efficiency Index, and Reliable Change Index) were all developed and validated to reduce error caused by variation in test environment or effort, and to assist the healthcare provider in interpreting of results.
- An Invalidity Indicator was included to aid in identifying invalid baseline examinations when performance falls below the expected range.
- . Baseline test results are not provided to test-takers (the results are only available for viewing by healthcare providers; a unique id, called an ImPACT Passport ID, is assigned to each test allowing the test-takers to share the results with trained healthcare providers).
- Instructions detailing the proper baseline testing environment available to the test . purchase and at the beginning of the test. These instructions must be viewed before proceeding to the baseline test.
- . A baseline test is not required for clinical assessment of concussion, but provides incremental validity to the management of a suspected concussion when used in conjunction with the normative database available for post-injury testing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
12-59
Intended User / Care Setting
Healthcare professionals; Supervised and unsupervised settings for baseline testing, supervised environment only for post-injury testing.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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 and security risks, are appropriately mitigated.
Additionally, to validate test takers' ability to perform the baseline test in an unsupervised environment, a usability assessment and a usability study was performed on 162 subjects. The sample included 74 college students, 44 Middle and High School students, and 44 adults. 5.8% of subjects reported invalid results. The results of the studies indicate that the number of invalid self-administered tests are not different when compared to the supervised environment reported in the literature.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains 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.
October 20, 2018
ImPACT Applications, Inc. Michael Zagorski Director of Regulatory Affairs 9665 Granite Ridge Drive, Suite 550 San Diego, California 92123
Re: K181223
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: June 27, 2018 Received: June 29, 2018
Dear Michael 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. 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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
(1-800-638-2041 or 301-796-7100).
Sincerely,
Jay R. Gupta -S
For Carlos L. Peña, PhD, MS 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) K181223
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 contains the logo for ImPACT Applications, Inc. The logo features a stylized outline of a human head with a brain inside on the left. To the right of the head is the company name, "ImPACT," in a two-tone blue color scheme, with "Im" in a darker blue and "PACT" in a lighter blue. Below the company name is the text "APPLICATIONS, INC." in smaller, black font.
Submission Date: September 19, 2018
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® |
| 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, K170209 |
| 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.
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.
Device Description:
ImPACT® (Immediate Post-Concussion Assessment and Cognitive Testing) is a computer-based neurocognitive test battery.
4
Image /page/4/Picture/0 description: The image is a logo for ImPACT Applications, Inc. On the left side of the logo is a blue outline of a head with a brain inside. To the right of the head is the word "ImPACT" in blue letters, with the "Im" in a darker blue than the "PACT". Below the word "ImPACT" is the phrase "APPLICATIONS, INC." in smaller, dark blue letters.
lmPACT 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.
lmPACT 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.
lmPACT for use in supervised and unsupervised settings incorporates several risk controls to mitigate the risk of external factors affecting the validity of the test results. These include:
- Test structure that assesses several different cognitive domains. .
- Subscale scores, composite scores based on factor analysis, and supporting measures (e.g., Invalidity Indicator, Cognitive Efficiency Index, and Reliable Change Index) were all developed and validated to reduce error caused by variation in test environment or effort, and to assist the healthcare provider in interpreting of results.
- An Invalidity Indicator was included to aid in identifying invalid baseline examinations when performance falls below the expected range.
- . Baseline test results are not provided to test-takers (the results are only available for viewing by healthcare providers; a unique id, called an ImPACT Passport ID, is assigned to each test allowing the test-takers to share the results with trained healthcare providers).
- Instructions detailing the proper baseline testing environment available to the test . purchase and at the beginning of the test. These instructions must be viewed before proceeding to the baseline test.
- . A baseline test is not required for clinical assessment of concussion, but provides incremental validity to the management of a suspected concussion when used in conjunction with the normative database available for post-injury testing.
Device Modifications:
The modified version of ImPACT is substantially equivalent to predicate device cleared under K170209. Both devices have the same intended use for use as computerized neurocognitive tests to aid in the assessment and management of concussion. They are also identical in terms of technological characteristics as both are standalone 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, functionality of both devices is identical.
The differences between the new device and the predicate include:
- change to the use environment to allow baseline testing in unsupervised environment, and
- modifications to the optional demographics portion of the test to shorten and streamline the test administration.
There are no changes to the intended use, users, patient population 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.
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Image /page/5/Picture/0 description: The image is a logo for ImPACT Applications, Inc. The logo features a stylized drawing of a human head with a brain inside, followed by the text "ImPACT" in blue and light blue. Below the text is the phrase "APPLICATIONS, INC." in smaller, uppercase letters. The logo is clean and professional, suggesting a focus on brain-related applications.
510(k) Summary
| Table 1. Predicate Comparison. | ||
|---|---|---|
| Characteristic | Predicate Device: ImPACT (K170209) | Modified Device: ImPACT |
| Intended 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. | Same as predicate | |
| Patient Population | 12-59 | Same as predicate |
| Use Environment | Recommended supervised environment for baseline and post-injury | |
| testing. | Similar to predicate | |
| Unsupervised and supervised | ||
| environment for baseline | ||
| testing. | ||
| Supervised environment only | ||
| for post-injury testing. | ||
| Neurocognitive test | ||
| battery | 1. Demographic data, (age, gender, concussion history, relevant | |
| medical information) |
- Symptoms list and questionnaires
- Neurocognitive test battery consisting of 6 modules:
Module 1: Word Memory and Delayed Memory Recognition Module 2: Design Memory and Delayed Design Recognition Module 3: X's and O's Module 4: Symbol Matching Module 5: Color Match Module 6: Three Letter Memory | Same as predicate |
| Results | 1. Recording and scoring of symptoms - Raw Scores and Composite Scores
- Normative data | Same as predicate |
| Suggest options or
treatment | No | Same as predicate |
| User Interface | Desktop or laptop computer screen to present stimuli. | Same as predicate |
| Platform | Stand-alone software running on general purpose commercial off-the-
shelf personal computers (desktops, laptops), with a modern web
browser connected to the internet. | Same as predicate |
| Software Technology | Software application, written in HTML5, accessed via standard web
browser | Same as predicate |
| Stimulus
presentation | Information and stimulus displayed on a desktop or laptop computer
screen | Same as predicate |
| Stimulus capture
(test taker response) | ImPACT uses computer peripherals to capture test taker's response | Same as predicate |
| Data Storage | Remote central database | Same as predicate |
| Standards Used | ISO 14971 and IEC 62304 | Same as predicate |
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 and security risks, are appropriately mitigated.
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Image /page/6/Picture/0 description: The image shows the logo for ImPACT Applications, Inc. The logo features a stylized outline of a human head with a brain inside, followed by the company name in a bold, two-tone blue font. The "Im" is a darker blue, while the "PACT" is a lighter blue. Below the company name, the words "APPLICATIONS, INC." are written in a smaller, sans-serif font.
Additionally, to validate test takers' ability to perform the baseline test in an unsupervised environment, a usability assessment and a usability study was performed on 162 subjects. The sample included 74 college students, 44 Middle and High School students, and 44 adults. 5.8% of subjects reported invalid results. The results of the studies indicate that the number of invalid self-administered tests are not different when compared to the supervised environment reported in the literature.
Summary of Clinical Data:
The goal of this is to demonstrate that performing a baseline test does without direct oversight of a baseline test administrator does not affect the test-retest reliability of ImPACT.
A total of 50 participants completed the ImPACT test and brief survey on two occasions, approximately 80 days between assessments (Mean=80 days, S.D.=17 days, Range=52 to 108 days). None of the participants were unable to complete the test independently, or in one test session, with no "Invalid Baselines" obtained.
Pearson correlations between baseline assessments ranged from .43 to .78. ICCs reflected higher reliability than Pearson's r, across all measures. Visual Motor Speed scores showed the most stability (mean ICC=.91, .84 to .95 (lower and upper 95% confidence intervals); UER=.91), followed by Reaction Time (.78, .61-.87; UER=.79), Visual Memory (.62, .34-.77; UER=.64), and Verbal Memory (.55, .20-.74; UER=.56). Mean ImPACT composite and symptom scores showed no significant improvement between the two assessments on any of the Composite Scores. There were no significant practice effects across the two assessments, at a mean of 80 days, and scores reflected considerable stability as reflected in ICCs and UERs.
Substantial Equivalence:
The differences in the use environment and software described above do not affect the safety or effectiveness of lmPACT for its intended use, which was demonstrated through risk management, usability assessment and performance testing. Therefore, the modified device is substantially equivalent to the predicate.