(117 days)
ImPACT (DEN150037)
No
The summary describes a computerized cognitive test that provides basic data and compares it to normative data and other tests. There is no mention of AI, ML, or any algorithms that learn or adapt based on data. The focus is on providing objective measures and comparing them to established norms and other validated tests.
No.
The device is intended for assessment and management of concussion, providing data related to neurocognitive functioning, and aiding in determining if further evaluation is needed. It does not provide treatment or therapy.
Yes
Explanation: The device is intended to be used as a "computerized cognitive test aid in the assessment and management of concussion" and is "designed to assist trained healthcare professionals in determining a patient's status after a suspected concussion," indicating its role in providing data for diagnosis.
Yes
The device is described as "iPad-based test" and the performance studies focus on software validation and clinical correlations, not hardware performance. While it runs on an iPad, the device itself is the software application.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states it's a "computerized cognitive test aid in the assessment and management of concussion." This involves evaluating cognitive function, not analyzing biological samples (like blood, urine, or tissue) to diagnose a disease or condition.
- Device Description: The description reinforces that it's a "computerized neurocognitive test" that provides data related to "neurocognitive functioning." It doesn't mention any interaction with biological specimens.
- Lack of IVD Characteristics: The description and other sections do not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for the diagnosis, monitoring, or prognosis of a disease based on biological sample analysis.
The device is a software-based tool for assessing cognitive function, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ImPACT Quick Test is intended for use as a computerized cognitive test aid in the assessment and management of concussion in individuals ages 12-70.
Product codes (comma separated list FDA assigned to the subject device)
POM
Device Description
ImPACT Quick Test (ImPACT) QT is a brief computerized neurocognitive test designed to assist trained healthcare professionals in determining a patient's status after a suspected concussion. ImPACT QT provides basic data related to neurocognitive functioning, including working memory, processing speed, reaction time, and symptom recording.
ImPACT QT is designed to be a brief 5-7 minute iPad-based test to aid sideline personnel and first responders in determining if an athlete/individual is in need of further evaluation or is able to immediately return to activity. ImPACT QT is not a substitute for a full neuropsychological evaluation or a more comprehensive computerized neurocognitive test (such as ImPACT).
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
12-70
Intended User / Care Setting
trained healthcare professionals / sideline personnel and first responders
Description of the training set, sample size, data source, and annotation protocol
To develop a normative data set, 772 subjects were recruited by utilizing 11 sites across the United States. All subjects completed an IRB approved consent form and met eligibility criteria before testing. The standardization sample was developed to be representative of the population of individuals ages 12-70 years, based upon the 2010 U.S. Census, approximating the targets for age, gender and race.
All subjects completed an IRB approved consent form and met eligibility criteria before testing. All testing was completed by professionals who were specifically trained to administer the test. These professionals consisted of neuropsychologists, physicians, psychology/psychology/psychology graduate students, certified athletic trainers and athletic training graduate students. All testing was completed in a supervised setting.
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
-
Concurrent Validity Study:
- Study Type: Comparison of ImPACT Quick Test to ImPACT.
- Sample Size: 92 subjects (41 males, 51 females); average age 36.5 years (range 12-76 years).
- Key Results: Correlations between the two instruments ranged from 0.32-0.63, suggesting they measure similar constructs with differences due to subset of tests and unique content in ImPACT Quick Test.
-
Construct Validity Study:
- Study Type: Comparison of ImPACT Quick Test to established neuropsychological tests (Brief Visuospatial Motor Test (BVMT-R), Color Trails Test (CTT), Symbol Digit Modalities Test (SDMT)).
- Sample Size: 118 subjects (73 females, 45 males); average age 32.5 years (range 18-79 years).
- Key Results: Attention Tracker and Motor Speed correlated more highly with BVMT-R and CTT, consistent with expectations. Lower correlation between Memory Scale and BVMT-R was attributed to format and task demand differences.
-
Test-Retest Reliability Study:
- Study Type: Repeated testing of individuals over time.
- Sample Size: 76 individuals.
- Key Results: All test-retest correlations were significant (p
§ 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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 21, 2017
Impact Applications, Inc. Michael Zagorski Director of Regulatory Affairs 9665 Granite Ridge Drive. Suite 550 San Diego, California 92123
Re: K170551
Trade/Device Name: ImPACT Ouick Test Regulation Number: 21 CFR 882.1471 Regulation Name: Computerized Cognitive Assessment Aid For Concussion Regulatory Class: Class II Product Code: POM Dated: May 22, 2017 Received: May 23, 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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
related 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リ. Hoffmann -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) K170551
Device Name ImPACT Quick Test
Indications for Use (Describe)
ImPACT Quick Test is intended for use as a computerized cognitive test aid in the assessment and management of concussion in individuals ages 12-70.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image is a logo for ImPACT Applications, Inc. The logo features a stylized image of a human head in profile, with a brain inside the head. The brain is colored in a light blue color. To the right of the head is the text "ImPACT" in a combination of dark blue and light blue colors. Below the word "ImPACT" is the text "APPLICATIONS, INC."
Section 5 - 510(k) Summary
Submission Date: May 22, 2017
Submitter Information:
| Company: | ImPACT Applications, Inc.
9665 Granite Ridge Drive, Suite 150
San Diego, CA 92123 |
|-------------------------|-----------------------------------------------------------------------------------------|
| Official Correspondent: | Michael Zagorski
Director of Regulatory Affairs |
Device Information:
| Trade Name: | ImPACT Quick Test™™ |
|---|---|
| Classification Name: | Computerized Cognitive Assessment Aid for Concussion |
| Device Class: | II |
| Device Classification: | 21 CFR 882.1471, Product Code POM |
| Review Panel | Neurology |
ImPACT (DEN150037)
ImPACT Applications, Inc. Tel: 412-567-8400 x.939
Email: mzagorski@impacttest.com
Predicate Device:
Indications for Use:
lmPACT Quick Test is intended for use as a computerized cognitive test to aid in the assessment and management of concussion in individuals ages 12-70
Device Description:
lmPACT Quick Test (ImPACT) QT is a brief computerized neurocognitive test designed to assist trained healthcare professionals in determining a patient's status after a suspected concussion. ImPACT QT provides basic data related to neurocognitive functioning, including working memory, processing speed, reaction time, and symptom recording.
lmPACT QT is designed to be a brief 5-7 minute iPad-based test to aid sideline personnel and first responders in determining if an athlete/individual is in need of further evaluation or is able to immediately return to activity. ImPACT QT is not a substitute for a full neuropsychological evaluation or a more comprehensive computerized neurocognitive test (such as ImPACT).
4
Image /page/4/Picture/2 description: The image is a logo for ImPACT Applications, Inc. The logo features a stylized image of a human head in profile, with the brain outlined in blue. To the right of the head is the word "ImPACT" in blue, with the "I" in a darker shade of blue than the rest of the word. Below "ImPACT" is the phrase "APPLICATIONS, INC." in a smaller, darker blue font.
Comparison to Predicate Device:
lmPACT QT is substantially equivalent to ImPACT, manufactured by ImPACT Applications, Inc., and cleared under DEN150037. ImPACT QT and Predicate Device ImPACT share the same intended use as Computerized Cognitive Assessment Aid for Concussion. Both devices enable administration of neuropsychological test taker's cognitive state. They are also similar in terms of technological characteristics as both administer neurocognitive test modules on a standard off-the-shelf computing device and record objective cognitive performance measurements as the test taker responds to stimuli presented on the screen.
lmPACT QT differs from Predicate Device in the content and design of the cognitive tasks, and the test reported for analysis, including different normative data set.
| Table 1 - Substantial Equivalence Comparison | |||
|---|---|---|---|
| Characteristic | New Device: ImPACT Quick | ||
| Test | Predicate Device: ImPACT | ||
| (DEN150037) | Reference Device: ImPACT | ||
| Pediatric (DEN150037) | |||
| Indications of Use | Similar to the Predicate and | ||
| the Reference Device. | |||
| ImPACT QT is intended for | |||
| use as a computerized | |||
| cognitive test to aid in the | |||
| assessment and management | |||
| of concussion in individuals | |||
| ages 12-70. | 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. | 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 5-11. | |||
| Patient | |||
| Population | Similar to the Predicate | ||
| ImPACT QT age range is 12-70 | 12-59 | 5-11 | |
| Technology | Similar to Predicate, and the | ||
| same as Reference Device. | Stand-alone software application | ||
| delivered on desktop/laptop | |||
| computers | Stand-alone software application | ||
| delivered on iPad | |||
| Neurocognitive | |||
| tasks | |||
| administered | Similar to Predicate and | ||
| Reference Devices | |||
| ImPACT QT includes: | |||
| Demographic data, (age, | |||
| gender);Symptoms list;Neurocognitive test battery | |||
| consisting of 3 modules:Module 1: Symbol MatchModule 2: Three letter | |||
| memoryModule 3: Attention | |||
| TrackerModules 1 and 2 are identical to | |||
| Modules 3 and 4 of the Predicate | |||
| Device. | 1. Demographic data, (age, | ||
| gender, concussion history); |
- Symptoms list;
- Neurocognitive test battery
consisting of 6 modules:
Module 1: Word Memory
and Delayed Memory
RecognitionModule 2: Design Memory
and Delayed Design
RecognitionModule 3: X's and O'sModule 4: Symbol
MatchingModule 5: Color MatchModule 6: Three Letter
Memory | 1. Demographic data, (age,
gender, concussion history); - Symptoms list;
- Neurocognitive test battery
consisting of 6 modules:
Module 1: Word Memory
and Delayed Memory
RecognitionModule 2: Design Memory
and Delayed Design
RecognitionModule 3: Stop and GoModule 4: Memory TouchModule 5: Picture MatchModule 6: Color Match |
5
| Image: IMPACT APPLICATIONS, INC. | ImPACT Quick Test - Traditional 510(k) | Section 5 - 510(k) Summary | |
|---|---|---|---|
| Reporting | Similar to Predicate and | ||
| Reference Devices. | |||
| The new device reports | |||
| symptoms and displays test | |||
| results in a form of composites | |||
| score percentiles based on | |||
| normative data. | • Symptom scores | ||
| • Raw Scores (subscales) | |||
| • Composite scores with | |||
| percentiles based on | |||
| normative data. | |||
| • Reliable Change Index. | • Symptom scores | ||
| • Raw Scores | |||
| • Factor Scores with | |||
| percentiles based on | |||
| normative data. | |||
| Results | |||
| Interpretation | Same as Predicate and | ||
| Reference Devices. | ImPACT does not provide a | ||
| recommendation that the | |||
| patient is impaired vs. | |||
| unimpaired. | |||
| Clinical interpretation of the | |||
| results includes comparison with | |||
| the normative database. | ImPACT Pediatric does not | ||
| provide a recommendation that | |||
| the patient is impaired vs. | |||
| unimpaired. | |||
| Clinical interpretation of the | |||
| results includes comparison with | |||
| the normative database. | |||
| Stimulus | |||
| presentation | Same as Predicate Device | Computer screen | Tablet (mobile device) screen |
| Test taker | |||
| response capture | Same as Reference Device | Computer mouse or keyboard | User input (finger touch) via |
| tablet touch-screen | |||
| Psychometric | |||
| properties | Same as Predicate and | ||
| Reference Devices | Demonstrates construct validity | ||
| with traditional | |||
| neuropsychological tests and | |||
| test-retest reliability. | Demonstrates construct validity | ||
| with traditional | |||
| neuropsychological tests and | |||
| test-retest reliability. | |||
| Standards used | ISO 14971 | ||
| IEC 62304 | ISO 14971 | ||
| IEC 62304 | ISO 14971 | ||
| IEC 62304 |
Summary of Non-Clinical Testing:
lmPACT QT software was developed, validated, and documented in accordance with IEC 62304 and FDA Guidance "General Principles of Software Validation." Software verification activities including code reviews, design reviews, evaluations, analyses, traceability assessment, and manual software testing were executed to demonstrate device performance and functionality. All activities were completed successfully and met the required acceptance criteria.
Risk Management activities, conducted in accordance on ISO 14971, assure that all risks related to use of a computerized neurocognitive test, including use related risks and cybersecurity risks, are appropriately mitigated.
Summary of Clinical Testing:
The 510(k) included the results of clinical studies that examined the construct and concurrent validity of ImPACT QT as a clinical tool by documenting correlations with ImPACT and traditional neuropsychological tests. Clinical data was also collected to examine test-retest reliability and to construct a normative database.
Normative Database:
To develop a normative data set, 772 subjects were recruited by utilizing 11 sites across the United States. All subjects completed an IRB approved consent form and met eligibility criteria before testing. The standardization sample was developed to be representative of the population of individuals ages 12-70 years, based upon the 2010 U.S. Census, approximating the targets for age, gender and race.
All subjects completed an IRB approved consent form and met eligibility criteria before testing. All testing was completed by professionals who were specifically trained to administer the test. These professionals consisted of neuropsychologists, physicians, psychology/psychology/psychology graduate students, certified athletic trainers and athletic training graduate students. All testing was completed in a supervised setting.
6
Image /page/6/Picture/2 description: The image is a logo for ImPACT Applications, Inc. The logo features a stylized head with a brain inside, followed by the word "ImPACT" in blue letters. Below the word "ImPACT" is the phrase "APPLICATIONS, INC." in smaller, blue letters. The logo is clean and professional, and it is likely used to represent a company that specializes in brain-related applications.
Concurrent Validity
A study was completed comparing ImPACT Quick Test to ImPACT, the test from which it was derived. This study compared 92 subjects who were given both ImPACT Quick Test. Tests were administered in counterbalanced order across subjects by trained examiners. The sample consisted of 41 (45%) males and 51 (55%) females with an average age of 36.5 years (S.D. = 19.8 years, range = 12-76 years).
The correlations between the two instruments tend to be in the moderate to high range, 0.32-0.63. This suggests that although the two instruments measure similar constructs, the fact that ImPACT Quick Test contains a subset of ImPACT tests as well as unique content explains the moderate relationship between the two instruments.
| Table 2. Concurrent Validity Between ImPACT and ImPACT Quick Test. | |
|---|---|
| Visual Motor Speed | |
| Three Letters Counting Average Correct | .63 |
| Reaction Time | |
| Three Letters Average Time First Click | .47 |
| Attention Tracker Rectangular Average Time Correct | .44 |
| Attention Tracker Figure Eight Average Time Correct | .40 |
| Attention Tracker Complex Average Time Correct | .43 |
| Symbol Match Correct Visible Average Answer Time | .61 |
| Symbol Match Correct Hidden Average Answer Time | .36 |
| Symbol Match Incorrect Hidden Average Answer Time | .32 |
| All correlations p |