(303 days)
No
The summary describes a software-only device that administers standardized neurocognitive tests and questionnaires to aid in the assessment of mild traumatic brain injury. It measures reaction time, memory, attention, and spatial processing speed. There is no mention of AI or ML algorithms being used for data analysis, interpretation, or any other function within the device. The performance studies focus on concurrent validity with traditional neuropsychological tests and comparison to normative data, not on the performance of an AI/ML model.
No.
The device is described as an aid in assessment and management, providing objective measures of neurocognitive functioning. It does not directly treat or restore health.
Yes
Justification: The "Intended Use / Indications for Use" section explicitly states that the device aids in the "assessment of mild traumatic brain injury" and provides "objective measure of neurocognitive functioning as assessment aids and in the management of mild traumatic brain injury." This indicates its role in diagnosing or assessing a medical condition.
Yes
The device description explicitly states "The ANAM Test System is a software only device" and clarifies that the hardware (PC or tablet) is purchased separately by the user.
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.
- Device Description: The ANAM Test System is a software-only device that administers computer-based neurocognitive tests and questionnaires. It measures cognitive performance and records symptoms. It does not analyze biological samples from the patient's body.
- Intended Use: The intended use is to aid in the assessment and management of mild traumatic brain injury through neurocognitive testing. This is a behavioral and cognitive assessment, not a diagnostic test performed on a biological sample.
Therefore, the ANAM Test System falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ANAM® Test System: Military, Military Expanded, Core, and Sports Batteries are intended for use as computerbased neurocognitive test batteries to aid in the assessment of mild traumatic brain injury. The ANAM Test System: Military, Military Expanded, Core, and Sports Batteries are neurocognitive test batteries that provide healthcare professionals with objective measure of neurocognitive functioning as assessment aids and in the management of mild traumatic brain injury in individuals ages 13-65.
The ANAM Test System should only be used as an adjunctive tool for evaluating cognitive function.
Product codes (comma separated list FDA assigned to the subject device)
POM
Device Description
The ANAM Test System is a software only device that provides clinicians with objective measurements of cognitive performance in populations, to aid in the assessment and management of concussion. ANAM measures various aspects of neurocognitive functioning including reaction time, memory, attention, and spatial processing speed. It also records symptoms of concussion in the test taker.
The software is downloaded from the Vista LifeSciences website and is for use on Dell Inspiron 15 3000 Series or similar Windows PC model or Android Samsung Galaxy tablet or similar Android device. The hardware is not provided as part of the device but is purchased separately by the user. Each ANAM battery consists of a collection of pre-selected modules that are administered in a sequential manner.
Specific modules included in the ANAM Test System:
-
- Questionnaires
-
- Demographics
-
- Mood Scale
-
- Neurobehavioral Symptom Inventory (NSI)
-
- PTSD Checklist (PCL)
-
- Sleepiness Scale
-
- Symptoms Checklist
-
- TBI Questionnaire
Performance Tests
-
- Code Substitution Learning
-
- Code Substitution Delayed
-
- Go/No-Go"
-
- Matching to Sample*
-
- Mathematical Processing
-
- Memory Search
-
- Procedural Reaction Time
-
- Simple Reaction Time*
-
- Spatial Processing*
- *Available for tablet platform.
The tests and questionnaires can be combined into custom batteries or users can choose from pre-configured standardized batteries. The standardized batteries include ANAM Core, ANAM Sports. ANAM Military, and ANAM Military-Expanded. These standardized batteries have fixed test settings and parameters to ensure standardized presentation and enable comparison to normative data.
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
13-65 years
Intended User / Care Setting
Healthcare professionals in a clinical setting.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The 510(k) includes the results of numerous studies that have examined the concurrent validity of ANAM as a clinical tool by documenting correlations with traditional neuropsychological tests with both normal and concussed populations. The results of these studies demonstrate that ANAM provides a reliable measure of cognitive function for use as an assessment aid and in the management of concussion and is therefore substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
March 25, 2021
Vista LifeSciences, Inc. Margaret Molloy President and CEO 7375 S. Peoria St. Suite 210 Englewood, Colorado 80112
Re: K201376
Trade/Device Name: ANAM Test System Regulation Number: 21 CFR 882.1471 Regulation Name: Computerized Cognitive Assessment Aid for Concussion Regulatory Class: Class II Product Code: POM Dated: February 11, 2021 Received: February 19, 2021
Dear Margaret Molloy:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201376
Device Name ANAM Test System
Indications for Use (Describe)
The ANAM® Test System: Military, Military Expanded, Core, and Sports Batteries are intended for use as computerbased neurocognitive test batteries to aid in the assessment of mild traumatic brain injury. The ANAM Test System: Military, Military Expanded, Core, and Sports Batteries are neurocognitive test batteries that provide healthcare professionals with objective measure of neurocognitive functioning as assessment aids and in the management of mild traumatic brain injury in individuals ages 13-65.
The ANAM Test System should only be used as an adjunctive tool for evaluating cognitive function.
| 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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3
5. 510(K) SUMMARY
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the ANAM Test System is provided below.
| Device Common Name: | Computerized Cognitive Test |
|---|---|
| Device Proprietary Name: | ANAM Test System |
| Applicant: | Vista LifeSciences, Inc. |
| PO Box 4670 | |
| Parker CO 80134 | |
| Phone: 888.733.8804 Ext. 1 | |
| www.vistalifesciences.com | |
| Contact: | Margaret E. Molloy |
| CEO and President | |
| Vista LifeSciences, Inc. | |
| PO Box 4670 | |
| Parker CO 80134 | |
| Phone: 888.733.8804 Ext. 4 | |
| Email: memolloy@vistapartners.com | |
| Prepared by: | Lori White |
| Quality Systems Program Manager | |
| Vista LifeSciences, Inc. | |
| PO Box 4670 | |
| Parker CO 80134 | |
| Phone: 888.733.8804 Ext. 1 | |
| Email: lori.white@vistalifesciences.com | |
| Date Prepared: | March 22, 2021 |
| Classification Regulation: | 882.1471 Computerized Cognitive Assessment Aid for |
| Concussion | |
| Panel: | Neurology |
| Product Code: | POM |
| Predicate Device: | DEN150037, ImPACT |
4
Indication for Use:
The ANAM® Test System: Military, Military Expanded, Core, and Sports Batteries are intended for use as computer-based neurocognitive test batteries to aid in the assessment and management of mild traumatic brain injury. The ANAM Test System: Military Expanded, Core, and Sports Batteries are neurocognitive test batteries that provide healthcare professionals with objective measure of neurocognitive functioning as assessment aids and in the management of mild traumatic brain injury in individuals ages 13-65.
The ANAM Test System should only be used as an adjunctive tool for evaluating cognitive function.
Device Description:
The ANAM Test System is a software only device that provides clinicians with objective measurements of cognitive performance in populations, to aid in the assessment and management of concussion. ANAM measures various aspects of neurocognitive functioning including reaction time, memory, attention, and spatial processing speed. It also records symptoms of concussion in the test taker.
The software is downloaded from the Vista LifeSciences website and is for use on Dell Inspiron 15 3000 Series or similar Windows PC model or Android Samsung Galaxy tablet or similar Android device. The hardware is not provided as part of the device but is purchased separately by the user. Each ANAM battery consists of a collection of pre-selected modules that are administered in a sequential manner.
Specific modules included in the ANAM Test System:
-
- Questionnaires
-
- Demographics
-
- Mood Scale
-
- Neurobehavioral Symptom Inventory (NSI)
-
- PTSD Checklist (PCL)
-
- Sleepiness Scale
-
- Symptoms Checklist
-
- TBI Questionnaire
Performance Tests
-
- Code Substitution Learning
-
- Code Substitution Delayed
-
- Go/No-Go"
-
- Matching to Sample*
-
- Mathematical Processing
-
- Memory Search
-
- Procedural Reaction Time
-
- Simple Reaction Time*
-
- Spatial Processing*
- *Available for tablet platform.
5
The tests and questionnaires can be combined into custom batteries or users can choose from pre-configured standardized batteries. The standardized batteries include ANAM Core, ANAM Sports. ANAM Military, and ANAM Military-Expanded. These standardized batteries have fixed test settings and parameters to ensure standardized presentation and enable comparison to normative data.
This 510(k) submission provides evidence demonstrating that the ANAM Test System is substantially equivalent to a POM predicate device and is therefore safe and effective to use following concussion. The ANAM Core, Sports, Military, and Military-Expanded batteries as well as the individual tests comprising these batteries have demonstrated sensitivity to the cognitive effects of concussion and, thus, will serve as the focus of the materials provided herein. In some cases descriptions and features of the entire ANAM Test System have been provided to better facilitate the understanding of the complete system and its many features as a computerized cognitive assessment aid.
Performance Data:
The 510(k) includes the results of numerous studies that have examined the concurrent validity of ANAM as a clinical tool by documenting correlations with traditional neuropsychological tests with both normal and concussed populations. The results of these studies demonstrate that ANAM provides a reliable measure of cognitive function for use as an assessment aid and in the management of concussion and is therefore substantially equivalent to the predicate device.
Substantial Equivalence:
Both the predicate device and ANAM "provide healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion". The predicate device does this by measuring verbal and visual memory, visual motor speed, impulse control, and reaction time. ANAM also measures fundamental neurocognitive functions including response speed, attention/concentration, immediate and delayed memory, spatial processing, inhibition, and decision processing speed and efficiency.
The intended use of ANAM is the same as that of the predicate device, namely for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion.
| Proposed Device | Predicate Device | |
|---|---|---|
| 510(k) Number | TBD | DEN 150037 |
| Device Name | ANAM Test System | ImPACT |
| Submitter | Vista LifeSciences, Inc. | ImPACT Applications, Inc. |
| Classification Regulation | Class II | Class II |
| Product Code | POM | POM |
| Proposed Device | Predicate Device | |
| Indication | The ANAM® Test System: | |
| Military, Military Expanded, | ||
| Core, and Sports Batteries are | ||
| intended for use as computer- | ||
| based neurocognitive test | ||
| batteries to aid in the assessment | ||
| and management of mild | ||
| traumatic brain injury. The | ||
| ANAM Test System: Military, | ||
| Military Expanded, Core, and | ||
| Sports Batteries are | ||
| neurocognitive test batteries that | ||
| provide healthcare professionals | ||
| with objective measure of | ||
| neurocognitive functioning as | ||
| assessment aids and in the | ||
| management of mild traumatic | ||
| brain injury in individuals ages | ||
| 13-65. | ||
| The ANAM Test System should | ||
| only be used as an adjunctive | ||
| tool for evaluating cognitive | ||
| function. | 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. | ||
| Platform | PC: Dell Inspiron 15 3000 Series | |
| or similar Windows laptop | ||
| computer, Windows 10 operating | ||
| system. | ||
| Tablet: Samsung Galaxy Tab A | ||
| tablet or similar Android device, | ||
| Android 7.1 – 8.1 operating | ||
| systems. | Internet browser. | |
| Use Cases | Measures change over time | |
| and/or compares performance | ||
| with normative data. | Measures change over time | |
| and/or compares performance | ||
| with normative data. | ||
| Patient Population | Individuals | Individuals |
| Age of Users | 13-65 years | 12-59 |
| How Provided | Software only, downloaded | Internet browser |
| Proposed Device | Predicate Device | |
| Reporting features | ANAM Performance Report | |
| (APR) provides raw scores and | ||
| standard scores (calculated with | ||
| the normative database) for each | ||
| test within the battery. APR also | ||
| yields the ANAM Composite | ||
| Score (ACS) summarizing | ||
| performance across the test | ||
| battery. The ACS is a summed T- | ||
| score that is computed relative to | ||
| the summed T-score of a | ||
| normative control group. The | ||
| ACS is reported in standard | ||
| deviation units. Reliable Change | ||
| Indices (RCI) are calculated and | ||
| displayed for each individual test | ||
| to capture change in performance | ||
| between a specified test session | ||
| and a previous test session (e.g. | ||
| baseline). | ImPACT Clinical Report | |
| provides composite scores for | ||
| tests in the battery including | ||
| Verbal Memory Composite, | ||
| Visual Memory Composite, | ||
| Visual Motor Speed Composite, | ||
| Reaction Time Composite, | ||
| Impulse Control Composite, | ||
| Total Symptom Score, and | ||
| Cognitive Efficiency Index | ||
| (CEI). Reliable Change Indices | ||
| (RCI) are calculated and | ||
| displayed to capture change in | ||
| performance between a specified | ||
| test session and a previous test | ||
| session (e.g. baseline). | ||
| Results Interpretation | Clinical interpretation of the | |
| results includes comparison with | ||
| the normative database and/or | ||
| previous test sessions. ANAM | ||
| provides raw scores, standard | ||
| scores, and reliable change | ||
| indices for each test. | ||
| Performance on sub-tests are | ||
| evaluated individually as well as | ||
| within the context of the entire | ||
| test battery. | Clinical interpretation of the | |
| results includes comparison with | ||
| the normative database and/or | ||
| previous test sessions. ImPACT | ||
| provides raw scores and | ||
| percentile scores. Performance | ||
| on sub-tests are evaluated | ||
| individually and presented as | ||
| composite scores. |
A technological comparison is provided in the table below.
6
7
Summary / Conclusion of Substantial Equivalence Rationale
Although there are some differences in the modules between ANAM and the predicate device, the performance testing demonstrates that ANAM provides a reliable measure of neurocognitive functioning to aid in the assessment and management of concussion and is therefore substantially equivalent to the predicate device.