ANAM Test System: Military Battery

K150154 · Vista Lifesciences, Inc. · PKQ · Aug 28, 2015 · Neurology

Device Facts

• Record ID: K150154
• Device Name: ANAM Test System: Military Battery
• Applicant: Vista Lifesciences, Inc.
• Product Code: PKQ · Neurology
• Decision Date: Aug 28, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1470
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The ANAM Test System: Military Battery provides clinicians with objective measurements of cognitive performance in military populations ages 18 to 65 years, to aid in the assessment of an individual's level of cognitive functioning. The ANAM Test System should only be used as an adjunctive tool for evaluating cognitive function.

Device Story

Software-only device; provides objective cognitive performance measurements; used by clinicians as adjunctive tool. Input: user performance on sequential modules (demographics, sleepiness/mood/symptom scales, TBI questionnaire, reaction time, mathematical processing, matching to sample, code substitution). Operation: software downloaded to Dell Latitude E6440 laptop; user completes battery of tasks. Output: ANAM Performance Report (APR) containing raw scores, standard scores (via military normative database), and ANAM Composite Score (ACS). Clinicians use output to assess cognitive function changes over time or against normative data; does not provide impairment diagnosis. Benefits: provides reliable, objective cognitive assessment data to support clinical decision-making.

Clinical Evidence

Bench testing only. Concurrent validity established via studies documenting correlations between ANAM and traditional neuropsychological tests, demonstrating reliable measurement of cognitive function.

Technological Characteristics

Software-only device; runs on Windows 7 Dell Latitude E6440 laptop; uses USB-connected mouse. Provides objective cognitive assessment via sequential task modules. No specific hardware materials or sterilization required.

Indications for Use

Indicated for military populations ages 18 to 65 years to provide objective measurements of cognitive performance as an adjunctive tool for assessing cognitive functioning.

Regulatory Classification

Identification

The computerized cognitive assessment aid is a prescription device that uses an individual's score(s) on a battery of cognitive tasks to provide an interpretation of the current level of cognitive function. The computerized cognitive assessment aid is used only as an assessment aid to determine level of cognitive functioning for which there exists other valid methods of cognitive assessment and does not identify the presence or absence of clinical diagnoses. The computerized cognitive assessment aid is not intended as a stand-alone or adjunctive diagnostic device.

Special Controls

*Classification.* Class II (special controls). Except when the computerized cognitive assessment aid is intended for diagnostic assessment of specific diseases or conditions and relies on inputs from visual cues, auditory cues, and/or functional use of the hand, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. The special control(s) for this device are:(1) The technical parameters of the device's hardware and software must be fully characterized and be accompanied by appropriate non-clinical testing: (i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed. (ii) 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). Appropriate software verification, validation, and hazard analysis must be performed. (2) The device must be designed and tested for electrical safety. (3) The labeling must include: (i) A summary of any testing conducted to demonstrate how the device functions as an interpretation of the current level of cognitive function. The summary of testing must include the following, if available: Any expected or observed adverse events and complications; any performance measurements including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) per the devices intended use; a description of the repeatability of measurements; a description of how the cut-off values for categorization of measurements were determined; and a description of the construct validity of the device. (ii) A warning that the device does not identify the presence or absence of clinical diagnoses. (iii) A warning that the device is not a stand-alone diagnostic. (iv) The intended use population and the intended use environment. (v) Any instructions technicians must convey to patients regarding the administration of the test and collection of cognitive test data.

In combination with the general controls of the FD&C Act, the Computerized Cognitive Assessment Aid is subject to the following special controls:

Predicate Devices

• Cerebral Assessment Systems Cognivue (DEN130033)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 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" arranged 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

August 28, 2015

Vista Lifesciences, Inc. c/o Calley Herzog Senior Consultant Biologics Consulting Group, Inc. 400 N. Washington St. Suite 100 Alexandria, Virginia 22314

Re: K150154

Trade/Device Name: ANAM Test System: Military Battery Regulation Number: 21 CFR 882.1470 Regulation Name: Computerized Cognitive Assessment Aid Regulatory Class: Class II Product Code: PKQ Dated: July 30, 2015 Received: July 31, 2015

Dear Ms. Herzog:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

the quality systems (OS) 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Michael J. 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) K150154

Device Name ANAM Test System: Military Battery

#### Indications for Use (Describe)

The ANAM Test System: Military Battery provides clinicians with objective measurements of cognitive performance in military populations ages 18 to 65 years, to aid in the assessment of an individual's level of cognitive functioning. 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) | |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

#### 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 [e-mail]

"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}------------------------------------------------

# 510(K) SUMMARY

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for ANAM Test System: Military Battery is provided below.

| Device Common Name: | Computerized Cognitive Assessment Aid |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Proprietary Name: | ANAM Test System: Military Battery |
| Applicant: | Vista LifeSciences, Inc.<br>PO Box 4670<br>Parker CO 80134<br>Phone: [phone] Ext. 1<br>www.vistalifesciences.com |
| Contact: | Lori White<br>Quality Systems Program Manager<br>Vista LifeSciences, Inc.<br>PO Box 4670<br>Parker CO 80134<br>Phone: [phone] Ext. 1<br>Email: [e-mail] |
| Prepared by: | Calley Herzog<br>Senior Consultant<br>Biologics Consulting Group, Inc.<br>400 N. Washington St. Suite 100<br>Alexandria, VA 22314<br>Email: [e-mail]<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | July 30, 2015 |
| Classification Regulation: | 882.1470 |
| Panel: | Neurology |
| Product Code: | PKQ |
| Predicate Device: | DEN130033, Cerebral Assessment Systems Cognivue |

### Indication for Use:

The ANAM Test System: Military Battery provides clinicians with objective measurements of cognitive performance in military populations ages 18 to 65 years, to aid in the assessment of an individual's level of cognitive functioning. The ANAM Test System should only be used as an adjunctive tool for evaluating cognitive function.

{4}------------------------------------------------

## Device Description:

ANAM Test System: Military Battery is a software only device that provides clinicians with objective measurements of cognitive performance in military populations, to aid in the assessment of an individual's level of cognitive function.

The software is downloaded from the Vista LifeSciences website and is for use on a Dell Latitude E6440 Laptop. The laptop 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: Military Battery:

- 1. Demographics
- 2. Sleepiness Scale
- 3. Symptoms Checklist
- 4. Mood Scale
- 5. TBI Questionnaire
- 6. Simple Reaction Time
- 7. Code Substitution Learning
- Procedural Reaction Time 8.
- 9. Mathematical Processing
- 10. Matching to Sample
- 11. Code Substitution Delayed
- 12. Simple Reaction Time (R)

### Performance Data:

The 510(k) included the results of numerous studies that examined the concurrent validity of ANAM as a clinical tool by documenting correlations with traditional neuropsychological tests. The results of these studies demonstrate that ANAM provides a reliable measure of cognitive function, and is therefore substantially equivalent to the predicate device.

### Substantial Equivalence:

Both devices are computerized assessment aids that use an individual's score(s) on a battery of cognitive tasks to provide an interpretation of the current level of cognitive function. In addition to perceptual and memory function, ANAM may be used as an adjunctive tool for evaluating additional functions including: visuomotor reaction time and processing speed, simple decision making, visual scanning, associative learning, visual-spatial processing, and attention.

{5}------------------------------------------------

| | Proposed Device | Predicate Device |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K150154 | DEN130033 |
| Device Name | ANAM Test System: Military<br>Battery | Cognivue |
| Submitter | Vista LifeSciences, Inc. | Cerebral Assessment Systems |
| Classification Regulation | Computerized Cognitive<br>Assessment Aid | Computerized Cognitive<br>Assessment Aid |
| Product Code | PKQ | PKQ |
| Indication | The ANAM Test System:<br>Military Battery provides<br>clinicians with objective<br>measurements of cognitive<br>performance in military<br>populations ages 18 to 65 years,<br>to aid in the assessment of an<br>individual's level of cognitive<br>functioning. The ANAM Test<br>System should only be used as an<br>adjunctive tool for evaluating<br>cognitive function. | Cognivue is an adjunctive tool<br>for evaluating perceptual and<br>memory function in individuals<br>aged 55-95 years old. |
| Platform | PC: Dell Latitude E6440 Laptop<br>Computer, two button USB<br>connected mouse, and Windows<br>7 operating system. | Computer, monitor, rotatory<br>manipulandum, printer, and<br>mouse/keyboard are provided on<br>a device cart. |
| Use Cases | Reports individual test results<br>and compares changes in<br>individual tests over time and/or<br>against military normative data. | Reports individual test results<br>and compares overall<br>performance to a cut-off. |
| | Proposed Device | Predicate Device |
| Patient Population | Military population | Adults |
| Age of Users | 18-65 years | 55-95 years |
| How Provided | Software only, downloaded | Software is pre-installed on<br>computer hardware provided by<br>the manufacturer. |
| Reporting features | ANAM Performance Report<br>(APR) provides raw scores and<br>standard scores (calculated with<br>the military normative database)<br>for each test within the battery.<br>APR also yields the ANAM<br>Composite Score (ACS)<br>summarizing performance across<br>the test battery. | Cognivue Performance Profile<br>report yields a single output<br>measure that is an average score<br>of the four perception scores and<br>four memory scores. |
| Psychometric Properties | ANAM demonstrates construct<br>validity with traditional<br>neuropsychological tests. | Cognivue demonstrates construct<br>validity with traditional<br>neuropsychological tests. |
| Results Interpretation | ANAM does not provide a<br>recommendation that the patient<br>is impaired vs. unimpaired.<br>Clinical interpretation of the<br>results includes comparison with<br>the normative database. ANAM<br>provides raw scores, standard<br>scores, and reliable change<br>indices for each test. | Cognivue provides an average<br>score that is categorized as<br>unimpaired, impaired, or<br>intermediate/indeterminate based<br>on comparison with a normative<br>database. Sub-tests may not be<br>evaluated individually. |

{6}------------------------------------------------

## Summary / Conclusion of Substantial Equivalence Rationale

Although there are some differences in the modules between ANAM and the predicate device, and ANAM provides a comparison to a normative database, the performance testing demonstrates that ANAM provides a reliable measure of cognitive function, and is therefore substantially equivalent to the predicate device.