Cantab Mobile

K161328 · Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd. · PKQ · Jan 13, 2017 · Neurology

Device Facts

• Record ID: K161328
• Device Name: Cantab Mobile
• Applicant: Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd.
• Product Code: PKQ · Neurology
• Decision Date: Jan 13, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1470
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The CANTAB Mobile is intended to be used as an adjunctive tool to assess memory by testing visuospatial associative learning in patients aged 50 to 90 years.

Device Story

CANTAB Mobile is a computerized cognitive assessment aid used in clinical settings by healthcare providers. It assesses memory function in patients aged 50-90 years by testing visuospatial associative learning. The device presents visual stimuli to the patient, who interacts with the system to complete cognitive tasks. The software processes these inputs to generate performance metrics related to memory function. These outputs are provided to the clinician as an adjunctive tool to assist in the assessment of memory, supporting clinical decision-making regarding cognitive health. The device does not provide a diagnosis but aids in the evaluation process.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Computerized cognitive assessment aid; software-based; intended for use on standard computing hardware; operates as a standalone assessment tool.

Indications for Use

Indicated for patients aged 50 to 90 years to assess memory via visuospatial associative learning as an adjunctive tool.

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:

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 13, 2017

Cambridge Cognition Ltd., % Nancy Clementi, MD Chief Medical Officer, Clementi Associates Ltd. Clementi Associates Ltd 919 Conestoga Rd, Building 3, Suite 312 Rosemont, Pennsylvania 19010

Re: K161328

Trade/Device Name: Cantab Mobile Regulation Number: 21 CFR 882.1470 Regulation Name: Computerized Cognitive Assessment Aid Regulatory Class: Class II Product Code: PKQ Dated: December 21, 2016 Received: December 21, 2016

Dear Dr. Clementi:

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

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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

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K161328

Device Name CANTAB Mobile

Indications for Use (Describe)

The CANTAB Mobile is intended to be used as an adjunctive tool to assess memory by testing visuospatial associative learning in patients aged 50 to 90 years.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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