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Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

Page Type
Product Code
Definition
A traumatic brain injury eye movement assessment aid is a prescription device that uses a patient’s tracked eye movements to provide an interpretation of the functional condition of the patient’s brain. This device is an assessment aid that is not intended for standalone detection or diagnostic purposes.
Physical State
The device has a screen that displays a stimulus for the patient's eyes to follow during the exam. An eye tracking camera measures the eye movements for the duration of the exam. A computer applies an analysis algorithm to the tracked eye movements. The device may be a standalone device or implemented as a software app on a smartphone/tablet.
Technical Method
Performs an analysis of a patient's tracked eye movements to assess their functional brain injury status.
Target Area
The device measures eye movements to assess brain function.
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1455
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.1455 Traumatic brain injury eye movement assessment aid

§ 882.1455 Traumatic brain injury eye movement assessment aid.

(a) Identification. A traumatic brain injury eye movement assessment aid is a prescription device that uses a patient's tracked eye movements to provide an interpretation of the functional condition of the patient's brain. This device is an assessment aid that is not intended for standalone detection or diagnostic purposes.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance data under anticipated conditions of use must evaluate tracked eye movement in supporting the indications for use and include the following:

(i) Evaluation of sensitivity, specificity, positive predictive value, and negative predictive value using a reference method of diagnosis;

(ii) Evaluation of device test-retest reliability; and

(iii) A description of the development of the reference method of diagnosis, which may include a normative database, to include the following:

(A) A discussion of how the clinical work-up was completed to establish the reference method of diagnosis, including the establishment of inclusion and exclusion criteria; and

(B) If using a normative database, a description of how the “normal” population was established, and the statistical methods and model assumptions used.

(2) Software verification, validation, and hazard analysis must be performed. Software documentation must include a description of the algorithms used to generate device output.

(3) Performance testing must demonstrate the electrical safety and electromagnetic compatibility (EMC) of the device.

(4) The patient-contacting components of the device must be demonstrated to be biocompatible.

(5) A light hazard assessment must be performed for all eye-tracking and visual display light sources.

(6) Labeling must include:

(i) A summary of clinical performance testing conducted with the device, including sensitivity, specificity, positive predictive value, negative predictive value, and test-retest reliability;

(ii) A description of any normative database that includes the following:

(A) The clinical definition used to establish a “normal” population and the specific selection criteria;

(B) The format for reporting normal values;

(C) Examples of screen displays and reports generated to provide the user results and normative data;

(D) Statistical methods and model assumptions; and

(E) Any adjustments for age and gender.

(iii) A warning that the device should only be used by trained healthcare professionals;

(iv) A warning that the device does not identify the presence or absence of traumatic brain injury or other clinical diagnoses;

(v) A warning that the device is not a standalone diagnostic; and

(vi) Any instructions to convey to patients regarding the administration of the test and collection of test data.

[86 FR 71384, Dec. 16, 2021]

Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

Page Type
Product Code
Definition
A traumatic brain injury eye movement assessment aid is a prescription device that uses a patient’s tracked eye movements to provide an interpretation of the functional condition of the patient’s brain. This device is an assessment aid that is not intended for standalone detection or diagnostic purposes.
Physical State
The device has a screen that displays a stimulus for the patient's eyes to follow during the exam. An eye tracking camera measures the eye movements for the duration of the exam. A computer applies an analysis algorithm to the tracked eye movements. The device may be a standalone device or implemented as a software app on a smartphone/tablet.
Technical Method
Performs an analysis of a patient's tracked eye movements to assess their functional brain injury status.
Target Area
The device measures eye movements to assess brain function.
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1455
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.1455 Traumatic brain injury eye movement assessment aid

§ 882.1455 Traumatic brain injury eye movement assessment aid.

(a) Identification. A traumatic brain injury eye movement assessment aid is a prescription device that uses a patient's tracked eye movements to provide an interpretation of the functional condition of the patient's brain. This device is an assessment aid that is not intended for standalone detection or diagnostic purposes.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance data under anticipated conditions of use must evaluate tracked eye movement in supporting the indications for use and include the following:

(i) Evaluation of sensitivity, specificity, positive predictive value, and negative predictive value using a reference method of diagnosis;

(ii) Evaluation of device test-retest reliability; and

(iii) A description of the development of the reference method of diagnosis, which may include a normative database, to include the following:

(A) A discussion of how the clinical work-up was completed to establish the reference method of diagnosis, including the establishment of inclusion and exclusion criteria; and

(B) If using a normative database, a description of how the “normal” population was established, and the statistical methods and model assumptions used.

(2) Software verification, validation, and hazard analysis must be performed. Software documentation must include a description of the algorithms used to generate device output.

(3) Performance testing must demonstrate the electrical safety and electromagnetic compatibility (EMC) of the device.

(4) The patient-contacting components of the device must be demonstrated to be biocompatible.

(5) A light hazard assessment must be performed for all eye-tracking and visual display light sources.

(6) Labeling must include:

(i) A summary of clinical performance testing conducted with the device, including sensitivity, specificity, positive predictive value, negative predictive value, and test-retest reliability;

(ii) A description of any normative database that includes the following:

(A) The clinical definition used to establish a “normal” population and the specific selection criteria;

(B) The format for reporting normal values;

(C) Examples of screen displays and reports generated to provide the user results and normative data;

(D) Statistical methods and model assumptions; and

(E) Any adjustments for age and gender.

(iii) A warning that the device should only be used by trained healthcare professionals;

(iv) A warning that the device does not identify the presence or absence of traumatic brain injury or other clinical diagnoses;

(v) A warning that the device is not a standalone diagnostic; and

(vi) Any instructions to convey to patients regarding the administration of the test and collection of test data.

[86 FR 71384, Dec. 16, 2021]