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- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
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- GXWEchoencephalograph2Product Code
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- GZODevice, Galvanic Skin Response Measurement2Product Code
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- NCGNeuropsychiatric Interpretative Electroencephalograph Assessment Aid2Product Code
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- OLTNon-Normalizing Quantitative Electroencephalograph Software2Product Code
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- OMCReduced- Montage Standard Electroencephalograph2Product Code
- ORTBurst Suppression Detection Software For Electroencephalograph2Product Code
- PIWBrain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid2Product Code
- PKQComputerized Cognitive Assessment Aid2Product Code
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- PTYComputerized Cognitive Assessment Aid, Exempt2Product Code
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- QEABrain Injury Adjunctive Interpretive Oculomotor Assessment Aid2Product Code
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Computerized Cognitive Assessment Aid, Exempt
- Page Type
- Product Code
- Definition
- This product code is the class II exempt counterpart of PKQ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 882.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
- Physical State
- Exemption applies only to computerized cognitive assessment aids that are not used for diagnostic assessment for specific diseases or conditions and rely on inputs from visual cues, auditory cues, and/or functional use of the hand.
- Technical Method
- This product code is the class II exempt counterpart of PKQ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 882.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
- Target Area
- This product code is the class II exempt counterpart of PKQ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 882.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
- Regulation Medical Specialty
- Neurology
- Review Panel
- Neurology
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 2
- Regulation Number
- 882.1470
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 882.1470 Computerized cognitive assessment aid
§ 882.1470 Computerized cognitive assessment aid.
(a) 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.
(b) 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.
[80 FR 49138, Aug. 17, 2015, as amended at 84 FR 71815, Dec. 30, 2019]