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Pediatric Autism Spectrum Disorder Diagnosis Aid

Page Type
Product Code
Definition
A pediatric Autism Spectrum Disorder diagnosis aid is a prescription device that is intended for use as an aid in the diagnosis of Autism Spectrum Disorder in pediatric patients.
Physical State
The device collects data based on the clinical presentation of a patient. An analysis algorithm is applied to the collected data. The device may be stand-alone or implemented as a software application on a smartphone or other general purpose computing platform.
Technical Method
Performs an analysis of patient behavioral data to aid in the diagnosis of Autism Spectrum Disorder.
Target Area
The device is intended to aid in the diagnosis of Autism Spectrum Disorder.
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1491
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.1491 Pediatric Autism Spectrum Disorder diagnosis aid

§ 882.1491 Pediatric Autism Spectrum Disorder diagnosis aid.

(a) Identification. A pediatric Autism Spectrum Disorder diagnosis aid is a prescription device that is intended for use as an aid in the diagnosis of Autism Spectrum Disorder in pediatric patients.

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

(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including an evaluation of sensitivity, specificity, positive predictive value, and negative predictive value using a reference method of diagnosis and assessment of patient behavioral symptomology.

(2) Software verification, validation, and hazard analysis must be provided. Software documentation must include a detailed, technical description of the algorithm(s) used to generate device output(s), and a cybersecurity assessment of the impact of threats and vulnerabilities on device functionality and user(s).

(3) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.

(4) Labeling must include:

(i) Instructions for use, including a detailed description of the device, compatibility information, and information to facilitate clinical interpretation of all device outputs; and

(ii) A summary of any clinical testing conducted to demonstrate how the device functions as an interpretation of patient behavioral symptomology associated with Autism Spectrum Disorder. The summary must include the following:

(A) A description of each device output and clinical interpretation;

(B) Any performance measures, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV);

(C) A description of how the cutoff values used for categorical classification of diagnoses were determined; and

(D) Any expected or observed adverse events and complications.

(iii) A statement that the device is not intended for use as a stand-alone diagnostic.

[87 FR 80445, Dec. 30, 2022]

Pediatric Autism Spectrum Disorder Diagnosis Aid

Page Type
Product Code
Definition
A pediatric Autism Spectrum Disorder diagnosis aid is a prescription device that is intended for use as an aid in the diagnosis of Autism Spectrum Disorder in pediatric patients.
Physical State
The device collects data based on the clinical presentation of a patient. An analysis algorithm is applied to the collected data. The device may be stand-alone or implemented as a software application on a smartphone or other general purpose computing platform.
Technical Method
Performs an analysis of patient behavioral data to aid in the diagnosis of Autism Spectrum Disorder.
Target Area
The device is intended to aid in the diagnosis of Autism Spectrum Disorder.
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1491
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.1491 Pediatric Autism Spectrum Disorder diagnosis aid

§ 882.1491 Pediatric Autism Spectrum Disorder diagnosis aid.

(a) Identification. A pediatric Autism Spectrum Disorder diagnosis aid is a prescription device that is intended for use as an aid in the diagnosis of Autism Spectrum Disorder in pediatric patients.

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

(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including an evaluation of sensitivity, specificity, positive predictive value, and negative predictive value using a reference method of diagnosis and assessment of patient behavioral symptomology.

(2) Software verification, validation, and hazard analysis must be provided. Software documentation must include a detailed, technical description of the algorithm(s) used to generate device output(s), and a cybersecurity assessment of the impact of threats and vulnerabilities on device functionality and user(s).

(3) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.

(4) Labeling must include:

(i) Instructions for use, including a detailed description of the device, compatibility information, and information to facilitate clinical interpretation of all device outputs; and

(ii) A summary of any clinical testing conducted to demonstrate how the device functions as an interpretation of patient behavioral symptomology associated with Autism Spectrum Disorder. The summary must include the following:

(A) A description of each device output and clinical interpretation;

(B) Any performance measures, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV);

(C) A description of how the cutoff values used for categorical classification of diagnoses were determined; and

(D) Any expected or observed adverse events and complications.

(iii) A statement that the device is not intended for use as a stand-alone diagnostic.

[87 FR 80445, Dec. 30, 2022]