SGB · Pain Assessment Software In Non-Communicative Adults

Neurology · 21 CFR 882.1472 · Class 2

Overview

Identification

PainChek Adult is an observational pain assessment software application used to assist healthcare professionals in the assessment of pain in non-verbal patients who have been diagnosed with moderate to severe dementia and who are living in nursing homes. It is a prescription-only device that combines information from clinical pain domains to produce an output indicative of a patient’s current level of pain in conscious adult patients who are unable to communicate their current pain level. It is intended for adjunctive use and not as a stand-alone diagnostic or prognostic tool.

Classification Rationale

FDA has determined that the device can be classified in Class II with the establishment of special controls for Class II, which provide reasonable assurance of the safety and effectiveness of the device type.

Special Controls

In combination with the general controls of the FD&C Act, the pain assessment software in non-communicative adults is subject to the following special controls: (1) Clinical performance validation testing acquired under anticipated conditions of use must demonstrate that the device performs as intended when used to analyze data from the intended patient population. Testing must demonstrate the accuracy and test-retest reliability for assessment of pain as compared to a relevant clinical reference standard. Objective performance measures must be reported. (2) Software verification, validation, and hazard analysis must be provided. Software documentation must include a detailed, technical description of the model/algorithm(s), and algorithm input(s) and output(s). (3) Human factors/usability assessment must demonstrate that the intended user(s) in the intended use environment can correctly use the device and interpret the device output, based solely on reading the instructions for use. (4) Labeling must include: (i) A detailed summary of the clinical performance testing methods, including results of the performance testing for tested performance measures/metrics, selection criteria, and the patient demographics; (ii) A description of the patient population that was used in development or training of the device algorithm/model; (iii) Device limitations or subpopulations for which the device may not perform as expected or for whom the device has not been validated; (iv) A statement that the device is not a stand-alone diagnostic tool, and that the device output should only be interpreted in the context of all available clinical information; and (v) Information for interpretation of the device output detailing the risks associated with misinterpretation of the device output.

Recent Cleared Devices (1 of 1)

Top Applicants

• Painchek Limited (Ltd.) — 1 clearance