# K190760: Cadwell Bolt Software

- Pathway: 510(k) (Traditional)
- Applicant: Cadwell Industries, Inc.
- Decided: Nov 23, 2019 after 243 days
- Product code: OLT (Non-Normalizing Quantitative Electroencephalograph Software)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K875179 (1988). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151929: Persyst 13 (P13) Eeg Review and Analysis Software, Persyst Development Corporation (2015) Summary page 5.
- K173366: NicoletOne, Natus Neurology Incorporated (2018) Summary page 5.
- K161027: Cadwell AmpliScan, Cadwell Industries, Inc. (2016) Summary page 5.

## Indications for use
1. Cadwell Bolt is a software-only device intended for post-hoc analysis of EEG data. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information. This device is intended to be used with EEG data from patients of all ages. 2. Cadwell Bolt includes the calculation and display of a set of quantitative measures intended to monitor and analyze the EEG data. These include the following 10 analyzers: -Amplitude Integrated EEG (aEEG), -Peak Envelope, -Envelope Asymmetry, -Spectrogram, -Band Power, -Power Ratio, -Spectral Entropy, -Burst Suppression Ratio, -Inter-burst Interval, and -Bursts-per-Minute. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG data. A minimum of one epoch of data is required to perform Bolt analysis. 3. The aEEG functionality included in Cadwell Bolt is intended to monitor the state of the brain. 4. Cadwell Bolt can provide notifications, based on user-defined thresholds, for quantitative EEG measures such as a notification within the application software that can be used when processing a record during acquisition. Delays can occur between the beginning of an event and when the Bolt notification will be shown to a user. Cadwell Bolt notifications cannot be used as a substitute for real-time monitoring of the underlying EEG data by a trained expert. This device does not provide any diagnostic conclusion about the patient's condition to the user as part of its output. The software does not contain automated detection algorithms.

Source page: https://510kreport.com/device/K190760
Methodology: https://510kreport.com/methodology