# K161650: Polysmith Sleep System, Model NTI7593

- Pathway: 510(k) (Traditional)
- Applicant: Neurotronics, Inc.
- Decided: Jan 19, 2017 after 218 days
- Product code: OLV (Standard Polysomnograph With Electroencephalograph)
- 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: 7 generations back to K915494 (1993). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142774: Polysmith Sleep System, Neurotronics, Inc. (2015) Summary page 5.

## Indications for use
The Polysmith Sleep System, Model NTI7593 is intended to measure, amplify, and record physiological signals acquired from a patient for archival in a sleep study. The physiological signals are recorded and conditioned for analysis and display. The data may be analyzed in real-time or offline on dedicated polysomnography software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of Sleep Disorders. The Polysmith Sleep System, Model NTI7593 is intended for use by healthcare professionals within a hospital, laboratory, clinic, or nursing home; or outside of a medical facility under direct supervision of a medical professional. The Polysmith Sleep System, Model NTI7593 is intended for use on both adults and children only under the direction of a physician or qualified sleep technician. The Polysmith Sleep System, Model NTI7593 includes automatic detection of some arrhythmias (including some potentially life threatening arrhythmias), however detection of an arrhythmia may be performed with 30 seconds or more delay, and is based on a single ECG lead only. The Polysmith Sleep System, Model NTI7593, or any accessory, is not intended for the life monitoring of high risk patients, does not include or trigger alarms, and is not intended to be used alone as, or a critical component of, • an alarm or alarm system; • an apnea monitor or apnea monitoring system; or • a life monitor or life monitoring system.

Source page: https://510kreport.com/device/K161650
Methodology: https://510kreport.com/methodology