(145 days)
Yes
The document explicitly mentions "automated analysis" and describes performance studies comparing this automated analysis to human scoring for various sleep events and stages. This strongly suggests the use of an algorithm, likely AI/ML, to perform these analyses. The description of training and test sets, although the training set is stated as not being used for the described testing, further supports the presence of an automated analysis algorithm.
No
The device is described as measuring, amplifying, and recording physiological signals for diagnosis, not for treatment or therapy. It aids in the diagnosis of Sleep Disorders by collecting data for analysis by a clinician, which is a diagnostic function, not a therapeutic one.
Yes
The device aids in the diagnosis of Sleep Disorders by recording and analyzing physiological signals for review by a qualified sleep clinician.
No
The device description explicitly states that the system consists of hardware components including a compatible amplifier, head box, PC, patient sensors, and optional external devices. While software is a key part of the system, it is not the sole component.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The intended use and device description clearly state that this device measures, amplifies, and records physiological signals acquired from a patient. These are signals like brain waves, muscle activity, heart rate, etc., which are measured on the body, not from a sample taken from the body (like blood, urine, or tissue).
- The purpose is to aid in the diagnosis of Sleep Disorders based on these physiological signals. The analysis is performed on the recorded physiological data, not on a biological sample.
The device is a Polysomnography (PSG) system, which is a type of medical device used to monitor and record various physiological parameters during sleep to diagnose sleep disorders. These systems are classified as medical devices, but not specifically as IVDs.
No
The letter does not explicitly state that the FDA has reviewed, approved, or cleared a PCCP for this specific device.
Intended Use / Indications for Use
The device is intended to measure, amplify, and record physiological signals acquired from a patient for archival in a sleep study. The physiological signals 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 device 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 device is intended for use on both adults and children only under the direction of a physician or qualified sleep technician.
The device or any accessory, does not include alarms, and is not intended to be used as a critical component of an alarm system.
The device or any accessory, is not to be used alone as an apnea monitor or as a component in an apnea monitoring system.
The device or any accessory, is not to be used alone as a life support device or as a critical component of a life support system.
Product codes (comma separated list FDA assigned to the subject device)
OLZ, OLV, DQA
Device Description
The Polysmith Sleep System, Model NTI6600 is intended to amplify and record physiologic potentials used for Polysomnography (PSG) or Sleep Studies. The device consists of a compatible amplifier, head box, PC, patient sensors, and may include optional external devices, USB DC Box, and audio/video input devices.
Compatible amplifiers may use commercially available sensors and electrodes, an internal SpO2 module, and internal pressure transducers to collect, digitize, and send physiological signals to the host PC.
The Polysmith software may record from video, speaker and microphone equipment. The Polysmith software may also record auxiliary signals from compatible amplifiers or USB DC Box which allow for data inputs from compatible sources.
Polysmith records and displays the data for online or offline review. Qualified practitioners use the information to score Polysomnograms and diagnose Sleep Disorders.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The device is intended for use on both adults and children
Intended User / Care Setting
healthcare professionals within a hospital, laboratory, clinic, or nursing home; or outside of a medical facility under direct supervision of a medical professional.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Our data included analysis of 8,053 recorded epochs, of which 7,606 were scored. These studies were chosen at random from existing sleep studies of acceptable signal quality from accredited labs.
The human scoring was completed by two expert scorers from different organizations. Each expert is a registered sleep clinician with at least 5 years' experience scoring sleep records.
The studies used for this testing were not used to train the algorithm. The experts were not affiliated with the development of the algorithm. Furthermore, these studies were chosen at random from a sleep lab independent of Neurotronics.
Scorers were instructed to make a copy of the ten test records to a separate folder before testing. This is to ensure the file settings do not change between test runs. Scorers were instructed to score the studies using the default Polysmith scoring settings using AASM scoring rules. Scorers were instructed to not change any file settings including the montage.
Additionally, twenty sleep studies were procured from at least three different sources. Each study was manually scored by three independent scorers. Each scorer was a registered sleep specialist with at least five years' experience in the field. Each scorer has had some prior experience using Polysmith to manually score studies. The manual scoring was compared against the automated scoring to determine the accuracy of the analysis algorithm.
Each scorer was given a collection of files that contain the 20 studies along with a copy of Polysmith. This copy of Polysmith had the capability to score but did not have any automated analysis capability. Each scorer was instructed to manually score each study for sleep stage, arousal, desaturation, and airflow events including apnea, and hypopnea, and to only use the copy of Polysmith provided. The studies were scored blind to all other scorers including the Polysmith automated scoring. Scorers were instructed to only follow AASM guidelines for scoring all events. All files were configured with a minimal montage. Scorers were instructed to, as much as possible, use this montage without alteration.
Scorers were instructed that some files are split-night studies. For these studies. scorers were instructed to use the CPAP Flow channel for scoring Hypopnea and Flow Limitation after CPAP start.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Automated Analysis and Additional Sleep Staging Analysis
Sample Size:
Automated Analysis: 8,053 recorded epochs, 7,606 scored. (10 studies based on Gender/BMI/Age/AHI table)
Additional Sleep Staging Analysis: 20 sleep studies, 18,657 total epochs, 17,556 total consensus epochs (2/3 majority-rule), 1,101 non-consensus epochs.
Key Results (Automated Analysis):
- Consistent with the AASM Inter-Scorer Reliability program, the percentage of agreement is calculated by True Positives (Agreements) divided by the total number of epochs compared. The overall results are as follows:
- Sleep Staging: Average Human Scoring Agreement 82.8%, Average Automated Analysis Agreement 71.53%, Confidence Interval +/- (95.0%) 3.04%
- Microarousal: Average Human Scoring Agreement 88.8%, Average Automated Analysis Agreement 80.15%, Confidence Interval +/- (95.0%) 3.98%
- Apnea: Average Human Scoring Agreement 98.7%, Average Automated Analysis Agreement 97.28%, Confidence Interval +/- (95.0%) 1.32%
- Hypopnea: Average Human Scoring Agreement 96.4%, Average Automated Analysis Agreement 95.44%, Confidence Interval +/- (95.0%) 2.55%
- Desaturation: Average Human Scoring Agreement 97.1%, Average Automated Analysis Agreement 95.72%, Confidence Interval +/- (95.0%) 1.32%
- Limb Movement: Average Human Scoring Agreement 98.9%, Average Automated Analysis Agreement 92.57%, Confidence Interval +/- (95.0%) 4.35%
Key Results (Additional Sleep Staging Analysis):
- Results comparing automated scoring to human consensus (2/3 majority-rule):
- W (Wake): Positive 67.75%, Negative 92.12%
- N1 (NREM Stage 1): Positive 36.50%, Negative 92.62%
- N2 (NREM Stage 2): Positive 79.65%, Negative 90.39%
- N3 (NREM Stage 3): Positive 92.43%, Negative 99.65%
- R (REM): Positive 63.24%, Negative 95.58%
- Total Agreement: 70.35%
- Kappa: 0.58 (kappa Lower Bound 0.57, k Upper Bound 0.59)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Automated Analysis:
- Sleep Staging: Average Automated Analysis Agreement 71.53%
- Microarousal: Average Automated Analysis Agreement 80.15%
- Apnea: Average Automated Analysis Agreement 97.28%
- Hypopnea: Average Automated Analysis Agreement 95.44%
- Desaturation: Average Automated Analysis Agreement 95.72%
- Limb Movement: Average Automated Analysis Agreement 92.57%
Additional Sleep Staging Analysis:
- Positive Predictive Value (Positive):
- W: 67.75%
- N1: 36.50%
- N2: 79.65%
- N3: 92.43%
- R: 63.24%
- Negative Predictive Value (Negative):
- W: 92.12%
- N1: 92.62%
- N2: 90.39%
- N3: 99.65%
- R: 95.58%
- Overall Agreement: 70.35%
- Kappa: 0.58
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K012686, K092699, K113117, K080546, K033475, K050833, K022121, K011204, K992742, K010460
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines connecting them, representing the department's focus on health and human well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 18, 2015
Neurotronics, Inc. David Pezet Quality Manager 3600 NW 43td Street, Suite F1 Gainesville, FL 32606
Re: K142774
Trade/Device Name: Polysmith Sleep System NTI6600 Regulatory Class: II Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Product Code: OLZ, OLV, DQA Dated: January 12, 2015 Received: January 13, 2015
Dear Mr. Pezet:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aquel -S
Carlos L. Peña, Ph.D., M.S. for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K142774
Device Name Polysmith Sleep System, Model NTI6600
Indications for Use (Describe)
The device is intended to measure, amplify, and record physiological signals acquired from a patient for archival in a sleep study. The physiological signals 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 device 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 device is intended for use on both adults and children only under the direction of a physician or qualified sleep technician.
The device or any accessory, does not include alarms, and is not intended to be used as a critical component of an alarm system.
The device or any accessory, is not to be used alone as an apnea monitor or as a component in an apnea monitoring system.
The device or any accessory, is not to be used alone as a life support device or as a critical component of a life support system.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
510(k) Summary
SUMMARY DATE:
February 18, 2015
510K SUBMITTER:
| Neurotronics, Inc. | Phone: | 352.372.9955 | |
|---|---|---|---|
| 3600 NW 43rd Street, Suite FL | |||
| Gainesville, FL, 32606 | Fax: | 815.550.2871 | |
| Primary Contact: | |||
| Name: | David Pezet | Title: | Quality Manager |
| Email: | quality@neurotronics.com | Phone: | 352.372.9955 Ext 355 |
| Establishment Registration Number: | |||
| 1063925 |
DEVICE TYPE (COMMON NAME):
Polysomnography Monitoring System
PROPRIETARY NAME OF THE DEVICE:
Polysmith Sleep System, Model NTI6600
4
CLASSIFICATION:
Product Code:
| Product
Code | Device | Regulation
Description | Regulation
Number |
|-----------------|----------------------------------------------------------------------------------------|---------------------------|----------------------|
| OLZ | Automatic Event Detection Software
For Polysomnograph With
Electroencephalograph | Electroencephalograph. | 882.1400 |
Subsequent Product Code:
| Product
Code | Device | Regulation
Description | Regulation
Number |
|-----------------|-------------------------------------------------------|---------------------------|----------------------|
| OLV | Standard Polysomnograph With
Electroencephalograph | Electroencephalograph. | 882.1400 |
| DQA | Oximeter | Oximeter. | 870.2700 |
PREDICATE DEVICES
| Submitter/Holder | Device Name | Model | Product Codes | 510(K) |
|---|---|---|---|---|
| Neurotronics, Inc. | Polysmith Sleep | |||
| System | NTI5498 | OLZ, DQA, OLV | K062943 | |
| Nihon Kohden Corp. | PSG-1100 Sleep | |||
| Diagnostic System | PSG-1100 | GWQ, OLV | K120888 |
5
DESCRIPTION
The Polysmith Sleep System, Model NTI6600 is intended to amplify and record physiologic potentials used for Polysomnography (PSG) or Sleep Studies. The device consists of a compatible amplifier, head box, PC, patient sensors, and may include optional external devices, USB DC Box, and audio/video input devices.
Compatible amplifiers may use commercially available sensors and electrodes, an internal SpO2 module, and internal pressure transducers to collect, digitize, and send physiological signals to the host PC.
The Polysmith software may record from video, speaker and microphone equipment. The Polysmith software may also record auxiliary signals from compatible amplifiers or USB DC Box which allow for data inputs from compatible sources.
Polysmith records and displays the data for online or offline review. Qualified practitioners use the information to score Polysomnograms and diagnose Sleep Disorders.
Image /page/5/Figure/5 description: This image is a block diagram of a patient monitoring system. The diagram shows the different components of the system, including patient sensors, an amplifier, a PC, and optional audio/video equipment. The patient sensors are connected to the amplifier, which is connected to the PC. The PC is also connected to the audio/video equipment and a USB DC box.
1 Polysmith Sleep System Basic Block Diagram
6
INTENDED USE
The device 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 device 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 device is intended for use on both adults and children only under the direction of a physician or qualified sleep technician.
The device, or any accessory, does not include alarms, and is not intended to be used as a critical component of an alarm system.
The device, or any accessory, is not to be used alone as an apnea monitor or as a component in an apnea monitoring system.
The device, or any accessory, is not to be used alone as a life support device or as a critical component of a life support system.
7
PREDICATE COMPARISON
Intended Use Comparison
The Polysmith Sleep System, Model NTI6600 improves upon the predicates' current capabilities access and review of on-line or previously recorded acquisitions. These improvements do not change the indications for use for the devices which it is an accessory. This device is intended to aid in diagnosis of sleep disorders, and other related disorders.
Technical Comparison
The Polysmith Sleep System. Model NTI6600 includes and improves upon the same feature set as found in the predicates. Therefore Neurotronics believes the Polysmith Sleep System, Model NTI6600 is substantially equivalent to the Polysmith Sleep System, Model NTI5498 (K062943), and PSG-1100 Sleep Diagnostic System (K120888).
| Software Technical
Comparison | Polysmith Sleep
System,
NTI6600
Polysmith
(NEW) | Polysmith Sleep
System,
NTI5498
Polysmith
(K062943) | PSG-1100
(K120888) | |
|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Display electrical activity of
the brain and other
physiological signals on a
monitor | Yes | Yes | Yes | |
| Device uses Windows on a
32-bit or 64-bit computer | 32-bit & 64-bit | 32-bit | 32-bit & 64-bit | |
| Display waveforms in
acquisition and review | Yes | Yes | Yes | |
| Maximum number of
waveforms on screen | 32 | 32 | 32 | |
| Simultaneously view
waveforms from multiple
EEG/PSG instruments and
display values from
external instruments | On-line & Off-line | On-line & Off-line | On-line & Off-line | |
| Variable waveform display
duration | On-line & Off-line | On-line & Off-line | On-line & Off-line | |
| Change waveform
parameters (pattern,
montage, amplifier
conditions, AV induction) | On-line & Off-line | On-line & Off-line | On-line & Off-line | |
| The device can record and
measure vital signs
(including ECG, EMG, | On-line & Off-line | On-line & Off-line | On-line & Off-line | |
| Software Technical
Comparison | Polysmith Sleep
System,
NTI6600
Polysmith
(NEW) | Polysmith Sleep
System,
NTI5498
Polysmith
(K062943) | PSG-1100
(K120888) | |
| Respiration, Ocular
Motility, SpO2, and CO2) | | | | |
| Nihon Kohden Amplifiers
Compatibility | Yes | Yes | Yes | |
| Lifelines Trackit Series
Amplifiers Compatibility | Yes | Yes | Yes | |
| USB DC Box Compatibility | Yes | Yes | Yes | |
| Sleep Stage Analysis | On-line & Off-line | On-line & Off-
line | On-line & Off-
line | |
| Arrhythmia Analysis | Off-line
(integrated
K012686) | Off-line
(integrated
K012686) | Off-line
(integrated
K012686) | |
| Respiratory Event Analysis | On-line & Off-line | On-line & Off-
line | On-line & Off-
line | |
| SpO2 Desaturation Analysis | On-line & Off-line | On-line & Off-
line | On-line & Off-
line | |
| Limb Movement Event
Analysis | On-line & Off-line | On-line & Off-
line | On-line & Off-
line | |
| Snore Event Analysis | On-line & Off-line | On-line & Off-
line | On-line & Off-
line | |
| FFT Analysis | Off-line | Off-line | Off-line | |
| Manual Event Scoring | On-line & Off-line | On-line & Off-
line | On-line & Off-
line | |
| Manual Custom Event
Scoring | On-line & Off-line | On-line & Off-
line | On-line & Off-
line | |
| Trend Plots | On-line & Off-line | On-line & Off-
line | On-line & Off-
line | |
| Display patient video along
with waveforms | On-line & Off-line | On-line & Off-
line | On-line & Off-
line | |
| Record Patient Audio and
Video | Yes | Yes | Yes | |
| Integrated Intercom
Interface | Yes
(with PMU710) | No | No | |
| For use by medical
personnel in a medical
facility, physician's office,
laboratory, clinic, or
nursing home | Yes | Yes | Yes | |
| Software Technical
Comparison | Polysmith Sleep
System,
NTI6600
Polysmith
(NEW) | Polysmith Sleep
System,
NTI5498
Polysmith
(K062943) | PSG-1100
(K120888) | |
| Any patient population
including adults and
children as determined by
a trained professional | Yes
Yes
Yes | | | |
| Patient Database and
Scheduling | Yes | Yes | Yes | |
| Reporting and Custom
Report Capabilities | Yes | Yes | Yes | |
| HL7 Interface Capabilities | Yes | Yes | Yes | |
| Remote Access Capabilities | On-line & Off-line | On-line & Off-
line | On-line & Off-
line | |
| Display Resolution | >=1600 x 1200 | >=1600 x 1200 | >=1600 x 1200 | |
| File Format | XDF (XML), EDF | XDF (XML),
EDF | XDF (XML),
EDF | |
| File Management | Yes | Yes | Yes | |
| Compatible Amplifiers for
Recording | · Neurotronics
Sphinx
PMU710
(NEW)
Neurotronics
●
Sphinx
PMU700
(K062943)
Neurotronics
Nomad
PMU800
(K092699)
Nihon Kohden
●
PSG-1100
(K120888)
Nihon Kohden
●
EEG-1200a
Amplifiers
(K113117,
K080546)
Nihon Kohden
Wireless Input
Unit, Model
WEE-1000a | Neurotronics
●
Sphinx
PMU700
(K062943)
Nihon Kohden
●
Wireless Input
Unit, Model
WEE-1000a
Series
(K033475)
Nihon Kohden
Electrode
Junction Box,
Model JE-921a
(K050833)
Nihon Kohden
●
PSG Input
Box, Model
JE-912ak
(K022121)
Nihon Kohden
●
Neurofax,
Models EEG-
1100a, EEG-
9100a | Neurotronics
Sphinx
PMU700
(K062943)
Neurotronics
●
Nomad
PMU800
(K092699)
Nihon Kohden
PSG-1100
(K120888)
Nihon Kohden
EEG-1200a
Amplifiers
(K113117,
K080546)
Nihon Kohden
●
Wireless Input
Unit. Model
WEE-1000a
Series
(K033475)
Nihon Kohden
●
Electrode
Junction Box, | |
| Software Technical
Comparison | Polysmith Sleep
System,
NTI6600
Polysmith
(NEW) | Polysmith Sleep
System,
NTI5498
Polysmith
(K062943) | PSG-1100
(K120888) | |
| | Series
(K033475)
• Nihon Kohden
Electrode
Junction Box,
Model JE-921a
(K050833)
• Nihon Kohden
PSG Input Box,
Model JE-
912ak
(K022121)
• Nihon Kohden
Neurofax,
Models EEG-
1100a, EEG-
9100a
(K011204,
K992742)
• Lifelines
Trackit Series
amplifiers
(K010460) | (K011204,
K992742)
• Lifelines
Trackit Series
amplifiers
(K010460) | Model JE-921a
(K050833)
• Nihon Kohden
PSG Input
Box, Model
JE-912ak
(K022121)
• Nihon Kohden
Neurofax,
Models EEG-
1100a, EEG-
9100a
(K011204,
K992742)
• Lifelines
Trackit Series
amplifiers
(K010460) | |
| Amplifier Technical
Comparison | Polysmith Sleep
System, NTI6600
Sphinx PMU710
(NEW) | Polysmith Sleep
System, NTI5498
Sphinx PMU700
(K062943) | PSG-1100
(K120888) | |
| Number of Channels | 23 | 33 | 42 | |
| Pulse Oximeter | Integrated Nihon
Kohden Oximeter
Module | Integrated Nonin
Oximeter Module | Integrated Nihon Kohden
Oximeter Module | |
| Input Impedance | >= 10 M Ohm | >= 10 M Ohm | 100 M ohm | |
| Calibration Check | Step square 50uV | Step square 50uV | Step square 50uV | |
| Impedance Check | Yes | Yes | Yes | |
| Common-Mode Rejection Ratio
(CMRR) | >= 90 dB | >= 90 dB | >= 105 dB | |
| Noise Level |