The Polysmith Sleep System, Model NT17593 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 NT17593 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 NTT7593 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 NTT7593 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.

Device Description

The Polysmith Sleep System, Model NT17593 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study as described in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria (from BSM-9100A, K082785, implicitly for 'comparable results')	Reported Device Performance (Polysmith Sleep System, NTI7593)
QRS Detection
Sensitivity (Se) - MIT	Comparable to BSM-9100A	99.56%
Se - AHA	Comparable to BSM-9100A	99.56%
Se - NST	Comparable to BSM-9100A	98.10%
Predictivity (+P) - MIT	Comparable to BSM-9100A	99.67%
+P - AHA	Comparable to BSM-9100A	99.80%
+P - NST	Comparable to BSM-9100A	84.78%
Ventricular Ectopic Beat
Se - MIT	Comparable to BSM-9100A	91.85%
Se - AHA	Comparable to BSM-9100A	85.46%
Se - NST	Comparable to BSM-9100A	88.28%
+P - MIT	Comparable to BSM-9100A	96.94%
+P - AHA	Comparable to BSM-9100A	98.18%
+P - NST	Comparable to BSM-9100A	90.94%
False Positive Rate (FPR)	Comparable to BSM-9100A	0.220% (MIT), 0.163% (AHA), 0.881% (NST)
Arrhythmia Detection (Episode)
Bigeminy Se	Comparable to BSM-9100A	90%
Bigeminy +P	Comparable to BSM-9100A	91%
Trigeminy Se	Comparable to BSM-9100A	87%
Trigeminy +P	Comparable to BSM-9100A	64%
R-on-T Se	Comparable to BSM-9100A	68.17%
R-on-T +P	Comparable to BSM-9100A	65.54%
R-on-T FPR	Comparable to BSM-9100A	0.267%
Asystole Se	Comparable to BSM-9100A	100%
Asystole +P	Comparable to BSM-9100A	100%
Idioventricular Rhythm Se	Comparable to BSM-9100A	50%
Idioventricular Rhythm +P	Comparable to BSM-9100A	100%
Accelerated Idioventricular Rhythm Se	Comparable to BSM-9100A	62%
Accelerated Idioventricular Rhythm +P	Comparable to BSM-9100A	57%
Ventricular Fibrillation E Se	Comparable to BSM-9100A	94%
Ventricular Fibrillation E +P	Comparable to BSM-9100A	88%
V-Tach E Se	Comparable to BSM-9100A	100%
V-Tach E +P	Comparable to BSM-9100A	86%
S-V-Tach E Se	Comparable to BSM-9100A	77%
S-V-Tach E +P	Comparable to BSM-9100A	18%
Pause E Se	Comparable to BSM-9100A	100%
Pause E +P	Comparable to BSM-9100A	92%
Couplet E Se	Comparable to BSM-9100A	83%
Couplet E +P	Comparable to BSM-9100A	96%
Atrial Fibrillation E Se	Comparable to BSM-9100A	91%
Atrial Fibrillation E +P	Comparable to BSM-9100A	47%
Short Run PVC E Se	Comparable to BSM-9100A	78%
Short Run PVC E +P	Comparable to BSM-9100A	95%
Long Run PVC E Se	Comparable to BSM-9100A	39%
Long Run PVC E +P	Comparable to BSM-9100A	94%

(Note: The document states the new device is "comparable" to the BSM-9100A, which includes the "same algorithm." It does not explicitly list the acceptance criteria values for the BSM-9100A, but rather assumes that comparable performance to a device with a more critical intended use is sufficient.)

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated as a number of patients or recordings. The document refers to the use of standard databases:
- MIT: The Massachusetts Institute of Technology–Beth Israel Hospital Arrhythmia Database
- AHA: The American Heart Association Database for Evaluation of Ventricular Arrhythmia Detectors
- NST: The Noise Stress Test Database
Data Provenance: The databases (MIT, AHA, NST) are widely recognized cardiological datasets. The document does not specify their country of origin for this particular study, nor whether the data was retrospective or prospective. Given they are established historical databases, they are inherently retrospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not explicitly stated in the provided text. The databases (MIT, AHA, NST) are widely recognized and have ground truths established by clinical experts during their creation. However, the document does not detail how this specific study confirmed ground truth for its testing or the number/qualifications of experts involved in the original ground truth creation of these databases.

4. Adjudication method for the test set:

Not explicitly stated. Given the use of established databases, the ground truth annotations within these databases would have been created through expert consensus or established protocols, but the specific adjudication method for this particular study is not detailed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted or described. The study focuses solely on the standalone performance of the algorithm against reference databases.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, a standalone algorithm-only performance evaluation was conducted. The tables provided show the "Polysmith Sleep System, NTI7593 (NEW)" performance metrics (Sensitivity, Predictivity, FPR) directly against the reference databases, without any mention of human-in-the-loop interaction. The document states: "The arrhythmia analysis results are to be reviewed by a qualified clinician and are not to serve as results for direct diagnosis or treatment of arrhythmia conditions. The arrhythmia analysis function is only to provide indicators for further investigation," which further reinforces its standalone, assistive role.

7. The type of ground truth used:

The ground truth used is based on expert consensus annotations embedded within the standard, publicly available databases:
- MIT: The Massachusetts Institute of Technology–Beth Beth Israel Hospital Arrhythmia Database
- AHA: The American Heart Association Database for Evaluation of Ventricular Arrhythmia Detectors
- NST: The Noise Stress Test Database

8. The sample size for the training set:

Not explicitly stated. The document indicates that the "newly integrated algorithm is the same algorithm implemented in the reference device, BSM-9100A (K082785)," implying this algorithm was likely trained or developed previously, possibly using portions of these or other similar databases. However, the training set size specific to this submission for the Polysmith device is not provided.

9. How the ground truth for the training set was established:

Not explicitly stated for this submission. Since the algorithm is adopted from the BSM-9100A, the ground truth for its original training would have been established during the development of that device or the algorithm itself, likely through expert annotation of ECG recordings, similar to how the ground truth for the testing databases was established. The document doesn't provide details on the development of this algorithm's ground truth.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem featuring three stylized human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 19, 2017

Neurotronics, Inc. David Pezet Quality Manager 3600 NW 43rd Street, STE F1 Gainesville, Florida 32606

Re: K161650

Trade/Device Name: Polysmith Sleep System, Model NTI7593 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLV, DQA, MLO, OLZ Dated: December 20, 2016 Received: December 21, 2016

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, listing 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

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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.

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" (21 CFR 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,

Michael J. Hoffmann -S

for

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161650

Device Name Polysmith Sleep System, Model NTI7593

Indications for Use (Describe)

The Polysmith Sleep System, Model NT17593 is intended for use on both adults and children only under the direction of a physician or qualified sleep technician.

an alarm or alarm system:
· an apnea monitor or apnea monitoring system; or
· a life monitor or life monitoring system.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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Image /page/3/Picture/0 description: The image shows the logo for Neurotronics, a Nihon Kohden Company. The logo features a blue circle with a white line running through it, resembling a heartbeat. To the right of the circle is the word "Neurotronics" in blue, and below that is the text "A Nihon Kohden Company".

K161650 510(k) Summary

Summary Date:

January 19, 2017

510(k) Submitter:

Neurotronics, Inc.3600 NW 43rd Street, Suite F1Gainesville, FL, 32606	Phone:	352.372.9955
PRIMARY CONTACT:	Fax:	815.550.2871

Name:	David Pezet	Title:	Quality Manager
Email:	quality@neurotronics.com	Phone:	352.372.9955 Ext 355

Common Name:

Polysomnography Monitoring System

Trade Name:

Polysmith Sleep System, Model NTI7593

510(k) Review Panel:

Neurology

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Image /page/4/Picture/0 description: The image contains the logo for Neurotronics, a Nihon Kohden Company. The logo features a blue circle with a white line running through it, resembling a heartbeat. To the right of the circle is the company name, "Neurotronics," in a blue sans-serif font. Below the company name is the text "A Nihon Kohden Company" in a smaller font size.

Classification:

PRIMARY PRODUCT CODE

ProductCode	Device	RegulationDescription	RegulationNumber
OLV	Standard Polysomnograph WithElectroencephalograph	Electroencephalograph	882.1400

Subsequent Product Codes:

ProductCode	Device	RegulationDescription	RegulationNumber
OLZ	Automatic Event Detection Software ForPolysomnograph WithElectroencephalograph	Electroencephalograph	882.1400
DQA	Oximeter	Oximeter	870.2700
MLO	Electrocardiograph, Ambulatory, WithAnalysis Algorithm	Medical magnetic taperecorder	870.2800

PREDICATE DEVICE

Submitter/Holder	Device Name	Model	Product Codes	510(K) Number
Neurotronics, Inc.	Polysmith Sleep System	NTI6600	OLV, DQA, OLZ	K142774

REFERENCE DEVICE

Submitter/Holder	Device Name	Model	Product Code	510(K)Number
Nihon Kohden Corp.	Nihon KohdenBedside Monitor	BSM 9100ASeries	MHX	K082785

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Image /page/5/Picture/0 description: The image contains the logo for Neurotronics, which is a company. The logo features a blue circle with a white line running through it, resembling a heartbeat. The text "Neurotronics" is written in blue next to the circle, and below that, it says "A Nihon Kohden Company".

Device Description

The following description of The Polysmith Sleep System, Model NTI7593 remains unchanged from the previous model Polysmith Sleep System, Model NTI6600.

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/7 description: The image is a block diagram of a polysomnography sleep system. The diagram shows the patient area, which includes the patient, speaker/mic (optional), and patient sensors. The patient sensors are connected to an amplifier, which is also connected to the speaker/mic and external auxiliary devices (optional). The amplifier is connected to a PC, which is also connected to the audio/video (optional), sleep clinician, and USB DC box (optional).

Polysmith Sleep System Basic Block Diagram

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Image /page/6/Picture/0 description: The image is a logo for Neurotronics, a Nihon Kohden Company. The logo features a blue circle with a white line that resembles a heartbeat. To the right of the circle is the word "Neurotronics" in blue, and below that is the text "A Nihon Kohden Company".

Intended 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 realtime 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 NT17593, 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
life monitor or life monitoring system. ●

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Image /page/7/Picture/0 description: The image shows the logo for Neurotronics, a Nihon Kohden Company. The logo features a blue circle with a white line running through it, resembling a heartbeat. To the right of the circle is the company name, "Neurotronics", in blue text, and below that is the text "A Nihon Kohden Company".

Predicate Comparison

INTENDED USE COMPARISON

The Polysmith Sleep System, Model NTI7593 improves upon the original model's current capabilities of data analysis for arrhythmia related events. These improvements do not change the indications for use for the devices which it is an accessory. This device continues to be intended to aid in diagnosis of sleep disorders, and other related disorders, as arrhythmia events are identified as related disorders by the American Academy of Sleep Medicine. The change clarifies the functionality of the arrhythmia detection feature and that the feature is not intended for life monitoring of high-risk patients.

Polysmith Sleep System, NTI7593 (NEW)	Polysmith Sleep System, NTI6600 (K142774)
The Polysmith Sleep System, Model NTI7593 is intended tomeasure, amplify, and record physiological signals acquiredfrom a patient for archival in a sleep study. Thephysiological signals are recorded and conditioned foranalysis and display. The data may be analyzed in real-timeor offline on dedicated polysomnography software runningon a personal computer by a qualified sleep clinician to aidin the diagnosis of Sleep Disorders.	The device is intended to measure, amplify, andrecord physiological signals acquired from a patientfor archival in a sleep study. The physiologicalsignals are recorded and conditioned for analysis anddisplay. The data may be analyzed in real-time oroffline on dedicated polysomnography softwarerunning on a personal computer by a qualified sleepclinician to aid in the diagnosis of sleep disorders.
The Polysmith Sleep System, Model NTI7593 is intendedfor use by healthcare professionals within a hospital,laboratory, clinic, or nursing home; or outside of a medicalfacility under direct supervision of a medical professional.	The device is intended for use by healthcareprofessionals within a hospital, laboratory, clinic, ornursing home; or outside of a medical facility underdirect supervision of a medical professional.
The Polysmith Sleep System, Model NTI7593 is intendedfor use on both adults and children only under the directionof a physician or qualified sleep technician.	The device is intended for use on both adults andchildren only under the direction of a physician orqualified sleep technician.
The Polysmith Sleep System, Model NTI7593 includesautomatic detection of some arrhythmias (including somepotentially life threatening arrhythmias), however detectionof an arrhythmia may be performed with 30 seconds or	The device, or any accessory, does not includealarms, and is not intended to be used as a criticalcomponent of an alarm system.
more delay, and is based on a single ECG lead only.	The device, or any accessory, is not to be used alone
The Polysmith Sleep System, Model NTI7593, or anyaccessory, is not intended for the life monitoring of high risk	as an apnea monitor or as a component in an apnea
patients, does not include or trigger alarms, and is notintended to be used alone as, or a critical component of,	monitoring system.
an alarm or alarm system;an apnea monitor or apnea monitoring system; orlife monitor or life monitoring system.	The device, or any accessory, is not to be used aloneas a life support device or as a critical component ofa life support system.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATES

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Image /page/8/Picture/0 description: The image contains the logo for Neurotronics, a Nihon Kohden Company. The logo features a blue circle with a white waveform inside, followed by the company name "Neurotronics" in blue, sans-serif font. Below the company name, the text "A Nihon Kohden Company" is written in a smaller, sans-serif font, underlined by a curved line.

The Polysmith Sleep System, Model NT17593 includes and improves upon the same feature set as found in the predicate software. Therefore, Neurotronics believes the Polysmith Sleep System, Model NT17593 is substantially equivalent to the Polysmith Sleep System, Model NTI6600 (K142774), and the arrhythmia analysis performance of the reference device, BSM 9100A Series Nihon Kohden Bedside Monitor (K082785).

Software Technical Comparison

Software Technical Comparison	Polysmith SleepSystem, NTI7593Polysmith(NEW)	Polysmith SleepSystem, NTI6600Polysmith(K142774)
Display electrical activity of the brain and otherphysiological signals on a monitor	Yes	Yes
Device uses Windows on a 32-bit or 64-bitcomputer	32-bit & 64-bit	32-bit & 64-bit
Display waveforms in acquisition and review	Yes	Yes
Maximum number of waveforms on screen	32	32
Simultaneously view waveforms from multipleEEG/PSG instruments and display values fromexternal instruments	On-line & Off-line	On-line & Off-line
Variable waveform display duration	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
The device can record and measure vital signs(including ECG, EMG, Respiration, OcularMotility, SpO2, and CO2)	On-line & Off-line	On-line & Off-line
Nihon Kohden Amplifiers Compatibility	Yes	Yes
Lifelines Trackit Series Amplifiers Compatibility	Yes	Yes
USB DC Box Compatibility	Yes	Yes
Sleep Stage Analysis	On-line & Off-line	On-line & Off-line
Arrhythmia Analysis	On-line & Off-line	Off-line(integrated K012686)
Respiratory Event Analysis	On-line & Off-line	On-line & Off-line
SpO2 Desaturation Analysis	On-line & Off-line	On-line & Off-line
Limb Movement Event Analysis	On-line & Off-line	On-line & Off-line
Snore Event Analysis	On-line & Off-line	On-line & Off-line
FFT Analysis	Off-line	Off-line
Manual Event Scoring	On-line & Off-line	On-line & Off-line
Manual Custom Event Scoring	On-line & Off-line	On-line & Off-line
Trend Plots	On-line & Off-line	On-line & Off-line
Display patient video along with waveforms	On-line & Off-line	On-line & Off-line
Record Patient Audio and Video	Yes	Yes
Software Technical Comparison	Polysmith SleepSystem, NTI7593Polysmith(NEW)	Polysmith SleepSystem, NTI6600Polysmith(K142774)
Integrated Intercom Interface	Yes(with PMU710)	Yes(with PMU710)
For use by medical personnel in a medical facility,physician's office, laboratory, clinic, or nursinghome	Yes	Yes
Any patient population including adults andchildren as determined by a trained professional	Yes	Yes
Patient Database and Scheduling	Yes	Yes
Reporting and Custom Report Capabilities	Yes	Yes
HL7 Interface Capabilities	Yes	Yes
Remote Access Capabilities	On-line & Off-line	On-line & Off-line
Display Resolution	>=1600 x 1200	>=1600 x 1200
File Format	XDF (XML), EDF	XDF (XML), EDF
File Management	Yes	Yes

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Image /page/9/Picture/0 description: The image shows the logo for Neurotronics, a Nihon Kohden Company. The logo consists of a blue circle with a white line running through it, resembling a heartbeat. To the right of the circle is the word "Neurotronics" in blue, and below that is the text "A Nihon Kohden Company".

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Image /page/10/Picture/0 description: The image shows the logo for Neurotronics. The logo consists of a blue circle with a white line running through it, resembling a heartbeat. To the right of the circle is the company name, "Neurotronics," in blue font.

A Nihon Kohden Company

Software Technical Comparison	Polysmith SleepSystem, NT17593Polysmith(NEW)	Polysmith SleepSystem, NTI6600Polysmith(K142774)
Compatible Amplifiers for Recording	Neurotronics Sphinx PMU710 (K142774)	Neurotronics Sphinx PMU710 (K142774)
	Neurotronics Sphinx PMU700 (K062943)	Neurotronics Sphinx PMU700 (K062943)
	Neurotronics Nomad PMU800 (K092699)	Neurotronics Nomad PMU800 (K092699)
	Nihon Kohden PSG-1100 (K120888)	Nihon Kohden PSG-1100 (K120888)
	Nihon Kohden EEG-1200a Amplifiers (K113117, K080546)	Nihon Kohden EEG-1200a Amplifiers (K113117, K080546)
	Nihon Kohden Wireless Input Unit, Model WEE-1000a Series (K033475)	Nihon Kohden Wireless Input Unit, Model WEE-1000a Series (K033475)
	Nihon Kohden Electrode Junction Box, Model JE-921a (K050833)	Nihon Kohden Electrode Junction Box, Model JE-921a (K050833)
	Nihon Kohden PSG Input Box, Model JE-912ak (K022121)	Nihon Kohden PSG Input Box, Model JE-912ak (K022121)
	Nihon Kohden Neurofax, Models EEG-1100a, EEG-9100a (K011204, K992742)	Nihon Kohden Neurofax, Models EEG-1100a, EEG-9100a (K011204, K992742)
	Lifelines Trackit Series amplifiers (K010460)	Lifelines Trackit Series amplifiers (K010460)

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Image /page/11/Picture/0 description: The image shows the logo for Neurotronics, a Nihon Kohden Company. The logo features a blue circle with a white line running through it, resembling a heartbeat. To the right of the circle is the company name, "Neurotronics," in blue text. Below the company name is the text "A Nihon Kohden Company" in a smaller font size.

Arrhythmia Analysis Event Comparison

Events detected by the third-party holter analysis software used with Polysmith Sleep System model NTI6600 compared to the integrated algorithm used in the new Polysmith software in model NTI7593. The newly integrated algorithm is the same algorithm implemented in the reference device, BSM-9100A (K082785) for applicable event types. This software allows the subject device to perform real-time arrhythmia analysis (with a 30 second or more delay for the applicable event types listed below).

Analysis Events	PolysmithSleepSvstem,NTI6600(K142774)	PolysmithSleepSystem,NTI7593(NEW)	Nihon KohdenBedsideMonitorBSM-9100A(K082785)
Pause	Yes	Yes	Yes
Sinus Tachycardia	Yes	Yes	Yes
Extreme Tachycardia	No	No	Yes
Bradycardia	Yes	Yes	Yes
Extreme Bradycardia	No	No	Yes
Wide-Complex Tachycardia(Ventricular tachycardia)	Yes	Yes	Yes
Narrow-Complex Tachycardia(Supraventricular tachycardia)	Yes	Yes	Yes
Atrial Fibrillation (Irregular R-R)	No	Yes	Yes
Asystole	Yes	Yes	Yes
PVC	Yes	Yes	Yes
Early PVC	Yes	Yes	Yes
PVC Run	No	No	Yes
Frequent PVC	No	No	Yes
Multiform PVC	No	No	Yes
IdioventricularRhythm (VentricularBradycardia)	No	Yes	Yes
Accelerated IdioventricularRhythm (Ventricular Rhythm)	No	Yes	Yes
Bigeminy	Yes	Yes	Yes
Trigeminy	No	Yes	Yes
Couplet	Yes	Yes	Yes
Ventricular Fibrillation	No	Yes	Yes

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Image /page/12/Picture/0 description: The image shows the logo for Neurotronics, which is a company of Nihon Kohden. The logo features a blue circle with a white line running through it, resembling a heartbeat. The text "Neurotronics" is written in blue next to the circle, and below that is the text "A Nihon Kohden Company".

Analysis Events	PolysmithSleepSystem,NTI6600(K142774)	PolysmithSleepSystem,NTI7593(NEW)	Nihon KohdenBedsideMonitorBSM-9100A(K082785)
Prolonged R-R	No	No	Yes
No Pacer Pulse	No	No	Yes
Pacer Non-Capture	No	No	Yes
ST Level	Yes	No	Yes
SupraVentricular Ectopic (SVE)	Yes	No	No

Non-Clinical Performance Data

APPLIED STANDARDS

The following applied standards are related to the integration of the arrhythmia analysis algorithm within the Polysmith software. All other applied standards from the previously registered Polysmith Sleep System, Model NTI6600 (K142774) remain unchanged.

StandardsNumber	StandardsOrganization	Standards Title
62304	AAMI ANSI IEC	Medical device software - Software life cycle processes
14971	AAMI ANSI ISO	Medical devices - Applications of risk management tomedical devices
62366	AAMI ANSI IEC	Medical devices - Application of usability engineering tomedical devices
EC57	AAMI ANSI	Testing And Reporting Performance Results of CardiacRhythm And St-Segment Measurement Algorithms.

PERFORMANCE RESULTS

Arrhythmia Analysis verification was performed in a manner consistent with the applicable portions of the AAMI ANSI EC57:2012, Testing and Reporting Performance Results of Cardiac Rhythm and St-Segment Measurement Algorithms standard.

The arrhythmia analysis results are to be reviewed by a qualified clinician and are not to serve as results for direct diagnosis or treatment of arrhythmia conditions. The arrhythmia analysis function is only to provide indicators for further investigation.

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Image /page/13/Picture/0 description: The image shows the logo for Neurotronics, a Nihon Kohden Company. The logo features a blue circle with a white waveform inside, followed by the word "Neurotronics" in blue. Below the word is a blue line and the text "A Nihon Kohden Company".

QRS & VPC Detection Performance

		Polysmith Sleep System, NTI7593(NEW)
		MIT	AHA	NST
QRS	Se	99.56%	99.56%	98.10%
	+P	99.67%	99.80%	84.78%
Ventricular Ectopic Beat	Se	91.85%	85.46%	88.28%
	+P	96.94%	98.18%	90.94%
	FPR	0.220%	0.163%	0.881%

MIT: The Massachusetts Institute of Technology–Beth Israel Hospital Arrhythmia Database AHA: The American Heart Association Database for Evaluation of Ventricular Arrhythmia Detectors NST: The Noise Stress Test Database +P: Predictivity Se: Sensitivity FPR: False Positive Rate

Arrhythmia Detection Statistical Summary

		Polysmith Sleep System,NTI7593(NEW)
Bigeminy	E Se	90%
	E +P	91%
Trigeminy	E Se	87%
	E +P	64%
R-on-T	Se	68.17%
	+P	65.54%
	FPR	0.267%
Asystole	E Se	100%
		Polysmith Sleep System,NTI7593(NEW)
	E +P	100%
Idioventricular Rhythm	E Se	50%
	E +P	100%
Accelerated Idioventricular Rhythm	E Se	62%
	E +P	57%
	E Se	94%
Ventricular Fibrillation	E +P	88%
	D Se	83%
	D +P	94%
Ventricular Tachycardia	E Se	100%
	E +P	86%
Supraventricular Tachycardia	E Se	77%
	E +P	18%
Pause	E Se	100%
	E +P	92%
Couplet	E Se	83%
	E +P	96%
	Avg E Se	62.00%
	Avg E +P	70.00%
Atrial Fibrillation	E Se	91%
		Polysmith Sleep System,NTI7593(NEW)
	E +P	47%
		D Se	75%
		D +P	57%
		NST E Se	-
		NST E +P	0%
		NST D Se	-
		NST D +P	0%
Short Run Premature Ventricular Contraction(PVC)1		E Se	78%
		E +P	95%
		Avg E Se	60%
		Avg E +P	80%
Long Run Premature Ventricular Contraction(PVC)1		E Se	39%
		E +P	94%
		Avg E Se	71%
		Avg E +P	91%
1 PVC Runs are not displayed or reported in Polysmith Software.
E: EpisodeD: Duration+P: Predictivity, the fraction of detections that are eventsSe: Sensitivity, the fraction of events that are detectedAvg: AverageNST: Noise Stress Test Database

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Image /page/14/Picture/0 description: The image shows the logo for Neurotronics, a Nihon Kohden Company. The logo consists of a blue circle with a white line running through it, resembling a heartbeat. To the right of the circle is the word "Neurotronics" in blue, and below that is the text "A Nihon Kohden Company".

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Image /page/15/Picture/0 description: The image shows the logo for Neurotronics, a Nihon Kohden Company. The logo consists of a blue circle with a white line running through it, resembling a heartbeat. To the right of the circle is the word "Neurotronics" in blue, and below that is the text "A Nihon Kohden Company".

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Image /page/16/Picture/0 description: The image contains the logo for Neurotronics, a Nihon Kohden Company. The logo features a blue circle with a white line running through it, resembling a heartbeat. To the right of the circle is the word "Neurotronics" in blue, with the text "A Nihon Kohden Company" underneath.

Results Discussion

Testing shows that the arrhythmia detection results are comparable to the already registered reference device, BSM 9100A Series Nihon Kohden Bedside Monitor (K082785), which includes the same algorithm. Since the BSM-9100A is much more critical in nature, comparable results are considered acceptable for the scope and intended use of the Polysmith software.

Conclusion

Based on the results of the Intended Use Comparison, the Technical Comparison, and Testing Data, it is believed that the Polysmith Sleep System, Model NT17593 presents no new questions of safety and effectiveness and, is substantially equivalent to the features provided by the identified predicate.

Regulation Number and Section

§ 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).