Polysmith Sleep System, Model NTI7593

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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 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 NT17593 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. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="padding-right: 5px;"> <div style="display: inline-block; vertical-align: middle;"> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.6 2.4L5.6 10.4L2.4 7.2L0 9.6L5.6 15.2L16 4L13.6 2.4Z" fill="black"></path> </svg> </div> Prescription Use (Part 21 CFR 801 Subpart D)</span> | | <span style="padding-right: 5px;"> <div style="display: inline-block; vertical-align: middle;"> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> </svg> </div> Over-The-Counter Use (21 CFR 801 Subpart C)</span> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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.<br>3600 NW 43rd Street, Suite F1<br>Gainesville, 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 {4}------------------------------------------------ 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 | Product<br>Code | Device | Regulation<br>Description | Regulation<br>Number | |-----------------|-------------------------------------------------------|---------------------------|----------------------| | OLV | Standard Polysomnograph With<br>Electroencephalograph | Electroencephalograph | 882.1400 | ## Subsequent Product Codes: | Product<br>Code | Device | Regulation<br>Description | Regulation<br>Number | |-----------------|----------------------------------------------------------------------------------------|-----------------------------------|----------------------| | OLZ | Automatic Event Detection Software For<br>Polysomnograph With<br>Electroencephalograph | Electroencephalograph | 882.1400 | | DQA | Oximeter | Oximeter | 870.2700 | | MLO | Electrocardiograph, Ambulatory, With<br>Analysis Algorithm | Medical magnetic tape<br>recorder | 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)<br>Number | |--------------------|---------------------------------|---------------------|--------------|------------------| | Nihon Kohden Corp. | Nihon Kohden<br>Bedside Monitor | BSM 9100A<br>Series | MHX | K082785 | {5}------------------------------------------------ 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. 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. 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 {6}------------------------------------------------ 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. ● {7}------------------------------------------------ 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 to<br>measure, amplify, and record physiological signals acquired<br>from a patient for archival in a sleep study. The<br>physiological signals are recorded and conditioned for<br>analysis and display. The data may be analyzed in real-time<br>or offline on dedicated polysomnography software running<br>on a personal computer by a qualified sleep clinician to aid<br>in the diagnosis of Sleep Disorders. | The device is intended to measure, amplify, and<br>record physiological signals acquired from a patient<br>for archival in a sleep study. The physiological<br>signals are recorded and conditioned for analysis and<br>display. The data may be analyzed in real-time or<br>offline on dedicated polysomnography software<br>running on a personal computer by a qualified sleep<br>clinician to aid in the diagnosis of sleep disorders. | | The Polysmith Sleep System, Model NTI7593 is intended<br>for use by healthcare professionals within a hospital,<br>laboratory, clinic, or nursing home; or outside of a medical<br>facility under direct supervision of a medical professional. | The device is intended for use by healthcare<br>professionals within a hospital, laboratory, clinic, or<br>nursing home; or outside of a medical facility under<br>direct supervision of a medical professional. | | The Polysmith Sleep System, Model NTI7593 is intended<br>for use on both adults and children only under the direction<br>of a physician or qualified sleep technician. | The device is intended for use on both adults and<br>children only under the direction of a physician or<br>qualified sleep technician. | | The Polysmith Sleep System, Model NTI7593 includes<br>automatic detection of some arrhythmias (including some<br>potentially life threatening arrhythmias), however detection<br>of an arrhythmia may be performed with 30 seconds or | The device, or any accessory, does not include<br>alarms, and is not intended to be used as a critical<br>component 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 any<br>accessory, 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 not<br>intended 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 alone<br>as a life support device or as a critical component of<br>a life support system. | #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATES {8}------------------------------------------------ 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 Sleep<br>System, NTI7593<br>Polysmith<br>(NEW) | Polysmith Sleep<br>System, NTI6600<br>Polysmith<br>(K142774) | |-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|--------------------------------------------------------------| | Display electrical activity of the brain and other<br>physiological signals on a monitor | Yes | Yes | | Device uses Windows on a 32-bit or 64-bit<br>computer | 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 multiple<br>EEG/PSG instruments and display values from<br>external 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,<br>amplifier conditions, AV induction) | On-line & Off-line | On-line & Off-line | | The device can record and measure vital signs<br>(including ECG, EMG, Respiration, Ocular<br>Motility, 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<br>(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 Sleep<br>System, NTI7593<br>Polysmith<br>(NEW) | Polysmith Sleep<br>System, NTI6600<br>Polysmith<br>(K142774) | | Integrated Intercom Interface | Yes<br>(with PMU710) | Yes<br>(with PMU710) | | For use by medical personnel in a medical facility,<br>physician's office, laboratory, clinic, or nursing<br>home | Yes | Yes | | Any patient population including adults and<br>children 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 | {9}------------------------------------------------ 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". {10}------------------------------------------------ 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 Sleep<br>System, NT17593<br>Polysmith<br>(NEW) | Polysmith Sleep<br>System, NTI6600<br>Polysmith<br>(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) | {11}------------------------------------------------ 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 | Polysmith<br>Sleep<br>Svstem,<br>NTI6600<br>(K142774) | Polysmith<br>Sleep<br>System,<br>NTI7593<br>(NEW) | Nihon Kohden<br>Bedside<br>Monitor<br>BSM-9100A<br>(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<br>(Ventricular tachycardia) | Yes | Yes | Yes | | Narrow-Complex Tachycardia<br>(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 | | Idioventricular<br>Rhythm (Ventricular<br>Bradycardia) | No | Yes | Yes | | Accelerated Idioventricular<br>Rhythm (Ventricular Rhythm) | No | Yes | Yes | | Bigeminy | Yes | Yes | Yes | | Trigeminy | No | Yes | Yes | | Couplet | Yes | Yes | Yes | | Ventricular Fibrillation | No | Yes | Yes | {12}------------------------------------------------ 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 | Polysmith<br>Sleep<br>System,<br>NTI6600<br>(K142774) | Polysmith<br>Sleep<br>System,<br>NTI7593<br>(NEW) | Nihon Kohden<br>Bedside<br>Monitor<br>BSM-9100A<br>(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. | Standards<br>Number | Standards<br>Organization | Standards Title | |---------------------|---------------------------|-------------------------------------------------------------------------------------------------------| | 62304 | AAMI ANSI IEC | Medical device software - Software life cycle processes | | 14971 | AAMI ANSI ISO | Medical devices - Applications of risk management to<br>medical devices | | 62366 | AAMI ANSI IEC | Medical devices - Application of usability engineering to<br>medical devices | | EC57 | AAMI ANSI | Testing And Reporting Performance Results of Cardiac<br>Rhythm 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. {13}------------------------------------------------ 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<br>(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,<br>NTI7593<br>(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,<br>NTI7593<br>(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,<br>NTI7593<br>(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<br>(PVC)1 | | E Se | 78% | | | | E +P | 95% | | | | Avg E Se | 60% | | | | Avg E +P | 80% | | Long Run Premature Ventricular Contraction<br>(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: Episode<br>D: Duration<br>+P: Predictivity, the fraction of detections that are events<br>Se: Sensitivity, the fraction of events that are detected<br>Avg: Average<br>NST: Noise Stress Test Database | | | | {14}------------------------------------------------ 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". {15}------------------------------------------------ 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". {16}------------------------------------------------ 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.