Who is the manufacturer of Polysmith Sleep System?

Neurotronics, Inc. filed the 510(k) submission for Polysmith Sleep System (K142774).

What is the FDA product code for Polysmith Sleep System?

OLV. It is classified under 21 CFR 882.1400 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Polysmith Sleep System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Polysmith Sleep System?

Polysmith Sleep System NTI5498 (K062943); PSG-1100 Sleep Diagnostic System (K120888).

Who can help prepare an FDA 510(k) submission like Polysmith Sleep System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Polysmith Sleep System

K142774 · Neurotronics, Inc. · OLV · Feb 18, 2015 · Neurology

Device Facts

Record ID	K142774
Device Name	Polysmith Sleep System
Applicant	Neurotronics, Inc.
Product Code	OLV · Neurology
Decision Date	Feb 18, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1400
Device Class	Class 2
Attributes	Pediatric

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.

Device Story

Polysmith Sleep System (NTI6600) records/amplifies physiological signals (EEG, ECG, EMG, respiration, SpO2, CO2, ocular motility) for sleep studies. System includes amplifier, head box, PC, sensors, and optional audio/video inputs. Used in hospitals, clinics, or supervised home settings by clinicians/technicians. Software processes data for real-time or offline display/scoring. Automated analysis algorithms assist in identifying sleep stages, arousals, apneas, hypopneas, desaturations, and limb movements. Clinicians review waveforms and automated scores to diagnose sleep disorders. Benefits include standardized data acquisition, efficient scoring, and diagnostic support.

Clinical Evidence

Bench testing and performance validation. Automated analysis algorithm evaluated against human expert scoring using 8,053 epochs (initial study) and 20 sleep studies (secondary study). Performance metrics: Sleep Staging (71.53% agreement), Microarousal (80.15%), Apnea (97.28%), Hypopnea (95.44%), Desaturation (95.72%), Limb Movement (92.57%). Secondary study showed 70.35% total agreement with human consensus (kappa 0.58).

Technological Characteristics

System includes amplifier, head box, PC, and sensors. 16-bit A-D conversion; 1000 Hz sampling. Input impedance >= 10 M Ohm; CMRR >= 90 dB. Connectivity via Ethernet. Software supports Windows (32/64-bit). Standards: AAMI/ANSI/IEC 62304, 62366, 60601-1, 60601-1-2, 60601-2-26; AAMI/ANSI/ISO 14971.

Indications for Use

Indicated for adults and children requiring polysomnography (PSG) or sleep studies to aid in the diagnosis of sleep disorders. Used by healthcare professionals in clinical settings or under professional supervision. Contraindicated for use as a standalone apnea monitor, life support device, or critical alarm system component.

Regulatory Classification

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.

Predicate Devices

Polysmith Sleep System NTI5498 (K062943)
PSG-1100 Sleep Diagnostic System (K120888)

Related Devices

K161650 — Polysmith Sleep System, Model NTI7593 · Neurotronics, Inc. · Jan 19, 2017
K955841 — SLEEP SYSTEM FOR CLINICS & RESEARCH · Compumedics Ptd , Ltd. · Mar 11, 1997
K253668 — Onera SleepMap (SLEEPMAP) · Onera B.V. · Mar 8, 2026
K062943 — POLYSMITH SLEEP SYSTEM, MODEL NTI5498 · Neurotronics, Inc. · May 9, 2007
K971803 — NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101 · Neurotronics, Inc. · Nov 12, 1997

Submission Summary (Full Text)

{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 | < 2 µV p-p (0.1 to 60 Hz) | < 2 uV p-p (0.53 to 60 Hz) | < 1.5 uV p-p (0.53 to 60Hz) | | | Hardware Frequency Response | .072 Hz to 300 Hz | 0.1 Hz to 100 Hz | 0.08 to 300 Hz | | | Software High-pass Filter | .072 Hz DC Standard | .1 Hz DC Standard | 0.08 to 53 Hz DC Standard | | | Software Low-pass Filter | 15 Hz to 300 Hz | 15 Hz to 100 Hz | 15 to 300 Hz | | | AC Filter | 50 or 60 Hz | 50 or 60 Hz | 50 or 60 Hz | | | Sensitivity | Off, 0.1 to 200 uV/mm (20 steps) DC: Off, 10 to 200 mV/mm (10 steps) | Off, 0.1 to 200 uV/mm (20 steps) DC: Off, 10 to 200 mV/mm (10 steps) | Off, 0.1 to 200 uV/mm (20 steps) DC: Off, 10 to 200 mV/mm (10 steps) | | | A-D Conversion | 16 bits | 16 bits | 16 bits | | | Sampling | 1000 Hz | 1000 Hz | All Channels 200, 250, 500, 1000, 2000 Hz | | | Power | Mains | USB | 100-240 V +/- 10% 50 / 60 Hz 42 VA (Main Unit only) | | | PC Connection | Ethernet | USB…